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FDA revises silicone implant data needs

– Although an FDA advisory panel recommended market approval of Inamed’s silicone gel-filled breast implants in October, rather than accepting that panel’s advice, last night the FDA deferred a decision on Inamed’s implant, pending submission of additional information. Today, the agency also issued a new Guidance Document expanding the data needed from any manufacturers looking to get FDA market approval for such devices.

The Guidance Document was issued to “more clearly define FDA’s recommendations for breast implant marketing applications and to reflect the availability of new information about the framework for assessing the safety and effectiveness of these products.”

The document is posted at and is subject to a 90-day period of public comment. It updates a previous version published in February 2003. A summary is available at

The substantive changes in the Guidance document released today deal with mechanical testing, modes and causes of rupture, clinical study information, postapproval requirements and labeling.

While many media outlets have reported this development as the FDA denying silicone gel-filled breast implants, a letter sent to Inamed last night stated that a decision on the company’s petition could not be issued without the benefit of the additional information requested.

FDA Conference Call

In a FDA conference call held this afternoon with “key stakeholders” involved in the debate over silicone gelfilled breast implants, including ASPS, it was noted that this action by the FDA was prompted by questions raised at the October Advisory Panel hearings, a prior Institute of Medicine study on implants and other data collected by the agency. The FDA stated that its goal in preparing an updated Guidance Document for implants is to ensure that manufacturers collect enough data on all of the critical issues related to implants to allow the agency to consider that data and, if all criteria are met, find the devices as “safe and effective” for public use.

One of the main concerns cited by the FDA was that it wanted more detailed information not just on rupture rates, but on the reasons and effects of implant rupture. As implant manufacturers consider their reactions to the new guidelines, silicone gel-filled implants will continue to be available under the existing clinical trial programs.

Society Supports Process and Putting Patients First

“It would have been laudable for the FDA to have given manufacturers these guidelines a long time ago,” says ASPS President Rod Rohrich, MD. “However, ASPS continues to support the FDA regulatory process and the FDA’s request for additional information prior to completing its review of silicone breast implants. The society has confidence that the FDA will make its ultimate decision based on the best interests of patients. We will continue to work with the FDA and manufacturers to provide whatever information may be helpful in the completion of FDA’s silicone breast implant review.”

ASPS has actively assisted in the review process over the past decade. Last year, the society developed an online patient education booklet, Silicone Breast Implant Surgery, to inform patients about benefits, risks and complications of the implants. The society also collects and analyzes data about breast surgery in its National Breast Implant Registry.

The society suggests that members consider the following points in discussing the implant situation:

  • Plastic surgeons are patient advocates. As plastic surgeons, our primary concerns are patient safety and satisfaction. What is ultimately important to all is that medical devices used for breast surgery are safe.
  • Nearly 237,000 women chose breast augmentation in 2002, the vast majority with saline implants, according to ASPS statistics.
  • The clinical experience over the past 35 years with breast augmentation shows a good track record. The number of women having breast augmentation has grown steadily – a 593% increase since 1992.

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Dr. Max Gouverne

Dr. Max Gouverne is a board-certified plastic surgeon in Corpus Christi with more than 20 years of practical experience. Paired with his approachable personality, his advanced knowledge and employment of leading-edge techniques ensure your utmost safety, comfort, and satisfaction.

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Dr. Max Gouverne, MD
Cosmetic Surgery

5642 Esplanade Drive
Corpus Christi, TX 78414

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