Mentor Gets Conditional Approval for Implant

Silicone gel breast implants, which are sold for cosmetic surgery in foreign markets, have been severely restricted in the U.S. since 1992 because implant-makers haven't been able to convince the FDA of their products' long-term safety.

Silicone gel implants are available today in the U.S. for patients undergoing reconstructive surgery after a mastectomy, women whose existing gel implants have ruptured and women who have congenital deformities of the breast. These implant recipients must be enrolled in a clinical trial.

Saline implants are available for cosmetic use in the U.S., although plastic surgeons supporting gel implants say these devices have a more natural look and feel than the salt-water implants. Mentor sells saline implants, as does its archrival Inamed (IMDC Quote).

One day before the FDA advisory panel approved the Mentor implant, the panel rejected a silicone-gel breast implant from Inamed by a 5-4 vote. Also based in Santa Barbara, Calif., Inamed recently said it was revising its implant application to the FDA.