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FDA approves saline breast implants
WASHINGTON (CNN) -- The U.S. Food and Drug Administration has approved the use of saline breast implants made by Mentor Corp. and McGhan Medical -- the first time the FDA has formally approved any brands of saline breast implant.
But FDA officials noted the relatively high complication and failure rates associated with the implants when issuing the approval Wednesday, and said the companies must provide women with information on these risks.
"It's clear from these studies that there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications" said David Feigal, director of the FDA's Center for Devices and Radiological Health.
"Women should understand that breast implants do not last a lifetime. And they should be aware that women who choose not to replace their implants after removal may have cosmetically unacceptable dimpling or puckering."
Implant manufacturers insist their products are safe. The American Society for Aesthetic Plastic Surgery said the benefits of saline implants outweigh the risks, citing a recent study showing that 95 percent of women surveyed say they would make the same choice to have implants again.
A three-day FDA advisory committee that met earlier this year found "complications including: 9.2 percent of saline filled implants used for reconstruction on cancer patients ruptured and deflated within three years of implantation, 40 percent of cancer patients needed repeat surgery after three years, 24 percent suffered from painful breast hardening from scar tissue."
Saline implants have been available to women for reconstruction and augmentation for 30 years. But the FDA did not require manufacturers to begin obtaining safety data until 1992, when safety concerns prompted the agency to restrict the use of silicone breast implants.
Since then, the number of women getting saline implants has increased. Now, more than 100,000 women get them every year.
Mentor Corp. and McGhan Medical are the leading makers of saline implants in the United States.
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Breast Implants Information
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