| Silicone Breast Implants Closer to Market |
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| Sunday, 31 July 2005 | |
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"This letter does not mean that the device is approved for marketing in the United States at this time," states an FDA news release. Federal law and regulations prohibit the government from discussing the letter's specific contents. However, an approvable letter is one of several intermediate steps in the FDA's review process for new products, says the FDA. The FDA's news release only mentions Mentor's product, not silicone implants from other makers. Then and Now In 1992, the FDA moved to make silicone implants available only if saline-filled implants weren't an option. The silicone implants were not totally banned. The FDA's 1992 investigation didn't conclude that silicone implants posed a health risk, but that implant manufacturers had not provided enough data to confirm the absolute safety of the devices. Fast forward to April 13, 2005. That's when an FDA expert panel voted 7-2 that Mentor's application was "approvable with conditions," states the FDA news release. One day earlier, the same FDA committee narrowly rejected another company's bid to market silicone breast implants. Company Encouraged "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," says Joshua H. Levine, Mentor's president and CEO, in the news release. "For more than a decade, choices for women seeking breast augmentation and reconstruction have been limited," says Levine. "If ultimately approved by the FDA, Mentor's Memory Gel breast implants will be a significant additional option for these women. Mentor is committed to making these important products available to women and will continue working with the FDA to address the approvable conditions." Plastic Surgeon's Comment |
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