PATIENT ADVISORY
Silicone Gel-filled Breast Implants
FDA Says Not Yet to Silicone
Gel-Filled Breast Implants
ASAPS Survey Shows Doctors Mixed on Impact of Gel Availability
New York, NY (January 08, 2004)— “The American Society for Aesthetic Plastic
Surgery (ASAPS) respects the scientific inquiry and regulatory process that led
the FDA to its current conclusion not to allow silicone gel-filled breast
implants back on the market right now,” says Robert Bernard, MD, a White Plains,
NY plastic surgeon and president of ASAPS. “The FDA has indicated that the
scientific information presented so far has been helpful, but apparently
believes that there are still questions that need to be answered about these
products,” he continued.
The FDA sent a Decision Letter to implant manufacturer Inamed, requesting
amendment to their silicone gel breast implant premarket approval (PMA)
application, and the agency released a Draft Guidance on all breast implants
that a spokesperson said was not meant to be “rules,” but to give advice about
what is required to establish that breast implants are safe and effective.
Today’s FDA decision is unusual because it is contrary to the October 15, 2003,
FDA advisory panel recommendation for approval with conditions. Today’s FDA
decision does not affect saline-filled breast implants, approved by the FDA in
May 2000, which are available to all women seeking breast augmentation and
reconstruction. The agency indicated that silicone gel implants will continue to
be available to women in approved clinical trials. The agency also stated in a
conference call that it would be desirable to improve access to clinical trials
for those women who want to participate.
David Feigal, MD, Director of the FDA’s Center for Devices and Radiological
Health, today encouraged manufacturers, the public, and other interested parties
to contact the FDA with comments on the Guidance issued today. Dr. Feigal
flagged specific issues in the Guidance that, he said, needed to be addressed
before the FDA could rule that silicone gel breast implants are safe and
effective. One key area of concern is the rate at which implants fail, why they
fail, and the consequences of failure. This information will help in the
assessment of the safety of breast implants so that doctors and their patients
can make informed choices. The full FDA Draft Guidance document has been
released for public comment and is available at
http://www.fda.gov/cdrh/ode/guidance/1239.html.
ASAPS Affirms Continued Support for Physician and Patient Education
In a statement issued following the October 15, 2003, FDA advisory panel vote to
approve silicone gel-filled implants with certain conditions, ASAPS affirmed its
support for a national breast implant patient registry and its ongoing
commitment to continuing medical education for plastic surgeons in breast
surgery techniques. ASAPS also emphasized that patient education and informed
consent are of paramount importance to all patients undergoing cosmetic surgery.
“ASAPS members are committed to patient safety and education,” says ASAPS
President Robert Bernard, MD. “As a society whose primary mission is education,
ASAPS helps its members to refine both their technical skills and their patient
skills. Physicians need to use the most modern and effective communication
methods, so that patients can fully understand the risks, benefits and
alternatives concerning any treatment being offered.”
ASAPS is the leading organization of board-certified plastic surgeons
specializing in cosmetic surgery of the face and body.
We are here to assist you and to make sure that you have
all the necessary information for an informed decision about your cosmetic
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