An independent advisory panel recommended Wednesday that silicone gel implants be made available to all women who want to enlarge their breasts or have breast reconstruction after cancer surgery.
If approved by the Food and Drug Administration, the panel’s recommendation would reverse an 11-year restriction that limited the device’s availability only to breast cancer survivors and other women willing to participate in closely supervised clinical trials. The recommendation also contained several conditions to which the manufacturer would have to agree.
In its 9 to 6 vote, the panel acknowledged the tendency of silicone gel implants to rupture and bemoaned a lack of conclusive information about the long-term effects of silicone in the human body. But a majority of the scientists, plastic surgeons and other physicians said data from a two-year study by implant maker Inamed Corp. of Santa Barbara gave them “reasonable assurance” of the implant’s safety and obligated the government to respond to consumer demand.
“We came in here with the attitude of letting the science speak for itself,” Inamed Chief Executive Nicholas Teti said after the vote. “But let’s not get ahead of ourselves. We haven’t won [final] approval yet.”
Indeed, Wednesday’s vote is hardly the last word on the issue. While the FDA usually follows the lead of its advisory committees, it doesn’t always. And FDA scientists told panel members on Tuesday that they remained concerned about the long-term health risks of the implants, including the incidence of rare autoimmune diseases in women whose implants had ruptured.
“I’m not convinced the FDA will approve this device,” Diane Zuckerman, executive director of the National Center for Policy Research for Women and Families, said after the vote. “It undermines the credibility of the FDA if it is willing to approve a product with no safety data.”
Nor is the vote likely to quell the controversy that has surrounded the device since the 1980s, when breast-cancer survivors with implants began comparing health problems and decided that perhaps their implants were to blame.
Even a multibillion-dollar lawsuit settlement against implant manufacturers failed to dampen demand for silicone devices, which generally are considered to look and feel more natural than saline-filled implants. And while silicone proponents cited scientific studies that found no cause-and-effect relationship between the implants and illness, other studies -- including one by the FDA -- concluded that there could be an association between fibromyalgia and silicone gel that had leaked out of ruptured implants. The government restricted access to the implants in 1992.
Both viewpoints were on display Tuesday and Wednesday, when 107 people -- all but 17 of them women -- spoke of their experiences with the implants as patients or surgeons, scientists or husbands. In light of what several panel members said was insufficient clinical data from Inamed, that testimony appeared to hold sway.
But in the final three hours of a hearing that spanned 25 hours over two days, the tide turned in Inamed’s favor. Company officials told the panel they would take eight specific steps to strengthen their ongoing study of how often and why patients with silicone implants suffer various complications.
The panel revised the company’s proposals, most of them related to recommendations to patients and plastic surgeons about follow-up treatment, and added six other conditions that it said Inamed must satisfy to qualify for final approval. Inamed is the only company seeking FDA approval to resume the widespread sale of implants. Other U.S. makers do sell implants in other countries.
Nancy A. Dubler, a bioethicist at Montefiore Medical Center in New York, said the company’s final pitch won her vote. She returned from lunch Wednesday “prepared to vote no,” she said. “But the company’s ability to recognize our concerns and come back with a plan to monitor [patients for complications] made all the difference.”
The firm’s proposal and the panel’s conditions were not enough for Dr. Michael A. Choti, a surgical oncologist at Johns Hopkins School of Medicine. “I do not think we had sufficient information to provide assurance of long-term safety, especially in patients who develop ruptures,” he said. “Part of this laundry list of conditions and attempted conditions emphasizes the fact that we still have concerns about long-term safety.”
Among the conditions the panel set for FDA approval of Inamed’s silicone implant:
* Inamed must work with the FDA to develop a model consent form, the information that informs a patient of the risks of a medical procedure;
* Inamed must work with professional organizations to develop patient education materials and to train plastic surgeons on how to handle the silicone implant and diagnose ruptures;
* Inamed’s product label must encourage patients to have annual exams and to have MRIs every other year to determine whether their implants have ruptured. The label must encourage patients with ruptured implants to have them removed.
* Inamed must collect information on the children of implant patients.
Dr. Celia Witten, director of the FDA division that reviews implants, told panel members the agency had very little regulatory authority to force Inamed to comply with such conditions.
As for the agency’s next step, Witten said her division would “take the recommendation and complete our scientific review.”