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.