A former senior engineer with Mentor Corp. has told the FDA that, although he and others found a solution to the problem that left the company's breast implant devices leaking silicone oil, the fix was only applied to demonstration models, and never to the ones meant to actually be implanted in women.

A "Slick of Oil"

Mentor Corp. is still seeking approval to sell its silicone-gel breast implants for general cosmetic use. It ran into difficulties last year when the demonstration models prospective customers tried on for size tended to leave behind a slick of silicone oil.

Controversy lingers over the safety of the implants. Possible health complications from silicone-gel "bleeds" are among the issues being assessed as the FDA ponders whether or not to allow unrestricted sale of silicone implants for breast enlargement for the first time since 1992.

Disturbing Side Effects

Although studies generally show that silicone in your body does not cause health problems, some women have reported disturbing side effects. Several have reported silicone oil seeping out of their foreheads, eyes and elsewhere. And new research may indicate that low but constant exposure to chemicals such as silicone may result in long-term health problems for some women.

Mentor dismissed the issue, saying the safety data indicates that the gel leakage is "more than a million fold below toxicological levels of concern."

Hundreds of Thousands Each Year

More than 300,000 breast implant surgeries were performed last year, either for cosmetic reasons or following a mastectomy. Since 1992, because of health concerns, silicone-gel implants 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, but many say they produce a less natural-seeming result.