DETROIT – American women will once again be able to get silicone breast implants, following a controversial decision announced late Nov. 17 by the federal government.
Women of any age who want silicone implants for reconstruction purpose after undergoing a mastectomy or because of abnormalities can get the implants, as well as women older than 22 who want breast-enhancement procedures.
“It is reasonable to conclude they are safe and effective,” said Dr. Daniel Schultz, director of the Center for Devices and Radiologic Health at the federal Food and Drug Administration.
Schultz cautioned women to study the complications of the surgery and to be aware that the implants most likely will have to be replaced at least once because they can harden, rupture or leak.
Complication rates and studies conducted by Mentor Corp. and Allergan Inc., California corporations that received approval to sell the implants, will be available on the FDA Web site. The FDA will continue to monitor implants for 10 years and share its findings on its Web site and at periodic public hearings.
To be sure the implants aren’t leaking, the FDA recommends women undergo breast MRIs three years after surgery and every two years afterward. Implant rupture is not often apparent to women or their doctors, Schultz said.
The decision is a major turnaround by the FDA, which has been studying the products since it banned their sale in 1992. Since then, only a few women have gotten silicone implants through clinical studies. Instead, doctors offered saline implants, salt water-filled implants considered safe but prone to ripple, particularly in thin women.
“I feel comfortable these are safe and it’s going to add another important option,” said Dr. Paul Izenberg, a plastic surgeon with St. Joseph Mercy Hospital in Superior Township, Mich.
He said the silicone devices are more durable than implants of the 1980s, which were linked to problems ranging from arthritis to muscle pain. “It’s really a whole different ball game.”
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, and Sybil Niden Goldrich, a California breast implant patient, blasted the FDA decision.
Wolfe said his advice to women is: “Don’t use them; they aren’t safe.”
The nation’s two largest plastic surgery physician groups disagreed and endorsed the return of the implants.
Until the early 1990s, the Midland-based Dow Corning Corp. was the nation’s largest breast implant manufacturer. It declared bankruptcy in 1995 amid thousands of lawsuits for which women are still seeking payment.
