This week, the Food and Drug Administration granted the second California breast implant manufacturer conditional approval to sell cosmetic silicone breast implants.  In June 2005, Mentor Corporation became the first company to gain conditional approval to begin selling silicone implants for the first time in nearly 13 years.  Inamed Corporation announced this week that the FDA has given the company an “approvable letter” to begin marketing their own cosmetic silicone breast implants.  Both Mentor and Inamed are based out of Santa Barbara, California.

Earlier this year, an FDA advisory panel supported Mentor’s application but rejected Inamed’s request to sell silicone breast implants for cosmetic purposes, despite the fact that concerns for each product are very similar.  Inamed revised their proposal and resubmitted it to the FDA with success.  The company is required by the FDA to comply with certain terms of approval before it receives its final go-ahead to sell silicone implants for cosmetic use. 
 
Silicone implants were originally pulled off the market by the FDA in 1992, due to mounting safety concerns.  At this time, silicone breast implants were not well studied.  In addition to significant rates of leakage, rupture and other local complications, silicone implants were linked to breast cancer, immune disorders, and connective tissue diseases.  The FDA halted sales of all silicone breast implants for cosmetic purposes but allowed the implants to be used in reconstructive patients and clinical trials.  The FDA also recommended that implant manufacturers conduct more research about the effects of both silicone and saline implants. 

Studies have subsequently discovered no link between silicone breast implants and cancer or other life-threatening medical conditions.  Many women in these studies have, however, experienced local complications, including capsular contracture (where scar tissue builds and squeezes on the implant).  Many experts are still concerned about the effects of silicone implant rupture and leakage. 

Silicone implants are thought by many to be more natural looking and feeling, compared to their saline filled counterparts.  According to statistics, approximately 250,000 women undergo cosmetic breast augmentation every year in the United States.