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Silicone Breast Implant Makers Have Not Adequately Tracked Patients, FDA Says

An FDA hearing on the safety and effectiveness of silicone breast implants was held this week; although the FDA decided to keep silicone gel implants on the market, agency officials stated that the manufacturers of these products did not sufficiently track thousands of women who received silicone implants. 

As a condition of the FDA’s approval of silicone gel implants in November of 2006, the two manufacturers of these products, Mentor and Allergan, were required to conduct large, 10-year post-market studies on the safety and effectiveness of their silicone implant products.

During this week’s hearing, both companies admitted that they failed to follow up with a significant number of women. Mentor’s study included 40,000 women when it started; within three years, the company was following up with just 21 percent of participants. Allergan was a little more successful in tracking patients; two years after the study started, the company was following up with 60 percent of the 39,300 women enrolled in their study.

Consumer advocate Diana Zuckerman, president of the National Research Center for Women and Families, testified at the FDA hearing, saying that Mentor and Allergan did a poor job of collecting the data that was required of both companies.

“This is one of the most visible, controversial medical devices, and they can’t even get the data right,” Zuckerman said. “Without proper data, we still don’t know how safe or effective they are and whether there are certain patients at risk for extremely negative outcomes.”

Christopher Allman, a spokesperson for Mentor, says that the company encouraged patient participation in the studies.

“At Mentor’s request, letters from FDA were sent to physicians and patients to encourage follow-up and state the importance of follow-up; unfortunately, there was minimal impact with respect to the follow-up rate,” Allman said.

Despite the poor patient follow up, the FDA maintains that silicone gel implants are safe and will remain on the market.

“We felt that way before the meeting, and we continue to feel that way after the presentations and discussions over the past two days,” Dr. William Maisel, chief scientist for the FDA’s Center for Devices, said.

FDA officials said that the agency would work with breast implant manufacturers and consumer groups to improve patient participation in studies.

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