#FDA: Breast implants reasonably safe but not lifetime devices

Silicone gel-filled implants are not lifetime devices, and the longer they're in the body, the more likely there'll be complications, U.S. health regulators said Wednesday.

Despite the likelihood of complications, the Food and Drug Administration announced that silicone breast implants, which the agency approved in 2006 after they'd been off the market for 14 years, are for the most part safe.

The report included preliminary data from post-approval studies, an analysis of adverse effects reported to the FDA and a review of clinical studies about the safety and effectiveness of the silicone gel-filled breast implants.

The safety of breast implants has long been controversial. The FDA banned them for most U.S. women in 1992 amid concerns that they could be linked to health problems such as cancer and rheumatoid arthritis. But after subsequent studies appeared to exonerate the implants, the FDA allowed sales to resume in 2006, despite protests from consumer advocates.

Between 5 million and 10 million women worldwide have received implants, either in reconstructive surgery after breast cancer or for breast augmentation. Nearly 400,000 women received the devices in the United States last year.

In January, the FDA said that implants might increase the risk of developing a rare form of lymphoma known as anaplastic large cell lymphoma, a cancer of the immune system.

On Wednesday, the agency announced the results of a review of data on the devices, including a preliminary analysis of information from studies the FDA had required from Allergan and Johnson & Johnson’s Mentor Corp. to conduct as a condition of the agency approving their devices.