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“Wine, Cheese and a Dash of Poison in the Forehead”:
Exploring the Evolution of the Injectable Filler Industry and the Consequent
Implications for Regulatory Action
Angela Esther Kim
Class of 2006
Food and Drug Law
3L Paper
Professor Peter Barton Hutt
May 19, 2006
Abstract: Although the American pursuit of youth and beauty has long influenced
female consumers, the recent introduction of injectable fillers has overwhelmed the country’s
current capacity to regulate. Millions of American women annually receive a plethora of
injections – some approved, some off-label, and others wholly unapproved. This paper
examines the new challenges the Food and Drug Administration must confront as consumer
obsession skyrockets, and manufacturers and physicians engage in questionable activity to meet
the rising demand. The public’s increasingly casual attitude toward FDA approval of cosmetic
uses has endangered an industry enamored, at all costs, with the pursuit of wrinkle-free, ageless
beauty. This danger is compounded by the Internet’s creation of unprecedented marketing
channels for manufacturers to inundate consumers with misleading information and sidestep
FDA prohibitions. Through case studies of the four injectable fillers Botox, silicone, Radiesse
and ArteFill, this paper addresses the obstacles the FDA must confront to adjust to a changing
frontier.
INTRODUCTION............................................................................................................. 2
PART I. Exploring the Consumer’s Pursuit of Youth and Beauty .............................. 5
PART II. Exploring the FDA’s Regulatory Role ........................................................... 9
A. Pre-Market Approval ............................................................................................ 10
B. Off-Label Use .......................................................................................................... 11
C. Marketing ............................................................................................................... 14
PART III. Case Studies .................................................................................................. 15
A. Botox........................................................................................................................ 15
1. Early History: Botulism ....................................................................................... 15
2. Responding to the Crisis through Warnings and Education ............................. 16
3. Modern Uses of clostridium bacterium ............................................................. 18
4. Off-Label Use: e.g., “Botox Parties”................................................................... 19
5. The FDA’s Role in the Botox Phenomenon ....................................................... 23
B. Liquid Silicone Injections ...................................................................................... 25
1. The History of Silicone ........................................................................................ 25
2. “Pump Parties” .................................................................................................... 29
C. Interlude.................................................................................................................. 33
1. The Information Game: Analyzing the Growth of an Evolving Industry ......... 33
2. … Blame it on the Patient: the Shifting Role between Patient and Doctor ...... 34
3. The Information Game and the Modern Consumer’s Access ........................... 35
D. Radiance.................................................................................................................. 37
1. Manufacturer Marketing ..................................................................................... 37
2. Physician Marketing ............................................................................................ 40
3. The FDA’s Approach to Off-Label Marketing ................................................... 44
E. ArteFill .................................................................................................................... 47
1. Conflicting Accounts of Incidences of Granuloma ............................................ 49
2. Accusations of Illegal Use and a Cover-Up Scam .............................................. 52
CONCLUSION ............................................................................................................... 54
INTRODUCTION
“My original plan was to age like one of those fantastic French women--Juliette Binoche, Isabelle Adjani,
Catherine Deneuve. But I waited in vain as my inner radiance refused to take over. Where lines and dark
circles made those women look interesting, I just looked tired. So of course I was intrigued when I heard
about a new procedure that could inject freshness and life into my face with less time and effort than a visit
to the hairdresser. This supposedly miraculous treatment isn't available in the U.S., but I happened to know
one of the doctors doing it in London…”1
1
Ann Marie Gardner, Beyond Botox: Imagine Looking Younger in an Instant, with No Surgery and No Side Effects,
HARPER’S BAZAAR, Apr. 1, 2002.
… and so begins another article, in another fashion magazine, read by another
intelligent, successful (yet unfailingly insecure) female consumer. She peers in the mirror to
examine her frown lines, her smile lines, her crows’ feet… all lines that she has memorized,
traced with her fingers, and wished away innumerable times before. But this time, she will be
brave… she will accept the role that hundreds, thousands, millions of women have assumed
before her; she will visit a dermatologist, a cosmetic surgeon, or maybe even just a Botox party,
and inject one of a plethora of fillers available to her today.
While the pursuit of youth and beauty has both encouraged scientific research and
tortured female consumers for ages, the cultural obsession with injectable fillers has
overwhelmed the fields of cosmetic surgery and dermatology in recent years. Botox was the first
to lure the American public with its promise of wrinkle relaxation; numerous other fillers – both
approved and unapproved – have subsequently flooded the marketplace.
Charged with the responsibility of regulating medical devices, the Food and Drug
Administration (“FDA”) assumes a frontline role in addressing the host of questions that
accompany this rapidly expanding industry of cosmetic fillers. Even so, illegal uses are rampant
and destructive, as black market fillers rage across the country, causing severe disfigurement and
multiple fatalities.
While illegal fillers continue to ravage lives and communities, equally difficult questions
require the FDA’s attention to the shades of gray – the potentially illegal marketing and
dangerous use of legal devices. For example, with the rise of the Internet, manufacturers have
discovered numerous methods to sidestep FDA regulations on advertising and promotion. These
tactics render virtually obsolete the agency’s power to police the marketing of cosmetic off-label
uses of devices. The FDA must acknowledge this evolution while refusing complicity with the
status quo, and must adjust to accommodate the changing times that come with changing
technology.
This paper seeks to illustrate the challenges confronting the FDA through case studies of
four distinct devices and the types of harms accompanying them. The first study analyzes the
transformation of Botox, derived from the toxin clostridium botulinum, otherwise known as “the
world’s most poisonous poison.” Years of laboratory research have transformed the bacteria
once responsible for fatal food poisoning into the much-desired fountain of youth. Once
approved to treat uncontrollable blinking and misaligned eyes, Botox found fame in its off label
use to reduce wrinkles. Upon approval, the floodgates opened – “Botox parties” and “Black
market Botox” emerged as significant threats to consumer safety.
While Botox was approved for cosmetic use merely four years ago, avid consumers today
have become unsatisfied with this basic, almost pedestrian, treatment. The second case study
examines liquid silicone injections, a permanent alternative for facial contouring. Despite a long
existence, silicone injections have gained massive popularity in recent years with silicone “pump
parties” that combine the most dangerous features of Botox parties and Black market Botox.
Cosmetic silicone injections currently constitute an off-label use, and rampant inappropriateness
surrounding its application serves as a fierce warning to an administration seeking to protect the
health and safety of consumers.
Impossible to ignore in an analysis of this filler craze is the paramount role of
technological progress. The Internet creates unparalleled channels of communication between
manufacturers and consumers, and consequently, unlimited opportunities for marketing. While
the FDA prohibits the marketing of a device’s off-label uses to consumers, manufacturers easily
transgress ethical and legal lines via the Internet. Physicians, too, reap benefits from this
medium, as they market devices to consumers with misleading language. Exemplifying this
phenomenon is the third case study, of the synthetic filler Radiesse. It is approved for
oral/maxillofacial defects, vocal fold insufficiency and radiographic tissue marking, but it is used
cosmetically as a contouring filler.
Lastly, this paper concludes with a case study of ArteFill, a device of Canadian origin
expected to receive FDA approval for U.S. use in the near future. The potential for consumer
harms is potentially more egregious, as Canadian physicians question the veracity and intentions
of the manufacturer’s safety and health claims. For example, the device’s co-founder allegedly
used the device illegally, disfigured a patient, and then attempted to exclude the results from
clinical studies. This unfortunate incident illustrates the extent to which manufacturers
attempting to meet the demands of an extraordinarily zealous public can (and will) mislead
unsuspecting consumers in the process.
These case studies collectively illustrate an industry expanding at exponential rates,
striving daily to reach a seemingly unlimited profit potential. In the crossfire, quite literally, are
human faces, driven by the promise of youth and yet often blinded by their own vanity. With the
rapid expansion of this industry and the pivotal changes introduced by technology, the FDA must
embrace flexibility and adjust to confront the issues ushered in by this evolving frontier.
PART I. Exploring the Consumer’s Pursuit of Youth and Beauty
While the obsession with the newest injectable filler from other continents may be a
modern development, the cultish pursuit of female beauty and youth is anything but. No matter
how advanced or how primitive, every culture has engaged in the pursuit of the “perfect” female
form. “Since Plato, feminine beauty has been idealized as representing moral or spiritual
qualities.”2 The “fair damsel” of medieval chivalry and the “female nude” during the
Renaissance embody the divinity and desirability associated with feminine beauty.3
Along with such idealizations come the hordes of hungry females, eager to adjust,
enhance and transform themselves at substantial cost The nineteenth century gave birth to
corsets, which caused “breathlessness, fainting spells, and shifting organs,”4 and the use of
arsenic-coated paper to brighten the face.5
Regardless of the extensive history of the woman’s plight to adjust to societal pressures,
the technology of today has ushered in a new era of transformation: “the twentieth century has
produced an even more constraining corset – the woman’s own skin.”6 In 2003, 2.8 million
women received Botox injections in the United States;7 in 2004, hundreds of thousands of
women received injection of other fillers, including collagen, hyaluronic acid or calcium
hydroxylapatite.8
Exploring the social, cultural, psychological causes “behind the craze”
Social scientists offer a plethora of reasons explaining this craze, this startling surge in
the popularity of cosmetic enhancements. In HOPE OR HYPE: THE OBSESSION WITH MEDICAL
ADVANCES AND THE HIGH COST OF FALSE PROMISES, Drs. Richard Deyo and Donald Patrick
attribute the sudden rise in popularity to the national obsession with technology: “We’re a
‘techniconsumptive’ culture. We’re pulled irresistibly to new technology, often without
2
KATHY DAVIS, RESHAPING THE FEMALE BODY: THE DILEMMA OF COSMETIC SURGERY 39 (1995).
Id. at 39.
4
Id. at 41.
5
See PETER MACINNIS, POISONS: FROM HEMLOCK TO BOTOX TO THE KILLER BEAN OF CALABAR 103 (2005).
6
DAVIS, supra note 2, at 41.
7
Massachusetts Plastic Surgery Network, Plastic Surgery Statistics, http://www.plastic-surgery.net/plastic-surgerystatistics.html (last visited May 18, 2006).
8
eBreastaug.com, ASAPS Statistics – Cosmetic Procedures, http://www.ebreastaug.com/breast-augmentation/asapsstatistics.html (last visited May 18, 2006).
3
recognizing the risks.”9 Further, he contends that “[m]any Americans have a sense of
entitlement – they feel that the latest medical advances are ‘owed’ to them.”10 This shared
mentality of seeking, desiring and “deserving” all that is newer, better and faster has created a
cultural phenomenon of a nation of avid consumers, eagerly devouring whatever filler claims
innovation and superiority.
In RESHAPING THE FEMALE BODY, Kathy Davis notes the allure of technology, but
focuses additionally on the market model of medicine and the burgeoning consumer culture:
“With the rise of medicine as a profession, medical cures and services become something which
could be obtained for a fee. In an open market system, the patient is a consumer, and like
consumers of other products, free to choose any treatment, provided it can be paid for.”11 As a
consequence, “[t]he body is no longer simply a dysfunctional object requiring medical
intervention, but a commodity – not unlike ‘a car, a refrigerator, a house- which can be
continuously upgraded and modified in accordance with new interests and greater resources.’ It
can be endlessly manipulated – reshaped, restyled, and reconstructed to meet prevailing fashions
and cultural values.”12 Combined with a narcissistic culture,13 this “disdain for material limits”
and “intoxication with change” has made the possibilities both “desirable and endless.”14
These cultural influences of technology and consumerism have likely provided the
groundwork for the increasing correlation that scholars note between the physical body and
emotional happiness. Davis highlights the influence of the media, noting magazine articles
describing women who just want “to feel a little better.” Through such portrayals, cosmetic
9
RICHARD A. DEYO & DONALD L. PATRICK, HOPE OR HYPE: THE OBSESSION WITH MEDICAL ADVANCES AND THE
HIGH COST OF FALSE PROMISES 13 (2005).
10
Id. at 17.
11
DAVIS, supra note 2, at 17.
12
Id.
13
Id. at 18.
14
Id. at 17.
enhancement “is presented as a relatively harmless way to improve appearance – an acceptable
path toward happiness and well-being.”15 Like Deyo and Patrick, Davis notes the integral role of
today’s cultural sense of entitlement; in today’s world of immediate gratification, people “expect
to be happy, to achieve a glamorous life style.”16
In CREATING BEAUTY TO CURE THE SOUL, Sander Gilman suggests a more direct link
between the increasing social acceptability of physical enhancement and the psyche: “The
decline of the stigma associated with aesthetic surgery is keyed to the change in the stigma
associated with mental illness. Both illnesses were socially unacceptable as they reflected the
pain and anguish of the ‘invisible’ psyche rather than the concrete body.”17 Cosmetic surgery, he
contends, has simply replaced psychotherapy as the popular means of seeking help for one’s
emotional disturbances: “the acquisition of an idealized or imagined body type or physiognomy
is a ‘cure’ for ‘unhappiness.’”18
This contention supports a novel understanding of the relationship between patient and
surgeon:
“On the one hand, the patient hands over responsibility for his or her happiness to the surgeon.
