FDA grants manufacturers conditional approval for silicone implants

But, concerns remain about ruptures and leaks

July 29, 2005|By LOS ANGELES TIMES

WASHINGTON - Silicone implants for cosmetic breast enhancement moved a step closer to approval yesterday as federal regulators laid out conditions for a manufacturer to begin marketing them.

The FDA said it spelled out the conditions in a letter to Mentor Corp., one of two Santa Barbara, Calif.-based companies seeking approval for implants. The letter and the conditions are considered confidential business information and were not released.

Silicone gel implants are regarded as having a more natural look and feel than saline-filled ones, but concerns remain about ill effects should they rupture or leak. They are now available only to women undergoing breast reconstruction, having been ordered off the market for cosmetic use in 1992 over concerns about health problems possibly caused by ruptured or leaking implants.

Studies have found no link between silicone breast implants and cancer or other life-threatening illnesses, but many women have experienced complications related to surgery, including painful contracture of the breasts. Some experts are concerned that leaking silicone can prompt chronic fatigue symptoms in certain women.

The FDA action came on the same day that Maryland Sen. Barbara A. Mikulski joined eight of her female Senate colleagues in a letter to FDA Commissioner Lester Crawford, expressing concerns that the agency might approve silicone implants for cosmetic surgery patients. Republicans Olympia J. Snowe of Maine and Kay Bailey Hutchison of Texas joined Democrats Hillary Rodham Clinton of New York and five others in urging Crawford to "protect the health and well-being of American women."

About 250,000 women have cosmetic breast surgery each year.

In April, an FDA advisory panel urged conditional approval of Mentor's implants. The 7-2 vote came with nine recommended requirements, including continuing safety studies, required follow-up care for patients, training for surgeons and voluntary tracking of every woman with implants.

The Los Angeles Times is a Tribune Publishing newspaper.

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