October 13, 2003 - More than 5,000 anonymously surveyed women have addressed specific concerns raised by the Food and Drug Administration (FDA) regarding breast augmentation patient satisfaction, reoperation, and informed consent, according to the American Society for Aesthetic Plastic Surgery (ASAPS).
"We've never had data like this to respond to the FDA's valid concerns, and it is important for the scientific record, for patients and the public," said plastic surgeon Leroy Young, MD, Co-Chair of ASAPS' national Breast Surgery Committee and author of the new studies that will be published in Aesthetic Surgery Journal, ASAPS' peer-reviewed clinical publication. Dr. Young will present key findings in testimony at FDA hearings in Gaithersburg, MD, October 14-15. The current hearings are part of the FDA's ongoing regulatory process. The hearings were requested by one of the major breast implant manufacturers, seeking FDA approval to market its silicone gel-filled product for general use in breast augmentation and reconstruction. In April 1992, the FDA determined that silicone gel-filled implants should be available only on a limited basis and through FDA-approved clinical studies.
"ASAPS-member plastic surgeons have not issued a position regarding reintroduction of silicone gel implants, because determining the safety and efficacy of these products is a matter between the FDA and the manufacturer," says Dr. Young. "Our purpose in testifying at the hearings is to present the FDA with the latest research about women's experiences with breast implants for cosmetic augmentation."
The FDA has expressed concerns in several areas including why women do or do not return for follow-up visits after breast augmentation; the reasons for reoperation; and whether women have the information they need to make informed choices about surgery. Dr. Young's surveys, which were funded by the nonprofit Aesthetic Surgery Education and Research Foundation (ASERF), were conducted via the independent web site, ImplantInfo.com. The online surveys were implemented by professional research firms with protections in place to help ensure the women's anonymity and prevent multiple survey submissions by one individual. Neither ASAPS, ASERF, nor ImplantInfo.com had access to the data before it was analyzed. The margin of error is +/- 3% at a 95 % confidence interval.
The surveys included a broad range of questions, all of which are reported in Dr. Young's upcoming publications. Key findings of the surveys include:
"Plastic surgeons are concerned that even a small percentage of women say that breast augmentation does not meet their goals; while we are gratified that an overwhelming number of women report satisfaction with the procedure, we are constantly striving to make women's experience with breast implants meet their expectations. These surveys will help plastic surgeons better understand what our patients want and need," said Dr. Young.
"This research shows that the typical breast implant patient is a 34-year-old mom with two kids who has seen her breasts sag and lose volume after childbirth," says ASAPS Communications Commissioner Laurie Casas, MD, a plastic surgeon practicing outside Chicago. "The typical breast implant patient wants to look better and feel better about herself," she continued. Dr. Casas will present new findings about patient satisfaction during her testimony for the FDA.
"Plastic surgeons' primary concerns are patient safety and satisfaction, and ASAPS fully supports the FDA's ongoing regulatory process regarding breast implants," says plastic surgeon and ASAPS President Robert Bernard, MD. "The FDA will determine which implants, in addition to the already FDA-approved saline-filled variety, will be available for general use."