ParfumGigi@aol.com

Thu, 19 Oct 2006 22:49:20 EDT

FDA's General and Plastic Surgery Devices Panel has recommended limited availability for silicone gel-filled breast implants under carefully controlled clinical protocols. The panel also recommended that FDA advise women who already have the implants to have them checked regularly by their physicians.

The outside advisory panel, which met Feb. 18-20, heard testimony from doctors, companies and consumers on benefits and problems associated with these devices, which have been implanted in an estimated one million women for breast augmentation or for reconstruction.

In making its recommendations, the panel cited a special medical need for women with breast cancer and certain other conditions, while expressing a concern about the risks represented by the implants. For this reason, members decided to permit use of the implants under clinical protocols that would allow access to all women requiring reconstruction who need silicone gel implants. They recommended only limited trials to study women who choose the implants for augmentation purposes. The number of augmentation patients to be studied will be determined by the nature of the scientific questions being asked.

The panel also advised women with implants to see their physicians regularly and, if an implant is found to have ruptured, to have it removed. It did not recommend that women with implants who have no symptoms undergo routine mammography just to look for a rupture. The panel did advise that these women follow established cancer screening recommendations. The panel noted that it is especially important that women inform the mammography facility that they have implants so that special techniques can be used by personnel trained in examining women with breast implants. Whenever possible they should seek a facility accredited by the American College of Radiology.

While it considered the possible link between certain immune-related or connective tissue disorders and the implants, the panel said there were insufficient data to reach a conclusion on this matter.

The panel's recommendations are not binding on the agency but will be carefully considered by FDA in reaching a decision. FDA Commissioner David A. Kessler, M.D., pledged to make a decision on the implants within 60 days, by April 20. Dr. Kessler had called for a moratorium on distribution and use of the implants on Jan. 6. The moratorium will remain in effect until FDA makes a decision.

Consumers wishing more information about breast implants and panel recommendations may call 1-800-532-4440, Mon. through Fri., 9 a.m. to 7 p.m., Eastern Standard Time.