Rather than changing their bodies through diet or cosmetics or fashion, approaches that demand
choices be made on the part of the individual, an ever growing number of people are turning this
process over to those whom modern society empowers to deal with problems of physical and
mental health, the physicians. Individual autonomy (with all of the limits on choice set by the
world in which we live) seems to be replaced by the role of the dependent patient.”19
Though these scholars (Davis, Deyo and Patrick, and Gilman) identify unique causes
behind the sudden national obsession with cosmetic enhancement, they commonly identify the
same channels that made its cultivation possible: the media and the Internet. Deyo and Patrick
15
DAVIS, supra note 2, at 19.
Id. at 47.
17
SANDER L. GILMAN, CREATING BEAUTY TO CURE THE SOUL 11 (1998).
18
Id. at 24.
19
Id.
16
explain how the media has dramatically increased accessibility to information and marketing,
and has thus helped shape the pursuit of medical quick fixes:
“In a media age, innovations spread through mass marketing. The Internet also spreads news and
creates demand through list serves, web sites, chat rooms and spam. Health news is a common
topic for magazine articles and cocktail party conversation. What used to be sequestered in
grandma’s medical book or in a medical library is now all around us: on paper, the radio, the
Internet, and television.”20
In short, with mass marketing comes increased accessibility. Davis expands upon Deyo
and Patrick’s contention by commenting on how this accessibility is constructed as desirable to
the consumer: “the media constructs cosmetic surgery as an option which is not only available to
everyone, but which bears the promise of an exalted life – one can partake in what was formerly
available to the chosen few.21 Thus, with the introduction of the Internet, marketers not only
have access to the mass public, but individual consumers likewise gain access to a luxurious
world defined by choice rather than by need.
Even so, boundless consumer choice inevitably leads to consumer confusion and,
frequently, consumer harm. In this context, the Food and Drug Administration, in its regulatory
capacity, plays a pivotal role in protecting consumers from dangerous devices.
PART II. Exploring the FDA’s Regulatory Role
As a division of the Department of Health and Human Services, the FDA seeks to
“promote the public health by promptly and efficiently reviewing clinical research and taking
appropriate action on the marketing of regulated products in a timely manner.”22 The agency’s
20
DEYO & PATRICK, supra note 9, at 19.
DAVIS, supra note 2, at 20.
22
The Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, § 406(b)(1), 111 Stat. 2296
(codified at 21 U.S.C. §§ 301 et seq.).
21
mission includes the goal to “protect the public health by ensuring that there is reasonable
assurance of the safety and effectiveness of devices intended for human use.”23
A. Pre-Market Approval
New medical devices face different routes to FDA approval depending on their market
familiarity. A manufacturer can seek approval through the § 510(k) process by proving
“substantial equivalence” to a device in commercial distribution prior to the Medical Device
Amendments of 1976 (“MDA”) to the Food, Drug and Cosmetics Act. This process requires the
manufacturer to submit substantial premarket notifications including the device’s proposed
labeling, the similarities and differences in design to the prior device, and other information
useful for the FDA in determining substantial equivalence.24
Devices that cannot claim substantial equivalence must undergo the significantly more
arduous “Premarket Approval” process. The applicant must file an application that contains “all
information published or known to or which should reasonably be known to the applicant,
concerning investigations which have been made to show whether or not such device is safe and
effective;”25 “statement of the components, ingredients, and properties and of the principle of
operation, of such device;”26 and “the methods used in, and the facilities and controls used for,
the manufacture, processing, and when relevant, packing and installation of, such device.”27
This application must include technical sections summarizing non-clinical laboratory studies and
clinical investigations. The non-clinical laboratory studies section “includes information on
microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, and other
23
The Food and Drug Administration Modernization Act of 1997 § 406(b)(2).
The Food and Drug Administration Modernization Act of 1997 § 205.
25
21 U.S.C. § 360e(c)(1)(A) (2000).
26
21 U.S.C. § 360e(c)(1)(B) (2000).
27
21 U.S.C. § 360e(c)(1)(C) (2000).
24
laboratory animal tests.”28 Alternatively, the clinical investigations section “includes study
protocols, safety and effectiveness data, adverse reactions and complications, device failures and
replacements, patient information, patient complaints, tabulations of data from all individual
subjects, results of statistical analyses, and any other information from the clinical
investigations.”29 The purpose of submitting this information is to provide the FDA with
“reasonable assurance” of the safety and affectiveness of the device.30
After the applicant submits the above information, the FDA has 180 days to grant or deny
approval of the application. Throughout this process, “the Secretary shall rely on the conditions
of use included in the proposed labeling as the basis for determining whether or not there is a
reasonable assurance of safety and effectiveness, if the proposed label is neither false nor
misleading.”31
B. Off-Label Use
Though the FDA regulates the commercial distribution and marketing of medical devices,
it does not regulate the practice of medicine:
“As the law now stands, therefore, the Food and Drug Administration is charged with the
responsibility of judging the safety and effectiveness of drugs and the truthfulness of their
labeling. The physician is then responsible for making the final judgment as to which, if any, of
the available drugs his patient will receive in the light of the information contained in their
labeling and other adequate scientific data available to him.”32
Thus, physicians are granted tremendous discretion in using these devices according to an
arguably abstract standard of care. The FDA provides the following vague advice: “Good
28
Food and Drug Admin., Device Advice on Pre-Market Approvals, http://www.fda.gov/cdrh/devadvice/pma (last
visited May 18, 2006).
29
Id.
30
See id.
31
21 U.S.C. §360e(d)(1)(A) (2000).
32
Peter Barton Hutt & Richard A. Merrill, FOOD AND DRUG LAW: CASES AND MATERIALS 619 (2d ed. 1991).
medical practice and the best interests of the patient require that physicians use legally available
drugs, biologics and devices according to their best knowledge and judgment.”33
Consequently, many physicians choose to prescribe drugs and use medical devices in
manners not addressed by the approval process. This procedure is called “off-label use,” defined
by the FDA as “use for indication, dosage form, dose regimen, population or other use parameter
not mentioned in the approved labeling.”34 In such cases, the FDA asks that physicians “be well
informed about the product, … base its use on firm scientific rationale and on sound medical
evidence, and … maintain records of the product's use and effects.”35
Not only is off-label use considered relatively common practice, the FDA largely
condones the practice: In a 1982 issue of its Drug Bulletin, the FDA noted that
“The FD&C Act does not … limit the manner in which a physician may use an approved drug.
Once a product has been approved for marketing, a physician may prescribe it for uses or in
treatment regimens or patient populations that are not included in approved labeling.”36
In 1993, when faced with questions regarding the off-label use of bone screws, the FDA
reiterated in its Drug Bulletin its refusal to regulate off-label usage:
“[i]n practice, surgeons often use orthopedic screws which FDA has cleared for other purposes . . .
as pedicle screws. Such use of medical devices for nonapproved purposes has traditionally been
regulated by the hospitals in which the physicians practice and not by the FDA.”37
And in 1997, the FDA passed the Food and Drug Administration Modernization Act
(“FDAMA”), in which it repeated its refusal to interfere with the practice of medicine:
Food and Drug Admin., Guidance for Institutional Review Boards and Clinical Investigators 1988 Update: “OffLabel” and Investigational Use of Marketed Drugs, Biologics and Medical Devices,
http://www.fda.gov/oc/ohrt/irbs/offlabel.html (last visited May 18, 2006).
34
Id.
35
Id.
36
Food and Drug Admin., Use of Approved Drugs for Unlabeled Indications, 12 FDA DRUG BULLETIN 4 (April
1982).
37
James Beck & Elizabeth Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and
Misconceptions, 53 FOOD & DRUG L.J. 71, 77 (1998).
33
“Nothing in this Act shall be construed to limit or interfere with the authority of a health care
practitioner to prescribe or administer any legally marketed device to a patient for any condition or
disease within a legitimate health care practitioner-patient relationship. This section shall not limit
any existing authority of the Secretary to establish and enforce restrictions on the sale or
distribution, or in the labeling, of a device that are part of a determination of substantial
equivalence, established as a condition of approval, or promulgated through regulations. Further,
this section shall not change any existing prohibition on the promotion of unapproved uses of
legally marketed devices.”38
And currently the FDA notes on its website that “off-label use by prescribers is often appropriate
and may represent the standard of care.”39
Such off-label use is rampant: an estimated 25% to 60% of all prescriptions are for
unapproved uses.40 Studies show that 56% of cancer patients and 81% of AIDS patients have
used off-label drugs.41 Nearly all pediatric patients have received off-label prescriptions, and
antidepressants commonly treat the off-label uses of anxiety and alcoholism.42
Legally, off-label use has emerged relatively victorious in the courtroom:
“No court has held that a physician’s deviation from the officially approved labeling – whether
directions for use, warnings, contraindications, or statements of relative efficacy – is per se
negligence. The practitioner who departs from the manufacturer’s recommendations does not
necessarily incur liability for any untoward effects which flow from a drug.”43
38
21 U.S.C. § 396 (2000).
Janet Woodcock, Presentation at DIA Montreal: A Shift in the Regulatory Approach (June 23, 1997), available at
http://www.fda.gov/cder/present/diamontreal/regappr/sld005.htm (last visited May 18, 2006).
40
Beck & Azari, supra note 37, at 80.
41
Alexander T. Tabarrok, Assessing the FDA via the Anomaly of Off-Label Drug Prescribing, 5 THE INDEP. REV.
25, 26 (2000).
42
See id.
43
HUTT & MERRILL, supra note 32, at 630.
39
In Buckman Co. v. Plaintiffs’ Legal Comm., the Supreme Court noted that “‘off-label’
usage of medical devices … is an accepted and necessary corollary of the FDA’s mission to
regulate in this area without directly interfering with the practice of medicine.”44
At the same time, courts have not entirely liberated the physician to use or prescribe any
device or drug without limitation. For example, in Cabiroy v. Scipione, the Pennsylvania
Superior Court affirmed the trial court’s decision to grant a new trial upon finding error in jury
instructions declaring that the FDA lacked authority to regulate the practice of medicine.45
Scipione had injected liquid silicone implants not yet approved by the FDA to cosmetically
improve Cabiroy’s nasal deformity. Unfortunately, the silicone allegedly resulted in bumps in
Cabiroy’s nasal area. In reviewing the jury charge, the Pennsylvania Superior Court found
error, noting that “Doctors do not have sole and absolute discretion in treating their patients.”46
C. Marketing
Though doctors may use approved drugs in off-label uses; pharmaceutical manufacturers
have significantly less discretion in marketing. According to the Food, Drug and Cosmetic Act,
“a company must specify the intended uses of a product in its new drug application to the FDA.
Once approved, the drug may not be marketed or promoted for so-called ‘off-label’ uses--any
use not specified in an application and approved by the FDA.”47
With the FDAMA in 1997, the FDA’s marketing policy was amended to allow
pharmaceutical companies to disseminate information on off-label uses to physicians, while still
prohibiting them from marketing such uses to the public. Section 551 allows a manufacturer to
disseminate to “(1) a health care practitioner; (2) a pharmacy benefit manager; (3) a health
44
531 U.S. 341, 349 (2001).
See 767 A.2d 1078, 1083 (Pa. Super. Ct. 2001).
46
Id.
47
Food and Drug Admin., Drug Maker to Pay $430 Million Fines, Civil Damages, FDA CONSUMER MAGAZINE,
July-Aug. 2004, http://www.fda.gov/fdac/features/2004/404_wl.html.
45
insurance issuer; (4) a group health plan; or (5) a Federal or State governmental agency; written
information concerning the safety, effectiveness, or benefit of a use not described in the
approved labeling of a drug or device.”48 Sixty days before such dissemination, the
manufacturer must submit to the Secretary “(A) a copy of the information to be disseminated;
and any clinical trial information the manufacturer has relating to the safety or effectiveness of
the new use, (B) any reports of clinical experience pertinent to the safety of the new use, and a
summary of such information.”49
While the FDA has successfully applied its rules and regulations to protect the American
public for years, the following case studies outlined in Part III illustrate additional issues that
require regulatory attention. The studies demonstrate the insufficiency of the agency’s current
tools in effectively mitigating the problems raised by injectable fillers and the evolving
technology used to market them.
PART III. Case Studies
A. Botox
Within the world of non-surgical enhancement, one particular gateway to selfimprovement revolutionized the industry; Botox, once a secret of Hollywood celebrities, is now
accessible to housewives and movie stars alike. A pioneer of sorts, Botox laid the groundwork
for the hordes of injectable fillers available today.
