Shari Graydon sgraydon@uottawa.ca

Hi Everyone:

I thought you might all be interested in the following story which ran in today's Seattle Times, reprinted from the Washington Post.

regards,

Shari

Engineer questions safety of breast implants

By Marc Kaufman

The Washington Post

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 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.

Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, confirmed the agency received the letter, adding, "We are evaluating it and do take it seriously."

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.

Since the 1992 decision to restrict silicone gel implants because of health concerns, they have been available only to mastectomy patients and women willing to participate in a clinical trial. Most women seeking breast enlargement have had to use saline-filled models, which many say produce a less natural-seeming result.

More than 264,000 breast implants were performed last year for cosmetic reasons, according to the American Society of Plastic Surgeons. An additional 63,000 were done for women who had had mastectomies

Shari Graydon
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