Download Prolapse - New Jersey Urologic Institute

Patient Name:
_
Date:
New Jersey Urologic Institute
Dr Betsy Greenleaf DO, FACOOG
Pelvic Medicine and Reconstructive Surgery
10Industrial Way East, Suite 101, Eatontown, New Jersey 07724
732-963-9091 Fax: 732-963-9092
Findings:
_
_
Post Operative Instructions (Vaginal Reconstruction/Sling Urethropexy)
1. Activity: May do as much as you feel up to. Your body will let you
know when you are doing too much. Don't push yourself, however.
Walking is ok and encouraged. If you sit too long you will become stiff
and it will make it more difficult to move. Lying around can promote
the formation of blood clots that can be life threatening. It is therefore
important to move around. If you don't feel like walking, at least move
your legs around in bed from time to time. Stairs are ok, just be careful
of standing up too quickly and becoming light headed.
Sitting still can also increase your risk of pneumonia. In addition to
moving around, practice taking deep breaths ( 10 times each every
hour or so) to keep your lungs properly aerated.
Limitations: Avoid lifting or pushing/pulling any objects heavier
than 1Olbs for at least 3 months. For patients with pelvic hernia or
prolapse repairs it is recommended not to lift objects heavier than
25 Ibs for life. This may seem unrealistic. Try to put off lifting as
long as possible. If you must lift, do not hold your breathe. Blow
out as you lift to decrease abdominal and pelvic pressure. Also be
aware that if you choose to lift objects heavier than recommended
you risk forming another hernia
2. Bathing: You may shower the day after surgery.
Limitations: Do not submerse until cleared by your doctor (on
average 6-8 weeks) No baths, Jacuzzi, swimming ...
.However, may do sitz baths ( purchase from a pharmacy).
Sitz bath instructions:
Place sitz basin on toilet. Add 2 tablespoons of Epson salt
in warm water. Fill sitz bath and sit in for no more than 20 minutes
at a time. Repeat as necessary for relief. Be sure to clean sitz
bath with disinfectant between uses
Epsom Bath Instructions:
You may also use the bathtub to do an epsom bath for
swelling relief. First take shower to rinse of skin bacteria. Make
sure the tub is then disinfected with cleaner. Fill the bath with
warm water and 2 cups of Epsom salt. Do no soak for longer than
20 minutes. Repeat as necessary for relief of discomfort and
swelling.
Page 1 : 4
3. Driving: You may drive when off pain medications (average 2-4
weeks)
4. Diet: You may return to regular diet as soon as possible. No
restrictions
5. Medications: Take all medicine prescribed as directed. Prescribed
medications will be checked below.
_ _Percocet one to two pills every 4-6 hours as needed for
severe pain ( may cause nausea and constipation)
_ _ _ _ every 4-6 hours as needed for severe pain. (may
cause nausea and constipation)
___Nucynta 50 mg one pill every 4-6 hours as needed for severe
pain
___ Sprix 15.75 mg one spray in nostril every 6 hours for pain
and to keep down inflammation. Do not use past 5 days.
___Motrin 600mg every 6 hours for pain and to keep down
inflammation. Take with food. (may cause stomach upset)
___Vimovo 375/20 mg one pill twice daily for pain and to keep
down inflammation.
_XX_ Miralax one tablespoon in 8 oz of liquid daily to prevent
constipation. Over the counter
___Premarin cream Apply one inch of cream to vulva with finger
three times a week. VERY IMPORTANT: aids in healing.
_ _Estrace Cream Apply one inch of cream to vulva with finger
three times a week. VERY IMPORTANT: aids in healing.
_ _You have an Estring hormone ring in place. This is a hormone
ring that will aid with healing. It is good for 3 months and then
needs to be removed. If falls out, wash it with soap and water
either replace in the vagina or notify the office to schedule an
appointment to have it replaced.
_ _Macrobid one pill twice daily ( preferably every 12 hours) if
you go home with catheter.
___ Bactrim one pill twice daily ( preferably every 12 hours) if
you go home with catheter.
_ _ Pyridium one pill every 8 hours as needed for bladder
irritation. May need if you go home with a catheter. Turns urine
orange.
Page 2: 4
_ _Urelle or Prosed OS one pill every 6 hours as needed for
bladder irritation. May need if you go home with a catheter. Turns
urine blue.
___ Other
6. Urinating: Sometimes after surgery you are too swollen to urinate
and will need to go home with a catheter until some of the swelling
diminishes. If you go home with a catheter you will need to follow
up in office in
days/weeks for removal. Call to schedule
appointment. Make sure you take antibiotics while catheter in place
(marked above)
Difficulty urinating: If you go home without a catheter and have
difficulty urinating, it is important to try and relax. Let the bladder
do the pushing. Often if you try bearing down to push the urine out
you will not be able to urinate. You may also try getting into the
shower to pee. The warm water may stimulate you to urinate. You
can also attempt to push on your lower abdomen with you hand to
attempt to start the flow. If you are still unable to urinate you may
need to come to the office for the placement of a catheter or if the
office is closed, go to the nearest emergency room.
Leaking: It is not unusual to leak after surgery. Sometimes you
are too swollen for the urethra to close all the way, or sometimes
the bladder is irritated after surgery and will spasm expelling urine.
This is not unusual for 4-8 weeks after surgery. If it continues past
12 weeks your doctor will look into further causes of your leaking.
7. Bleeding: It is not unusual for the vagina to bleed and ooze after
surgery. Sometimes the bleeding will pick up a week or two after
surgery. This is commonly caused by the body dissolving any
blood clots that formed at the surgery site. This dissolved blood will
then leak through your incisions. It may be seen as a gush of fluid
after standing or walking around. It is not unusually for this vaginal
discharge to have an odor. If it is itching or burning, please notify your
doctor.
Change maxi pads every 2-4 hours to prevent infection. Pads hold
in bacteria thus it is important to keep clean.
If the bleeding is continuous and you are soaking through more than
a maxi pad an hour for two hours, notify your doctor. Also call if this
bleeding is associated with shortness of breath, light headedness,
fainting .......
8. Constipation: DO NOT GET CONSTIPATED. This is easier
said than done. Surgery alone can cause constipation as can pain
medications. You can avoid constipation by increasing your activity.
The more you walk the more you will get your bowels to work properly.
Stick with a high fiber (unless otherwise instructed by your doctor) diet
and increase your fluid intake preferably water ( 64-96 oz a day). You
may also use over the counter constipation products and combine
Page 3 : 4
them if necessary. Just make sure to drink a lot of lluids. You
may try Milk of Magnesia, Maalox, Dulcolax suppositories, Glycerin
Suppositories, Metamucil, Fleets phosphasoda, or enemas. Stay away
from Senekot or "senna" containing products: your body can become
dependent on these.
9. Fever: A fever is any temperature above 100.4 F. Fever can be a
normal reaction of your body to the stress of surgery. However, notify
your doctor for temperatures above 101 F.
10. If you are diabetic: The stress of surgery may cause your sugars
to increase. Pay close attention to your sugars and notify your
endocrinologist or primary doctor if your sugars are running high. High
sugars can prevent healing and can increase your risk of infection
11. Pelvic Rest: Nothing in the vagina until your doctor clears you. On
average this is for 4-8 weeks. This means no vaginal sex, no tampons,
no douching ....... 00 not receive oral sex until cleared by doctor. Other
sexual activities may be engaged in as tolerated. Feel free to contact
your doctor with any questions.
12. Wound care: Other than using a hormone cream or ring vaginally to
aid in healing there is nothing that you need to put on your incisions.
