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FDA and Breast implants update October 2003

Breast Implant Patients Need Public Health Registry, Says American Society for Aesthetic Plastic Surgery

FDA Advisory Panel Recommendations on Silicone Gel Implants Emphasize Need for Additional Research

NEW YORK, NY (October 15, 2003) – A national public health registry for breast implant patients would help to answer questions posed by the FDA advisory panel on silicone gel breast implants, according to Robert Bernard, MD, president of the American Society for Aesthetic Plastic Surgery (ASAPS). “Regular and long-term tracking of a sufficient number of implant patients is key,” said Dr. Bernard, commenting on the panel’s October 14-15 hearings in Gaithersburg, MD, which concluded with the advisory panel recommending approval of silicone gel breast implants with specified conditions.

Testifying at the hearings for the Aesthetic Surgery Education and Research Foundation (ASERF), Leroy Young, MD, who is also Co-chair of ASAPS’ Breast Surgery Committee, cited new data from two studies of over 5,000 women who have or are considering breast implants (13% with silicone gel). His data show that many breast augmentation patients skip recommended visits with their surgeons because they are not experiencing problems. Dr. Young’s data, which will be published in Aesthetic Surgery Journal, ASAPS’ peer-reviewed clinical publication, also indicate an extraordinarily high level of patient satisfaction among women who undergo cosmetic breast augmentation.

“The only way researchers can gather longer-term data on the benefits and risks of these devices is if women who have silicone gel implants, including those who received implants as part of FDA-approved clinical trials, stick to their surgeons’ recommended follow up schedules,” said Dr. Young. “It is also important that analysis of removed devices be performed by an independent source such as the Center for Device Retrieval and Analysis, established jointly by the two major plastic surgery societies,” he continued. “Assuming that the FDA accepts the advisory panel’s recommendations for conditional approval, we still need more information on the causes, frequency and consequences of implant rupture.”

Laurie Casas, MD, who chairs ASAPS’ Communications Commission and also testified at the hearings, said the panel’s recommendations reaffirm plastic surgeons’ commitment to fully educate patients about implant risks, choices and alternatives. “Whatever implant options are available to patients now or in the future, we are committed to providing women with the information they need to make informed decisions,” she said. “This includes talking with them about alternatives to implants, as well as making sure they understand the benefits and risks of breast implant surgery.”

In her testimony for ASAPS, Dr. Casas cited data from Dr. Young’s studies showing that more than 90 percent of women surveyed remembered being told by their surgeons about specific risks associated with breast implants.

Dr. Young said his data also provide additional insight into how to improve patients’ experiences with breast augmentation and decrease the rate of reoperation. “We found that one of the major reasons for reoperation is patient desire to change implant size.” He said that surgeons will continue to look for ways to communicate more effectively with patients. “We need to listen to what our patients tell us about their expectations and then help them to understand whether their goals are realistic,” he said. Dr. Young, who chairs ASERF’s Research Consortium, said the Foundation is committed to funding additional research on surgical outcomes and patient satisfaction.

“ASAPS’ primary mission is the continuing medical education of aesthetic plastic surgeons,” said Dr. Casas. “If the FDA agrees with the advisory panel’s recommendation for approval, ASAPS will help surgeons update their knowledge and surgical techniques for breast augmentation using silicone gel implants.”

According to ASAPS statistics, nearly 250,000 breast augmentation procedures were performed last year, an increase of 147 percent since 1997.

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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

Phone (361) 993-2222 Monday–Thursday:
8 a.m.–5 p.m.
Friday: 8 a.m.–12 p.m.