Silicone breast implant makers expect that the US Food and Drug Administration (FDA) will soon follow in Canada’s footsteps in clearing the implants for sale and implantation.
"FDA is currently reviewing applications submitted by Inamed and Mentor for cohesive silicone gel breast implants," says Heidi Valetkevitch, a press officer at the FDA. "Canada’s decision to approve standard silicone gel breast implants manufactured by Inamed and Mentor is consistent with FDA’s determination in 2005 that these devices are ‘approvable’ pending resolution of certain issues."
According to Roxanne Guy, MD, president of the American Society of Plastic Surgeons, because physicians have not been able to use silicone breast implants for the past 12 to 13 years, they have been able to come up with ways to mask the "water-bag feel." Instead of putting saline implants directly under the skin, surgeons wedge it between muscle to give a more natural look and feel.
The FDA says silicone and saline implants carry risks including asymmetry, pain, hematoma, inflammation, scarring, and rippling.
[www.wired.com, November 6, 2006]