FDA Panel Votes to Lift Silicone Breast Implant Ban
Devices may be brought back for cosmetic purposes
WEDNESDAY, Oct. 15, 2003 (HealthDayNews) -- A U.S. Food and Drug Administration (FDA) advisory committee voted late Wednesday to recommend approval of the controversial silicone gel breast implants for cosmetic use.
The committee's recommendation, if adopted by the FDA, would reverse a 1992 ban on the implants for cosmetic use and give the go-ahead to Inamed Corp. to sell the breast-enhancement devices for aesthetic use. The company already sells the implants for medical use, largely for breast reconstruction after cancer.
"There were lots of facts to consider and this has been controversial for many years, so we are absolutely thrilled with the end result," said Joann Kuhne, senior director for regulatory and clinical affairs for the Santa Barbara, Calif., company and one of those who testified at two days of hearings.
The agency approval is conditional upon Inamed providing approximately a half dozen more pieces of information. Those includes supplying an "informed decision" brochure for women contemplating the surgery, providing an 800 number for women to call for information and training physicians in surgical techniques for the devices, Kuhne said.
She added it was difficult to speculate when the devices would be available.
"We have to work with the FDA. The ball is in their court," she said. But, she added the company hopes to have the implants available for cosmetic augmentation within a year.
The FDA is not bound by Wednesday's decision, but often follows the recommendations of its advisory panels. The panel voted 9-6 in favor of the implants.
The panel's vote to recommend approval followed two days of hearings that included reports on the results of clinical trials conducted by Inamed and involving 26,000 women who have had the devices implanted.
There was also emotional testimony from women who spoke for and against the implants. Some urged the committee not to approve the devices, citing what they said were health problems caused by the silicone in the implants. Other women spoke in favor of FDA approval of the implants, based on their own positive experiences with the devices.
Dr. Loren Schechter, a Chicago plastic surgeon who is participating in clinical trials for another implant manufacturer, Mentor Corp., was pleased with the panel's decision.
"The company has submitted data, and the FDA has made a good decision," he said. "The major issue is what's best for the patient, and this will offer a very reasonable option for women. This issue is really about choice."
Not everyone was happy with the panel's ruling, however.
Diana Zuckerman, president of the National Center for Policy Research for Women and Families in Washington, D.C., testified against approving the gel implants. She said Inamed's studies consisted of only two-year follow-ups, which she said was not nearly enough time to conclusively show the devices were safe. She said other data presented at the hearings, including women's reports of hair loss, rashes, fatigue and feelings of dissatisfaction within two years of receiving the implants, should have persuaded the panel to reject the company's application.
"We rely on the FDA for safety, and what happened today really undermines the credibility of the FDA," Zuckerman said. "I was really shocked that the panel voted for approval."
The history of the silicone implants is long and controversial. The silicone gel implant was at one time the preferred method of breast augmentation for women because of its soft, pliable texture. But in 1992, responding to hundreds of women's claims that ruptured implants had leaked silicone into their bodies and caused long-term chronic immune system disorders, the FDA banned the sale of the gel implants.
The ban and subsequent lawsuits against the four companies that manufactured the gel implants resulted in millions of dollars in settlements to the women. One company, Dow Corning, filed for bankruptcy to pay $3.2 billion to settle the claims against it.
But then science weighed in on the other side. Studies by the Mayo Clinic, Harvard Medical School and, in 1999, the Institute of Medicine (IOM) panel from the National Academy of Sciences found no evidence that leaked silicone from gel implants caused systemic disease, although they did report localized problems of pain and the potential for scarring at the site of the implant.
There has been a major increase in the number of women choosing to have breast augmentation, up from 32,000 in 1992 to 225,000 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, with are FDA-approved.
Silicone gel implants have been used during the past decade in reconstruction surgery, particularly for women who have had breast cancer.