Just keep incision sites clean and dry. Clean with mild soap and
water. You do not need Neosporin, Bactroban, Bacitracin, Vitamin
E ....or any other topical ointments. These products can actually
prevent healing initially by getting into the incision and preventing it
from coming together. Vitamin E can be used on external incisions
after 2-4 weeks, but check with doctor before using.
13.Bruising: It is not unusual to get bruising after surgery. You may
apply heat to these areas 48 hours after surgery to help your body
absorb the bruising.
14.Air under skin if you had laparoscopic surgery: You can also get
some leakage of air under your skin from the laparoscopic portion of
the procedure. Your tissue may feel like "rice Krispies" from these air
bubbles. This air will be absorbed over a period of 3-5 days.
15. Follow up appointments: Call office to make follow up appointment.
You will need to be seen:
_ _ 2-4 weeks after surgery
_ _ 6-8 weeks after surgery
_ _6 months after surgery
_ _12 months after surgery
_ _Yearly after surgery
_XX_ If you have any problems or concerns
Page 4: 4
Take the Floor: Types of Surgery
8/22113
Types of Surgery
Apical Suspensions
The most important aspect of a prolapse repair (when maintaining sexual function is desired) is restoration of the
support of the top of the vagina which is also called the vaginal apex or vault. Common procedures that do this are:
Abdominal Sacral Colpopexy (ASC) - The ASC is performed through an abdominal incision (about 3-4 inches
long), laparoscopically (through 4 half inch incisions) or roboticaly. In this procedure straps of graft material are used
to reinforce the front and back walls of the vagina. These straps are then attached to a strong ligament o'Rrlying the
sacrum. The end result is that the vagina is suspended O'Rr the pelvic muscles to the back-bone. The mesh graft
straps replace the original natural support provided by the uterosacral ligaments.
Uterosacral or Sacrospinous Ligament Fixation - When a vaginal incision is preferred, the top of the vagina is
most often suspended to a woman's own uterosacral ligament or the sacrospinous ligaments. Traditionally these
procedures did not use graft material. Recently, more surgeons are adding graft reinforcement to the natural ligament
suspensions in an effort to impro'R the durability of the prolapse repair when surgeons find the vaginal wall to be
weak. Research studies are being conducted to determine if this desired benefit will result in superior outcomes.
Anterior Vaginal Prolapse Repair
A Cystocele or bulge of the front wall of the vagina usually results in loss of support to the bladder that rests upon
this part of the vagina. The goal of a cystocele repair is to elevate the anterior vaginal wall back into the body and
support the bladder. This can be done either vaginally called anterior colporrhaphy or through an abdominal approach
at the time of a sacral colpopexy.
Anterior colporrhaphy is a commonly performed repair of a cystocele. In an anterior colporrhaphy, an incision is
made in the front wall of the vagina. The vaginal skin is separated from the bladder wall behind it. The weak or
frayed edges of the deep vaginal wall are found and the strong tissue next to edges are sutured to each other
lifting the bladder and recreating the strong "wall" underneath it. The vaginal incision is then closed with
dissolving stitches. Unfortunately, this part of the pelvic floor is subjected to significant pressure with each
cough or when picking up heavy things. As many as one third of women will de\€ l op recurrent anterior prolapse
after an anterior colporrhaphay. To reduce this recurrence of prolapse, a surgeon may chose to place a "patch"
of graft material O'Rr the repair line to reinforce the repair. Studies are in progress to help us learn whether or not
using grafts provides superior results when compared to traditional surgeries. The studies will also compare the
risks of the two types of procedures and who benefits most from the mesh reinforcements.
Posterior Vaginal Prolapse Repair
A rectocele or bulge of the back wall of the vagina is most often repaired by a vaginal procedure called posterior
colporrhaphy. If the muscles at the opening of the vagina ha'R been stretched or separated during childbirth, the
repair may include a perineorrhaphy. A rectocele may also be fixed abdominally at the time of a sacral colpopexy.
Posterior Colporrhaphy - Colpo- means "vagina" and -rhaphy means "repair of." Posterior colporrhaphy is a
procedure that repairs the rectal bulge protruding through the back wall of the vagina. During the colporrhaphy
procedure, an incision is made in the back wall of the vagina. The vaginal skin is separated from the rectal wall
underneath. The weak or frayed edges of the deep vaginal wall tissue are identified. The strong tissue next to edges
are sutured to each other recreating the strong "wall" between the rectum and the vagina. The vaginal incision is then
closed. At times, a surgeon may chose to place a "patch" of graft material o\€ r the repair line to reinforce the repair.
Studies are ongoing to help understand the role of these graft materials in rectocele repair. Your surgeon will most
likely close the incision with self-dissolving stitches.
Perineorrhaphy - Surgical reconstruction of the muscles of the perineum, the area between the vagina and the
rectum. This procedure invol\€s reattaching a number of small muscles that normally connect in this area.
Obliterative Procedures
For those women who do not need to maintain sexual function, an obliterati\€
WMV.l.Oicesforpfd.org/p/cm'ld/fid= 135
procedure may be the quickest and
1/2
8122113
Take the Floor: Types of Surgery
least risky method to correct prolapse. Obliterative operations correct prolapse by narrowing and shortening the
vagina. These procedures support the pelvic organs with the patients own pelvic muscles in such a way as to make
the vagina too small to accommodate a penis for sexual intercourse. The skin overlying the vaginal bulge is removed,
and the front and back walls of the vagina are sewn to each other. A woman who has undergone this surgery will look
the same on the outside of her genital area and she will be able to have bowel movements and urinate normally. Her
ability to have an orgas m with clitoral stimulation is similar to before her surgery.
There are two main types of obliterative surgery:
• partial (colpocleisis)
• complete (colpectomy)
Both are very effective and durable in correcting prolapse. Prior surgeries often influence which procedure is offered to
women. The benefit of obliterative surgery is that it is very durable, does not involve the risks of graft materials, tends
to be less invas ive and therefore is associated with a quicker recovery.
Sources
Original publication date: May, 2008; Updated, February 2012.
WNN.\Qicesforpfd.org/plcm'ldlfid~
135
212
Safety Communication~ > FDA Safety Communication: UPDATE on Serious Complicati...
Page 1 ot 4
Home Medical Devices Medical Device Safety Safety Communications
Medical Devices
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh
for Pelvic Organ Prolapse
Date Issued: July 13, 2011
Audience:
• Health care providers who implant surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence
• Health care providers involved In the care of patients with surgical mesh implanted to repair pelvIc organ prolapse and/or stress
urinary incontinence
• Patients who are considering or have received a surgical mesh implant to repair pelvic organ prolapse and/or stress urinary
incontinence
Medical Specialties: gynecology, urogynecology, urology, general surgery, internal medicine, family practice, emergency medicine
Device:
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue, It is made from porous absorbable or non­ absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to
reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence,
Background:
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs In place become weak or stretched, Thirty to fifty percent of
women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) Into the
vagina and sometimes prolapse past the vaginal opening, More than one pelvic organ can prolapse at the same time, Organs that can be
involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.
Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or
exercise.
Purpose:
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on senous complications associated with
surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.
Based on an updated analysis of adverse events reported to the FDA and complications described In the sCientific literature, the FDA
identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern,
The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not
rare, This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair
with mesh is more effective than traditional non-mesh repair in all patients with POP and It may expose patients to greater risk. This Safety
Communication prOVides updated recommendations for health care providers and patients and updates the FDA's activities involVing
surgical mesh for the transvaginal repair of POP,
The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.
For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for
Pelvic Organ Prolapse,l
Summary of Problem and Scope:
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to
repair POP and SUI for the previous 3-year period (2005 - 2007) was "over 1,000." Since then, from Jan. 01, 2008 through Dec, 31, 2010,
the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503
reports associated with POP repairs and 1,371 associated with SUI repairs. Although it IS common for adverse event reporting to increase
following an FDA safety communication, we are concerned that the number of adverse event reports remains high.
From 2008 - 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh eroSion
through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain dunng sexual intercourse (dyspareunia),
organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal
scarring/shrinkage, and emotional problems, Many of these complications require additional intervention, including medical or surgical
treatment and hospitalization.
In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific
literature from 1996 - 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not
improve symptomatic results or quality of life over traditional non-mesh repair, The FDA continues to evaluate the literature for SUI
surgeries using surgical mesh and will report about that usage at a later date,
In particular, the literature review revealed that:
• Mesh used in transvaginal POP repair Introduces risks not present in traditional non-mesh surgery for POP repair.
• Mesh placed abdominally for POP repair appears to result In lower rates of mesh complications compared to transvaginal POP surgery
with mesh.
• There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior
repair) With mesh prOVides any added benefit compared to traditional surgery without mesh,
• While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh
augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, thiS anatomic benefit may not
result in better symptomatic results,
The FDA's literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related
complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for
some women, In some cases, even multiple surgeries will not resolve the complication.
Mesh contraction (shrinkage) is a previously Unidentified risk of transvaginal POP repair with mesh that has been reported in the published
http://www.fda.govlMedicalDevices/Safetv/AlertsandNotices/ucm262435.htm
7/2/2013
Safety Conununications > FDA Safety Communication: UPDAIE on Serious CompJicati...
Page 2 of 4
scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature
associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.
Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual Intercourse or an inability to engage in sexual
intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.
The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.
Recommendations for Health Care Providers:
As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should:
• Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
• Be vigilant for potential adverse events from the mesh, especially erosion and infection.
• Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel
perforations.
• Inform patients that Implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh
may require additional surgery that mayor may not correct the complication.
• Inform patients about the potential for serious complications and their effect on quality of life, inclUding pain during sexual
intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh.
• Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.
In addition, the FDA also recommends that health care providers:
• Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
• Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical
alternatives.
• Consider these factors before placing surgical mesh:
a Surgical mesh is a permanent implant that may make future surgical repair more challenging.
o A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
a Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient's quality of
life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including
paill.
a Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP
surgery with mesh.
• Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the
likely success of these alternatives compared to transvagillal surgery with mesh.
• Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
• Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term
outcomes data.
Recommendations for Patients:
Before Surgery
Be aware of the risks associated with surgical mesh for transvaginal repair of POP. Know that having a mesh surgery may put you at risk for
needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.
Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand
why your surgeon may be recommending treatment of POP with mesh.
In addition, ask your surgeon these questions before you agree to have surgery in which surgical mesh will be used:
• Are you planning to use mesh in my surgery?
• Why do you think I am a good candidate for surgical mesh?
• Why is surgical mesh being chosen for my repair?
• What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
• What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully
performed without using surgical mesh?
• Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal
wall?
• If surgical mesh IS to be used, how often have you implanted this particular product? What results have your other patients had with
this product?
• What can I expect to feel after surgery and for how long?
• Which specific side effects should I report to you after the surgery?
• What if the mesh surgery doesn't correct my problem?
• If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
• If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the
consequences?
• If a surgical mesh is to be used, is there patient information that comes With the product, and can I have a copy?
After Surgery
• Contillue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are
satisfied with your surgery and are not haVing complications or symptoms.
• Notify your health care provider if you have complications or symptoms, IIlciuding persistent vaginal bleeding or discharge, pelvic or
grolll pain or pain with sex, that last after your follow-up appointment.
• Let your health care prOVider know you have surgical mesh, espeCially if you plan to have another surgery or other medical
procedures.
• Talk to your health care prOVider about any questions you may have.
http://www.fda.gov/MedicalDevices/Safety/AJertsandNotices/ucm262435.htm
7/2/2013
Satety CommuDlcations > FDA Satety CommunicatlOn: UPDATE on Serious Complicati...
Page 3 of 4
If you had POP surgery, but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit.
FDA Activities:
The FDA is working in several areas to assess and improve the safety and effectiveness of urogynecologic mesh products. The FDA will:
• Convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, on September 8-9, 2011.The panel will
discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and SUI.
• Explore regulatory solutions to answer questions about the safety and effectiveness of urogynecologic mesh products that are now
being marketed and those that will be reviewed for marketing in the future.
• Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing
any and all data as it becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you
suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and
Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting
requirements 2 should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical
Device Reporting (MDR) regulations 3
To help us learn as much as possible about the adverse events associated with surgical mesh to repair POP and SUI, please include the
following information in your reports, if available:
• Manufacturer's name
• Product name (brand name)
• Catalog number
• Lot number
•
•
•
•
Size
Date of implant
Date of explant (if mesh was removed)
Details of the adverse event and medical and/or surgical interventions (if required)
• Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
• Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
• Reason for mesh Implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
• Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance
(DSMICA) at [email protected], 800-638-2041 or 301-796-7100.
This document reflects the FDA's current analysis of available information, in keeping with our commitment to inform the public about
ongoing safety reviews of medical devices.
Additional Information
• Urogynecologic Surgical Mesh Implants 4
• Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (July
2011) (PDF - 243KB)5
• Press Release: Surgical placement of mesh to repair pelvic organ prolapse poses risks 6
• Federal Register Notice: Urogynecologic Surgical Mesh?
• Federal Register Notice Amendment: Urogynecologic Surgical Mesh 8
Page Last Updated: 06/18/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA
For Government For Press
Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness
International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local OffiCials Consumers
Industry Health Professionals FDA Archive
~
U.s. DepartJ'l.lem of Health &. Human 5ervice-s
Links on this page:
1. / downloads/Medical Devices/Safety/ Alertsand Notices/UCM 2627 60 .pdf
2.
/M edlcal Devices/D evice Regulationa ndGuida nce/Postma rketReq ui rements/Reporti ngAdverseEvents/ucm 20 OS7 3 7. htm
3.
/M edi ca IDevices/Devi ceRegulationandGu ida nce/Postma rketRequ ire ments/Reporti ngAdverseEve nts/ucm 2 00 57 3 7. htm
4.
/Med ica IDevlces/ Prod uctsa ndMedica IProcedu res/1m plantsa nd Prosthetics/U roGynSurgica IMesh/defa u It. htm
http://www.fda.govlMedicalDevices/Safety/AlertsandNotices/ucm262435.htm
7/2/2013
8/22113
Take the Floor: Prel.€nting
Pel\ic Organ Prolapse
Prevention
Because vaginal and uterine prolapse have several different causes, there is no single way to prevent these problems.
Currently, a woman cannot change her genetic risk profile which influences the strength of her connective tissue.
Women can make lifestyle choices that can influence risk factors that are modifiable. In general, avoiding increased
pressure inside the abdomen will diminish pressure placed upon the pelvic floor is wise.
This can be done by:
•
•
•
•
•
•
•
Maintaining a normal weight or losing weight if overweight. Overweight women are at a significantly increased
risk of developing prolapse.
Avoiding constipation and chronic straining during bowel movement, which increase a woman's chance of
developing prolapse, especially a rectocele. A diet with plenty of fiber and fluids, as well as regular exercise is
important for maintaining regular bowel function. If constipation persists despite these measures, further
evaluation and treatment is recommended.