1. Early History: Botulism
48
49
The Food and Drug Administration Modernization Act of 1997 § 551.
The Food and Drug Administration Modernization Act of 1997 § 551.
Clostridium botulinum, an anaerobic bacterium, produces a number of neurotoxins
universally regarded as the most potent of bacterial toxins.50 Though the molecular events
involved are not precisely known, “it appears that binding of the toxin is followed by a series of
events that result in blocking the calcium-dependent fusion of synaptic vesicles with the
presynaptic membrane and the subsequent release of acetylocholine.”51 The effect is paralysis,
“to kill nearby flesh, providing more oxygen-free living space for the bacteria.”52
Though botulism poisoning has likely infected humans since the beginning of time, the
early 18th century marked its first documentation, as outbreaks of “sausage poisoning” struck
Southern Germany.53 Similar outbreaks struck in the 19th and 20th centuries before scientists
discovered methods to inactivate clostridium botulinum spores. Though refined canning
techniques have since drastically reduced outbreaks, the Center for Disease Control reports that
approximately 110 cases of botulism poisoning are reported each year.54 Twenty-five percent of
those cases manifest as foodborne illness, usually a result of the improper canning of foods with
low acid content. Infant and wound botulism account for the remainder.55
2. Responding to the Crisis through Warnings and Education
Throughout the 1900s, canneries adjusted with relative swiftness to prevent further
outbreaks of botulism poisoning. However, the popularity of home-canning required substantial
community effort to educate the domestic population. A 1935 article in Scientific Monthly warns
50
DAVIS, supra note 2, at 161.
Id.
52
MACINNIS, supra note 5, at 101.
53
Center for Disease Control., Foodborne Botulism in the United states, 1990-2000, 10 EMERGING INFECTIOUS
DISEASES 1606 (Sep. 2004), available at
http://www.cdc.gov/foodborneoutbreaks/pulication/2004/j_sobelBot_US_EID2004pdf.pdf.
54
Center for Disease Control, Botulism, http://www.cdc.gov/ncidod/dbmd/diseaseinfo/botulism_g.htm (last visited
May 19, 2006).
55
Infant botulism results from the ingestion of clostridium bacterium spores, producing toxin in the intestinal tracts;
it affects infants under 12 months of age. Infant botulism is often contracted through exposure to soil, dust and
foods. Wound botulism results from the entry of clostridium bacterium into open wounds, and is often associated
with intravenous drug users. See Food and Drug Admin., Foodborne Pathogenic Microorganisms and Natural
Toxins Handbook: Clostridium botulinum, http://www.cfsan.fda.gov/~mow/chap2.html (last visited May 19, 2006).
51
households of the dangers of botulism poisoning (“It is probably the most dangerous of all”)56
and educates homemakers on proper canning techniques:
“There are certain rules that every housewife should observe in order to avoid botulism. All
home-canned, non-acid foods should be thoroughly boiled just before eating. This will destroy
any poison present. Canned products should always be opened by an adult familiar with their
normal appearance and odor. If there is the least trace of off-standard condition the product
should be ruthlessly destroyed and never fed to animals or fowls. If there is no pressure cooker
available in the home preserving of non-acid foods, it is safer to substitute drying, salting or
pickling for canning.”57
Despite these efforts to educate home-canners and commercial canneries, the food
industry did not remain immune to subsequent outbreak. In 1987, eight individuals suffered fatal
consequences from ingesting clostridium bacterium spores, and investigations traced the poison
to a dried white-fish, Kapchunka, produced in New York City. Despite sufficient levels of salt
that met safety requirements for canning, the Kapchunka products nevertheless housed the
deadly bacteria. As a result, the FDA issued a Class I Recall and prohibited the processing,
distribution and sale of any Kapchunka products in the United States.58
In 1989, three individuals in Kingston, New York, suffered from botulism poisoning after
ingesting a chopped garlic-in-oil bottled mix. As a result, the FDA prohibited companies from
creating any such mixture, and also issued extensive warning guidelines to the public:
“The Food and Drug Administration today warned that consumers may risk potentially fatal
botulism food poisoning from some commercial and homemade chopped garlic-and-oil mixes if
they are left at room temperature instead of refrigerated. The warning follows an investigation of
three hospitalizations in New York after use of such a product. … The labels of non-preserved
commercial products call for refrigeration, and FDA emphasized this means refrigeration from
56
K.F. Meyer, Prevention of Food Poisoning, 40 SCI. MONTHLY 546 (1935).
Id. at 565.
58
See Food and Drug Admin., Foodborne Pathogenic Microorganisms and Natural Toxins Handbook: Clostridium
botulinum, http://www.cfsan.fda.gov/~mow/chap2.html (last visited May 19, 2006).
57
manufacturing to consumption. In particular, garlic-and-oil mixes containing little or no acidifying
agent such as phosphoric or citric acid should be kept refrigerated at all times, FDA stressed.”59
3. Modern Uses of clostridium bacterium
Hoping to gain a better understanding of the toxin associated with food poisoning,
scientists began to study clostridium bacterium in the early 1900s. Soon thereafter, botulism
research shifted its focus to the bacterium’s injectability “because of the unique and specific
muscle paralysis induced by minute amounts of the toxins. During the past 30 years of work on
the use of the toxin for human treatment, selective procedures for the production, purification,
and dispensing of the toxin have been developed to make it suitable for injection.”60
In the 1960s, researchers discovered that upon extraction, precipitation, purification and
crystallization with ammonium sulfate, the toxin could safely be injected in ophthalmologic
treatments.61 In 1989, the FDA approved Botox to treat uncontrollable blinking (blepharospasm)
and misaligned eyes (strabismus).62 This much-awaited approval finally allowed Allergan to
announce: “More than 100 years of research have expanded our knowledge of botulinum toxin
type A from the identification of the bacterium Clostridium botulinum to the commercialization
of botulinum toxin type A as BOTOX®.”63
In 2000, the FDA further approved the usage of Botox in treating cervical dystonia, a
neurological movement disorder causing neck and shoulder contractions.64 During this process,
59
Id.
WebMD, Botulinum Toxin (BOTOX), http://www.emedicine.com/neuro/topic585.htm (last visited May 19,
2006).
61
See id.
62
Carol Lewis, Botox Cosmetic: A Look at Looking Good, FDA CONSUMER MAGAZINE, July-Aug. 2002,
http://www.fda.gov/fdac/features/2002/402_botox.html.
63
http://www.botox.com.
64
Lewis, supra note 62.
60
physicians at Columbia University witnessed a serendipitous side effect,65 that “Botox softened
the vertical frown (glabellar) lines between the eyebrows that tend to make people look tired,
angry or displeased.”66
4. Off-Label Use: e.g., “Botox Parties”
“The world’s worst poison is becoming US’ first wonder drug for facial beauty.”67
Upon such discovery, the movement that followed was largely expected, but arguably
farcical in its magnitude. In 1999, three years before Botox would receive FDA approval for
cosmetic purposes, Beverly Hills plastic surgeon Larry Koplin reported to CNN that nearly all of
his patients had received the treatment off-label.68 In explaining his philosophy, Koplin shared:
“I don't believe we are creating a generation of Dorian Grays, but rather than that, we're creating
the ability for people to look the way they feel.”69 It appears that Koplin referred to the age
rather than the emotions of his patients – as Botox paralyzes facial lines, inhibiting facial
expressions.
And even then, critics worried that
“the obsession with looks has gone too far. Sociologists say people don't need plastic surgery to
have their looks reflect how they feel. ‘If we were to change our values towards aging ... we might
find beauty in some of the characteristics we're trying to change,’ said Merrill Silverstein,
professor of gerontology at the University of Southern California. Perhaps then we could learn to
love our wrinkles instead of poisoning them.”70
65
Columbia University College of Physicians and Surgery, Botox Injections for Wrinkles,
http://www.entcolumbia.org/botox.htm (last visited May 19, 2006).
66
Lewis, supra note 62.
67
Meena Shah, Botulinum Toxin’s Off-Label Uses: Poison for Beauty, EXPRESS PHARMA PULSE, May 9, 2002,
http://www.expresspharmapulse.com/20020509/offbeat.shtml.
68
Siobahn Darrow, Botulin Derivative New Poor Man’s Face Lift, CNN.COM, July 1, 1999,
http://www.cnn.com/HEALTH/9907/01/botox.boom/.
69
Id.
70
Id.
Learn to love our wrinkles we did not, as over 1.6 million people received Botox
injections in 2001, according to the American Society for Aesthetic Plastic Surgery. 71
Consequently, the FDA approved the use of Botox injections for the reduction of wrinkles
between the brows in April, 2002, “satisfied by its review of studies indicating that Botox
reduced the severity of frown lines for up to 120 days.”72
Although rampant off-label use of Botox to treat wrinkles pre-dated its approval for
cosmetic purposes, “When the FDA recently approved Botox for cosmetic use, it opened the
floodgates on what's rapidly becoming a billion-dollar business.”73 Hotels in Las Vegas began
offering Botox spa weekends; radio hosts offered free injections as giveaway prizes at the local
mall.74 And most interestingly, those floodgates burst open in convivial form, giving rise to a
phenomenon known as “Botox Parties”: “No matter where you live, all you need is a little
curiosity to snag an invitation to a Botox party, where there is plenty of food, drinks and a very
compelling show.”75 Botox parties are simply just that, parties with Botox, an unusual hybrid of
wildly different offerings. Provide some hors d’oeuvres, combine with poison, and voila, the
innovation of the 20th century: “The beautiful people. Not a frown line, crow's foot, or wrinkled
brow in the room. While it looks like your typical wine and cheese party, there's a little
chardonnay, [a] little brie, and botox.”76 An explanation of the events at a typical party:
“Maria Brown's fete began at 7 p.m., when guests arrived at her four-bedroom home in
Westchester, a tony neighborhood in Redmond, Wash. As the hors d'oeuvres circulated, Dr. David
Stephens, a Bellevue, Wash., plastic surgeon, laid out a tray on the dining room table: sterilized
needles and several vials of Botox, botulinum toxin type A -- a purified protein derived from
71
Lewis, supra note 62.
Id.
73
Tracy Smith, Throw a Botox Party?, CBS NEWS, June 7, 2002,
http://www.cbsnews.com/stories/2002/06/06/earlyshow/contributors/tracysmith/main511360.shtml.
74
Rand Richards Cooper, The Yyear in Ideas; Botox Parties, N.Y. TIMES, Dec. 15, 2002, available at
http://query.nytimes.com/gst/fullpage.html?sec=health&res=9C00E4DE153AF936A25751C1A9649C8B63.
75
Smith, supra note 73.
76
KRON 4, Botox Parties, http://www.kron4.com/Global/story.asp?S=787444 (last visited May 19, 2006).
72
bacteria that, when ingested, can cause botulism. Botox, when injected in the face, temporarily
erases the signs of aging. After a 15-minute talk on how the procedure works and a bit of history
about the drug, made by Allergan Inc., Dr. Stephens took questions about costs (discounted to
$250 a pop for these special partygoers) and potential side effects, which can include paralysis of
nearby muscles, headache, localized numbness, rash, bruising, local swelling, disorientation and
double vision. Then, after each woman signed a consent form, the lineup began. With soft jazz
playing in the background, the partyers chatted in the living room as each guest slipped away into
the formal dining room for a quick procedure. Every time a patient emerged, post-Botox, the
others offered a round of applause. Ms. Brown went last. She got five injections in her face: three
between the eyebrows; one on each temple. Then she had a drink. Four days later, she says: ‘No
frown, no frown lines.’”77
Though the phenomenon has been received with mixed reactions, individuals involved in
the process extol its benefits. Particularly, they stress the psychological comfort of removing the
procedure from a medical office setting. Dr. Stephens explains his thought process behind these
events: “I started out with about five patients a week, then soon it was 15 to 20 a week, then a
patient said, wouldn't this be great with a glass of champagne.”78 Brown explains the attraction:
“‘Ours was just so fabulous,’ says Ms. Brown, 32 years old, who held her first Botox party
recently with 10 friends, over champagne, chocolate truffles and brie. […] ‘The private setting
makes it so relaxed -- it didn't feel so much like it was this big procedure.’”79 Similarly, while
on vacation in New York, Maureen Ingram accepted an invitation to a party, and “recalled how
over drinks at Dr. Sachs's office, she got injections between her eyes. ‘Just amazing,’ is how she
described the results. And the setting, she said, was ideal. ‘It takes away the whole doctor/patient
feel.’”80
77
Rachel Zimmerman, Old Business Model Adds a New Wrinkle, STARTUP J.,
http://www.startupjournal.com/ideas/services/20020424-zimmerman.html (last visited May 19, 2006).
78
Id.
