Safety Data Released for Silicone Breast Implants

The US Food and Drug Administration (FDA; Silver Spring, MD, USA) has released a report updating the clinical and scientific information for silicone gel-filled breast implants, including preliminary safety data from studies conducted by the manufacturers.

The report includes preliminary safety data from postapproval studies conducted by Allergan (Irvine, CA, USA) and Mentor (Santa Barbara, CA, USA), the two approved manufacturers of silicone gel-filled breast implants in the United States. The data includes a summary and analysis of adverse events received over the years by the FDA, and a comprehensive review and analysis of recent scientific publications that discuss the safety and effectiveness of silicone gel-filled breast implants. The FDA approved silicone gel-filled breast implants in November 2006 for breast augmentation in women over age 22 and for breast reconstruction in all women.

Based on the report, women should know that breast implants are not lifetime devices, and the longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications. One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation; for those who received implants for breast reconstruction, almost half will require removal 10 years after implantation. The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation, and implant removal.

Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection. The complications that existed for women receiving breast implants at the time of approval are similar to the complications observed today. The preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems, or connective tissue disease such as rheumatoid arthritis (RA).

“The FDA will continue to monitor and collect safety and performance information on silicone gel-filled breast implants, but it is important that women with breast implants see their health care providers if they experience any symptoms,” said Jeffrey Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health. “Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems.”

The FDA recommends that health care professionals and women who have silicone gel-filled breast implants maintain follow up, including undergoing routine magnetic resonance imaging (MRI) to detect silent rupture. Women should also notify their health care professionals if they develop any unusual symptoms and report serious side effects to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program.

Related Links:
US Food and Drug Administration
Allergan
Mentor