Seeking medical attention to evaluate and treat a chronic cough which increases abdominal and pelvic
pressure.
Avoiding heavy lifting and learn how to lift safely by using leg and arm muscles as much as possible.
Not smoking or kicking the habit!
Avoiding repetitive strenuous activities.
Learning and performing pelvic floor muscle exercises (Kegels) regularly to improve the strength of the pelvic
floor and limit the likelihood of developing prolapse. Once prolapse has developed, pelvic floor exercises will not
correct the prolapse, but they may limit the development of worsening prolapse and may diminish some of the
symptoms.
There has been considerable discussion about whether a cesarean delivery (C-section) might reduce the chance of
developing prolapse later in the life. Operative vaginal deliveries (forceps or vacuum deliveries) may increase the risk of
pelvic floor injury and increase woman's risk of developing prolapse. Route of delivery is very important and a
complicated topic, which one should address with their obstetrical provider. It is clear that being pregnant alone,
regardless of the type of delivery, contributes to the development of pelvic floor disorders. However, it is important to
remember that there are women who have never been pregnant who leak urine and stool or have prolapse - and
women who have delivered many times who do not. There is no clear answer to this question at this time.
When considering your treatment options it is best to work with your urogynecologist to make a plan that works best
for you. A lot depends on your individual problems, and more depends on your preferences. A woman should seek
treatment whenever her symptoms have a negative impact on her life - you don't have to wait until your symptoms
are 'really bad'. Prolapse can worsen one's quality of life and vaginal and uterine prolapse, while common, is not a
normal result of childbirth and aging. You do not have to 'learn to live with it'. Seeking medical help does not mean
that you have to have surgery right away. Some women start with more conservative treatment like physical therapy,
and go on to surgery only if their symptoms from prolapse are not under control.
www.VJicesforpfd.org/p/cmlld/fid=25
1/1
Betsy A.B. Greenleaf DO, FACOOG, Specializing in Female Pelvic Medicine and Reconstructive Surgery
New Jersey Urologic Institute, 10 Industrial Way East, Eatontown, NJ 07724732-963-9091
Pelvic Prolapse options:
Options:
I. Do nothing but conservative therapy
a. Drink A LOT of water. Drink enough that your urine is clear and
urinating at least 8 times a day.
b. Cranberry supplements of 802 of Cranberry Juice a day ( however acidity
may aggravate bladder symptoms)
2. Low Dose Preventative Antibiotic
a. Risks include you can still get an infection, side effects, allergies, bacterial
resistance
3. Pessary: Non surgical. Support device that can be worn in vagina to hold pelvic
floor up.
4. Surgery:
a. Open incision through abdomen:
i. See same as laparoscopy
II. Surgery takes approximately 1-2 hours
111. Can be a longer hospital stay: which can increase risk of picking
up an infection from the hospital.
IV. Compared to other procedure: higher risk of hernia development
later on, higher risk of incision infection,
b. Laparoscopically through abdomen: Hysterectomy and Sacral Colpopexy
1. Overnight in hospital
II. Remove uterus and wrapping a piece of Y shaped mesh around
vagina and attach tail to tail bone
111. Risk is up to 6 hours of surgery, overnight in hospital. Increased
immediate risks of surgery near bowel, and major blood vessels
IV. Advantages: Right now the studies show this has better long term
success rates
c. Vaginally: does not have to be combined with a hysterectomy: Surgical
length of surgery approximately 2-4 hours. Same day surgery.
i. Stitches only: Has 60% lifetime risk of recurring
11. Biologic Graft
I. Processed pig, cow or cadaver skin that is implanted
2. Better longevity than stitches but not as good as synthetic
mesh
3. Advantages: softer material so less risk of eroding or pain
with intercourse
4. Disadvantage: Your body process the material and breaks it
down
111. Synthetic Mesh
1. Advantages: Holds up the best of the vaginal approaches
over time but we do not have long term studies on how
successful it is over time
2. Disadvantages: risk of erosion, and risk of permanent pain
if mesh rubs on nerve.
Take the Floor: Mesh Information for Patients
8/22113
. Mesh Information for Patients with Pelvic Floor Disorders
On July 13, 2011, the FDA issued a safety communication and update, intending to inform patients and health care
providers that "serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are
not rare."
Pelvic floor disorders (PFDs) include leakage of urine, pelvic organ prolapse and bowel problems. Surgical mesh is a
synthetic material that has been used in other kinds of hernia repairs as well as in surgical treatment of pelvic floor
disorders. Surgical mesh is used to treat pelvic organ prolapse (POP), when the bladder vagina or uterus, or rectum
"drops," and stress incontinence (SUI), leakage of urine with coughing, sneezing, or physical exercise due to weak
ligaments and weak pelvic muscles.
For POP, surgical mesh can be placed both abdominally and vaginally. Mesh is placed abdominally to repair POP as
part of an operation called a "sacral colpopexy." This operation lifts the vagina to the tailbone often using a piece of
mesh. This procedure can be performed through an open incision in the belly or through multiple tiny scars using a
robotic or camera (Iaparoscopic) technique. Mesh placed vaginally is done through incisions in the vaginal walls.
Mesh placed to treat POP can be individually tailored or can come as part of a "mesh kit" procedure. Mesh used to
treat stress urinary incontinence is placed under the urethra (the tube that empties urine from the bladder). This
operation is called a mid-urethral sling.
The American Urogynecologic Society (AUGS), a physician-based organization dedicated to research, education and
sharing of best practices in Female Pelvic Medicine and Reconstructive Surgery that results in improved care for
women, presented information to an FDA advisory panel in September 2011 and reiterates these same points to
patients who have undergone treatment using mesh or may be candidates for treatment.
There are different types of mesh for different purposes that have different outcomes. There is not enough
supporting evidence to justify taking mesh off the market. There are differences in the uses and outcomes related to
synthetic mesh used to treat stress urinary incontinence and mesh used for transvaginal or abdominal repair of pelvic
organ prolapse. Synthetic mesh in the form of mid-urethral slings is used to treat stress urinary incontinence. This is
the standard of care and research shows that they are safe and effective.
Mesh may be appropriate for repair of pelvic organ prolapse in some cases.AUGS does not support
the routine use of transvaginal mesh for the repair of pelvic organ prolapse, but there maybe particular circumstances
when the placement of transvaginal mesh is beneficial and appropriate. Placement of transvaginal mesh for pelvic
organ prolapse should be used cautiously by experienced surgeons with extensive training in pelvic surgery.
It is important for patients to be informed about all treatment options for pelvic organ prolapse are pluses
and minuses of each. There should be discussion between a doctor and a patient that identifies risks, benefits and
possible adverse outcomes of all available treatment options. You should be informed about non-surgical treatment
options, surgical repairs that use your own tissues, and abdominal repairs and transvaginal mesh repairs.
Additional information is required to make recommendations about mesh that is rooted in research. AUGS
recommends research trials to get more information for transvaginal mesh for pelvic organ prolapse. AUGS supports
the FDA's call for better data upon to determine whether or not mesh devices are safe and effective.
What you can do now - talk with your doctor:
1. Let you doctor know about any problems you had in the past healing from mesh surgery or rejecting certain
material. If you have been treated with mesh and are not experiencing any symptoms or side effects (recurring
prolapse/incontinence, pelvic pain, etc.), you do not need to have the mesh removed.
2. If you are considering surgery for SUI or POP, ask your doctor what are all the options available for your
particular case and what are the pros and cons of each.
3. If your doctor is recommending using transvaginal mesh, ask why he or she is recommending using mesh in
your case versus using your own tissues for the repair.