79
Id.
80
Id.
While some physicians welcomed the brilliant income-generating opportunity with open
arms, others reacted with horror. The American Academy of Dermatology released a Patient
Alert, warning consumers of the dangers present in Botox Parties.81 Fred F. Castrow II, M.D.,
President of the American Academy of Dermatology declared: “A casual social activity for the
purpose of administering botulinum toxin, such as a ‘Botox® Party,’ is an inappropriate and a
potentially dangerous setting for performing medical procedures of any kind […] Adding alcohol
to the mix is a bad idea for a number of reasons, especially since bruising can be intensified.”82
Further, the alert attempted to remind the public of a fact long forgotten amidst wine and cheese:
“Botulinum toxin is a purified form of one of the most potent toxins in the world. In high doses,
it can cause the clinical disease botulism.”83
Other prominent physicians voiced similar concerns. Dr. Patricia Wexler, dermatologist
of many celebrities, commented, “As a doctor I feel it's inappropriate. It sends a wrong signal. It
also trivializes the person doing the procedure. Privacy is important and these parties are a
marketing tool.”84 Dr. Richard Glogau, a clinical dermatologist at the University of California,
San Francisco, agreed: "This is a medical procedure … and I think it should remain one and I
think it's wrong to trivialize it that way … and… I don't think it's ever a good idea to mix alcohol
with elective medicine.”85
Despite the detractors, Botox Parties still claim the support of many established
physicians. However, the toxin’s surge in popularity has given rise to another far more harmful
phenomenon, this one condemned by all: black market Botox. “With more and more Americans
81
American Academy of Dermatology, Patient Alert: American Academy of Dermatology Stresses the Safe Use of
Botulinum Toxin, Apr. 30, 2002,
http://www.aad.org/public/News/NewsReleases/Press+Release+Archives/Cosmetic+Dermatology++Aging/BotoxParties.htm.
82
Id.
83
Id.
84
Smith, supra note 73.
85
Kron 4, supra note 76.
anxious to smooth their wrinkles, experts say black market Botox copycats are being produced
around the world and marketed to doctors in the United States.”86
Though numbers and statistics are difficult to come by, black market Botox gained great
publicity when it caused paralysis in a Floridian clinic. Dr. Bach McComb, an osteopathic
physician, injected himself, his girlfriend and friends Bonnie and Eric Kaplan with botulinum
toxin as a cheap alternative to Botox.87 Each was afflicted by severe botulism as a result. The
vials had contained potentially fatal amounts of the toxin and were obtained from a facility in
Arizona, run by Dr.Chad Livdahl and Dr. Zarah Karim.88 The physicians allegedly created vials
from raw botulinum toxin meant for research purposes, and sold over 3,000 vials to 200 doctors
nationwide.89 More recently, in March 2006, a hairstylist from Salinas, California was arrested
for allegedly injecting “bogus Botox” into numerous women. Unlicensed, she allegedly used
cooking oil, and as a result one woman died.90
Not only are counterfeit vials available from laboratories; they can be purchased on the
Internet: “Dermatologist Leslie Baumann, 37, does research for Botox's manufacturer and she
uses it herself so she was shocked when she caught a Chinese company she'd never heard of
fraudulently listing her as endorsing their product on a Web site.”91 Black market Botox even
began using the Botox seal; Allergan responded by adding a holographic prism to its packaging.
5. The FDA’s Role in the Botox Phenomenon
86
CBS, Cracking Down On Bogus Botox, CBS NEWS, Jan. 3, 2005,
http://www.cbsnews.com/stories/2005/01/03/eveningnews/main664518.shtml.
87
Center for Infectious Disease Reasearch and Policy, Reports Blame Florida Botulism Cases on Misused Toxin,
Dec. 15, 2004, http://www.cidrap.umn.edu/cidrap/content/bt/botulism/news/dec1504botulism.html.
88
Peter Franceschina, S. Florida Botulism Victims Begin Therapy, Seek to Warn Others, SUN-SENTINEL Feb. 5,
2005, available at
http://www.sun-sentinel.com/news/local/southflorida/sfl-pkaplans05feb05,0,6487282.story?coll=sfla-homeheadlines.
89
No Pundit Intended, Bootleg Botox Blues, http://www.nopunditintended.com/2005/02/bootleg_botox_blues.html
(Feb. 3, 2005, 13:21 EST).
90
Lilian Kim, Woman Dies After Bogus Botox Injection: Hair Stylist Has No Medical License, ABC NEWS KGO,
Mar. 15, 2006, http://abclocal.go.com/kgo/story?section=local&id=3994596.
91
CBS, supra note 86.
The transformation of botulinum toxin into commercially marketed Botox presents a
unique study in the progression of the FDA’s role. In the 1980s, the FDA used its regulation
powers to protect the public from the foodborne illness. As detailed above, the agency recalled
products that facilitated death by botulism poisoning. In the 1990s, the FDA gave its approval
for the use of that same toxin transformed into an injectable meant to cure blepharospasms,
strabismus and cervical dystonia. And finally, after widespread off-label use, in 2002 the FDA
approved “the world’s most poisonous poison” for cosmetic purposes.
One might expect a device’s pre-approval use to accompany significant hesitation, with
post-approval use resulting in common, appropriate use. However, rather than follow this
expected trajectory; Botox welcomed an expedited timeline. Before its approval, Botox was
common practice. Millions of women used it, and whether the FDA had granted its approval
seemed meaningless in practice.
Upon approval, the proverbial floodgates flew open, as Botox Parties and black market
Botox hit the streets, the clinics and the social circuits. In response, the FDA issued the
following statement: “The FDA is concerned that Botox has the potential for being abused. The
ASAPS recently reported that unqualified people are dispensing Botox in salons, gyms, hotel
rooms, home-based offices, and other retail venues. In such cases, people run the risks of
improper technique, inappropriate dosages, and unsanitary conditions.”92
Whereas a simple warning may have been sufficient in educating housewives in proper
home-canning, Botox has engaged a far more aggressive public. Beyond issuing statements, an
FDA reaction must acknowledge how limited its control has been over the market effects of its
own regulation. Approval in this case, is equated not to widespread appropriate use, but to a
92
Lewis, supra note 62.
dangerous, potentially unmanageable national obsession. In whatever form, whether appropriate
or legal, consumers and physicians alike are cutting costs and throwing safety to the wind.
And thus, whereas the agency may have successfully addressed botulinum toxin as a
foodborne illness, monitoring the dangers associated with the cosmetic use of Botox provides
new challenges. The potential harms associated with black market Botox and Botox Parties are
real; they falsely eliminate any perceived risks associated with the medical procedure. And even
if one finds these particular risks relatively harmless, the nation’s now-casual attitude toward
banishing wrinkles has overwhelmed an entire industry. Botox is no longer the Holy Grail of
treatments; rather, consumers are turning to a host of injectable fillers that further promise the
elusive attainment of youth and beauty. And many of these treatments present even greater
dangers than the Botox phenomenon.
B. Liquid Silicone Injections
Botox paved the way for the widespread social acceptance of reducing wrinkles;
following an even more expedited trajectory of rampant use is liquid silicone. Though still used
off-label, the dangerous uses of Botox that erupted post-approval have already affected/corrupted
the application of injectable silicone. The accompanying dangers are terrifying: pain,
disfigurement and fatalities.
1. The History of Silicone
“Silicone” is a term used to describe a “group of polymers based on the element Silicon
that range in viscosity from fluids to solids.”93 During World War II, silicone began its journey
as an implant in increasing the breast size of Japanese prostitutes. According to Dr. Edward
Kopf, a plastic surgeon and historian of silicone, “Japanese cosmetologists realized that
93
Lance H. Brown & Paul J. Frank, What's New in Fillers?, J. DRUGS DERMATOLOGY, June 2003, at 5,
http://www.findarticles.com/p/articles/mi_m0PDG/is_3_2/ai_110808287/pg_5.
American servicemen preferred women with larger breasts than were common among Japanese
women. After experimenting with goats’ milk, paraffin and a variety of other substances, they
tried silicone, injecting it directly into the breast.”94 This practice was adopted by American
plastic surgeons in the 1960s and 1970s; but even then, adverse physical reactions were dramatic
and documented: “United States literature became littered with grotesque stories and pictures of
women with lumpy, ulcerated breasts and scars and other problems in their abdomen, chest, arms
and back from the drifting sticky bits of silicone. In a few cases in which the silicone migrated
to the lungs, the result was death.”95 In the 1970s, Dr. John Paul Heggers of the University of
Texas medical campus at Galveston discovered that the immune system reacted problematically
to the silicone in breast implants by developing antibodies.
As researchers sought innovative uses for silicone, studies illustrated a wide array of
disconcerting results. Patients on kidney dialysis using silicone tubing had an unusually high
rate of liver disease. Some died from the disease, and autopsies revealed a large amount of
silicone in their livers.96 In cardiac bypass surgery, researchers used silicone as an antifoam
agent to oxygenate patients’ blood; silicone particles then blocked capillaries and caused tissue
damage.97
Silicone use for breast augmentation persisted through the ‘60s and the ‘70s, and
increased widely in popularity. However, in 1992, after numerous women reported health
problems associated with the implants and their rupture, the FDA banned silicone implants for
cosmetic breast augmentation. Adding to its controversy, this ban left unprohibited the use of
silicone in clinical studies for reconstruction after mastectomy, correction of congenital
94
Philip J. Hilts, Strange History of Silicone Held Many Warning Signs, N.Y. TIMES, Jan. 18, 1992, available at
http://query.nytimes.com/gst/fullpage.html?res=9E0CEFD8153BF93BA25752C0A964958260.
95
Id.
96
See id.
97
See id.
deformities, or replacement of ruptured silicone gel-filled implants due to medical or surgical
reasons.98
Nevertheless, liquid injectable silicone continued to be used illegally in the United
States; one popular such use that emerged was to contour the face. In the early 1990s, the
epidemic became so prevalent that the Department of Justice began filing injunctions on behalf
of the FDA to prohibit physicians from injecting liquid silicone in patients.99 FDA investigators
attended a seminar held by Dr. James E. Fulton, and thus verified suspicions that he used and
promoted injectable liquid silicone.100 Soon thereafter, investigators inspected his clinics and
confirmed its use.101 Similarly, the Department of Justice filed injunctions against Drs. Norman
and David Orentreich; inspections of their clinics revealed that they too used silicone injections
to shape facial tissue.102
In 1994, the course of silicone use changed drastically as the FDA granted the pre-market
approval of Adatosil 5000, a medical grade liquid injectable silicone device for use in the
ophthalmologic procedure to tamponade retinal detachments. In 1997, Silikon 1000 was
approved for the same use. Both agents contain polydimethylsiloxane polymers, composed of
silicon, oxygen and methane molecules, varying in length and viscosity.103
Since the FDA allows for off-label use of approved devices (as exemplified by Botox,
above), liquid injectable silicone regained popularity as a wrinkle filler. In 2000, the Orentreichs
studied the “microdroplet serial puncture technique, which is applied at monthly treatment
intervals until the desired cosmetic result is achieved. Small aliquots of .005-.01 ml liquid
Food and Drug Admin., FDA Breast Implant Consumer Handbook – 2004; Timeline Of Breast Implant Activities,
http://www.fda.gov/cdrh/breastimplants/handbook2004/timeline.html (last visited May 19, 2006).
99
Press Release, Food and Drug Admin., Physicians to Stop Injecting Silicone for Cosmetic Treatment of Wrinkles
(Feb. 28, 1992), available at http://www.fda.gov/bbs/topics/NEWS/NEW00267.html.
100
Id.
101
Id.
102
Id.
103
Brown & Frank, supra note 93, at 5.
98
silicone are inserted in the skin at 2-10 mm intervals and is suggested to provide a safe,
permanent, and consistent result for several cosmetic applications which include the filling of
rhytides, scars, and dystrophies of varied depths and anatomic locations.”104 In this procedure,
the “mechanism of action” is thought to be the “combination of the displacement of the dermal
connective tissue by silicone microdroplets and the production of thin-walled collagen capsules,
which surrounds them.”105
Despite its growing popularity, medical opinions on the safety of injectable silicone
differ. Dr. David Morrow, a plastic surgeon in Rancho Mirage, California, claims: “I’ve been
using it for years. … It's an excellent agent. The results are fabulous. There's nothing wrong with
it.”106 Others report a different experience.
