FDA allows silicone breast implants back on the market
American women once again will be able to get silicone breast implants for reconstruction and enhancement, following a controversial decision announced late Friday by the federal government.
Now women of any age who want silicone implants for reconstruction after cancer surgery or because of severe breast abnormalities, as well as women 22 or older who want elective breast-enhancement procedures, can get the devices.
“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 complications and to be aware that the devices most likely will have to be replaced at least once in a woman’s lifetime, because they can harden, rupture or leak.
Complication rates, as well as studies conducted by two manufacturers, Mentor Corp. and Allergan Inc., both California corporations, that received approval to sell the implants, will be available on the FDA web site, www.fda.gov/cdrh/breastimplants. 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 don’t leak, women need to undergo breast magnetic resonance tests three years after implant surgery and every two years afterwards, the FDA recommends. Implant rupture often is silent, Schultz said, and unknown to women or their doctors.
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 small numbers of women have gotten silicone implants through clinical studies, mostly at academic centers. In their place, doctors offered saline implants, salt-water-filled devices considered safe but which were 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, an Ann Arbor plastic surgeon with St. Joseph Mercy Hospital, Superior Twp.
He said the devices are more durable than implants of the 80s linked to problems 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.
Goldrich said the Bush administration is trying to put the devices back on the market before a Democratic majority in Congress takes over in January.
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 devices.
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 that women still are seeking payment for. The court overseeing as many as 360,000 claims can be reached at 866-874-6099 or go to the court’s Web site, www.dcsettlement.com.
On Friday, Dow Corning released a statement saying the company was “pleased that the scientific evidence led” the FDA to return the devices for commercial sale. But it has no plans to reenter the market.
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Now women of any age who want silicone implants for reconstruction after cancer surgery or because of severe breast abnormalities, as well as women 22 or older who want elective breast-enhancement procedures, can get the devices.
“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 complications and to be aware that the devices most likely will have to be replaced at least once in a woman’s lifetime, because they can harden, rupture or leak.
Complication rates, as well as studies conducted by two manufacturers, Mentor Corp. and Allergan Inc., both California corporations, that received approval to sell the implants, will be available on the FDA web site, www.fda.gov/cdrh/breastimplants. 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 don’t leak, women need to undergo breast magnetic resonance tests three years after implant surgery and every two years afterwards, the FDA recommends. Implant rupture often is silent, Schultz said, and unknown to women or their doctors.
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 small numbers of women have gotten silicone implants through clinical studies, mostly at academic centers. In their place, doctors offered saline implants, salt-water-filled devices considered safe but which were 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, an Ann Arbor plastic surgeon with St. Joseph Mercy Hospital, Superior Twp.
He said the devices are more durable than implants of the 80s linked to problems 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.
Goldrich said the Bush administration is trying to put the devices back on the market before a Democratic majority in Congress takes over in January.
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 devices.
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 that women still are seeking payment for. The court overseeing as many as 360,000 claims can be reached at 866-874-6099 or go to the court’s Web site, www.dcsettlement.com.
On Friday, Dow Corning released a statement saying the company was “pleased that the scientific evidence led” the FDA to return the devices for commercial sale. But it has no plans to reenter the market.
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