Breast Implants Have Limited Lifespan

Women who get silicone-gel breast implants shouldn't be surprised if they need to have them removed a decade down the road, the FDA says.

It's not only because the implants themselves might fail, but also because of breast changes or complications that can occur.

"The longer a woman has the implants, the more likely she is to experience complications," says Jeffrey Shuren, M.D., director for the FDA's Center for Devices and Radiological Health.

Variety of complications

Common complications include capsular contracture, in which the breast tissue hardens around the implant; the need for additional surgeries; and the need to remove the implant. Other frequent problems are implant rupture, breast wrinkling, breast asymmetry, scarring, pain, and infection, the FDA says.

One in five women who receive silicone-gel implants to increase their breast size will need to have these devices removed within 10 years because of complications. As many as half of women who have implants during breast reconstruction surgery will also need them removed within the same time frame.

Silicone-gel implants had been banned by the FDA for 14 years because of concerns that the implants might be linked to cancer, lupus, and other connective tissue diseases. The FDA lifted the ban in 2006.

The new FDA report deals only with silicone-gel implants, not saline implants.

"Preliminary data doesn't show an increased risk of breast cancer or connective tissue disease such as rheumatoid arthritis," Dr. Shuren says. "But to rule those out, we need studies that are larger and longer than those conducted thus far."

Slight risk for rare cancer

The FDA recently said that breast implants might be linked to a higher risk for a rare form of cancer called anaplastic large cell lymphoma, but Dr. Shuren says those risks are actually "profoundly slim."

The agency based its latest report on preliminary data from six ongoing post-approval studies conducted by Allergan and Mentor, the two companies that manufacture the silicone-gel breast implants. The studies were mandated by the FDA in 2006 as a condition of approval. The agency will also continue to discuss the issue of implant safety.

The advocacy group Public Citizen continues to be critical of the FDA’s decision to allow silicone breast implants back on the market.

"The agency's newer information about the risk of implant-associated lymphoma and the previously known risks are serious enough to warrant advising women against having these implanted," says Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group.

FDA recommendations

Women with gel implants should:

• See their doctor regularly for follow-up, including having occasional MRIs to detect potential ruptures.
• Pay attention to any breast changes and notify their health care provider if they notice any unusual symptoms such as pain, asymmetry, or swelling.
• Educate themselves on the signs and symptoms of complications.

Always talk with your health care provider to find out more information.