By Christine Mai-Duc, Washington Bureau
June 22, 2011, 11:34 a.m.
WASHINGTON — Five years after allowing silicone breast implants back on the market, the Food and Drug Administration said Wednesday that further studies showed that the decision was sound.
The FDA was criticized by consumer groups in 2006 for approving the implants after a 14-year hiatus because of widespread fear that they caused a wide range of illnesses.
But research by the two manufacturers of the implants, released in a report Wednesday, indicates that they have a "reasonable assurance of safety and effectiveness" when used properly, the FDA said.
"I don't know what the critics will ultimately say," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, in an interview, "but what we can say is the current data doesn't indicate that silicone-gel-filled breast implants are linked to breast cancer or connective tissue disease or infertility."
Until 2006, women seeking implants for cosmetic reasons had been limited to the less-popular saline variety, which stayed on the market.
But the report was also quick to warn consumers against the assumption that silicone implants are risk free. Patients should still get MRIs every two years to screen for "silent ruptures" of the silicone implants, which don't deflate when they break, as saline implants do.
The agency also stressed that women should not think of silicone implants as long-term devices. According to the data, as many as 1 in 5 women getting implants for strictly cosmetic reasons had to have them removed within eight to 10 years. For patients undergoing reconstructive surgery — often after mastectomies — as many as 1 in 2 were forced to have them removed within that time frame.
The FDA effectively banned them in 1992, after fears arose of a possible link between the implants and certain autoimmune diseases. Their use was restricted to mastectomy patients participating in clinical trials.
At the time, some in the medical research community criticized the ban, saying the decision was based on public opinion, not science – and that in fact little evidence existed on either side of the debate.
What followed was a rash of lawsuits by women claiming leaked silicon from burst implants had caused ailments including lupus, cancer and arthritis. Dow Corning, the biggest manufacturer of silicone implants at the time, went bankrupt after settling a $4-billion class-action suit brought by women claiming injuries.
Since then, there have been a number of major studies that show no link between the silicone implants and connective tissue disease, reproductive problems or breast cancer.
In January, however, the FDA warned of a possible link between breast implants, both silicone and saline, and a rare form of cancer, anaplastic large cell lymphoma. But the FDA says that the low number of cases identified — just 60 worldwide — means that much more research needs to be done.
The report summarizes initial findings by the devices' manufacturers, Santa Barbara-based Mentor Inc. and Irvine-based Allergan, which were required to conduct post-approval studies on more than 80,000 women over 10 years. Five years in, the evidence doesn't link silicone implants to such diseases.
This is welcome news to the more than 300,000 women who received breast implants last year, more than 60% of whom opted for silicone.
The studies, however, will continue. Mentor and Allergan will be required to continue the research until 2016.