GAITHERSBURG, Md. — The Food and Drug Administration reaffirmed its position that silicone-gel breast implants are “safe and effective for their intended use,” an FDA official said Wednesday, although the agency is looking for ways to improve long-term follow-up of women who receive them.
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“We believe that the benefits and risks are sufficiently well understood,” Dr. William Maisel, deputy director for science and chief scientist for the Center for Devices and Radiological Health, told reporters.
His comments came at the end of a two-day meeting of outside experts convened by the federal agency to discuss ways to improve collection of information about silicone-gel implants' long-term effects. On both days, panel members heard what Maisel described as “compelling” testimony from women who said they suffered numerous complications from their implants.
U.S. surgeons performed nearly 400,000 breast implant procedures last year. About three-quarters were for breast augmentation, while the rest were for breast reconstruction. About half the operations used silicone gel-filled implants; the other half used implants filled with saline, or salt water.
Concerned about a possible link to autoimmune disease, the FDA placed a moratorium on sales of silicone-gel implants in 1992. But clinical trials failed to show a connection, so in November 2006, the agency approved silicone-gel implants made by Mentor and Allergan. As a condition of approval, the FDA required the companies to conduct decade-long studies of their implants’ performance.
Low rates of follow-up in study participants
However, many study participants have been lost to follow-up. Mentor has three-year data for only one out of every five women in its study, while Allergan has two-year data for three out of every five, according to the FDA.
Panel member Nancy Dubler, an ethicist who consults for the New York City Health and Hospitals Corp., called the post-market studies “clearly and deeply inadequate.”
Cynthia Pearson, executive director of the National Women’s Health Network, told panel members on Tuesday that the FDA should give manufacturers one year to improve follow-up rates. If they don’t, Pierson said, the agency should withdraw approval of silicone-gel implants.
But, Maisel said, the decision to keep the implants on the market is based on more than the companies’ post-market studies. The FDA has also looked at the studies conducted to gain approval, which have longer and better follow-up than those launched after approval, he said. Other studies published in the scientific literature and reports of adverse events help complete the picture, Maisel said.
“You could have the most well-meaning company that wants to do a good study, but if the patients don’t want to participate, the study won’t be completed,” he said.
One frequently cited reason at the meeting for the post-market studies’ low follow-up rates was that augmentation patients see no reason to return for checkups. In addition, one requirement of the post-market studies is that women get regular MRIs — an expensive scan for which women who had breast augmentation must pay out-of-pocket — to check to see if their implants have torn.
Registry could boost follow-up
Panelists suggested that the post-market studies drop the MRI requirement and that the FDA work with surgeons’ professional organizations and consumer groups to develop a registry of women who receive silicone-gel implants.
The American College of Cardiology has established such a registry for implantable cardiovascular devices, such as stents and defibrillators, Maisel said. If doctors and hospitals don’t enter their patients into that registry, he said, Medicare won’t reimburse them.
‘’The current studies are definitely going to continue,” Maisel said. “We’re committed to seeing them completed. We’re committed to seeing that follow-up rates improve.”
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