The two largest organizations of board-certified
plastic surgeons welcome today's ruling
by the Food and Drug Administration (FDA)
regarding the safety and efficacy of saline-filled
breast implants. The FDA ruled that saline-filled
breast implants made by at least one company,
Mentor Corporation, are safe and meet the
agency's requirements and may continue to
be marketed. Decisions on whether other
breast implant companies will continue to
market their products will be determined
are expected over the next few days.

"This confirms what countless scientific
studies have suggested: that the benefits
of saline-filled breast implants far outweigh
the risks, " Today there is ample scientific
evidence supporting the safety of saline-filled
breast implants," said C. Lin Puckett,
MD, president of the American Society of
Plastic Surgeons. "We believe that
Women should must be fully informed of the
potential risks and benefits of implants
and should have the right to choose. This
ruling provides that option."

"Studies have shown that the vast
majority of patients with saline-filled
breast implants would make the same choice
again," says Fritz E. Barton, Jr.,
MD, president of the American Society for
Aesthetic Plastic Surgery (ASAPS). "The
high satisfaction rate and the determination
of so many women to undergo a surgery with
the knowledge that it is not a perfect operation
suggests just how deeply the benefits are
felt." This ruling concludes months
of investigation and research by the FDA.
Saline-filled breast implants have been
available since the late 1960s. No breast
implant is guaranteed to last a lifetime,
but Like most medical devices, they have
evolved in both design and production. Today's
This ruling marks the end of a regulatory
process that began in the 1980s, when the
FDA categorized saline-filled breast implants
as Class III devices, requiring the highest
level of premarket review.

In March, 2000 the FDA's General and Plastic
Surgery Advisory Panel held hearings to
determine whether the safety of current
safety and efficacy data for saline implants
met the agency's requirements for approval.
The FDA's regulatory process calls for the
agency to evaluate medical devices on a
product-specific basis, manufacturer by
manufacturer. The panel found no evidence
that the saline-filled implants cause major
disease, and recommended approval for devices
manufactured by Mentor and McGhan. Each
company's devices implants were evaluated
on their own safety and effectiveness data.
A final FDA ruling on McGhan's saline-implant
product is expected within the next few
days. A third implant company, Poly Implants
Prosthesis, was not recommended for approval
by the Advisory Panel.

ASAPS is the largest organization of board-certified
plastic surgeons in the world. ASAPS is
the leading organization of board-certified
plastic surgeons who specialize in cosmetic
surgery. Members of both organizations are
certified by the American Board of Plastic
Surgery. ASPS: www.plasticsurgery.org ASAPS:
www.surgery.org