FDA to Restrict Cosmetic Silicone Breast Implants : Health: Devices will be allowed for reconstructive surgery, but women must participate in clinical studies.
The use of silicone gel breast implants will be severely restricted for cosmetic purposes but it will be allowed for women seeking reconstructive surgery, the Food and Drug Administration announced Thursday.
The devices no longer will be available generally and all women who receive them will be participants in scientific studies designed to answer unresolved questions about their safety, the FDA said.
“The manufacturers have not shown these devices to be safe,” FDA Commissioner David A. Kessler said at a press conference. “The devices will not be available for any other users outside these protocols. . . . All further use of these devices will be limited to controlled clinical studies--that’s the message we are sending. No one should think we are resuming business as usual.”
The announcement marked the final chapter of an emotional national debate over the fate of the controversial devices that has lasted nearly a year.
The decision, which closely followed the recommendations of an FDA advisory committee in February, reflected an effort to reconcile concerns about the known and suspected dangers of silicone with concerns for some women--particularly breast cancer patients who have undergone mastectomies--who have a compelling psychological need for the devices.
Dr. Norman Cole, president of the American Society for Plastic and Reconstructive Surgery, called the FDA decision “the first sign that science, logic and compassion are being returned to the review process for these devices.” He said that he is “relieved” that women with the most pressing need for the implants will be able to obtain them.
But “we continue to be disappointed that the government has placed itself in the role of judging the morality of a woman’s reasons for choosing breast implants,” he added. “The needs of women who seek augmentation of their breasts are poorly understood by those who do not share this desire.”
Ann Marcou, co-founder and director of counseling for Y-ME, a national information and support network for women with breast cancer, called the FDA’s action “just about the best decision that could have been made. It’s really what I would call a compassionate decision. It helps women with breast cancer, who are in a terrible dilemma, and also establishes a basis to collect some solid scientific research.”
Kessler said his agency believes that the “risk-benefit equation” is different for otherwise healthy women who want the devices for augmentation than for women who want them for reconstruction after breast cancer surgery.
“We believe . . . reconstructive surgery is part of the treatment,” Kessler said. “There’s also a compassionate aspect to this. If we’re making it easier (for breast cancer patients), we’re doing it because of compassion.”
But Kessler urged breast cancer patients seeking reconstruction to consider all available options, including the use of saline implants and a more complicated surgical procedure that involves using tissue from another part of the body to reconstruct the breast.
Saline implants, which are still available but expected to come under FDA scrutiny next year, are considered safer than the silicone devices, although many believe that they do not feel as natural as the silicone devices.
“I certainly would not jump to silicone breast implants without spending a lot of time thinking about what the right option is,” Kessler said.
Breast implants have been on the market for three decades and an estimated 1 million to 2 million women now have them. About 150,000 women yearly have been having the surgery, about 80% for augmentation and the rest for reconstruction.
Thursday’s decision effectively ends a voluntary moratorium on use of the devices that has been in effect since Jan. 6.
Under the FDA ruling, women with an “urgent need” for silicone implants can receive them almost immediately--as early as next week in some cases.
These women include breast cancer patients who had begun the reconstruction process before the moratorium and are wearing temporary tissue expanders while waiting for permanent implants. This category also includes women who must have their implants replaced for medical reasons--such as ruptures.
Future breast cancer patients and others seeking reconstruction for correction of severe deformities will be allowed to obtain the devices under “open availability” study protocols that will be established in coming months, Kessler said. This means that--although they will be part of an overall research program--they will receive the implants virtually without question.
Kessler said that allowing breast cancer patients to receive the implants for a “public health need” means that insurance companies could continue to pay for the procedure.
But women seeking silicone gel implants for augmentation will only have access under tightly controlled research studies that will be designed to obtain more information on safety and effectiveness, Kessler said. The studies will concentrate on specific safety questions and only enough women to answer these questions will be enrolled in the studies and receive the devices, he said.
To qualify for these studies, a woman’s physician must certify that saline implants are not a satisfactory alternative and both physician and patient must agree to abide by the conditions and the follow-up studies required. Women who wish to obtain implants presumably will have to do so through a physician involved in one of the clinical studies.
Both the research studies and the “open” protocols will be sponsored by the implant manufacturers and be subject to approval by the FDA.
A national registry of implant recipients also will be established, Kessler said.
Kessler said that he hopes the studies will answer questions about the side effects of the implants. These include capsular contracture--or hardening of scar tissue around the device--calcium deposits, interference with mammography readings, changes in breast sensation, implant rupture and slow leakage, or “gel bleed,” through the envelope surrounding the implant.
Questions about the long-term health consequences will be answered through studies of women who already have implants, Kessler said. Research is already under way at New York University and the University of Michigan and a third study will begin later this year under the sponsorship of the National Institutes of Health.
Silicone has been tentatively linked to the development of autoimmune diseases, including certain connective tissue disorders, and cancer, although a firm scientific cause-and-effect relationship has not been established.
If such studies establish safety and effectiveness, manufacturers will be able to reapply for marketing approval, Kessler said.
Only two companies continue to manufacture silicone implants, Mentor H/S, the plastic surgery subsidiary of Mentor Corp., and McGhan Medical Corp., both of Santa Barbara. Dow Corning Wright, the leading manufacturer of silicone implants, announced last month that it would quit the silicone implant business. Another firm, Bioplasty Inc., of St. Paul, Minn., earlier stopped making the devices.
“We see nothing in the FDA’s latest decision that would represent a hurdle for us,” said Dennis Condon, president of Mentor H/S. “We know the exact parameters and we will comply with them.”
Rep. Ted Weiss (D-N.Y.), chairman of a House subcommittee that has been investigating silicone implants for more than a year, called the FDA decision “a reasonable compromise,” but said that he continues to be concerned about women who already have implants and “urgently need information about what they should do to safeguard their health.”
Kessler said that there is no need for women who have implants to get them removed if they are not experiencing problems. But he urged such women to undergo periodic checkups and to call the FDA toll-free hot line if they have questions. The number is 1-800-532-4440. The number for hearing impaired is TTI 1-800-688-6167. The hot line operates Monday through Friday between 7 a.m. and 5 p.m. PDT.