“Minor adverse reactions that have been documented are very similar to those associated with
other traditional filling agents and include pain upon injection, local and transient edema,
dyschromia, and textural complaints. More concerning adverse reactions that appear to be more
specific to liquid injectable silicone include granulomatous reactions, idiosyncratic inflammatory
reaction, and reports of drifting. What appears most problematic about these reactions is that they
have been reported to occur anywhere from 1 month to 25 years after initial treatment. In
addition, because liquid injectable silicone is a permanent filler, any complication becomes
compounded by the fact that the substance will not eventually be metabolized and the reaction
can potentially persist despite treatment.”107
One issue of substantial concern is the relative dearth of information surrounding
silicone’s long term consequences:
“the lack of long-term clinical data regarding the incubation period of a serious adverse reaction
deems liquid injectable silicone a time bomb to its opponents. Unfortunately, we have a lack of
long-term clinical data and reporting regarding the number of patients who have been treated
properly or improperly and how many patients have had appropriate results or serious
104
Id. at 6.
Id.
106
Hilts, supra note 94.
107
Brown & Frank, supra note 9394, at 6.
105
complications. These facts often cloud the ability of clinicians to appropriately weigh the risks
and benefits of liquid silicone for use in soft tissue augmentation.”108
Regardless of the spectrum of medical opinions that surround silicone use, physicians
agree that when used improperly, the adverse consequences can be disastrous. For example,
Robert T. Rylee, chairman of the health care business for Dow Corning Wright, a major
manufacturer of silicone products notes that “[i]n the wrong hands, injectable silicone is a
disaster.” Specifically, “Dow strictly controls the distribution of its pure liquid silicone … and
does not market it for injection into people. Nevertheless … unscrupulous people occasionally
obtain the material and inject it into the breasts, buttocks and other body parts of people who
cannot afford plastic surgery and who are not aware of the health risks involved.”109
Furthermore, “[i]njectable silicone has been around the longest and, when used improperly, can
maim or kill people. When injected freely into the body, it tends to travel to vital organs, causing
severe toxic reactions. These include autoimmune diseases, blindness and death of tissue at the
injection site.”110
2. “Pump Parties”
Examples of such improper use are most prominent in an extraordinarily dangerous
setting called “pump parties,” a growing phenomenon within the transgender community. Just
like “Botox parties,” “pumping parties” have gained in popularity as a relatively cost-effective
way for individuals to receive injections. As the Miami-Dade County Healthy Department’s lead
detective said: “cases of silicone parties are skyrocketing.”111 These parties are often attended by
108
Lance H. Brown & Paul Jarrod Frank, The Cosmetic Clinic: The Silicone Conundrum, 10 SKIN & AGING 15
(DEC. 2002), available at http://www.skinandaging.com/sa/displayArticle.cfm?articleID=article1102.
109
Sandra Blakeslee, Fighting Wrinkles with Fat; Other Remedies at Issue, N.Y. TIMES, July 24, 1991,
http://query.nytimes.com/gst/fullpage.html?res=9D0CE3DA1430F937A15754C0A967958260.
110
Id.
111
Local 10.com, Silicone Injected At Parties In South Florida, http://www.local10.com/news/564792/detail.html
(last visited May 19, 2006).
transgender individuals who seek more feminine features, and “groups of patients typically
receive silicone injections from an unlicensed, untrained person who is often using non-medical
silicone.”112 In fact, physicians have discovered that pump-party patients have been injected
with “[i]ndustrial-grade silicone, floor products and sealers, and a host of contaminants including
motor oil and paraffin.”113
The potential for harm is overwhelming:
“And so, transgendered people pay $200, $300, even $500 for a few injections of impure silicone,
administered, usually, by someone with no medical training, no knowledge of human anatomy, no
knowledge of sterile techniques, no idea of what to do if a medical emergency develops, and who
may well be reusing needles without sterilizing them-- and this individual will more than likely
have a very poor aesthetic sense. The result is Dangerous Curves-- what I sometimes refer to as
Cheekbones from Hell-- body contours, especially lips and cheekbones, which just do not occur in
nature. With repeated visits (and much money spent), the individual becomes a caricature, a
cartoon, a person of exaggerated proportions. … And the long term consequence is
disfigurement.”114
One man in South Florida attended silicone pump parties for twelve years, first receiving
the injections to eliminate wrinkles and creases, and finally in the buttocks. Now, his legs have
become numb.115 Even more disconcerting than disfigurement is the potential for fatalities; one
woman in Miramar, Florida died after the silicone leaked into her bloodstream.116 Three women
died in Houston, and one more passed away in Georgia in 2003.117 Also in 2003, two women in
Marty Graham, U.S. Experts Warn of Risky Silicone ‘Pump Parties’, REUTERS, JULY 5, 2005, available at
http://www.msnbc.msn.com/id/8463413/.
113
Id.
114
Dallas Denny, Cheekbones from Hell, or Injectable Silicone: Bad News, GENDER.ORG,
http://www.gender.org/resources/bad_news.html (last visited May 19, 2006).
115
Local 10.com, supra note 1111.
116
Id.
117
Graham, supra note 1122.
112
San Diego experienced severe respiratory arrest and were “near death” after being injected by
unlicensed practitioners.118
According to Dr. Walter Bockting, coordinator of transgender health services at the
University of Minnesota’s Center for Human Sexuality, transgendered individuals are
particularly willing to forego safety costs in the pursuit of beauty: “Being beautiful and shapely
is very important to certain segments of the transgender community — it’s a self-esteem builder
for people who are feeling rejected by their families and communities.”119
Additionally, Mara Keistling, of the National Center for Transgender Equality in
Washington, D.C., notes that transgendered individuals often face difficulty seeking treatment in
more traditional forums: “Are you going to trust your best girlfriend or a doctor who may be
rude to you and refuse to treat you or disrespect your reasons?”120
While pump parties are particularly popular within transgender communities, other
groups of women have likewise picked up the trend. In South Florida, Enrique T. Torres, chief
investigator for unlicensed activity with the state Health Department, describes the phenomenon
with words commonly attributed to Botox Parties: “‘It's food, drink and injections … . They
gather, they eat, they drink, they have cash and everybody watches.’ He notes that ‘many of the
procedures are taking place at in-home gatherings that resemble Tupperware parties or multilevel
marketing meetings.’”121 Women are lured in by a social setting created in a casual atmosphere:
“A woman told state investigators she went to such an event in a Fort Lauderdale warehouse,
where wine, low light and music set the mood.”122 Additionally, “[r]ecently a group of freshly
118
Id.
Id.
120
Id.
121
Thomas C. Tobin, It's Food, Drink and Injections, ST. PETERSBURG TIMES, Apr. 18, 2001,
http://www.sptimes.com/News/041801/State/_It_s_food__drink_and.shtml.
122
Id.
119
injected women were seen leaving a condo in the comfortable Miami suburb of Aventura. A
local television crew spied them patting their numbed faces and studying their reflections in car
windows.”123
The prevalence of these parties is overwhelming. As Torres noted: “This is in every
corner, everywhere, because there's money to be made and people want to look good… If the
state would be so kind as to give me 10 more investigators, they would be over-loaded the
moment they started work.”124 Mariano E. Busso, a dermatologist who teaches at the University
of Miami shared that “[p]eople with problems from the injections show up almost daily” at his
Coconut grove office.125 Busso speaks of a woman he recently hospitalized who received
silicone injections on her smile lines in 1993: “Eight years later, her face blew up like a
balloon.”126
Investigators in South Florida take these accounts seriously, and have documented
numerous disturbing cases. “One day in 1999, undercover investigators watched as a steady
stream of people entered a small Miami apartment and waited in the cramped living room for the
man they knew only as ‘Doctor David.’ In the suitcase he brought from Caracas, [Doctor David],
who is not a doctor, always carried a crude brochure. Written in Spanish, it was a hand-drawn
face with arrows connecting prices with body parts.” 127
Angelina McCabe, 48, of Palm Beach County, used local beauty salons to network and
get referrals for her silicone lip injection business. She had no authority to perform such
injections, and was reported by a victim who “suffered pain, bleeding and swelling,” later
123
Id.
Id.
125
Id.
126
Id.
127
Id.
124
suffering “a severe staph infection.”128 Another salon worker reported “getting herpes from one
of McCabe’s needles.” Upon searching her medical bag, investigators found $2,200 in cash and
“used syringes and implements covered with dog hair.”129
The rampant use of liquid silicone illustrates a number of concerns. First, even when
used by legitimate licensed physicians off-label, injectable silicone presents a host of potential
harms. The dearth of information surrounding liquid silicone’s long term consequences creates
cause for significant concern and more research.
Second, in the context of today’s cultural, obsessive pursuit of youth and beauty, the
regulation of medical devices requires a fierce dedication to acknowledging illegal and blackmarket uses. Research and approval cannot focus solely on the effects of devices within the
realm of legality, as the tragic consequences of black market Botox and silicone pump parties
illustrate. Regulatory agencies must be flexible in adjusting to the demands of an obsessive
consumer society; in these cases, the obsession has reached unacceptable extremes, as fatalities
and permanent disfigurement occur frequently.
And thus, the FDA must acknowledge its experience with Botox in its consideration of
silicone injections. If the agency chooses to grant the approval of liquid silicone for facial
treatments, the FDA will elevate the injections from an off-label use to an approved use.
Considering the expedited trajectory liquid silicone has already experienced, such floodgates will
arguably create unprecedented danger.
C. Interlude
1. The Information Game: Analyzing the Growth of an Evolving
Industry
128
129
Id.
Id.
Though the prescription of drugs and use of medical devices in unapproved manners
remains fairly common in the practice of medicine, great controversy surrounds its applications
in the cosmetic enhancement industry. The off-label use of approved devices and the rampant
use of those yet unapproved have transformed the frontier – they have aggressively overwhelmed
the fields of plastic surgery and dermatology.
2. … Blame it on the Patient: the Shifting Role between Patient and Doctor
In its explanations for allowing off-label use, the FDA acknowledges that its authority
falls short of regulating the practice of medicine. That discretion lies in the hands of physicians,
individuals trained to apply a stringent standard of care to their patients. Such authority assumes
that while patients exercise autonomy over which procedures are performed, doctors are the
experts - the ones most capable of limiting options to the safe and effective. However, in recent
years, the obsessive pursuit of youth and beauty has arguably shifted that delicate balance;
physicians have substantially transferred decision-making powers to the patient. In many cases,
the doctor’s role has receded sharply from expert advisor to mere facilitator. As NewYork
Magazine reports:
“To hear some doctors tell it, client demand pushes physicians to experiment
with unapproved treatments. ‘There’s a new kind of patient out there,’ says
Stephen Bosniak, an ophthalmic plastic surgeon at New York Eye & Ear
Infirmary. ‘They come in asking for these things. In this competitive market,
people want to be the first to offer something new, because it is exciting.’”130
In New York City, physicians discuss the patient’s role in the use of Restylane, a dermal
filler, prior to its approval:
“‘Three different patients came to me this summer with vials of Restylane in
their purses and asked me to inject them with it,’ says a prominent Upper East
130
Beth Landman, Beyond Botox, N.Y. MAG., Oct. 6, 2003,
http://newyorkmetro.com/nymetro/health/bestdoctors/cosmeticsurgery/2003/n_9281/.
Side plastic surgeon who asked not to be named. ‘I told them to go down the
street to one of the dermatologists.’ To which dermatologist Soren White
replies, ‘Plastic surgeons like to make our ethics or skills look questionable.’
White runs SkinKlinic, a spa that has long administered Botox and Restylane.
‘But my friends who are plastic surgeons are always asking me about the latest
fillers.’”131
New York is not alone in witnessing this phenomenon; in San Francisco, patient interest
and initiative is not dissimilar:
“Angelina Umansky, owner of a day spa in San Francisco, has observed plenty of trends
in cosmetic procedures over the years, from breast implants to collagen injections to
glycolic acid peels and, more recently, Botox. These days, she says, all she seems to hear
from her clients is talk of the cosmetic fillers that are supposed to work faster on facial
flaws and last longer than Botox … ‘Safety is not a concern; they just want results.’”132
Likewise, in Chicago, Dr. Michael Byun, co-author of THE NON-SURGICAL FACELIFT
BOOK, A GUIDE TO FACIAL REJUVENATION PROCEDURES and a Northbrook plastic surgeon,
“doesn't object to unapproved medications — as long as a patient is fully informed about a
substance's FDA status and the doctor's training background.”133 His contemporary, Dr.
Anthony Terrasse, harbors a bit more concern, but likewise notes: “it’s buyer beware.”134
3. The Information Game and the Modern Consumer’s Access
One reason behind this enormous shift in balance is undoubtedly the modern consumer’s
unprecedented accessibility to information. As earlier noted, the Internet catapulted information
previously held only by physicians and researchers to anyone and everyone’s fingertips.
Whereas the average woman, years ago, may not have known about the existence of Restylane,
131
Id.
Sana Siwolop, Personal Business; Beyond Botox: An Industry's Quest for Smooth Skin, N.Y. TIMES, Mar. 9,
2003, http://query.nytimes.com/gst/fullpage.html?res=9806EFD7103FF93AA35750C0A9659C8B63.
