Manufacturers’ research indicates that the implants, which were allowed back on the market five years ago, are safe, the agency says. Critics say data are still inadequate.
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 range of illnesses. During that period, women seeking implants for cosmetic reasons had been limited to the less-natural-feeling saline implants, which stayed on the market.
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,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said 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, connective tissue disease or infertility.”
But some critics say there is not enough data to back up the agency’s safety claims.
“There’s a lot of wishful thinking,” said Dr. Diana Zuckerman, president of National Research Center for Women & Families, a group that examines the safety of medical products. Zuckerman said participation rates by patients in the manufacturers’ studies were so low – 20% for one study – that she considered some of the results “unusable.”
Many women who were seeking implants for cosmetic reasons – as opposed to post-mastectomy reconstruction – dropped out. These women, who made up 3 of every 4 implant surgeries last year, are generally younger and healthier and have less incentive to follow up with doctors. But Zuckerman said the manufacturers had little incentive to get good data once their devices were approved. “Any parent knows that if you want your child to clean up their mess, you offer the reward after they clean up,” she said.
Plastic surgeons, however, breathed a collective sigh of relief. “This is a great day for plastic surgeons and especially for their patients,” said Dr. Phil Haeck, president of the American Society of Plastic Surgeons.
The report was quick to warn consumers against assuming 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 tear like saline implants, it said.
It is unclear how many women actually get biannual MRIs, which are part of the implant labeling recommendations and can cost as much as $2,000.
The FDA effectively banned silicone implants in 1992, after fears arose of a possible link with certain autoimmune diseases. The implants’ use was restricted to mastectomy patients participating in clinical trials.
At the time, plastic surgeons and 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 silicone from burst implants had caused their 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 showed no link between 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 the incidence of a rare form of cancer, anaplastic large-cell lymphoma. The FDA says the number of cases identified – 60 worldwide – was too small to conclude that implants were linked to the disease.
The report summarizes initial findings by the devices’ manufacturers, Santa Barbara-based Mentor Worldwide and Irvine-based Allergan Inc., which were required to conduct post-approval studies on more than 80,000 women over 10 years.
Nearly 400,000 women received breast implants last year, and more than 60% opted for silicone.