FDA Lifts Ban on Silicone Breast Implants After Years Of Personal Injury Suits
After 14 years off the market, silicone breast implants are now available for women aged 22 or older as well as those undergoing reconstructive breast surgery. The FDA declared silicone-gel implants reasonably safe and effective allowing two California companies to produce and sell the implants. As a condition of the FDA approval, Allergan Inc. and Mentor Corporation are required to study leaks on women who already have the implants as well begin a new study on 40,000 other women receiving the silicone implants.
The FDA originally placed the ban on the silicone implants in 1992 when huge numbers of women complained that the implants leaked causing severe pain and infection. In 1995, implant manufacturer Dow Corning was named in 19,000 personal injury lawsuits alleging the implants were defective. Dow was forced into bankruptcy and later emerged from it after setting up a $2.35 billion fund to settle the personal injury claims.
Approximately 291,000 women received breast implants last year made out of materials other than silicone. Tens of thousands of women were waiting for the silicone implants to come back on the market. The women who will receive the newly approved silicone breast implants are required to undergo regular MRI test to check for leaks. Opponents say the implants are still defective products and should not be on the market.