NEW YORK, NY (June 6, 2000) — A Hazard Notice issued today by the U.K. Medical Device Agency (MDA) concerning the use of soybean oil-filled breast implants is deeply troubling but does not affect a large number of patients in the United States, says the American Society for Aesthetic Plastic Surgery (ASAPS). ASAPS is the nation's leading organization of board-certified plastic surgeons specializing in cosmetic surgery.

"Plastic surgeons are aware of less than 200 women who have received soybean oil-filled implants as part of approved clinical trials in the U.S.," says James L. Baker, Jr., MD, chair of the ASAPS Breast Surgery Committee. "We believe that about 10,000 women worldwide have these implants, with half of these in the United Kingdom."

According to the MDA, to date there has been no clinical evidence of any serious health problems associated with soybean oil-filled implants. However, the British agency is advising that women with the devices consider having them removed due to concerns about possible break-down products that may be created by soybean oil over time.

The concerns about soybean oil-filled implants do not apply to either saline-filled or silicone gel-filled breast implants, both of which are widely used in the U.S. The U.S. Food and Drug Administration (FDA) recently ruled that saline-filled breast implants manufactured by two companies meet the agency's standards for safety and effectiveness and may be used without restriction for women 18 years of age and older. Silicone gel-filled implants also are available but with significant restrictions on their use.