133
Judy Marcus, The Latest Wrinkle: Finding Eternal Youth Without Going Under the Knife, N. SHORE MAG.,
http://www.northshoremag.com/cgi-bin/ns-article?article=/healthfam/02-04-healthfam-3.dat (last visited May 19,
2006).
134
Id.
132
let alone how to procure it – today, she can surf the web to discover, in mere seconds – in what
countries said filler is available, and consequently, how to find its way to her purse and to her
doctor’s office. For example, websites like “www.yestheyrefake.com” devote extensive space to
providing such information.135 Listed alphabetically, each segment includes a description of a
different filler, including its ingredients, approximate cost, how to use it, cautions, what countries
have approved it, and how to procure it. For example, the filler “Amazingel,” “a medical grade,
hydrophilic polyacrylamide gel” can be found by contacting “Futian Dist. Shenzhen, China,
Shenzhen, China, Guangdong (China) 518000.”136 Phone and fax numbers are included.
With regards to whether Aquamid, an “injectable hydrophilic polyacrylamide gel (HPG,
or PAAG) with 5 ppm residual unpolymerized acrylamide monomer” is available in the United
States, the website states: “No, okay well not officially, but some physicians have brought it into
the states or bought it from those who have and are offering it to their patients. This injectable is
available throughout Europe, particularly in Germany, and also in Australia, Asia, Canada,
Mexico, and more.”137 Similarly, the filler Bioalcamid is obtainable though unapproved; the
website states: “some patients have gotten it from their surgeons who have brought it into the
country or bought it from those who have. It is available in Mexico, and found in border cities.”
Likewise, the silicone oil Biopolimero is said to be found “near border towns - this product is
found in abundance in Mexico.”
And thus, it would seem, the modern woman is armed with far more information than her
predecessors, and consequently, with far more knowledge to make well-informed decisions.
However, such contention holds true only if the increase in volume presents accessibility to the
135
Injectable Micro-implants, http://www.yestheyrefake.net/injectable_fillers_micro_implants.htm (last visited May
19, 2006).
136
Id.
137
Id.
entire spectrum of viewpoints.
Unfortunately, while women today technically have access to
varied medical opinions; the Internet bombards consumers less with an unbiased spectrum, and
more with mass marketing.
The following case study illustrates the potential for consumers earnestly seeking
information to be significantly deceived, as manufacturers and physicians alike skate ethical
lines in their marketing approaches. Such deception requires the FDA to monitor promotional
channels more substantially, and to adjust their current regulatory approach.
D. Radiance
1. Manufacturer Marketing
The FDA prohibits medical device manufacturers from marketing their products for offlabel uses; however, the FDA does not prohibit non-manufacturers from discussing their
benefits, and obviously cannot prohibit international marketing. This line is extraordinarily thin,
as witnessed by the information available online for the product Radiance, otherwise known as
Radiesse.
Radiesse is a synthetic filler composed of microspheres of calcium hydroxylapetite, a
material similar to that found in teeth and bones. The FDA has approved its use for bladder neck
augmentation for urinary incontinence, vocal cord augmentation for paresis, and periodontal
defects.138 However, the filler is also commonly used to treat wrinkles, most popularly
marionette lines, nasiolabal folds and lip augmentation.
When entering the website for Radiesse, the viewer is presented with two options:
“Radiesse USA” or “Radiesse Worldwide.”139 Upon clicking the “USA” option, the consumer
reads only that Radiesse has been cleared for “oral/maxillofacial defects, vocal fold insufficiency
138
139
WebMD, Dermal Fillers, http://www.emedicine.com/derm/topic515.htm (last visited May 19, 2006).
Radiesse, http://www.radiesse.com (last visited May 19, 2006).
and radiographic tissue marking.”140 Adjacent to the language, is a large button that reads “click
here for Radiesse Worldwide.”
At this point, the consumer is presented with a far more sophisticated website, with
numerous options allowing the viewer to pursue vast amounts of information. In bold, the
opening page notes: “Radiesse is the newest non-surgical facial contouring filler that delivers an
immediate, longer lasting result.”141 The writing continues:
“Whether you’re longing to reverse the common signs of aging or address a health issue that otherwise
would require an invasive treatment, you have more options in looking and feeling better with Radiesse.
Developed with safety and longevity in mind, Radiesse is a new generation injectable filler that offers
superior versatility for both cosmetic and reconstructive use without surgery. What sets Radiesse apart
from other dermal fillers? The answer is in its durability, longevity, and versatility. The unique
composition of Radiesse provides immediate visual improvement common with other fillers, along with the
benefit of long-lasting results. This is because Radiesse is made of very tiny, smooth calcium
hydroxylapatite (CaHA) microspheres. The microspheres (particles) form a scaffold through which your
body’s own collagen grows, and this produces the desired long-term effect. These unique advantages make
Radiesse the ideal choice for facial shaping and contouring – along with other therapeutic applications.”142
Accompanying such language is a rendering of a woman’s youthful face, wrinkle-free
and with luscious, plump lips. The consumer can explore many more options by clicking on
“treatment solutions,” “advantages,” “success stories,” “clinical effectiveness,” or “news and
events.”143
The above documentation seeks to demonstrate the realistic implications of the
prohibition on marketing placed by the FDA. Any consumer who discovers Radiesse’s website
is highly likely to click on “Radiesse Worldwide,” after viewing the paltry information offered to
those interested in “Radiesse USA.” One assumes that this technique is intentional on the part of
the manufacturer. And thus, for all intensive purposes, the manufacturer has bypassed the
140
Radiesse-USA, http://www.radiesse.com/radiesse-usa.html (last visited May 19, 2006).
Radiesse-Worldwide, http://www.radiesse.com/worldwide.html (last visited May 19, 2006).
142
Id.
143
Id.
141
FDA’s prohibition, and is directly marketing to the American consumer, while touting the filler’s
off-label uses.
Radiesse was formerly known as “Radiance,” and one can discover a similar marketing
loophole at www.radiancetreatment.com. The website is beautifully designed in muted purples
and grays, and accompanied again by photographs of beautiful women with youthful skin and
plump lips. At the page’s center, the engorged text reads: “Imagine a more vibrant you. Restore
that youthful glow. Enhance your natural features. Radiance injection can smooth and revitalize
key areas of your face.”144 Again, the website presents the viewer with numerous options,
including “Formula,” “Treatment,” “Before & After” and “Testimonials.” Upon clicking
“Formula,” one is faced with: “The Ideal Solution.” Underneath, it reads:
“Finding a safe and lasting way to reverse the effects of aging on the face has been a longstanding search of
medical science. The ideal approach would fill in the lines and creases that normally develop, and restore
fullness to the lips and cheeks. It would be safe and totally compatible with the body. And it would last for
many years. Until now, no treatment has met those high standards. Introducing Radiance, the first truly safe
and enduring way to restore vitality to the face.”145
Again, for all intensive purposes, this website directly markets off-label uses to the
consumer. In fact, one can even click a button to “find a Radiance Certified Aesthetic Center
near you.”
However, in its attempt to avoid explicit violation of the FDA’s prohibition, one can peer
closely to find the following shrunken text at the bottom of the page: “This website is maintained
and operated by Aesthetic Communications, Inc. (ACI). ACI has no affiliation or relationship
with the manufacturer of the Radiesse product, BioForm Medical, Inc. (BMI) or any other filler
product manufacturer. The information contained herein has been obtained independently by
144
Radiance Treatment, http://www.radiancetreatment.com (last visited Apr. 20, 2006). The website has apparently
since been discontinued.
145
Id.
ACI through interviews with physicians, patients and other medical research and market
sources.”146
Whatever affiliation exists, explicit or not – the website arguably mirrors what a
marketing website produced by the manufacturer, and aimed at the consumer would be. And
thus, the manufacturers found a successful way to market the off-label uses of their product
through whatever convoluted channels allowed them to escape affiliation, and thus, liability.
2. Physician Marketing
The websites discussed above illustrate just the beginning of the monumental amounts of
information targeted at attracting consumers. An Internet search re: Radiesse results not in a
predominance of scientific commentary, but rather, excess amounts of marketing. One such
avenue is the physician’s website, plastered with advertising for various procedures, and often
disguising important consumer information.
For example, the Metropolitan Institute of Plastic Surgery, located in Washington D.C., is
a partnership of three plastic surgeons who advertise their practice through a website dedicating
extensive space to Radiesse. Under the headline “Is Radiesse Safe?” the text reads, “Radiesse
was approved by the Federal Food and Drug Administration (FDA) nearly a decade ago and
since then has undergone continued testing in accordance with strict FDA requirements.
Thousands of men and women have used Radiesse to safely and successfully smooth out deep
facial wrinkles, creases, and folds.”147 In response to “Where can Radiesse be used?” it is clear
that the institute refers to off-label uses: “Radiesse is injected just below the surface of the skin,
filling in the deep creases and folds that often form between the nose and mouth and on either
side of the nose. It can also be used to enhance the area surrounding the lips and to minimize
146
Id.
Metropolitan Institute of Plastic Surgery, Skin Care – Radiesse, http://www.metplasticsurgery.com/scare_rad.asp
(last visited May 19, 2006).
147
acne scars. The doctor will determine which areas to inject with Radiesse based on an evaluation
of the skin on your face and neck.”148
Such advertisement is arguably deceptive, as the language implies that the FDA approved
Radiesse for the uses outlined on the website. A consumer reading that the FDA approved
Radiesse “nearly a decade ago,” and that Radiesse has been used on “thousands of men and
women” safely, would have no reason to assume that approval had actually been granted for uses
other than those described. Thus, this example demonstrates that while the modern consumer
has far more access to information than her predecessors; such information is far from
straightforward and unbiased. Those with the greatest financial investments tend to be the ones
disseminating information on the Internet; and unfortunately, that leads to bias and deception.
The Metropolitan Institute is far from alone in its advertising spin. Dr. Douglas Hamilton
skates around the issue of FDA approval by providing the following description of his
experience with Radiesse on his website: “We have been treating patients with Radiesse™ since
December 2002 in our Beverly Hills, Woodland Hills & Irvine offices for the above purposes
and to also help introduce this procedure in the United States … As of April 2006 we had treated
over 400 patients with Radiesse.”149 The “above purposes” refer to “lip enhancement” and
“wrinkle removal,” described earlier in the entry.150 With his language combined with his
emphasis on the large number of patients treated, Hamilton gently sidesteps the issue of FDA
approval; a consumer would only become aware of its off-label status if she knew enough to
inquire about it.
148
Id.
Douglas Hamilton, M.D., Injectables, http://www.douglashamiltonmd.com/html/injectables.html (last visited
May 19, 2006).
150
Id.
149
Similarly deceptive is the advertising on the website for Dr. Jay Garcia of Florida. On his
site (with the intriguing address www.beautyinaflash.com), Garcia poses the question: “Is
Radiesse™ Radiance FN FDA approved?”151 He responds: “Yes, it is currently being used in
cosmetic procedures and also being safely injected for cosmetic purposes; Bioform is approved
by the FDA for off-label use.”152 The website’s claim of having received off-label approval is
misleading. The FDA does not approve devices for their off-label uses; they approve them for
very specific uses, and then doctors choose to use them off-label. The circuitous manner of the
above response illustrates the physician’s attempt to manipulate the comfort levels of patients.
Yet another example is found on the website of Dr. Most, a cosmetic surgeon in
Washington. He offers the following description of Radiesse: “Radiesse is an FDA-approved
injectable filler material. It is gel-like material composed primarily of hydroxyapetite, an
important component of our bone tissue. As a gel, however, it is soft (not like bone!). As a filler
material, Radiesse is used to 'fill in' areas of wrinkles or other depressions that would benefit
from 'filling out'.”153 Again, though Radiesse is technically “an FDA-approved injectable filler
material,” it is FDA approved for uses other than those for which Dr. Most promotes it. In fact,
by following the above language immediately with: “As a filler material, Radiesse is used to ‘fill
in’ areas of wrinkles,” the text suggests that these uses are exclusively those for which Radiesse
was created, and consequently, the only uses for which the FDA could grant approval.
The above examples of advertisements on websites illustrate the majority of content
available to consumers seeking information on Radiesse. Admittedly, with extensive searching,
one can find alternate opinions. In an online article originally published in Town and Country
Magazine, two dermatologists practicing in New York City note the risks involved with using
151
The Body Image Laser Institute, http://www.beautyinaflash.com/radiance.html (last visited May 19, 2006).
Id.
153
Sam P. Most, M.D., http://www.drmost.com/radies.html (last visited May 19, 2006).
