FDA Approves Silicone Implants
10/15/03 - After 16 hours of testimony and debate from over 100 women, plastic surgeons and consumer advocates the FDA government panel voted 9-6 to approve silicone breast implants for implant manufacturer, Inamed (formerly McGhan).
The panel stressed women will need yearly mammograms to check for signs of leakage since silicone can leak without immediate knowledge to the patient because the silicone leaks out slowly (whereas saline implants will deflate fairly quickly). If there is leakage or a break in the implant, the implant(s) should be replaced.
The panel also advised Inamed to follow patients for 10 years after implants, thus, all implant recipients will be enrolled in a registry to track their health. Inamed will continue to track the health of patients in its current study for another seven years, as they already have 3 years of research of these patients.
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.
For more detailed information and descriptions of diseases that women believe to be related to breast implants, read the FDA Breast Implant Handbook.
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. Below are some of the major findings.
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.)
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 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 Levels:
|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.
Go here for more on Capsular Contracture
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:
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
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.
When saline-filled breast implants deflate, the saline solution leaks either through an unsealed or damaged valve or through a break in the implant shell. Implant deflation can be immediate or progress over a period of days, months, or years and is noticed by loss of size or shape of the implant. Additional surgery is needed to remove deflated implants. Photograph 2 below shows deflation of a 30-year-old woman's left saline-filled breast implant.
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.
One type of reoperation is the removal of the breast 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.
Resource: Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. (IOM Report).
FDA Approves Saline Breast Implants
May 10, 2000: FDA has approved saline breast implants. U.S. health officials said saline-filled breast implants made by Inamed (formerly McGhan) and Mentor, the two leading maker/s of the products, are safe and effective for continued use. Other companies that make implants that do not hold FDA approval must stop distributing the products after May 15, 2000. Click here to see story.
surgery was before the FDA approval. I had to sign a "Product
Summary" for the saline implants, as well as a "permit"
for the doctor. Both of which described possible risks, summarized
here. Most of these complications require additional surgery, and
your surgeon may charge you for any additional surgery.
The Danish Registry for Plastic Surgery of the Breast registered 1,240 women who received breast implants for the first from June 1999 to November 2001 and shows that a low number of silicone and saline implant recipients experience complications.
85% received breast implants for augmentation and 15% had breast reconstruction following mastectomy; 88% were silicone gel.
16% experienced complications (the majority of which was change in feeling)
4% (of the 16%) had capsular contracture, the majority of which were categorized as minor; and 1% (of the 16%) required additional surgery.
Summary, Saline Implants
Silicone Implant Reports and Studies Here
Condensd Product Summary for Saline Filled Implants indicates the following:
MOST COMMON RISKS:
1. Deflation (aka Rupture)
2. Making Breast Cancer Harder to Find
3. Capsular Contracture (Hardness and/or pain due to the tightening of scar tissue). Rebecca's note: I see this to be most common with overs and more common with smooth implants.
OTHER KNOWN RISKS:
1. Calcium Deposits (occasionally, these need to be removed surgically)
2. Additional Surgeries (there is a fairly high chance for the need to replace or remove the implant)
3. Infection (implant may need to be removed)
4. Hematoma (collection of blood that may need to be drained surgically)
5. Delayed wound healing (in rare instances, the implant could push out through the skin)
6. Changes in feeling in the nipple and breast (increased or decreased, temporary or permanent, may effect nursing)
7. Shifting of the implant.
AUTOIMMUNE DISEASES: According to scientific studies, women with breast implants, in general, are not at an increased risk for autoimmune or connective tissue diseases. Studies have been too small to indicate increased risk in of any rare disease. Some reported symptoms have been: Swelling and/or joint pain or arthritis-like pain, general aching, unusual hair loss, unexplained or unusual loss of energy, greater chance of getting colds, viruses and flu, swollen glands or lymph nodes, rash, memory problems, headaches, muscle weakness or burning, nausea, vomiting, and Irritable Bowel Syndrome.
BREAST FEEDING: There is limited research.
The following are complications and the frequency varies from person to person and procedure to procedure. Many of the complications were repeated on this form, so I left out those that were previously stated above.
1. Bleeding (may require additional surgery and/or transfusion)
2. Neuroma (temporary or permanent painful areas in the breast, may require additional surgery)
3. Excess Scarring (thicker, wider, longer, different in complexion, or painful).
4. Asymmetry of Breasts (size and shape may change).
5. Sagging of the Breasts.
6. Allergies or unexpected responses to anesthetic agents, medications, skin preparations, or dressings used.
7. Other complications which are not listed.
8. Severe and unusual complications rarely occur that may place the patient's health and life in jeopardy.
The following should also be recognized:
A. Saline implants have a silicone shell, the concern with these is less than with the gel-filled implants.
B. Pain and discomfort.
C. Loss of time from work and other activities.
D. All surgical procedures produce scars, and that these will be permanent.
E. Must have a someone to drive you home and take care of you for at least 24 hours following surgery and possibly longer.
F. Must not drive for at least 3 days.
Disease or Cord -- (pictured) Hardening or blood clot in a vein
leading away from the surface of the breast. This is a blocked vein
that it will go away in a month or two. If it is large or painful, you
can put a warm washcloth on the cord or to break up the matter that
is blocking the vein, massage the cord. Push on it and rub it and the
blockage will dissipate faster.
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