Breast Implant Safety: American Society for Aesthetic Plastic Surgery (ASAPS) Supports FDA Oversight

En Español

NEW YORK, NY (July 21, 2003) — The American
Society for Aesthetic Plastic Surgery (ASAPS)
urges the continuation of research on the
long-term safety of silicone gel-filled
breast implants and fully supports the Food
and Drug Administration's (FDA's) regulatory
process, says ASAPS President Robert W.
Bernard, MD. ASAPS, the leading national
organization of board-certified plastic
surgeons specializing in cosmetic surgery,
issued its statement following release of
a document from the National Organization
for Women (NOW) voicing concerns about the
long-term safety of silicone gel-filled
implants.

"As plastic surgeons interested in the
safety and welfare of our patients, we welcome
the entry of women's organizations such
as NOW into the dialog about breast implants,"
says Dr. Bernard. "At the same time, we
believe that the FDA should proceed with
a review of all the available data on silicone
gel-filled breast implants and, on that
basis, determine whether current scientific
evidence is adequate to establish their
safety."

In 1999, the National Academy of Sciences
Institute of Medicine (IOM) issued an extensive
report that found no scientific evidence
of an association between breast implants
and disease. A recent National Institutes
of Health report to Congress included its
assessment of research on the long-term
health effects of breast implants. The report
echoed the findings of the IOM, stating
there was not sufficient evidence to support
any relationship between implants and connective
tissue disorders. In addition, a report
of the National Cancer Institute concluded
that women with implants showed a slight
decrease in the risk for breast cancer.

The 1999 IOM report, and other implant
research, acknowledges local complications
associated with implant surgery. Capsular
contracture (tightening of the scar capsule
around a breast implant that causes breast
firmness) is the most common problem associated
with breast implants and, in some instances,
leads to additional surgery.

"ASAPS members believe in women's right
to make choices about their own health care,"
says Dr. Bernard. "Breast implant patients
must have the information they need to make
fully informed decisions. It is essential
that women understand that implants are
not lifetime devices and that reoperation
is always a possibility."

Sterile saline solution and silicone gel
are both used as breast implant fillers.
Some plastic surgery patients prefer silicone
gel-filled breast implants for their natural
look and feel. Silicone gel-filled devices
may be particularly beneficial to breast
reconstruction patients who have lost their
natural breast tissue as a result of mastectomy,
and the FDA has continued to allow the use
of gel implants for breast reconstruction
despite prohibiting their general use for
breast enlargement. Since the FDA's ban
on silicone gel-filled implants for first-time
breast augmentation patients, saline-filled
implants have been the only choice for this
patient population. Breast augmentation
has remained one of the most popular cosmetic
procedures, and the vast majority of patients
are happy with the results. According to
ASAPS statistics, the number of breast augmentations
rose 147 percent between1997 and 2002.

ASAPS says that the FDA must sort through
new data from implant manufacturers to determine
whether previous safety concerns about silicone
gel-filled implants have been adequately
addressed.

"Ultimately, it will be a combination
of science and the best interests of patients
that determines what the FDA's decision
on this matter is," says Dr. Bernard.

About ASAPS
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body.  ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.

WE ARE AESTHETICS.

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