152
Radiesse. Dr. Rhoda Narins comments: “You may get an immediate benefit but end up with a
permanent problem, like granulomas, years later.”154 Likewise, Dr. Howard Sobel notes: “I'm
cautious about things that surface too quickly, like Artecoll and Radiance.”155 Text at
eMedicine.com under “Radiesse” reads: “Caution is advised when treating the lips, as a high risk
of subcutaneous nodules has been noted when treating this area.” And furthermore, Health 24
reports “a small but significant risk of ‘granuloma,’ a localised skin reaction to a foreign body
that can result in hardened, sometimes itchy bumps just under the skin. And, the problem can last
months or even years, studies show. The lumps can also migrate to other parts of the body with
a potential for complications that doctors know little about, according to the American Society of
Plastic Surgeons.”156
However, despite the capacity of an Internet surfer to discover these cautionary opinions
on Radiesse, the available information, to an overwhelming degree, can be found on the
promotional websites examined above.
And thus, this case study of Radiesse demonstrates two distinct phenomena; first,
consumers develop an arguably false sense of empowerment by their increased access to
information, and second, the FDA regulations on the marketing of off-label uses are – for all
practical purposes – completely useless.
In an age when the average consumer is capable of smuggling in illegal fillers from
another country, the burdens of protecting the health and safety of patients complicate and
increase. Years ago, consumers submitted to the medical degrees of their physicians; today, they
provide doctors with the very tools shipped from abroad to perform their procedures. The
154
Janet Carlson Freed, The Latest Wrinkle-Fixers, TOWN & COUNTRY, Nov. 2003,
http://magazines.ivillage.com/townandcountry/style/health/articles/0,,284694_602549,00.html.
155
Id.
156
Health24.com, A New Fountain of Youth?, July 21, 2003, http://www.health24.com/news/Plastic_surgery/1938,23440.asp.
modern patient seeking an injectable filler has visited the websites; she has read the “frequently
asked questions” sections on physicians’ homepages. And thus, she feels no less knowledgeable
than the caretaker she entrusts.
On one hand, this increased access to information represents the most powerful tool in a
patient’s arsenal. No longer is she bound by the constraints of a single cosmetic surgeon’s
consultation; she can surf the Internet and seek treatments that she finds most desirable, most
appropriate.
On the other hand, that same access represents the greatest hindrance to an unbiased
education. The naïve consumer fails to recognize that the majority of available information on
the Internet seeks to manipulate, rather than educate. Manufacturers and cosmetic physicians
have invested their finances, their livelihoods in the use of these fillers; and consequently, they
construct the content of webpages accordingly.
And thus, when one discerningly examines the information available on the Internet, one
realizes the astounding dysmmetry. A plethora of physicians skate around the issue of FDA
approval, and only a few note the potentially serious side effects, focusing their content on luring
in customers rather than educating the public. A patient might easily conclude that the use of
Radiance to treat wrinkles is FDA approved, considering the deceptive language outlined above
on physicians’ webpages.
The result is not the empowerment of the average consumer, but rather, deception. The
patient feels empowered by her new knowledge, when in reality, she was the recipient of a multimillion dollar marketing campaign - not an education.
3. The FDA’s Approach to Off-Label Marketing
In examining the FDA’s role to protect the consumer, one considers the agency’s policies
on marketing off-label uses of products. As demonstrated by the Radiesse case study,
manufacturers have discovered numerous ways to sidestep the technicalities; despite the FDA’s
prohibitions, consumers today are the direct recipients of off-label marketing by manufacturers.
On one hand, the government has taken the illegal marketing of drugs and devices very
seriously. In 1996, the government brought criminal misbranding charges against WarnerLambert for the off-label promotion of its drug Neurontin.157 The case was settled in 2004, after
the government alleged that Warner-Lambert “actively promoted Neurontin for off-label uses
through its sales reps, medical liaisons, teleconferences, consultants’ meetings, and advisory
boards.”158 Warner-Lambert pled guilty to distribution of an unapproved new drug and
distribution of a misbranded drug. Warner-Lambert settled the case by agreeing to pay $430
million in criminal fines and civil payments.159
Between 2000 and 2004, the federal government investigated the pharmaceutical
company Serono for alleged violation of the False Claims Act for its illegal marketing of
Serostim, a drug approved by the FDA to treat AIDS wasting. Serono allegedly expanded the
definition of AIDS wasting to include loss of body cell mass, “despite an absence of objective
weight loss.” Additionally, Serono illegally promoted the drug for lipodystrophy. 160
In 2005, the federal government and Serono reached a settlement, in which Serono
agreed to pay $704 million in criminal fines.161
157
Jack Cinquegrana & Diana K. Lloyd, Legal: Shifting Perspective on Off-Label Promotion, PHARMACEUTICAL
EXECUTIVE, Jan. 1, 2006, http://pexec.adv100.com/pharmexec/article/articleDetail.jsp?id=282490&pageID=2.
158
Id.
159
See id.
160
See id.
161
Id.
These examples indicate that the government has successfully initiated investigations into
illegal off-label promoting; thus providing some mechanism to tame the aggressive techniques of
pharmaceutical marketers. However, while governmental regulation may target blatant,
uncontroversial violations of the law; the most questionable territory involves the shades of gray.
The evolution of the Internet has created marketing channels so expansive that pharmaceutical
manufacturers face little difficulty bypassing FDA regulations to market off-label uses to
consumers. For example, the above case study of Radiesse illustrates the ease with which
pharmaceutical manufacturers can functionally achieve that which the FDA seeks to prohibit;
while falling short of blatant illegality. First, Radiesse’s own promotional website fails to
provide any substantial information regarding the product on its “USA” page, requiring
customers to enter its far more engaging, “Radiesse Worldwide” page to obtain information.
This transition is marketed by a large icon on the American site. The result is that American
consumers receive direct promotional materials from the manufacturer itself on the off-label use
of the device. Not even hidden, or earmarked as “off-label,” the description of this use occupies
the entire front page and most of the site’s space. Additionally, websites embodying every
attribute of a manufacturer’s promotional site can skate the line of liability by denying affiliation;
the promotional website for Radiance claims no link to the actual manufacturer.
And unfortunately, while naïve consumers believe the information they gather from these
websites increases their decision-making abilities, they are in fact recipients of limited and
biased information: “Unfortunately, information presented by pharmaceutical companies is often
a poor substitute for the substantial evidence presented to the FDA. As the Neurontin
controversy shows, pharmaceutical companies are beholden to the interests of stakeholders and
investors rather than the public, and simply do not adhere to the ethical guidelines outlined in
Section 401 of the FDAMA.”162
These examples of marketing illustrate the ability of the pharmaceutical industry to
sidestep technicalities, qualitatively deeming the FDA’s regulatory power useless. The Internet
has simply revolutionized the industry, and provided direct access to consumer markets at an
unprecedented level. Thus, marketing channels have transformed, and manufacturers have
discovered a myriad of ways to bypass marketing prohibitions. In response, the FDA must adapt
its guidelines and strengthen its positions to accommodate a technologically changing society;
useless guidelines reflect a useless agency.
E. ArteFill
The case study of Radiesse illustrated questionable tactics used by a manufacturer to
market an off-label use of a product, despite FDA prohibitions. A study of the injectable filler
known by the names of Arteplast, Artecoll and ArteFill illustrates another example of such
manipulation.
Arteplast was first used as an injectable filler in Europe between 1989 and 1994,
“sieved from bone cement using a nylon mesh.”163 Although the “rate of satisfaction was
consistently high … the rate of side effects was unacceptably high as well.”164 In fact,
researchers noted that “there are several reports from Europe of foreign body granuloma formation
associated with Arteplast and other permanent filler substances.”165 In a 1989 study conducted by
162
American Medical Student Association, Off-Label Marketing of Pharmaceuticals,
http://www.amsa.org/hp/OffLabel.cfm (last visited May 19, 2006).
163
Food and Drug Admin., Gen. and Plastic Surgery Devices Panel of the Med. Devices Advisory Comm. (Feb. 28,
2003), at 28, available at http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3934t1-am%20session.doc.
164
Id. at 29.
165
Id.
the Ethical Commission of Frankfurt University, 15 subjects of 587 “developed foreign-body
granulomas from 6 to 19 months after injection.”166
In response, researchers modified Arteplast by changing “the PMMA microsphere sieving
procedure and use of collagen as a suspension medium.”167 They labeled the result Artecoll, which
“is composed of PMMA microspheres, 30 to 42 microns in size, suspended in a water based
carrier gel composed of 3.5% bovine collagen, 96.5% buffered, isotonic water for injection
including 0.3% lidocaine.”168
Artecoll is injected through a tunneling technique with a hypodermic needle: “The
plunger is depressed and deposits the Artecoll while pulling out of the skin, leaving a small
cylindrical mass of Artecoll. Each microbead is coated in bovine collagen to keep from clumping
together; after the body gradually absorbs the collagen, it replaces it with its own collagen and
causes a plumping up of the wrinkles or lips.”169
After conducting a one-year study of 117 women and 11 men, Artecoll’s manufacturer
sought approval from the FDA in 2003. Though the FDA Advisory Panel recommended
Artecoll, the FDA expressed concerns, and did not grant approval, but sent an “approvable
letter” in 2004.
Even in the manufacturer’s study, within the first year – “16 percent of the 128 patients
had complications, including persistent swelling, lumpiness, flu-like symptoms, and blurred
166
Steven R. Cohen & Ralph E. Holmes, Artecoll: A Long-Lasting Injectable Wrinkle Filler Material: Report of a
Controlled, Randomized, Multicenter Clinical Trial of 251 Subjects, COSMETIC, Sep. 15, 2004, available at
http://www.artesmedical.com/pdf_download/cohen_revd_proof.pdf.
167
Food and Drug Admin., Summary of Safety and Effectiveness Data: Artecoll, at 3, available at
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3934b1_01_SSE-artes.doc
168
Id. at 1.
169
DIANA ZUCKERMAN & BETH NICHOLS, NAT’L RESEARCH CTR. FOR WOMEN AND FAMILIES, THE WRINKLE IN
FACIAL INJECTIONS AND IMPLANTS: SAFETY QUESTIONS 3 (July 2005), available at
http://center4research.org/injectables.pdf.
vision.”170 As Dr. Lowe notes, when questioned about Artecoll: “Still not approved for cosmetic
use in the US. Problems can arise when granulomas develop around the remaining beads. The
beads can also form crystals which can be felt beneath the skin.”171
After using Artecoll in their respective countries for years, doctors in Switzerland and
Canada encountered problems with the device that support the FDA’s hesitance:
“Three Swiss medical societies issued a warning against its use in the face because of reports that it causes
granulomas, which lead to unsightly bumps that usually have to be removed surgically. Many Canadian
doctors disavow its use for lip augmentation for the same reasons. A large portion of the medical
community believes Artecoll can cause inflammatory reactions that induce scar tissue, making removal of
the beads nearly impossible without causing some lip disfigurement. In 2003, the Canadian company that
sells Artecoll claimed that only 10 cases out of 8,000 patients worldwide have reported nodules within two
years, but interviews with Canadian doctors indicate many more problems. Plastic surgeons explain that
they don’t report lumpy lips because it doesn’t seem sufficiently important, but that means that there is no
way to determine how many patients have experienced unattractive and sometimes disfiguring lumps and
nodules.”172
As a result of the “large, unsightly bumps” that develop after a few years, the Swiss federal
office of public health recommended that physicians halt their usage of permanent cosmetic
fillers such as Artecoll. “Swiss authorities say complications, such as inflammation, can occur
long after an injection and they say the cosmetic benefits of a permanent filler don't
counterbalance those risks.”173
1. Conflicting Accounts of Incidences of Granuloma
170
Id.
Alice Hart-Davies, Do You Really Want This in Your Face, EVENING STANDARD (LONDON), Mar. 15, 2005,
http://www.findarticles.com/p/articles/mi_qn4153/is_20050315/ai_n12942296/pg_4.
172
ZUCKERMAN & NICHOLS, supra note 1699, at 3.
173
Leslie Papp, Lumpy Lips a Danger with Canadian Substance, Artecoll,
http://www.talksurgery.com/consumer/new/new00000103_6.html (last visited May 19, 2006).
