FDA Advisory Panel Recommends Opening Market for Silicone Breast Implants
F.D.A. Panel Backs Silicone Breast Implants
Gaithersburg, MD — After 11 years off the market, an advisory panel to the Food and Drug Administration has voted to recommend that silicone breast implants be allowed to be used in breast surgery.
The FDA typically follows the recommendations of the advisory panel and expects to make a ruling on this decision within weeks, although no specific time frame has been given.
Inamed Corporation, maker of silicone gel implants, has agreed to certain conditions, such as increased education for physicians and patients who use the implants and continued monitoring of women who get implants.
Breast augmentation and reconstruction surgery has been performed primarily with saline-filled implants over the last decade, due to health concerns with silicone gel implants. The studies haven’t concluded these health risks to be attributable to the silicone implants, which many women believe feel softer and more natural. Inamed testified that their device has been improved over the last decade with a thicker shell and filling it with a more cohesive gel, to reduce risk of rupture.
Should you be interested in finding out more about silicone gel breast implants, please contact our office at 425-827-7878, or make an appointment here.