Thu, 19 Oct 2006 22:49:20 EDT
PANEL ISSUES BREAST IMPLANT RECOMMENDATIONSThe General and Plastic Surgery Devices Panel, a group of outside experts, has advised FDA that data submitted by four manufacturers of silicone gel-filled breast implants do not provide reasonable assurance of the safety and effectiveness of these devices. The panel chairperson, Dr. Elizabeth Connell of Emory University School of Medicine, emphasized that the group did not find evidence that the implants are unsafe, but rather that there was not enough information about the risks and benefits of their use. Despite the lack of data, the panel voted unanimously to advise the agency that the implants serve a public health need and that they should continue to be available while the manufacturers collect the additional data. The panel urged FDA to hold the manufacturers strictly accountable for providing, without delay, the needed data on safety and effectiveness.Although the committee's recommendation's are not binding upon FDA, they will be given a great deal of consideration in the agency's decisions on the silicone breast implant applications. About 2 million women in the United States have received breast implants for augmentation or reconstruction. Silicone gel-filled breast implants Breast Implant Recommendations were already on the market in l976, when FDA was given authority to regulate medical devices. The law provided that these breast implants could remain on the market until FDA, through regulation, required the submission of data supporting the implants' safety and effectiveness. In opening the meeting of the advisory panel, FDA Commissioner David A.Kessler, M.D., called the breast implant issue one of the most difficult he has faced during his tenure as Commissioner. He pledged that FDA would require manufacturers to provide the information needed to answer safety questions about these products, and that the agency would take into account the needs of women who now have the implants or who might desire them in the future. Following testimony from FDA scientists and implant manufacturers, the committee concluded that the four manufacturers had not provided adequate information concerning the chemical properties of the implant material, the mechanical and physical properties of the implants, the frequency of adverse effects such as rupture and contracture, the extent to which implants mask tumor detection during mammography and risks of cancer or immune disorders. Under the law, the manufacturers had until July 9, l991, to submit data to FDA, and the agency has 180 days from then -- until early January l992 -- to decide whether to approve silicone gel-filled breast implants for continued marketing. If FDA follows the panel's advice, it could extend this deadline to allow the manufacturers more time to collect data. During such an extension, the implants would remain on the market. The length and conditions of the extension, should it be allowed, would be determined by the agency.