171
Artecoll was approved for commerical use in Canada in 1988, where 10,000 syringes
have been sold; and as many as 12,000 patients have been injected.174 Artecoll’s manufacturer,
Canderm, markets the product in pamphlets and on its website with the following claim: "Since
Artecoll was introduced on the Canadian market in August, 1998, no incidences (of granuloma)
have been reported."175 In 2004, Dr. Stefan Lemperle, CEO of Artes Medical, made the
following grand claims to Business Wire: “Many attempts have been made to develop a safe,
partially synthetic material to permanently fill wrinkles and scars because the body absorbs all
biological substances within one year. Previous synthetic products have been associated with
negative side affects such as granulomas or late allergic reactions.”176 However, “Artecoll has
been specifically engineered to overcome these obstacles and provide safe, enduring results.”177
Despite Dr. Lemperle’s confident proclamations, other physicians deeply question the
veracity of these claims: “at least three Toronto doctors each say they've found two granulomas
associated with Artecoll and have told the company. A fourth doctor says he had seen and treated
one of the lumps but didn't call Canderm. Among those finding granulomas was Toronto plastic
surgeon Dr. Frank Beninger, who teaches Artecoll use on behalf of the firm and is paid for that
service by Canderm.”178 Beninger continues: “Both (cases) that I've seen were in the lip, [and]
confirmed by a pathologist's analysis while the other precisely matched every characteristic of a
granuloma, including disappearing with a steroid injection.”179
174
Mark Blanchard, Filler Material May Cause Nodules, Lumps in Lips, COSMETIC SURGERY TIMES, June 1, 2002,
available at http://mediwire.mediwire.com/main/Default.aspx?P=Content&ArticleID=20543.
175
Papp, supra note 1733.
176
Landmark U.S. FDA Clinical Trial Results for First Permanent Injectable Wrinkle Filler Published in Journal of
Plastic and Reconstructive Surgery, BUSINESS WIRE, Nov 9, 2004,
http://www.findarticles.com/p/articles/mi_m0EIN/is_2004_Nov_9/ai_n6337543.
177
Id.
178
Papp, supra note 1733.
179
Id.
In 1999, four physicians published their discoveries of granuloma in three Artecoll
patients in the American Journal of Surgical Pathology. The granuloma consisted of round
vacuoles surrounding circumscribed, translucent, nonbirefringent foreign bodies. Their existence
led to the excisions of the cosmetic implants in each patient.180
Dr. Stephen Mulholland, a cosmetic surgeon in Toronto, admits to having used “gallons”
of Artecoll on his patients. However, he notes that “A lot of doctors are afraid to use it in the
lips because you get those little nubbins… In about 50 per cent of (lip) patients you have lumps
— no question about it. And patients need to know that.”181
Although bumps can also be caused by other types of injectable fillers, the permanence of
Artecoll makes the bumps far more problematic: “long-term bumps are clearly a bigger problem
with Artecoll,” as “Artecoll is an implant. You're putting solid material in there.”182
Furthermore, as Canadian plastic surgeon Dr. Claudio De Lorenzi notes: “There's no way to
remove this stuff except by cutting it out … This is not acceptable for my patients.” De Lorenzi
has since stopped offering Artecoll injections in his patients’ lips.183 In fact, De Lorenzi felt so
strongly, that he warned American doctors at the Aesthetic Meeting 2002 in Las Vegas: “It’s a
part of our duty to tell others what our experience has been … Instead of getting uniform
enlargement, you get little tiny bits of gravel under the skin … When the material coalesces
together, you get a hard lump in the lip.”184 While physicians have observed fewer problems
180
Christina M. Rudolph et al., Foreign Body Granulomas Due to Injectable Aesthetic Microimplants, 23 AM. J.
SURGICAL PATHOLOGY 113 (1999), available at http://www.ajsp.com/pt/re/ajsp/abstract.00000478-19990100000013.htm;jsessionid=EYcjybXh3Yd4804PtCn4YU9UJYj4vZ0h21J8AaeBnX2zhz0e2Unz!-839643570!949856144!9001!-1.
181
Papp, supra note 1733.
182
Id.
183
Id.
184
Blanchard, supra note 1744.
when using Artecoll in other areas: “In what appeared to me as possibly its best possible use - lip
enlargement, the material has failed miserably and unfortunately causes significant problems.”185
Largely as a result of De Lorenzi’s “warning,” Canadian doctors called for further
clinical guidelines and additional research on adverse reactions to injections of Artecoll. Even
patients themselves are issuing “warnings” to their peers; one patient posted the following on a
public web discussion forum on lip augmentation:
“BE CAREFUL WITH THIS STUFF!!! Read my post earlier in the board. I am extreemely(sp) unhappy
with my results. Raised scars now, wrinkled skin, uneven bumps and overcorrection (I now have labial
folds when I did not before). Lips are probably safer areas, but scars and wrinkles and hollowed areas
require exact and aesthetic injections. Unfortunately, my "technician" was inexperienced and inexact. I am
now considering a facelift, dermabrasion, peels, implants and lipo for my face.”186
Even if Artecoll eventually receives FDA approval, Dr. Michelle Copeland, plastic surgeon in
New York City and author of CHANGE YOUR LOOKS, CHANGE YOUR LIFE, expresses hesitation to
use it on her patients. “My concern is even if it gets FDA approval, there's a chance you could
have a problem with it and the correction can cause more irregularities in your tissues. Do you
want to take that chance?”187
2. Accusations of Illegal Use and a Cover-Up Scam
And if the questionable veracity of the manufacturer’s health claims does not give rise
to sufficient suspicion of Artes Medical’s integrity, the corporation has recently been accused of
engaging in other severely misleading tactics. Whereas the above case studies involved false
claims by unlicensed practitioners using bogus ingredients, at the center of this investigation is
185
Id.
Posting of spoonman to Healthboards.com, http://www.healthboards.com/ubb/Forum36/HTML/000448.html
(Dec. 31, 2001, 15:35 PM EST).
187
Kristi Palma, Injecting Youth, EAGLE TRIBUNE, Mar. 10, 2003,
http://www.eagletribune.com/news/stories/20030310/LI_001.htm.
186
the manufacturer’s co-founder, Dr. Gottfried Lemperle.188 Lemperle is attributed with the
invention of Artefill, and maintains a license to practice dermatology in Germany. However, he
remains unlicensed in the United States.189
Hairdresser Elizabeth Sandor, 40, alleged in May 2006 that Dr. Lemperle used Artefill
as an injection to fill her facial wrinkes in 2002, when Artes Medical was still a small start-up
company.190 She alleges that Lemperle falsely convinced her that Artefill had received FDA
approval, and that he never disclosed his lack of license in California.191 Her claims detail
suffering of pain and disfigurement: “[b]y March 2004, Sandor’s face was inflamed, she had
scarring near the injection sites and had a fever and aches and pains, all of which she attributed
to a negative reaction to Artefill.”192 As a follow-up to her reactions, Sandor contends that
Artes’ chief executive and Gottfried Lemperle’s son, Stefan Lemperle, convinced her to refrain
from visiting a hospital, and referred her to dermatologist Steven Cohen. Sandor alleges that she
was unaware that Cohen was the lead physician in the Artefill clinical trials, and an investor in
Artes Medical. Despite the persistence of her negative reaction, Sandor claims that Cohen
refrained from referring her to anyone else. Further, she alleges that the Lemperles and Cohen
“sought to hide her negative reactions to Artefill so that it would not be included in the clinical
trial results submitted to the FDA.”193
Although the Lemperles deny the accusations, attorneys say that emails verify Sandor’s
story. Additionally, “[a]n internal investigation by Artes also determined that Gottfried
Lemperle had used Artecoll, a predecessor product to Artefill that was sold outside the United
188
Terri Somers, Product Disfigured Her, Woman Says in Lawsuit, UNION TRIBUNE, May 13, 2006, available at
http://www.signonsandiego.com/news/business/20060513-9999-1b13artes.html.
189
Id.
190
Id.
191
Id.
192
Id.
193
Id.
States, on four people in this country, according to SEC documents.”194 Meanwhile Stefan
Lemperle had been publicly denouncing consumers who inappropriately sought injections in a
practitioner’s home: “These people have money and could have chartered a plane, flown to
Vancouver and had someone who is trained in using Artecoll do their work and avoid all these
problems … Instead they paid someone they didn’t know to do it in the bathroom.”195
These allegations create cause for substantial concern on the part of both consumers and
regulators. The incentives of manufacturers and consumers are misaligned, and thus, consumers
suffer as recipients of misleading information. The case study of Radiesse illustrates the new
difficulties in policing off-label marketing that have arisen with the growth of technology. The
case study of Artes Medical further demonstrates inappropriate techniques used by
manufacturers in tending to the needs of a population crazed with desire for youth and beauty.
While the government can and should be trusted to engage in criminal investigations, the
magnitude and breadth of these improprieties are overwhelming. And unfortunately, the burden
of confronting these barriers erected by a changing society is shared by the FDA; in its mission
to protect the health and safety of the public, the regulatory agency must adapt to accommodate
and preempt the cunning ways of the new frontier.
CONCLUSION
This paper has sought to illustrate the regulatory challenges and consumer risks that
have accompanied the nation’s obsessive pursuit of the newest injectable filler. The promise of
attaining youth and beauty has eluded cultures since Cleopatra, but the relatively novel potential
to eliminate wrinkles and re-contour the face has lured more consumers than ever - from
194
195
Id.
Id.
hairdressers to suburban housewives, from men to transgendered women. Researchers and
pyschologists identify the causes of this phenomenon as rooted in technology, in consumption,
and in the changing opinions of mental illness.
The first case study traced the incredible progress of the “world’s most poisonous
poison” from its role in sausage poisoning and canning outbreaks, to its injection as a wrinklefiller. Whereas the FDA successfully combated botulism and educated housewifes on proper
home-canning techniques, the task of controlling the safety and appropriateness of injectable
Botox has proven more difficult. Little hesitation accompanied off-label uses before the FDA
approved cosmetic applications of Botox. Once the FDA granted its approval, the floodgates
opened, and women across the nation now request a glass of white wine along with their
potentially fatal poison. Even more disconcerting has been the emergence of widespread illegal
use; black market Botox disfigures and kills, but has been embraced by unfortunate recipients as
a cost-effective way to reduce wrinkles.
The next case study observed the even more dangerous phenomenon of liquid silicone
injections. Banned by the FDA in 1992, then approved for ophthalmologic procedures in 1994,
silicone injections are accompanied by an appropriately significant amount of hesitation by many
in the medical community. Unfortunately, consumers are less afraid, and innumerable instances
of disfigurement and fatalities have emerged as results of “pump parties.” Without a remote nod
to the health risks involved in any type of injection, women, in the masses, have welcomed
industrial-grade silicone into their bodies and faces – with disfigurement and death as common
consequences. In contemplating its potential approval, the FDA ought to use the expedited
trajectory of Botox as a warning; if pump parties are accepted practice within certain
communities now – imagine what the floodgates will usher in upon approval.
In observing the cultural obsession with injectable fillers, it is impossible to ignore the
pivotal role played by technology. As a result of the Internet, consumers have access to vast
amounts of previously unattainable information – and manufacturers have unprecedented access
to consumers. The FDA prohibits manufacturers from marketing the off-label uses of devices;
however, the Internet provides innumerable ways for manufacturers to sidestep regulations. The
third case study examined the filler Radiesse, and detailed the cunning ways the manufacturer
marketed off-label uses. And manufacturers are not alone; physicians similarly lure online
customers by describing devices with deceptive language. In particular, some physicians skate
around the issue of FDA approval by using text that implies the approval of an off-label use.
While not technically constituting blatant lies, much of this information is severely misleading.
And thus the emergence of the Internet as a massive marketing channel forces the FDA
to confront changing times; new technology requires that the FDA recognize the obselete nature
of its marketing guidelines. Perhaps the solution requires physicians to inform patients of a
device’s FDA approval status. Regardless of its conclusions, the FDA must acknowledge the
role played by technological evolution, and address it accordingly.
Lastly, the final case study examined the path of Arteplast/Artecoll/ArteFill. Perhaps
more blatantly than the above examples, Artes Medical similarly crossed ethical lines by
misrepresenting accounts of granulomas. Additionally, co-founder Gottfried Lemperle
allegedly lied to a patient about the device’s approval status and attempted to exclude her
negative reactions to the treatment from clinical studies. She suffered pain, disfigurement and
massive deception, in this case not at the hands of a hairstylist masking as a practitioner, but
from the chief scientist of a product likely to receive FDA approval. This behavior exemplifies
the unfortunate ramifications of an industry crazed and overwhelmed in its attempt to meet the
needs of a zealous public.
And thus, it seems, that most of the players involved in the industry have demonstrated
great flexibility and cunningly quick, if not unethical, response to change. Psychotherapists have
adjusted their musings on the pursuit of beauty to accommodate technology, rampant
consumerism and the changing perceptions of mental illness. The result is in modified theories,
which use the above factors to explain the cultural obsession with re-contouring faces and
eliminating wrinkles. Likewise, the manufacturers have seamlessly integrated their marketing
techniques with the rapid growth of the Internet; they have brilliantly used online channels of
communication to mass market repeatedly and intensively to consumers. And finally, the last to
change, the last to adapt: the government. Regulatory agencies must confront the changing
times, must react to new developments with flexibility and creativity. Acknowledging the craze,
identifying the factors that have caused consumer harm, and actively seeking change will allow
the FDA to confront and manage the debacle created by injectable fillers, and ultimately fulfill
its role of providing safety and protection to the American public.