4. Ask your doctor about his/her experience using mesh and handling complications associated with mesh
placement. Find a specialist online.
5. Ask your doctor what to expect after surgery, for how long, what side effects to look out for and if there are any
wNw.\Qicesforpfd.org/plcm'ldlfid=87
1/2
8122113
Take the Floor. Mesh Information for Patients
restrictions after surgery.
6. Read FAQs on SUI Slings.
You can report any problems related to mesh to the FDA's MedWatch Adverse Reporting program.
WMN.\Oicesforpfd.org/p/crnlldlfid=87
212
Name:
---------------
Dr Betsy A.B. Greenleaf DO, FACOOG
Prolapse Surgery Risks:
Nothing in life or medicine is 100% . Risks of surgery include
but are not limited to: bleeding, bruising, infection, medication
complications, anesthesia complications, allergic reactions, injury to
surrounding tissues, organs, nerves, bowel, bladder, blood vessels,
bone .....There is a risk that you could re-herniate. This commonly
happens on the opposite side of the initial surgery or in areas where
mesh has not been placed. Those with a history of re-herniation,
have an increased risk of herniating again in the future.
There is a risk of urinary incontinence or urinary retention. If
this continues past 12 weeks after surgery, this may require
additional procedures.
If there is a bladder/urethral injury or perforation at the time of
surgery, you will be asked to have a catheter in place for 2 weeks.
Most times the bladder/urethra heals on its own without additional
intervention. Bowel injuries will be examined for and repaired at the
time of surgery. They require that nothing be placed in the rectum (
i.e. enemas, suppositories) and avoidance of constipation. Injuries to
these area may prevent the placement of mesh. Constipation is a
complication of surgery.
There is a risk of graft exposure or erosion. Exposure occurs
secondarily to the way some people heal. The incision line can
retract as it heals exposing the graft below. Graft erosion occurs
when the vaginal tissue is thin and the graft wears through the
vaginal tissue. This is often treated with a hormone cream to thicken
the vaginal tissue. Sometimes the graft needs to be trimmed in the
office, rarely this may require a repeat surgery in which the vaginal
tissue is loosened over the graft and then re-closed. Having a history
of a graft erosion/exposure puts you at increased risk of developing it
again. Graft erosions can be an important medical concern if the
mesh wears into any organs. Graft erosions may also be related to
infection, that may require additional therapy.
Fistulas can develop with any pelvic surgery. Fistulas are
connections between organs such as a hole between the bladder and
vagina or rectum and vagina. These may require additional surgery
to correct.
Patient Initials: - - - - -
Date: - - - - - -
Name:
---------------
There is a risk of pain after surgery. This pain may be
temporary or permanent. It is theorized that pain is from nerves that
are pinched by scar tissue or by the mesh. This can be treated with
steroid injections, nerve blocks, and rarely additional surgery. Nerve
blocks dissolve the irritated nerve and there can be a risk of
numbness, and loss or altered sensation. Additional surgery mayor
may not relieve the source of pain. There is a risk that additional
surgery can cause more scar tissue.
There is a risk of back or leg nerve irritation or damage. Your
legs are positioned prior to surgery in the stirrups, to assure comfort.
However, from being in the stirrups for an extended period of time
this can cause back muscle spasms, leg and hips spasms, and nerve
stretch injuries with disturbance in gait (walking) and sensation. The
majority of times these complications are temporary, but can be
permanent.
Any surgery can put you at risk of developing life threatening
blood clots that can go to your brain causing stroke, heart causing a
heart attack, or to your lungs. Massage boots are worn during your
procedure to prevent the risk of developing blood clots in your legs.
After surgery the more you move around, this too will aid in the
prevention of these blood clots. Pneumonia can occur from not
taking deep enough breaths. After surgery, you might splint yourself
from the pain by taking shallow breaths. It is imperative to practice
deep breathing to prevent developing pneumonia. Antibiotics are
administered at the time of surgery to prevent common surgical
infections, however, there are always bacteria that are not affected by
these antibiotics. Antibiotics can also kill off the good bacteria in our
bodies and lead to diarrhea or yeast infections. It is suggested that
you eat a yogurt containing live cultures, or supplements containing
lactobacillus acidophilus such as FloraQ. Bladder irritation can occur
as a result of surgery and/ or a side effect of the catheter. Bladder
infections are also possible.
Sexual dysfunctions can be a complication of gynecologic
surgery and can include but are not limited to altered/decreased
sensation, decrease libido, decreased or inability to orgasm, pain with
intercourse .... Other generalized risks included extended
hospitalization, intensive care treatment, coma, severe disability, and
death.
Patient Initials: - - - - -
Date: - - - - - -
Name: - - - - - - - - - - - - - - - - - - The above has been explained to me. I am aware of the risks of surgery. I do not have
any additional questions or concerns at this time. I have been informed that ifI have
additional questions and concerns I am to contact the office and my physician to discuss
these concerns
Patient! Representative Signature
Date
Witness
Date
Doctor's Signature
Date
Patient Initials: - - - - - - -
Date: - - - - - - -
,--­
PROLAPSE TREATMENT OPTIONS
Procedure
Observation
Pessary
Medical Procedure name
Observation
Pessary
Procedure Information
No intervention
Vaginal Repair with
Vaginal Site Specific Repai r Biologic Graft
Colporraphy, or
Colporraphy, or
Colpopexy, or Cystocele!
Colpopexy, or Cystocele!
Rectocele Repair
Rectocele Repair
Fit vagina for a silicone
support that can hold up
prolapse through the
vagina
Vaginal incision with repai r Vaginal incision with repai r
of damaged tissue and re- of damaged tissue and re­
enforcement with a
Vaginal incision with repai r enforcement with a
of damaged tissue with
biologic graft ( pig, cow, or synthetic polypropylene
human tissue)
stitches alone
hernia mesh
Additional Testing
Recommended
Possibly
Possibly
cystoscopy: look into
bladder with scope
Urodynamics: test bladder
function
Estimated length of
Procedure
Need for Hysterectomy
NA
lOminutes
2-3 hours
NA
NA
No
heavy discharge, vaginal
discomfort, vaginal
Specific Risks: All
ulcerations, difficulty or
procedures have risk. This
discomfort with placing or
is not an all inclusive list.
discomfort of prolapse and removing, depending on
Surgical risks I paper work
This is a generalize
risk of recurrent bladder
size and shape may not be provided) + 60% lifetime
summary
infections
risk of recurrence
able to have intercourse
Major Procedure
NA
No
Yes
General, sedation, or
Type of Anesthesia
none
none
spinal
General, sedation, or
11,
",I Timp in
Recovery time
Lifelime Avoidance of
lifting or straining
Risk of Recurrence
Risk of Product Erosion
Possibility of Continued"
Urinary Dysfunction
Advantages
"
'.
l.
I nnnp
,nno
none
none
Yes
Yes
Yes
NA
Yes
Yes
Yes
Yes
No procedure. Condition
Mayor may not worsen
Vaginal Repair with
Synthetic Mesh
Colporraphy, or
Colpopexy, or Cystocele!
