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Thu, 19 Oct 2006 22:49:20 EDT

The Food and Drug Administration today announced that silicone breast implants will be available only under controlled clinical studies. Women who need these implants for reconstruction will be assured access to those studies. This decision reflects the recommendations of the General and Plastic Surgery Devices Panel, which met Feb. 18-20 to discuss safety issues surrounding the use of silicone gel breast implants. The panel recognized that the implants serve an important need for breast cancer patients and recommended that they remain available for reconstruction under controlled trials. However, it expressed concern about special problems for augmentation patients because of their greater difficulty in obtaining good mammography and in determining if an implant has ruptured. FDA Commissioner David A. Kessler, M.D., said, "I am acutely aware that the many women who already have these devices in place are eager for reliable clinical information. The decision announced today will require studies ensuring that information will be gathered so that we will learn, once and for all, how safe these devices are." The agency is denying pending applications for use of breast implants for augmentation and providing for continued availability of the implants for reconstruction purposes on the basis of a public health need.

Two categories of reconstruction patients with an urgent need for the implants will be able to receive them without delay. The first group consists of women in whom the reconstruction process had already been started prior to a Jan. 6, 1992, moratorium on the implants, who have temporary tissue expanders in place and who are waiting for a permanent implant. The second group consists of women who need their implants replaced for medical reasons such as rupture. Other women desiring implants for reconstruction, including the correction of severe deformities, will be able to obtain them under "open availability" protocols, to be set up in a number of months. "I am highly conscious that some women need these implants for reconstruction after cancer surgery or traumatic injury, or for certain congenital disorders," said Dr. Kessler. "While this policy is meant to be compassionate toward these patients, it is not to be interpreted as 'business as usual.' Our primary goal is to put in place a process to obtain adequate information about the safety of these devices. "All of the women in the open availability protocols will be enrolled in clinical studies, carefully monitored and followed for years to come. They will be informed of the potential risks involved and will have to give their consent. To be enrolled in these protocols, their physicians will have to certify that saline implants are not a satisfactory alternative, and both physician and patient must agree to abide by the conditions and followup required under the protocol," he said. Further tightly controlled research studies will be set up to obtain more information on safety and effectiveness. They will allow limited availability for women desiring the implants for augmentation, as well as for certain reconstruction patients. Manufacturers will be required to conduct a separate study for each model of implant they wish to market. The studies will focus on specific safety questions about the implants -- for example, the frequency of rupture or capsular contracture. Only enough women to answer these questions will be enrolled in the studies and receive the implants. Both the research studies and the open protocols will be sponsored by the implant manufacturers. FDA must approve them before they will be allowed to begin. The studies will help answer questions about side effects, such as capsular contracture, calcium deposits, interference with mammography readings, implant leakage or rupture and changes in the sensation of the breasts. Questions about possible long-term effects such as immune-related disorders and cancer will be answered by epidemiological studies of women who already have implants. Such studies are already underway at New York University and the University of Michigan. A third study on cancer risk will begin this year under the auspices of the National Institutes of Health. Manufacturers will also be required to follow each patient and keep records on her health experiences. If these studies establish safety and effectiveness, the manufacturers will be able to reapply for marketing approval. In addition, FDA is working with the current and former manufacturers to set up a centralized registry so that women with implants can be notified quickly of significant new findings about the devices.

FDA will also require laboratory studies to be conducted by the manufacturers, under a strict time table, to look at the chemical composition and toxicity of the silicone material that "bleeds" out of the implant shell, the strength of the implant shell, its resistance to rupture and the physical and chemical changes that the implants may undergo in the body. FDA has established a toll-free telephone line to provide information materials to consumers on breast implants. The number is 1-800-532-4440. It is also available to the hearing impaired by calling TT 1-800-688-6167. About one million women in this country have received breast implants for augmentation or reconstruction. Silicone gel breast implants were on the market prior to 1976, when FDA was given authority to regulate medical devices. They were permitted to remain on the market until FDA required the submission of data supporting the implants' safety and effectiveness. The manufacturers who are seeking marketing approval are Mentor Corp. and McGhan Inc.