FDA Paves Way For Unrestritced Silicone Breast Implants

Silicone Implant makers Allergan Inc. and Mentor Corp. have won U.S. approval to resume unrestricted sales of silicone breast implants.

The Food and Drug Administration ended restrictions that had limited the products to clinical trials for 14 years. Silicone, also used in the Silly Putty toy, was the target of breast-implant litigation that cost Dow Corning Corp. $3.2 billion.
Dr. Stephen Greenberg, a New York cosmetic surgeon, performs thousands of breast augmentations each year. He has long been a proponent of silicone implants.

"Silicone offers the patient the most true to life representation of breast tissue and the most natural result. It is also a very user friendly material to work with as a surgeon," says Greenberg. "I expect that this will signal an immediate increase in breast augmentation procedures as patients who had previous reservations will now
be more willing to move forward with the procedure," he continues.

Silicone closely resembles the texture of breast tissue and has been used extensively in other countries. Sales of the implants and the subsequent procedures are expected to sky rocket in the next few years. In their decision to approve the implants the FDA didn't link the implants to connective-tissue diseases, as did allegations against Dow Corning.

About 290,000 women received cosmetic implants in 2005, a 37 percent increase in a five-year period, according to the American Society of Plastic Surgeons.