Rectocele Repair
cystoscopy: look into
bladder with scope
Urodynamics: test bladder
(unction
Robotic or Laparoscopic
Prolapse Repair
Open Abdominal Prolapse Vaginal Obliteration
Repair
Surgery
Sacral Colpopexy
Sacral Colpopexy
Small incisions located
upper abdomen. Surgery
performed through
abdomen. Attachment of
performed through
abdomen. Attachment of
vagina and tailbone
Sewing shut of the vagina
so that no organs (an
prolapse
cystoscopy: look into
bladder with scope
Urodynamics: test bladder
function
cystoscopy: look into
bladder with scope
Urodynamics: test bladder
function
synthetic mesh to internal synthetic mesh to internal
vagina and tailbone
cystoscopy: look into
cystoscopy: look into
bladder with scope
bladder with scope
Urodynamics: test bladder Urodynamics: test bladder
function
function
2-3 hours
1.5-3 hours
2-6 hours
1-2 hours
45 minutes-l.5 hrs
No
No
Preferred
Preferred
No
Surgical risks ( paper work
provided) , Risk of
recurrence from
absorption of graft
material
Surgical risks ( paper work
provided). Risk of Mesh
Erosion, Slightly higher risk
of pain with intercourse
Surgical risks ( paper work Surgical risks (paper work
provided) higher
provided) higher
immediate risk of damage immediate risk of damage
to major organs or bowels to major organs or bowels
Surgical risks I paperwork
provided). No longer able
to have internal sexual
activity
Yes
General, sedation} or
spinal
Same Day Surgery ( out
Yes
General, sedation, or
spinal
Same Day Surgery ( out
Yes
Yes
General
General or spinal
Yes
General, sedation, or
spinal
General, sedation, or
n,
-
-
Non Surgical
General, sedation, or
spinal
General, sedation, or
spinal
Yes
Yes
Yes
No abdominal scars, Less
risk of damage to major
organs or blood vessels
Colpocleisis
Large incision usually
bikini cut but can be up
and down in middle of
abdomen. Surgery
8 weeks
8 weeks
8weeks
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No abdominal scars, Less
risk of damage to major
organs or blood vessels
,
8 weeks
8 weeks
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
No abdominal scars, Less
risk of damage to major
organs or blood vessels.
Permanent graft material
decreases risk of
recurrence
long Term Studies show
bener long term success
rates, Less risks of erosion,
and less risks of pain with
intercourse. Permanent
graft material decreases
risk of recurrence
long Term Studies show
better long term success
rates, less risks of erosion,
and less risks of pain with
intercourse. Permanent
least invasive of the
graft material decreases
surgical protedures
risk of recurrence
:J:
0;;
r
C.
:J
CL
'"
'"
3
3
o
~
:z
~.cr
"U
:J
'"
n
"2.
0
cr
0­
'"'"
:J
'"
~ 3
0 ~.
Before Surgery
After Surgery
Be aware of the risks associated with surgical mesh for
transvaginal repair of POP. Know that having a mesh surgery
may put you at risk for needing additional surgery due to mesh­
related complications. In a small number of patients, repeat
surgery may not resolve complications.
• Continue with your annual and other routine check-ups and
follow-up care. There is no need to take additional action
if you are satisfied with your surgery and are not having
complications or symptoms.
• Notify your health care provider if you have complications or
symptoms, including persistent vaginal bleeding or discharge,
pelvic or groin pain or pain with sex, that last after your
follow-up appointment.
• Let your health care provider know you have surgical mesh,
especially if you plan to have another surgery or other
medical procedures.
• Talk to your health care provider about any questions you may
have.
Ask your surgeon about all POP treatment options, including
surgical repair with or without mesh and non-surgical options,
and understand why your surgeon may be recommending
treatment of POP with mesh.
In addition, ask your surgeon these questions before you agree
to have surgery in which surgical mesh will be used:
• Are you planning to use mesh in my surgery?
• Why do you think I am a good candidate for surgical mesh?
• Why is surgical mesh being chosen for my repair?
• What are the alternatives to transvaginal surgical mesh repair
for POP, including non-surgical options?
• What are the pros and cons of using surgical mesh in my
particular case? How likely is it that my repair could be
successfully performed without using surgical mesh?
• Will my partner be able to feel the surgical mesh during
sexual intercourse? What if the surgical mesh erodes through
my vaginal wall?
• If surgical mesh is to be used, how often have you implanted
this particular product? What results have your other patients
had with this product?
• What can I expect to feel after surgery and for how long?
• Which specific side effects should I report to you after the
surgery?
• What if the mesh surgery doesn't correct my problem?
• If I develop a complication, will you treat it or willi be referred
to a specialist experienced with surgical mesh complications?
• If I have a complication related to the surgical mesh, how
likely is it that the surgical mesh could be removed and what
could be the consequences?
• If a surgical mesh is to be used, is there patient information
that comes with the product, and can I have a copy?
If you had POP surgery, but do not know whether your
surgeon used mesh, ask your health care provider at your next
scheduled visit.
Selected Pelvic Organ Prolapse Treatment Options
Please be sure Lo request a copy of our Pelvic Prolapse Patient
Guide to pelvic floor reconstruction from your physician. There
are several treatment options available to address your pelvic
organ prolapse. Please consult with your physician to discuss
the various treatment options including post operative care.
What can I expect after my surgery?
Your physician will provide specific post-operative guidance
The following points are designed to offer general patient
information that we recommend you review with your physician
Avoid constipation and straining with bowel mOv{,ments
The Pinnacle! Pelvic Floor Repair Kits and the Uphold'" Vaginal Support
Avoid driving until you can safely and comfortably operate a car
System are surgical treatment options designed to correct vaginal wall
prolapse utilizing vaginal incisions. They were developed by Boston Scientific.
a leader in pelvic floor reconstruction solutions. Each kit contains a thin.
light, synthetic mesh and an intra-vaginal delivery device for a minimally
Limit lifting objects during the recovery process
You may experience light vaginal bleeding for up to
2-4 weeks after surgery
You may have vaginal discharge for up to 6 weeks after surgery
invasive approach Your physician may use the synthetic mesh assembly to
reinforce the vaginal wall back into place and stabilize your pelvic support
You may feel some discomfort after surgery when sitting
structures At the discretion of a physician, most patients resume normal
See next page for a more complete list of potential
complications and adverse events
Normal Female Anatomy
activities within six to eight weeks
The four sample illustrations below demonstrate the placements for the Pinnacle Pelvic Floor Repair Kits and the Uphold Vaginal Support System.
Pinnacle PeLvic FLoor Repair Kits
Uphold VaginaL Support System
shown in
Anterior / Apical
Posterior
for reinforcement of the
vaginal wall near the bladder
for reinforcement of the vaginal wall
near the rectum/intestines
Post-hysterectomy Anatomy
shown in
Natural Anatomy
for reinforcement of the vaginal wall at the vaginal apex
Intended Use/Indications for Use
Mesh based transvaginal surgeries are indicated for
tissue reinforcement and stabilization of fascial
structures of the pelvic floor in vaginal wall prolapse
where surgical treatment is intended.
Contraindications
Synthetic mesh is contraindicated for use in
any patient in whom soft tissue implants are
contraindicated
Biologic mesh should not be used for patients
with a known history of hypersensitivity of collagen
or bovine products.
Pregnant patients, or patients that are considering
future pregnancies
The potential of future growth (e.g. infants, children)
Any pathology, including known or suspected uterine
pathology, which would compromise implant placement.
Any pathology that would limit blood supply and
compromise healing.
Warnings/Potential Complications
Hysterectomy may be needed in the future; Use of mesh may make a
future hysterectomy more difficult due to tissue in-growth and scarring
Adverse Events
Potential adverse reactions that may be associated with
surgically implanled materials include
Continued screening and surveillance for cervical and lJterine disease
may be required; Regular pelvic exam, Pap test and endometnal
biopsies should be continued as medically indicated
Abscess formation/Foreign body reaction;
Adhesion formation;
Should dysuria, bleeding or other problems occur, contact your
physician immediately
BrUising, hematoma, hemorrhage;
Refrain from heavy lifting, exercise and intercourse for a minimum of
six (6) weeks after the procedure Your physician should determine
when it is suitable for you to return to normal activities.
