Mentor Corp., a maker of silicone gel breast implants, is hoping for FDA approval to sell its implants for general cosmetic use. However, the implants have exhibited a problem of leaking silicone oil. A former engineer for Mentor told the FDA that when the company was alerted to the problem, it fixed the demonstration models of the implants that would be used in doctor offices, but not the models that would be used for actual implants.
In his letter to the FDA, the engineer indicated that it was misleading to demonstrate the modified devices to patients, but implant devices that had not been fixed. The patch used to modify the implants was effective and inexpensive. However, Mentor decided not to modify the devices that would actually be implanted in women.
There remains controversy over the safety of silicone gel implants, and the FDA is considering possible health implications from silicone bleeds, in its review of applications to approve the devices for widespread use. Due to health concerns, since 1992, silicone gel breast implants have only been available to mastectomy patients and women willing to participate in a clinical trial. The Mentor website urges women not to worry about the so called myth of bleed. It maintains that all Mentor gel implants are low bleed and studies have not linked bleeds to illness.
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