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17 août, 2005 18:22 

Silicone breast implants closer to return

By DAN OLMSTED

WASHINGTON, July 29 (UPI) -- The return of silicone-gel breast implants to the U.S. market is a step closer this week after action by the Food and Drug Administration.

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The FDA issued a document called an approvable letter to Mentor Corp. of Santa Barbara, Calif., a maker of implants, as one of several intermediate steps that suggests the product is getting closer to final agency approval.

The agency said federal law prohibits it from disclosing the contents of the letter, however.

Last April, an FDA advisory committee voted 7-2 that Mentor's application was "approvable with conditions."

"We are very encouraged by this communication from the FDA, and view this letter as a positive sign for women and their surgeons that another option will soon be available," Joshua H. Levine, Mentor's president and chief executive officer, said in a statement.

"For more than a decade, choices for women seeking breast augmentation and reconstruction have been limited," Levine said. "If ultimately approved by the FDA, Mentor's Memory Gel breast implants will be a significant additional option for these women. Mentor will continue working with the FDA to address the approvable conditions."

The company added that the conditions set forward in the approvable letter were consistent with those outlined as part of the advisory panel vote in April.

Among the conditions recommended by the panel were allowing the devices to be implanted only by certified plastic surgeons who have worked with them before, that a major study of the implants be continued until the devices have been in use for 10 years, and that the implants be subject to another FDA review in five years.

The FDA banned silicone breast implants outright in 1992 because of worries they might contribute to serious conditions such as multiple sclerosis and connective-tissue disease, but many health authorities later concluded there is no evidence the implants cause serious disease, and now cancer patients and others undergoing major breast reconstructive surgery are allowed to get them.

Most patients undergoing breast-enlargement surgery are restricted to saline implants, however.

E-mail: sciencemail@upi.com

 


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