An FDA Advisory was expected to take a formal vote on February 6 regarding the safety and potential future FDA approval of nine silicone breast-implant models by Inamed. The FDA may then choose to accept the recommendations of the panel or act independently. A vote on additional implant models by Mentor is expected February 7. At issue is the rupture rate of the implants and whether or not the panel of experts believes the implants to be “reasonably” safe.
In December, formal approval for one design of implants each by Inamed (now a wholly-owned subsidiary of Allergan) and Mentor received final FDA market approval, allowing women ages 22 and older the option of silicone implants for breast enhancement. The approval came with recommendations that women go through a specific informed-consent process, participate in a national breast-implant registry, and that at three years after insertion and every two years thereafter a women undergo MRI to assess the condition of the implants to detect potential silent rupture of the implant shell.
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