of Silicone Gel Implants
2005 - USA
Plastic Surgery Societies Applaud FDA Panel Recommendation that Mentor's
Silicone Breast Implants be Approved with Conditions
GAITHERSBURG, MD - 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 re-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
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
www.breastimplantsafety.org . This will be the authoritative website
for both saline and silicone breast implants and offer objective and
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. 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. www.surgery.org.
The 2200-member American Society for Aesthetic Plastic Surgery (ASAPS)
is the only plastic surgery organization devoted entirely to the advancement
of cosmetic surgery. ASAPS is recognized throughout the world as the
authoritative source for cosmetic surgery education. U.S. members
are certified by the American Board of Plastic Surgery. Canadian members
are certified in plastic surgery by the Royal College of Physicians
and Surgeons of Canada.
Corporation Presentation - April 2005
FDA's Data re Gel Implants