Plastic Surgery Societies Applaud FDA Panel Recommendation That Mentor's Silicone Breast Implants Be Approved With Conditions

GAITHERSBURG, Md., April 13 /PRNewswire/ -- The FDA advisory panel's 7-2
vote today to recommend to the FDA that Mentor's silicone breast implants be
approved with conditions is applauded by the American Society of Plastic
Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery
(ASAPS), the two largest plastic surgery membership organizations. This
recommendation comes 13 years after the FDA restricted access to the silicone
implants because of safety concerns.
"We are pleased that the panel based its decision on scientific evidence,
not on special interests, emotion or anecdotes," said James Wells, MD, ASPS
past president. "The comments by Josh Levine, Mentor's CEO, during his
summation confirm Mentor's long-term commitment to safety. This should go a
long way to assure the FDA and the public that the panel's recommendation is
prudent and sound."
ASPS and ASAPS are optimistic that the FDA will follow the panel's
recommendation. "By doing so, Mentor can move forward to reintroduce silicone
implants as an option for American women. Organized plastic surgery is
enthusiastic about working with the manufacturer to ensure women's health and
safety," said ASAPS President-Elect Mark Jewell, MD. "Plastic surgeons are
committed to helping women make informed choices about their health care based
on all the available and accurate information about these devices."
Both societies are prepared to work with the FDA and Mentor to fulfill the
conditions which include physician education, patient education, a registry,
and a commitment from the manufacturers for continued data collection. Prior
to today's decision, ASPS and ASAPS have taken a leadership role in physician
education, patient informed consent, and development of a registry.
On April 12, the FDA advisory panel issued in a 5-4 vote a
"non-approvable" recommendation to Inamed's application for approval of its
silicone breast implants. The panel encouraged Inamed to address its
remaining concerns and then request panel review of its application for
approval. "We are hopeful that a similar favorable recommendation will be
issued in the near future to Inamed if it can satisfy the FDA's remaining
concerns," says Dr. Jewell.
To that end, the two societies believe continued data collection and study
of the procedure and device are essential, and they are committed to being
active participants in post-market monitoring of the implants.
In addition, ASPS and ASAPS will continue to offer assistance to the
manufacturers with additional conditions set forth by the FDA related to
physician and patient education. At the forefront of their ongoing education
campaign is the recently launched joint website
http://www.breastimplantsafety.org. This will be the authoritative website
for both saline and silicone breast implants and offer objective and science-
based information.
An increasing number of women are choosing breast augmentation to enhance
their appearance. According to ASAPS, nearly 335,000 women chose breast
augmentation in 2004. More than 62,000 women had breast reconstruction in
2004, according to ASPS. Breast reconstruction has been proven in numerous
studies to have many psychological and physical benefits for women who have
undergone a mastectomy.

The American Society of Plastic Surgeons (ASPS) is the largest
organization of board-certified plastic surgeons in the world. With more than
5,000 members, the society is recognized as a leading authority and
information source on cosmetic and reconstructive plastic surgery. ASPS
comprises 94 percent of all board-certified plastic surgeons in the United
States. Founded in 1931, the society represents physicians certified by the
American Board of Plastic Surgery or the Royal College of Physicians and
Surgeons of Canada. http://www.plasticsurgery.org .

The American Society for Aesthetic Plastic Surgery (ASAPS) is the leading
organization of board-certified plastic surgeons specializing in cosmetic
plastic surgery. Since 1967, ASAPS has been the authoritative source in
cosmetic surgery education and research. ASAPS' 2,200 plastic surgeons are
elected to membership and are certified by the American Board of Plastic
Surgery or the Royal College of Physicians and Surgeons of Canada.
http://www.surgery.org .

SOURCE American Society for Aesthetic Plastic Surgery
Web Site: http://www.surgery.org http://www.plasticsurgery.org
http://www.breastimplantsafety.org