The US Food and Drug Administration (FDA) General and Plastic Surgery Devices Panel has recommended by a vote of seven to two that the FDA ‘approve with conditions’ Mentor Corporation's silicone breast implant application1,2. The move came just one day after the same panel returned a verdict of ‘non approvable’ for Inamed's application saying the implants showed inadequate performance and that there needed to be additional patient follow-up data. If Mentor's application is approved, the silicone implants would be the first on the US market in over ten years after an FDA moratorium was imposed in 1992. The decisions came during a three-day public hearing on 11-13 April 2005.
The panel attached a number of conditions to Mentor's recommendation of approval including:
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