FDA Moves Closer to Approving Silicone Implants

The FDA has moved one step closer to allowing silicone gel implants back onto the market for aesthetic use after issuing an approvable letter to Santa Barbara, CA-based Mentor Corp. for its gel implants. The letter is a precursor to premarket approval.

The letter came after the agency’s General and Plastic Surgery Devices Advisory Committee recommended in April that the medical device be allowed for sale for general use. The agency since 1991 had banned silicone gel implants for other than reconstructive use after safety concerns were raised. While the FDA stressed that the letter is not equivalent to premarket approval, it moved closer to giving women seeking cosmetic surgery a choice of either silicone or saline implants.

Mentor would be the first and only company to resume selling silicone gel implants following the ban. Competitor Inamed, also based in Santa Barbara, CA, was rejected by the same panel in April. It has since revised its product submission to the FDA, which has not yet ruled on it.