FDA Reconsidering Silicone Breast Implants
Three days of hearings on rupture rates begin
MONDAY, April 11, 2005 (HealthDay News) -- The U.S. Food and Drug Administration opened a three-day hearing Monday on whether to allow silicone breast implants back on the market for women who want aesthetic breast-enhancement surgery.
The first day was devoted to public comment, with some women who had received the implants detailing what they called devastating health problems caused by the devices.
Other women, however, called silicone implants a superior product to saline implants for breast enhancement. They also said consumers should be allowed to chose freely between the two.
"They poisoned my mother," testified Brenna Dowd of Boise, Idaho, according to the Associated Press. "I have never known a healthy mother."
"I don't want anybody else to suffer this way," said Susan Helman of Florida, who blamed her autoimmune diseases on platinum that leaked into her body when her implants broke, the AP said.
But Virginia Silverman, of Orange County, Calif., said, "We have a right to decide what is right for our own bodies." She said she initially opted for salt water-filled implants for reconstruction after breast cancer surgery. But she found them too hard, so she replaced them in 2001 with silicone gel implants that she finds more comfortable, the news service said.
The hearing is the latest in the long and contentious history of the medical devices.
In October 2003, the FDA's General and Plastic Surgery Devices Panel, by a nine-to-six vote, approved the sale of the silicone implants for aesthetic purposes. But the panel chairman, Dr. Thomas Whalen, disagreed with the vote and recommended that the FDA not follow the panel's decision.
The following January, the FDA disregarded the panel's recommendation and refused to approve the devices, pending more data on long-term safety issues, particularly the devices' rate of rupture.
Now the FDA has decided to once again review the applications from two companies that manufacture the products, Inamed Corp. and Mentor Corp., both in Santa Barbara, Calif.
These companies are again presenting data on the safety of the products among women who have had the devices implanted. Inamed will offer results of new research on why silicone implants have ruptured and where silicone ends up when an implant does rupture, said Dan Cohen, the company's vice president of corporate and government affairs.
"The FDA, in its non-approval letter in January of 2004, focused on two questions: Why do the implants rupture and where does the gel go to? And we have studied those questions," he said.
Another big concern for opponents of the implants is their long-term safety. The FDA, in research presented on its Web site, estimates that up to three-quarters of the devices might rupture within 10 years of implantation.
Cohen questioned that FDA research.
"Their findings are based on statistical models rather than actual data because the number of ruptures is too low to predict future trends," he said.
He added that more than 200,000 women have received silicone implants in the United States and in Europe, either through clinical trials or through exceptions allowed by the FDA, like breast cancer reconstruction or severe asymmetry.
"That's a substantial number of women, and that rupture rate would be manifested in the world today, and it's just not there," he said.
But opponents of silicone implants say there is still not enough data on long-term safety to justify lifting the ban.
"There is no real new information. What approval of the implants will do is to expose lots of women to what we don't know is safe," said Barbara Brenner, executive director of Breast Cancer Action, a San Francisco advocacy group for women with breast cancer. A representative from the organization will be testifying at the hearing, she said.
There has been a big increase in the number of women choosing to have breast augmentation, up from 32,000 in 1992 to 237,000 in 2002, an increase of nearly 600 percent, according to the American Society of Plastic Surgeons. The large majority of these women had saline implants, which are FDA-approved.
However, many women prefer the silicone gel implants, saying they look more natural.
The controversy about silicone breast implants traces back 13 years, when the devices were thought by some to cause a variety of serious ailments. In 1992, the FDA banned the sale of the silicone implants for cosmetic surgery.
By 1998, more than 170,000 lawsuits had been filed against implant manufacturers by women claiming their silicone gel implants had made them sick with problems such as 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.
More recent research has focused on the problems of scar tissue developing at the site of the implant and on the rate of rupture of the devices.
The U.S. Food and Drug Administration offers more information about breast implants.