FDA Continues Its Downward Decline By Approving Silicone Implants

Considering the rigged "debate" over Vioxx, Bextra and Celebrex generated a lot of attention and criticism in the media, I wondered if the FDA really understood what kind of crazy message it was sending to medicine and the public. Or if they would finally get a hint.

Not so, I'm afraid.

In a completely mixed-up message, a nine-member FDA panel voted 7-2 to approve an application by Mentor Corp., one of the two companies vying for reinstatement into the U.S. market of its silicone breast implant products. The decision surprised many experts for two really compelling reasons:

  • The same panel rejected a similar request by Mentor's chief competitor, Inamed Corp, by a narrow 5-4 count the previous day.
  • Because Mentor's application was based on a study that was a year shorter than the one done by Inamed, many experts believed Mentor's chances for approval were much slimmer.

In addition to "sales pitches" by Inamed and Mentor, the panel listened to more than 160 witnesses on both sides of the issue over three days. Many women described the sickening effect of these implants, including gruesome testimony about silicone from ruptured implants squeezing out of their eyes and ears.

I'm sure this decision will add the coffers of Mentor, considering more than 260,000 breast augmentation procedures and more than 62,000 breast reconstruction procedures were performed last year in the United States, according to the American Society of Plastic Surgeons.

Another unexpected benefactor: The city of Houston, the birthplace of the silicone implant, created by plastic surgeons Thomas Cronin and Frank Gerow more than 40 years ago. Since then, Houston has become an implant destination spot, second only to Los Angeles in the number of procedures performed.

I wondered why Mentor, in a strangely providential move, announced last summer it was buying commercial time on Extreme Makeover and The Swan -- TV programs that show the results and after-effects of plastic surgery makeovers -- to tout its breast implant products. Now I know...

New York Times, April 14, 2005 Registration Required

The (Lakeland, Fla.) Ledger.com, April 14, 2005

Houston Chronicle, April 14, 2005

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