Known and Possible Risks of Breast Implants

by Food and Drug Administration (FDA)

(Page 3 of 3)

Known Risks of Breast Implants

Signing a consent form is now part of the procedure for all women undergoing breast implant surgery. They must also be given information about the devices' known and possible risks.

Surgical Risks

• possible complications of general anesthesia, as well as nausea, vomiting and fever
• infection
• hematoma (collection of blood that may cause swelling, pain and bruising, perhaps requiring surgical draining)
• hemorrhage (abnormal bleeding)
• thrombosis (abnormal clotting)
• skin necrosis — skin tissue death resulting from insufficient blood flow to the skin. The chance of skin necrosis may be increased by radiation treatments, cortisone-like drugs, an implant too large for the available space, or smoking.

Implant Risks

• capsular contracture (hardening of the breast due to scar tissue)
• leak or rupture — silicone implants may leak or rupture slowly, releasing silicone gel into surrounding tissue; saline implants may rupture suddenly and deflate, usually requiring immediate removal or replacement
• temporary or permanent change or loss of sensation in the nipple or breast tissue
• formation of calcium deposits in surrounding tissue, possibly causing pain and hardening
• shifting from the original placement, giving the breast an unnatural look
• interference with mammography readings, possibly delaying breast cancer detection by "hiding" a suspicious lesion. Also, it may be difficult to distinguish calcium deposits formed in the scar tissue from a tumor when interpreting the mammogram. When making an appointment for a mammogram, the woman should tell the scheduler she has implants to make sure qualified personnel are on-site. At the time of the mammogram she should also remind the technician she has implants before the procedure is done, so the technician can use special techniques to obtain the best mammogram and to avoid rupturing the implant.

Possible Risks of Breast Implants

Autoimmune-like disorders — signs include joint pain and swelling; skin tightness, redness or swelling; swelling of hands and feet; rash; swollen glands or lymph nodes; unusual fatigue; general aching; greater chance of getting colds, viruses and flu; unusual hair loss; memory problems; headaches; muscle weakness or burning; nausea or vomiting; and irritable bowel syndrome.

Recent studies have shown, however, that there is not a large increased risk of traditional autoimmune, or connective tissue disease, from silicone gel implants.

Fibrositis/fibromyalgia-like disorders (pain, tenderness and stiffness of muscles, tendons and ligaments).

Polyurethane-Coated Implants

About 110,000 women have silicone gel-filled implants with a polyurethane coating, intended to reduce the risk of capsular contracture. In April 1991, an FDA analysis showed that polyurethane foam could break down under human body conditions to form a chemical called TDA, which can cause cancer in animals. As a result, the manufacturer immediately stopped selling the product.

Recently, however, a study to measure TDA in women with polyurethane implants found that a woman's risk of cancer from exposure to TDA released by the implant is negligible — about one in a million over a lifetime. FDA considers it unlikely that even one woman would develop cancer from these implants. The study supports the agency's original recommendation that women who are not having problems should not have the implants removed solely because of concern about cancer from TDA exposure.

Immunology Tests

Several laboratories are offering tests that claim to detect levels of antibodies to silicone that presumably indicate a leaking or ruptured implant.

FDA has not cleared or approved these tests for such purposes, and the agency has sent letters to several companies, warning of future regulatory action if they continue to promote the devices without a premarket approval application.

"There are important unresolved issues with these tests," says Peter Maxim, Ph.D., chief of the Center for Devices and Radiological Health's immunology branch of the division of clinical laboratory devices. "For one thing, the very existence of silicone antibodies has not been proven to the satisfaction of all scientists," he says. "Secondly, if antibodies are detected, is there in fact a correlation with the presence or the status of implants, or do they reflect prior environmental exposure? Silicone is in a myriad of products, including foods, medicines, and antiperspirants absorbed by the skin, to name a few."

The next problem, Maxim says, is that there are claims that extremely high antibody levels may indicate a leaking or ruptured implant. This, then, raises the question of what medical intervention, if any, should be taken.

Sahar M. Dawisha, M.D., a rheumatologist in FDA's division of general and restorative devices, adds that no one really knows what the clinical significance of an antibody to silicone means or at what level it is harmful.

"Furthermore," she says, "in autoimmune or connective tissue disease — where antibody tests are generally used — the presence of antibodies doesn't define the disease. A disease is defined by clinical signs and symptoms, and antibodies are used as supporting evidence."

Finally, John Nagle, consumer safety officer in the Center for Devices and Radiological Health's diagnostic devices branch, says, "The tests themselves may be harmless, but they sure are expensive, somewhere between $500 and $1,000," adding that "a lot of them are being done for litigation purposes rather than to help the patient medically."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.