More than five months after the surprise approval of Mentor's application by a FDA panel to begin producing silicone breast implants again, the other firm seeking federal approval for their product -- Inamed -- finally received conditional approval yesterday.
How they secured that approval apparently may have involved some slight-of-hand too. In a statement, the FDA mentioned Inamed had provided the feds with "additional information to address the primary safety concerns."
The company also discontinued a specific product (Style 153), prompting the National Research Center For Women and Families to point out most of the research Inamed submitted to the FDA involved women who used that implant. Thus, eliminating that product erased many of the roadblocks in Inamed's path for FDA approval.
As I've said before, I just don't understand how the FDA could have made that their decision to allow silicone breast implants back on the market, unless it was influenced by greed.
Yahoo News September 21, 2005