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Introduction
FDA has produced this brochure to highlight the more common problems that occur
in the breast or chest area (local complications), when you choose to have
silicone gel-filled or saline-filled breast implants.
Institute of Medicine’s Independent Review
The Institute of Medicine (IOM) completed its independent review of past and
ongoing scientific research of both silicone gel-filled and saline-filled breast
implant safety in June 1999.1 Below are some of the major findings.
Local complications
* are the primary safety issue because they are frequent enough to be a concern
* accumulate over the lifetime of the implant and have not been well studied
* are crucial for women deciding if they want breast implants
Potential Local Complications and Reoperations
Potential local complications are shown alphabetically below. You may need
non-surgical treatments or reoperations (including removal of your implant) to
treat any of these. (See the Glossary in the Handbook for definitions.)
* Asymmetry
* Breast pain
* Breast tissue atrophy
* Calcification/calcium deposits
* Capsular contracture
* Chest wall deformity
* Delayed wound healing
* Extrusion
* Galactorrhea
* Granuloma
* Hematoma
* Iatrogenic injury/damage
* Infection, including Toxic Shock Syndrome
* Inflammation/irritation
* Malposition/displacement
* Necrosis
* Nipple/breast changes
* Palpability/visibility
* Ptosis
* Redness/bruising
* Rupture/deflation
* Scarring
* Seroma
* Unsatisfactory style/size
* Wrinkling/rippling
Capsular contracture and rupture/deflation are the most common local
complications that occur with both silicone gel-filled and saline-filled breast
implants.
Capsular Contracture
Capsular contracture occurs when the scar tissue or capsule that normally forms
around the implant tightens and squeezes the implant. It can happen to one or
both of the implants. There are four grades of capsular contracture known as
Baker grades.
The Baker grading is as follows
Grade I breast is normally soft and looks natural
Grade II breast is a little firm but looks normal
Grade III breast is firm and looks abnormal
Grade IV breast is hard, painful, and looks abnormal
Capsular contracture may require reoperation, usually for Grades III and IV, and
it may occur again.
Rupture/Deflation
Breast implants do not last a lifetime. Some breast implants may rupture/deflate
in the first few months after surgery and some after several years. Others may
take 10 or more years to rupture/deflate.
The reasons for rupture are not well understood and are currently being studied.
Some possible causes of rupture/deflation include:
* normal aging of the implant
* damage by surgical instruments
* too much handling during surgery
* damage during procedures to the breast, such as biopsies and fluid drainage
* compression during a mammogram
* stresses such as trauma or intense physical pressure
* capsular contracture
* overfilling or underfilling of saline-filled breast implants
* placement through a belly button (umbilical) incision site because it involves
too much handling of the implant.
When silicone gel-filled implants rupture, some women may notice decreased
breast size, hard knots, uneven appearance of the breasts, pain or tenderness,
tingling, swelling, numbness, burning, or changes in sensation. Other women may
unknowingly experience a rupture without any symptoms (silent rupture).
Magnetic resonance imaging (MRI) with equipment specifically designed for
imaging the breast may be used for evaluating patients with suspected rupture or
leakage of their silicone gel-filled implant. Silicone gel may
* escape from the scar tissue capsule around the implant
* migrate away from the breast
* cause lumps, called granulomas, to form in the breast, chest wall, armpit,
arm, or abdomen
Plastic surgeons usually recommend removal of the implant if it has ruptured,
even if the silicone is still enclosed within the scar tissue capsule, because
the silicone gel may eventually leak into surrounding tissues.
Reoperations
It is likely that you will need to have one or more reoperations over the course
of your life because of local complications from breast implants. Reasons for
reoperations could include any of the potential local complications above.
Multiple reoperations to either improve the appearance of the breasts, to remove
ruptured/deflated implants, or both may result in an unsatisfactory cosmetic
outcome.
Removals
One type of reoperation is the removal of the implant(s), with or without
replacement. Removal involves surgery. You are likely to have your implant
removed at some time over the course of your life because of one or more local
complications above. Many women decide to have the implants replaced, but some
women do not. Women who do not have their implants replaced may have
cosmetically undesirable dimpling, puckering, or sagging of the breast following
removal of the implant.
Key Points to Consider
* Breast implants will not last a lifetime.
* Either because of rupture or other complications, you will probably need to
have the implants removed.
* You are likely to need additional doctor visits, reoperations, or removals
because of one or more complications over the course of your life.
* Many of the changes to your breast following implantation may be cosmetically
undesirable and cannot be reversed.
* If you later choose to have your implants removed, you may experience
unacceptable dimpling, puckering, wrinkling, breast tissue loss, or other
undesirable cosmetic changes of the breasts.
Source :
http://www.fda.gov/cdrh/breastimplants/breast_implant_risks_brochure.html