FDA: Silicone Breast Implants Appear Safe, But Need to Be Monitored

Article date: June 28, 2011

By Stacy Simon

In a new report, the US Food and Drug Administration (FDA) says as many as half the women who receive silicone gel-filled implants for breast reconstruction may need them removed within 10 years.

The FDA allowed silicone gel-filled breast implants back on the market in November 2006, for either breast augmentation or for breast reconstruction after mastectomy. As a condition of its approval, the FDA required the manufacturers to conduct follow-up studies of the implants’ long-term performance and safety. The new report includes this information as well as other safety information from recent scientific publications, and from problems reported to the FDA.

The FDA report says the implants appear to be safe and effective when used as intended. But it also advises women to understand the risks involved and to take steps to stay safe.

The report makes these key points:

• Breast implants do not last a lifetime. The longer a woman has them, the more likely she is to experience complications and need them replaced or removed. Women with implants need to monitor them for life.

• The most common complications are tightening of the area around the implant, a rupture in the implant, wrinkling, uneven appearance, scarring, pain and infection.

• Early results from studies do not indicate that the implants cause breast cancer, reproductive problems, or rheumatoid arthritis or other connective tissue disease. But no study has been large enough or long enough to rule this out.

“It is important that women with breast implants who experience any symptoms see their health care providers,” says Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health. “Women who have enrolled in clinical studies should continue to participate so that we can better understand the long-term performance of these implants and identify any potential problems.”

Unlike implants filled with saline (salt water), which tend to "deflate" noticeably if they rupture, silicone gel-filled implants may leak slowly, without obvious changes in appearance. Because of this, the FDA recommends that women with silicone gel-filled breast implants get screenings for silent ruptures 3 years after they get implants and every 2 years after that. These are MRIs of the breast to look for ruptures that the women may be unaware of.

Women should also see their doctor if they notice any changes in their breasts.

For information about breast reconstruction after breast cancer surgery, see our document Breast Reconstruction After Mastectomy or call 1-800-227-2345. To learn more about breast cancer, visit cancer.org/breastcancer.

Reviewed by: Members of the ACS Medical Content Staff

ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases.