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amendment to their silicone gel breast implant premarket approval (PMA) application, and the agency released a Draft Guidance on all breast implants that a spokesperson said was not meant to be “rules,” but to give advice about what is required to establish that breast implants are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.

ASAPS Survey Shows Doctors Mixed on Impact of Gel Availability

A recent survey sent by ASAPS to 100 of the leading aesthetic plastic surgeons in the United States, following the FDA panel recommendation (October 2003) but prior to the FDA decision today, showed that more than half (54 percent) of the surgeons said that they believe the availability of silicone gel implants would have no significant effect on the demand for breast augmentation.

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.”

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