FRIDAY, Oct. 17, 2003 (HealthDayNews) -- Despite Wednesday's recommendation for their approval, silicone gel breast implants face several hurdles before they're back on the American market.
A U.S. Food and Drug Administration advisory panel voted 9-6 to approve the devices after a two-day hearing. But the panel couched its OK with a long list of follow-up procedures for the implants' manufacturer, Inamed Inc. of Santa Barbara, Calif., to implement that would monitor the risk of the popular yet controversial devices.
Even then, the FDA, which must ultimately rule on the panel's recommendation, is not making any promises for approval.
"We are in the process of reviewing Inamed's application for the safety and effectiveness of the device, and will take the panel's recommendations into consideration as we continue in our review of the company," said an FDA spokesperson, who would not give a time frame for the decision.
Most of the recommended procedures are in response to the fact that the data presented by Inamed included two-year follow-ups on 26,000 women who got the implants. While this is the standard time frame for data required by the FDA for applying for approval of a medical device, those who oppose the gel implants are not convinced this was enough.
"There is no data on the safety of the [implants] for more than two years," said Diana Zuckerman, president of National Center for Policy Research for Women and Families in Washington, D.C., who testified against approving the gel implants at the hearing. "We need at least 10 years."
Joann Kuhne, who is the senior director for regulatory and clinical affairs for Inamed and testified at the hearing about the study results, feels strongly that the implants are safe.
"These implants have probably been tested more than any other medical device," she said. However, she added that the company would work closely with the FDA on follow-up procedures to make sure the implants are safe in the longer term.
"We have to work with the FDA. The ball is in their court," she said.
Inamed has agreed to the following:
- Having the patient sign an informed consent form that will be written by the advisory panel and the FDA.
- Writing and distributing a patient education booklet on breast implants so women can be as informed as possible on potential risks posed by the implants.
- Following patients for 10 years after they receive their implants, with physical examinations and MRIs at five, seven, and nine years and longer if necessary. MRIs are able to spot ruptures in the silicone implants.
- Supplying the FDA with annual reports on the post-approval study, which will include statistics on how many implants have ruptured. The company will also retrieve broken implants to understand why they have failed.
- Recommending that patients with silicone gel implants have regular physician follow-ups as long as they have the devices.
- Providing a toll-free number for patients that will offer advice on how to monitor their breasts after a silicone gel implant.
- Developing a surgeon education and certification program to train doctors to perform silicone gel implant surgery.
Regarding the safety of the implants, Inamed reported at the hearing that the two main safety concerns were the rupture rate for the gel implants and the rate of "capsular contracture" -- when the scar tissue that normally forms over the implants tightens, squeezing the implant, which can be painful.
The rupture rate of the devices over the period of the study was 3.4 percent. Of the 26 reported ruptures, there was no leakage of silicone into the body as diagnosed from MRI scanning and physical examinations, according to the advisory panel's report. It was delivered by Dr. Scott Spear, a Washington, D.C., plastic surgeon who participated in the Inamed trials.
The rate of capsular contracture was 8.3 in those women who received the implants for cosmetic reasons, and 16 percent in the women who had the implants for breast reconstruction following cancer surgery.
Spear also reported that 20 percent of those women who had augmentation for cosmetic reasons and nearly half of those who had the implants as part of breast reconstruction had to have "re-operations." He said the high numbers had to be put in the context of plastic surgery, where re-operations are much more common that in other surgeries. Twenty percent of rhinoplasties, for instance, require re-operations. Also, 12 percent of the breast re-operations were due to implant rupture or capsular contracture. Most of the remaining re-operations were for cosmetic reasons, he said.
Silicone gel implants were at one time the preferred method of breast augmentation for women because of their 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.