FDA: Breast Implants Don't Last Forever

Women who get silicone gel breast implants should plan on additional surgery later to deal with complications, the Food and Drug Administration (FDA) said.

The FDA said it would revise safety labels on implants after reviewing preliminary data from several long-term studies that highlighted potential problems, including a potential for the implants to rupture.

While the report confirms that silicone gel-filled breast implants are safe and effective when used as intended, women should fully understand the risks prior to considering silicone gel-filled breast implants for breast augmentation or reconstruction, the agency said.

No lifetime guarantee

First and foremost, the FDA said, women should understand that breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications.

One in five patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 50 percent will require removal 10 years after implantation.

According the FDA, the most frequently observed complications and outcomes are a hardening of the area around the implant, additional surgeries and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

No evidence implants cause breast cancer

The FDA says that peliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, the agency said studies would need to enroll more women and be longer than those conducted thus far.

Much of the data the FDA reviewed came from studies conducted by Allergan and Mentor, two implant manufacturers. Also, the data included 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.

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.