Download Meridian Surgical Services, Inc

Robert C Wright, MD, PS
Informed Consent – Open Breast Biopsy
(right/ left/ both sides)
Your symptoms, physical exam and mammogram or breast ultrasound show a lump in your breast which should
be surgically removed. I cannot be absolutely certain at this time whether or not the lump is malignant. The
lump will need to be studied carefully in the laboratory to determine if it is cancerous. After careful
consideration, an open breast biopsy is recommended.
Purpose and Alternatives for this Procedure
The usual purpose of an open breast biopsy is to determine the nature of the breast lump. Sometimes
we might be able to biopsy the breast lump with a small needle; an open biopsy would usually still be
indicated as an adjunct to biopsy with a small needle. The biopsy will be adequate treatment if it is
benign; if it is malignant (cancer), further treatments will be necessary. Open breast biopsy is the most
accurate method for diagnosis of a breast lump.
Description of the Procedure
An open biopsy may be performed with you either awake or asleep under anesthesia; this will be
discussed with you before the procedure. You will first receive local anesthesia to numb the area that
will be biopsied (if you are awake). A small incision will be made in the skin of the breast overlying
the lump, and the lump will be removed in part or in whole, depending on the size of the lump. The
skin is usually closed with absorbable sutures and skin tapes. A pressure dressing is then usually
applied. Occasionally, a small drain may be placed that is removed in my office the next day. You
may go home on the day of the operation. It will take several days or more to determine the results of
the breast biopsy. If you have a mass that is seen on mammography or ultrasound but cannot be
definitely felt, you will require needle localization to assist us in performing the biopsy. You will go to
the mammography (or ultrasound) suite before your biopsy, and a thin wire will be placed into the
lump as guided by the radiologist. I will then remove the breast tissue around the wire, thus removing
the lump.
Risks/Complications of Procedure
Treatment risks fall into two categories; those that could happen during any operation under
anesthesia, and those specific for a breast biopsy. In any medical treatment, it is impossible to predict
all the things that could go wrong. Fortunately, complications are the exception rather than the rule.
Every reasonable effort is made to avoid complications. The most common possible complications are
as follows:
Possible risks of major surgery
1.
Bleeding – this is a problem that could happen any time the skin is cut. The need for a blood
2.
3.
4.
5.
transfusion is rare.
Infection – we take special care to prevent infection, but it is always a possibility. An infection is a
special concern as it could cause deformity or complicate cancer treatment.
Reactions to medications – this could be many things, from a minor rash to possible death.
Reactions to anesthesia and surgery – this could show up as a heart attack, blood clots,
pneumonia, sore throat, or potential death (in rare cases).
Poor wound healing – breakdown of the incision.
(see other side)
Possible complications of breast biopsy
1. Hematoma/seroma formation – a collection of blood or fluid within the cavity from which the lump was
removed will occasionally happen. On occasion, a small part of the wound will need to be opened to
drain the blood or fluid from the cavity.
2. Breast deformity – nipple inversion or breast dimpling may occur.
3. Missed lesion – although uncommon, it is possible to biopsy a suspicious lump in the breast, but have a
cancer adjacent to the removed lump. This might be a problem if your breasts are very lumpy, or with
needle localization.
Anticipated Recovery/Expected Rehabilitation
Recovery is quite variable, depending on the individual. You should be able to return to office work or light
duty in one or two days. I would like you to refrain from heavy lifting for several weeks. For your safety, do
not drive a motor vehicle or operate dangerous machines while on pain medication.
Consent for Treatment
I understand my condition to be a breast lump and am aware of its risks if undiagnosed. I have read and
understand the above explanation of the procedure being proposed. My surgeon has answered my
questions, and I choose to proceed with surgery.
I understand that every operation may yield unexpected findings. I give the surgeon permission to act on
his best judgment in deciding to remove or biopsy tissues that appear to be diseased, understanding that
complications may arise from that action.
I understand that the purpose of a breast biopsy is for diagnosis, and not necessarily for treatment. My
condition may not improve, and it may worsen. No absolute guarantee can be made.
HIPAA: Before and after surgery, unless otherwise requested in writing by you, visitors whom you invite
to attend the surgery will be informed of the surgical finding, your surgical status, and anticipated
recovery issues for effectiveness of communications. Because of the anesthetic, you may or may not
remember these important details.
PRINT NAME__________________________________________________________________________
SIGNATURE ______________________________________________ DATE _________________
WITNESS ________________________________________________ DATE _________________
SURGEON ________________________________________________ DATE _________________
RELATIONSHIP TO PATIENT IF SIGNATURE OF LEGAL GUARDIAN ________________________________
I waive the right to read this form, and do not want to be educated and informed of treatment risks;
nonetheless I understand the need for this surgery and grant permission to the surgeon to proceed on my
behalf.
SIGNATURE _____________________________________________________ DATE ______________
rev 6-03/kab