Dehiscence and/or necrosis;
Dyspareunia,
In the event that infection presents post procedure, the entire
mesh may have to be removed or revised
Like all foreign bodies, the mesh may potentiate an existing
infection reaction or sepsis
Tissue responses to the implant could include local irritation at the
wound site, vaginal erosion or exposure through the urethra or other
surrounding tissue, migration of the device from the desired location, fistula
formation, foreign body reaction, and inflammation. The occurrence of these
responses may require removal or revision of the mesh
Blood coagulation disorder
Excess tension may cause temporary or permanent lower urinary tract
obstruction and retention
AUloimmune connective tissue disease
Mild to moderate incontinence may occur due to incomplete support.
Renal insufficiency and upper urinary
tract obstruction.
Known risks of surgical procedures for the treatment of prolapse include
pain, infection, erosion/exposure, device migration, complete failure of the
procedure resulting in recurrent or de Novo prolapse and/or incontinence
Pre-existing local or systemic infection. Treat the
infection with the appropriate antiseptics and/or
antibiotics to eliminate the infection before
performing a repair
Punctures or lacerations of vessels, nerves, bladder, urethra, or bowel
may occur during placement and may require surgical repair.
Overweight women may be prone to interoperative and postoperative
complications (weight parameters to be determined by your physiclan)_
AllergiC, hypersensitivity or other immune reaction;
Constipation;
Erosion/ extrusion;
Fistula formation;
Granulation tissue formatIOn;
Infection/Sepsis potentiation;
Inflammation (acute or chronic);
Mesh and/or tissue contracture:
Organ perforation;
Pain, discomfort, irritation;
Post-operative bleeding;
Recurrent prolapse:
Surgical site wound irritation, erythema, edema:
Ureteric injury,
Ureter obstruction;
Urinary Incontinence;
Urinary retention:
Vaginal discharge;
Vaginal shortening or stenosis;
Vessel/Nerve injury/perforation;
Wound dehiscence
Boston
SCIentIfic
Delivering what's next:"
Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537
'IN'INW.boslonscientific.com/gynecology
© 2009 Boston Scientific Corporation
or its affiliates. All rights reserved.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a phvsician.
MVU8700 Rev A 5M 9/10
Have you ever felt a bulge or lump in your
vagina?
Yes
No
Do you feel like something is falling out of
your vagina?
Yes
No
Do you experience pain or discomfort during
intercourse?
Yes
No
Do you experience vaginal pain, pressure,
irritation, bleeding or spotting?
Yes
No
Do you experience problems with urination,
particularly when coughing or sneezing?
Yes
No
Do you have difficulty with bowel movements?
Yes
No
Do you have delayed or slow urinary stream?
Yes
No
Do you have frequent lower back pain?
Yes
No
,
Common Uses of Pessaries
The vaginal pessary has a long
history, dating back thousands of
years! Ancient pessaries were
stones,
pomegranates,
To Improve or restore continence.
.
linen,
wool, and sponges. In the middle
The Use
And Care
Of Pessaries
For diagnosis to determine if surgery is
necessary.
ages brass, cork, gold, and silver
..
were the new materials. During
the 1800's, the ring pessary was
To delay or preclude surgery.
..
developed. Vaginal pessaries
were refined in the 1900's with
advances in material science.
As an alternative to surgery.
.
Now there are silicone ones in
many shapes and sizes. Few
To manage uterine prolapse and vaginal
wall hernias.
medical inventions have stood
..
the test of time so well as the
pessary.
To relieve a cystocele (bladder prolapse)
or a rectocele.
..
Compliments of Bioteque America
Written by: Margaret G. Dorsey
To relieve lower back pain caused by
retroversion.
+­
Diagnosis and therapy in obstetrics .
.
,
BioteQue
America Inc.
tJ
'
To prevent miscarriage by relieving
pressure on a weak cervix.
~~~~I~:bue
If you are a candidate for a
pessary, YOll wil/filld tlte
following i,,{ormatioll lIseful.
A pessary is a vaginal prosthesis that has
evolved over centuries to become an
effective medical device to relieve the
stress of a cystocele, a rectocele, a uterine
or bladder prolapse, or the problems
associated with urinary incontinence.
Pessaries come in various, shapes, sizes,
and materials. They are perfectly safe and
comfortable for long term usage.
healthcare provider and make an appoint­
ment for removal and cleaning. Do not be
alarmed if your appointment date is
weeks away. It is not unusual for pessaries
to remain in place from 4 [0 12 weeks.
What is my respollsibility?
Your responsibility is to follow your
healthcare provider's instructions, wear
your pessary, and keep all follow-up
appointments. If you should move, be
sure to notify your healthcare provider.
Commonly asked questions:
Will my pessary set off'tlle alarm at the
ailport?
Will I always have to use this pessary?
Absolutely not.
Not necessarily. Although pessaries are an
alternative to surgery, your vaginal mus­
cles may strengthen to the extent that
your pessary is no longer required.
Sometimes pessaries are only required for
strenuous exercises like jogging or hiking.
Certainly, if you are a candidate for sur­
gery, your pessary is only temporary until
corrective surgery can be performed.
Can 1 /tave sex with my pessary in
place?
Can a pessary hurt or become UIICOIll­
fortable?
A properly fitted pessary will never cause
pain or discomfort. You should be able to
pelform your normal daily activities with­
out any di fficu Ity.
How oftell shouLd I remove my pessary?
It is recommended that you remove your
pessary daily to clean it using mild soap
and water. However, if you have difficulty
removing your pessary, contact your
Daily Care and HelpfuJ Hints:
I can 'I remove my pessary,
1I0W
what?
If you want to remove your pessary but
can't, don't panic. Simply call your
health care provider and schedule an
appointment.
My pessary seems to have moved out of
position and is uncomfortable.
Wash your hands, lie down and push the
pessary up as far as you can. Don't worry,
it can't get lost. It's impossible to push
your pessary into your abdomen.
I see some discharge alld bleeding. What
should I do?
You certainly can. If you need to remove
your pessary, then do so.
Sometimes pessaries can irritate body tis­
sue causing a slight discharge or bleeding.
Call your healthcare provider if it persists.
Will my pessary prevellt pregnancy:
What do 1 do about daily bathillg:
No, it will not. A pessary is not a contra­
ceptive device. If you are sexually active,
wear a pessary and need to avoid preg­
nancy, then discuss this with your health­
care provider.
Do not change your normal bathing rou­
tine because you are wearing a pessary.
Call my pessary fall Ollt?
Yes it can. If your pessary is too small or
you need a different type of pessary,
sometimes it will fall out. Whenever this
happens, simply clean your pessary with
mild soap and water and reinsert it. If it
is a persistent problem, then call your
healthcare provider for an appointment.
You may need a different size or type.
Should I douche?
You do not have to douche unless
instructed to do so by your healthcare
provider.
~1~5~~~~ue
1-800-889-9008
Fax: 51 0-438-9388
viSit our websitc ,11: \\\\\\".l>iotequc.({)111
or C' ma;1 u~ at: bioleque@\ILlI.\·"111
Regaining Control.
Restoring Quality of Life
To learn more about pelvic organ prolapse, visit www.
