The Food and Drug Administration conditionally approved Inamed's reapplication to sell silicone implants. The implants were banned by the FDA for health reasons years ago, but in April an FDA committee suggested approving competing company Mentor's implants and the FDA acted on this in July.
The Boston Globe article notes that an association for plastic surgeons "paid travel expenses for scores of healthy women and their doctors to testify before the federal advisers in favor of relaxing restrictions on implants." The article proposes an explanation for the differential FDA committee treatment of the two companies in April:
"Some attributed the April rejection to fewer plastic surgeons on the advisory panel than at an earlier session, when federal advisers voted 9-6 in favor of Inamed's application."
However this explanation is different then what Acronym Required found in April when we read accounts of the committee process. At that time we reported on evidence revealed by the New York Times that the data produced by Mentor in April downplayed the risks of the implants by distorting evidence of manufacturing defects. While Inamed's reports to the FDA committee did show a higher leakage rate then Mentor's, Mentor's implants also had a large number of leaks and contamination, not to mention that they were sometimes "infected with fleas", however evidence submitted to the Times suggested that Mentor had distorted their manufacturing data to acquire committee approval.
