Will someone explain to me again why the government thinks we can trust the health care industry, the pharmaceutical companies, et al.?
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 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 implanted in women who want to have their breasts restored after surgery or enlarged, 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 the condition that he not be identified because of family and job concerns. He also wrote that he believed it was misleading to show patients the modified devices but implant the others.
The former Mentor engineer's allegations are now before the agency and several congressional oversight committees, adding a new factor to the long-running debate over wider use of silicone breast implants.http://www.washingtonpost.com/wp-dyn/content/article/2005/12/04/AR2005120400887.html
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