WASHINGTON – Mentor Corp, which hopes to win Food and Drug Administration approval soon to sell its silicone-gel breast implants for general cosmetic use, faced a problem last year as it prepared to distribute to doctors the demonstration models that prospective customers would try on for size: The implants sometimes left behind an unsettling slick of silicone oil.
A former senior engineer with the company told the FDA last month that he and others were asked to solve that problem and came up with a fix, a less permeable material for the one-inch patch that seals a hole left by the manufacturing process.
But despite urging from its staff, the company never made the same modification to the devices destined to be actually implanted in women who have their breasts enlarged or restored after surgery, the engineer said in a letter to the agency.
“I am very concerned about the safety of women using these breast implants if they were to become widely available as an FDA-approved product,” wrote the engineer, who provided a copy of his letter to The Washington Post on condition he not be identified because of family and job concerns. He also wrote that he believed it was misleading to show patients the modified models but implant the others.
The former Mentor engineer’s allegations are before the agency and several congressional oversight committees.
Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, confirmed last week that the agency had gotten the letter, adding, “We are evaluating it and do take it seriously.”
Earlier, FDA spokeswoman Julie Zawisza said the agency had received sufficient gel “bleed” data from Mentor and did not have concerns about the issues being raised. She also said the agency would not object if Mentor used a different demonstration model for “sizing” as long as the practice was “not misleading.”
Possible health complications from silicone gel “bleeds” are among the issues being assessed by the FDA as it moves toward a final decision on two applications to allow unrestricted sale of silicone-gel implants for breast enlargement for the first time since 1992. Both Mentor and Inamed Corp. have received letters from the FDA saying their devices are “approvable” if certain conditions are met, and both companies have undergone final plant inspections by the agency.
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