WASHINGTON — A sharply divided panel of outside experts recommended Wednesday that the government permit general use of silicone gel implants for breast enhancement, a decision that would reverse a decade-old restriction triggered by widespread reports of serious side effects.
The committee voted 9 to 6 in favor of resuming use of the implants after the majority concluded that the health risks were not significant enough to keep the popular implants off the market.
The panel’s recommendation, which followed two days of public hearings, is not binding on the Food and Drug Administration. The agency usually follows the lead of its advisory groups, but FDA officials said the divided verdict would make the decision more difficult than usual.
Panel members unanimously voiced concern over the lack of long-term data on the health risks, but the majority concluded that the best available studies showed they were acceptable. The evidence on both sides has long been the subject of intense controversy, with critics saying the implants caused serious health problems for thousands of women, while manufacturers and plastic surgeons said the risks had been exaggerated and were not supported by good research.
The panel’s recommendation could open the door to general use of the implants 11 years after the FDA limited their use to women who had undergone mastectomies or took part in clinical studies. That left implants filled with saline solution as the only product approved for general use.
If the FDA accepts the recommendation, plastic surgeons said during two days of hearings, many of the 1 million women expected to seek implants over the next three years will probably choose the silicone version, which women tend to prefer on the grounds that they look and feel more natural.
The recommendation was tied to conditions that would require the implant maker, Inamed Corp. of Santa Barbara, Calif., to set up a program to retrain surgeons in the use of the devices, create a registry of implant users and hire an outside group to oversee it, and extend its studies of implant users for as many as 10 years. Inamed would also have to develop a model informed consent form in conjunction with the FDA and panel members.
Implant critics, who spoke emotionally and at length during the hearing, said they were dismayed.
"It was a split vote, and all the plastic surgeons on the panel were for it," said Diana Zuckerman of the National Center for Policy Research for Women and Families. "There were too many people involved with a conflict of interest."
The 1992 decision to restrict the use of silicone implants was based largely on widespread complaints that they triggered neurological or connective tissue disorders such as arthritis, lupus erythematosus or fibromyalgia. But in 1999, the federally chartered Institute of Medicine reviewed all the available studies and concluded there was no evidence that silicone implants were causing serious disease.
But in the hearing, Inamed presented data showing that significantly more women with implants complained of joint pain, fatigue and similar conditions two years after receiving the implants. Asked whether the company’s data had reopened the issue of connective tissue disorders, Sahar Dawisha, the FDA medical officer who reviewed the data, said, "The issue is not resolved at this time."
But Caroline Glickman, a plastic surgeon at Memorial Sloan-Kettering Cancer Center in New York, said: "Men have the right to choose Viagra even if they have a risk of heart disease. Women have the right to make a choice like that, too, with silicone implants."
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