FDA Approves Silicone Gel-Filed Breast Implants

November 17, 2006, the FDA approved the marketing of silicone gel-filled breast implants manufactured by two companies, one of which is Allergan, formerly known as Inamed Corp., which Cosmetic Surgery of New York has had a long-standing association.

This decision ends the controversy over safety, and the findings of the Institute of Medicine and the FDA conclude that silicone, gel-filled implants do not cause major illnesses. Approved for all reconstructive breast surgery and for cosmetic purposes for women over the age of twenty-two.

Since 2001, CSNY - one of the few practices in the region - has been a long-term participant in the Inamed Clinical Trials of the Style 410 cohesive gel implants. CSNY has had the opportunity to see first-hand the clear advantages and improved outcomes gel-filled implants provide.

"Cohesive Gel-filled implants offer women a variety of options and benefits; size and shape have a more natural contour and are much more consistent with breast tissue compared to saline implants" said Dr. Jacobs. Dr. Hillard Warm added "The difference between silicone implants of the past and the implants of today are quite significant. The surrounding envelope or shell is stronger and the silicone is cohesive. If a leak should occur, the gel stays together and is less likely to migrate into surrounding tissue. Our experience with these implants has given us first-hand knowledge and great confidence for general use.

"Gel-filled implants have been used in Europe for over a decade and were recently approved for use in Canada. In a New York Times article on November 18, 2006, Dr. Richard D' Amico, president elect of the American Society of Plastic Surgeons says "For us it's a triumph of science...we've always felt that science would bear out the use of the implants." The article continued; "Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, said that the agency's review, based upon company-sponsored studies as well as long-term use of the implants abroad, had determined that their sale is in the best interest of women."

Read The Full FDA Press Release