Posted on Saturday, Oct. 15, 2005
HealthCentral.com
The U.S. Food and Drug Administration said Wednesday that it has granted a second manufacturer of silicone gel-filled breast implants a "conditional approval," taking the company a step closer to returning the controversial implants to the market, the Associated Press reported.
The FDA told Inamed Corp., of Santa Barbara, Calif., that its implants can be approved under certain conditions, but the agency did not spell out those conditions.
In July, the agency gave a similar, conditional approval to manufacturer Mentor Corp., also of Santa Barbara, after an FDA advisory panel voted to recommend approval of the company's application to sell the implants, the AP said.
But the panel at the time recommended against Inamed's implants, citing safety concerns. The FDA said Wednesday that Inamed has subsequently provided additional information to address those concerns.
Silicone gel implants went on sale in 1962 in the United States. Thirty years later, the FDA banned all but those used for breast cancer reconstruction, amid fears that leaks might be responsible for autoimmune diseases and even cancer. Other problems included the fact that many women needed repeat operations to deal with painful scar tissue.
By 1998, more than 170,000 lawsuits had been filed against implant manufacturers by women claiming their silicone implants had caused immune system disorders and chronic diseases such as rheumatoid arthritis and systemic lupus. Four companies paid out millions of dollars in settlements to the women, and one of them, Dow Corning, filed for bankruptcy to pay $3.2 billion to settle its claims.
However, studies by the Mayo Clinic, Harvard Medical School and the Institute of Medicine ( IOM ) panel from the National Academy of Sciences subsequently found no evidence that leaked silicone from gel implants caused systemic disease.
Proponents of silicone implants say they look and feel more natural than saline implants.