WebMD.com
This brochure is not intended as a substitute for
professional medical care, Only your physician can
diagnose and appropriately treat your symptoms,
S<lrd: PelvIc Organ Prolapse
L
An overview of
. R. Bard, Inc
Covington GA 30014
.. 2011 C. R. Bard Inc All Rights
1101-28 RO /11
THP
P04/11
Reserv~d
10M
WW'"
bardml!r.fILal :om
Pront.>rl In U.S.A.
•
eVIC gan
Pro apse
Pelvic Organ Prolapse
Notes:
Throughout a woman's lifetime, her body undergoes
tremendous stress. The strain of pregnancy. The effort
of childbirth. Even the trauma of certain gynecologic
surgeries such as hysterectomies.
All of these stresses - accumulated over the years
- can weaken the natural support structures of the
pelvis, causing problems like pelvic organ prolapse,
a feeling of vaginal fullness, chronic constipation and
urinary incontinence. Any of these may require pelvic
reconstructive surgery to repair.
The symptoms of a weakened pelvic floor can range
from mild to debilitating, and can affect your ability to
lead an active life - and even maintain sexual intimacy.
There are many non-surgical and surgical options which
can correct problems associated with pelvic organ
prolapse, and help restore a better quality of life.
What is Pelvic Organ Prolapse?
The vagina and its surrounding structures (bladder,
rectum, etc.) are attached to the pelvis by connective
tissues, These tissues help form walls around the vagina
and ensure that normal urinary voiding and bowel
movements can occur, As the pelvic muscles become
weak, the connective tissues can fail, allowing pelvic
structures like the bladder or rectum to bulge into the
vaginal wall. This can cause the following symptoms:
A feeling of vaginal fullness, heaviness, or even
pain
Pain or discomfort during intercourse
Loss of bladder control
Involuntary urination or inconsistent urinary
stream
Difficulty with bowel movements
Recurrent urinary infections
2
11
Notes:
What causes Pelvic Organ Prolapse?
Pelvic muscles and connective tissues which have
been weakened with age are the primary causes,
but many other factors may playa role. These may
include vaginal childbirth, previous vaginal surgeries,
menopause, smoking, diabetes, obesity, repeated heavy
lifting, chronic coughing, and chronic constipation.
Sometimes pelvic organ prolapse can be caused simply
by genetic factors.
What are the different types of
pelvic organ prolapse?
When vaginal prolapse occurs, an organ has dropped
(prolapsed) out of its normal position and can
sometimes even protrude from the vagina. The
definition of pelvic organ prolapse is different
depending on what anatomic structure in the pelvis is
pushing into the vagina, such as the bladder or rectum.
When vaginal prolapse occurs, the upper part (apex)
of the vagina has dropped to a lower position. It is
possible for more than one organ to prolapse into the
vagina at the same time.
pelvic/
Bone
Vagina
Rectum
Nnrmal Female Anatomy
The different types of pelvic organ prolapse:
•
•
•
•
•
10
Cystocele
Rectocele
Enterocele
Vaginal Vault Prolapse
Uterine Prolapse
Cystocele (pronounced "sis'to-sel")
A cystocele occurs when the bladder falls into the
vagina, As the connective tissue in the front wall
(sometimes referred to as the roof) of the vagina fails,
its attachment to the pelvis may be lost, allowing
the bladder to drop into the vagina, This is the most
common form of pelvic organ prolapse and is often
called a "dropped bladder",
Rectocele (pronounced "rek'to-sel")
A rectocele occurs when the rectum falls into the
vagina, Similar to the cystocele, when the connective
tissue in the rear wall (the floor) of the vagina fails, the
rectum can then bulge into, or even out of, the vagina,
As the rectum bulges upward, this can cause difficulty
or pain during bowel movements,
4
Are there risks with a procedure
using synthetic mesh materials?
As with any surgical procedure, the prolapse repair
procedure itself has the risk of certain complications
such as the use of anesthesia, the surgical approach
used, and how pre-existing conditions may affect
the outcome, Your physician can further explain
your specific risks and can provide a list of warnings
associated with the procedure,
The synthetic mesh may strengthen the repair, although
results vary from patient to patient. In addition, there
are risks associated with the use of a permanent
synthetic mesh There is a risk that the mesh material
will protrude into the vagina causing difficulty and pain
with sexual intercourse, Complications can also include
localized fluid collection (blood, pus, clear serous fluid),
erosion of the graft into surrounding tissues, infection,
inflammation, pain, tightening of the repair (resulting
in pain), perforation of neighboring tissues or organs,
urinary incontinence and recurrence of vaginal wall
prolapse, Given the permanency of synthetic mesh,
post-procedure removal of the implant may be difficult.
Additionally, repair of prolapse using synthetic mesh
materials should not be undertaken if you are pregnant
or may become pregnant. Specifically related to the
ALYTE'" Y-Mesh Graft, the effectiveness of this product
has not been validated by a prospective randomized
clinical trial,
If you experience any complications, please notify your
physician immediately, Speak with your physician
regarding his/her experience with this procedure,
and the anticipated probability of any of these
complications,
9
~acrocolposu~pensionLSacro~olpoJ~exy
For treatment of prolapse at the top of the
vagina (vaginal vault or uterine prolapse), a
sacrocolposuspension / sacrocolpopexy is a common
treatment. It involves attaching the top of your
vagina to a piece of graft material which is then
secured to the top of your tailbone (bottom of your
spine). This procedure can be done using either an
open or minimally invasive approach.
Vaginal Vault or Uterine Prolapse repair with graft
(Sacrocolposuspension /Sacrocolpopexy)
Enterocele (pronounced "en'ter-o-sel")
An enterocele occurs when the small intestines push
the back of the vagina toward the opening. This usually
occurs in conjunction with another form of prolapse and
is repaired during the same procedure.
Vaginal Vault Prolapse
In women who have had a hysterectomy (no longer
have a uterus), the natural support structures in the
vagina provided by the uterus no longer exist. The top
portion of the vagina can then push down into the lower
vagina, causing vaginal vault prolapse.
k.,2009 Tim Peters and Company, Inc. All Rights Reserved. Developed in consultation
with Patrrck Culligan, Mo.
8
5
Uterine Prolapse
For women who still have a uterus, the support
structures holding the uterus in place can also be
compromised, allowing the uterus to fall down into the
vagina. This is called uterine prolapse.
Non-Surgical Treatments
K~flel
Exercises
Your physician may suggest an exercise program of
repeated contractions of the muscles of the pelvic
floor. These muscles are identified as those that can
be used to halt the flow of urine. Routine exercising
of these muscles will help to build strength and
maintain elasticity in the pelvis.
Pessary Devices
A pessary is a device that is worn in the upper
portion of the vagina similar to a diaphragm, and is
designed to support the surrounding tissues. Your
physician will determine the appropriate size and
design of the pessary that will best support your
prolapse.
Surgical Treatments
How is Pelvic Organ Prolapse
Treated?
Traditionally physicians have used sutures to sew
weakened tissues back together. Sometimes, a piece
of graft material (man-made or natural tissue) can be
used to reinforce these repairs.
The best treatment for a specific type and severity of
pelvic organ prolapse will vary from patient to patient.
If your symptoms are mild, the doctor may recommend
lifestyle changes, Kegel exercises to strengthen the
pelvic muscles, or the use of a pessary to relieve the
symptoms. When the symptoms are severe enough
to affect your quality of life, your physician may
recommend surgery.
'f)2009 Tim Peters and Company. Inc, All Rights Reserved. Developed m consultatton
wW, Patrick Culligan, MD.
6
Cystocele repair with graft
(Anterior repair)
Rectocele repair with graft
(Posterior repair)
7