Wednesday, April 13, 2005

The FDA approves the Mentor Silicone Breast Implant

Somewhat surprisingly (at least to me), an FDA advisory panel voted to allow the Mentor silicone breast implant to be marketed in the U.S. under limited conditions. Yesterday the same panel rejected a similar application for the Inamed implant.

Apparently the panel's concerns about implant rupture in the Inamed product did not extend to Mentor's. Mentor's reliability data appears to have been more compelling to the Panel than Inamed's.

Contrary to the headline of this (and numerous other headlines on the same story) the panel's action did not constitute a "flip-flop" or reversal. They simply ruled against one product and in favor of a completely different product.

For Mentor to sell their implant, the panel's recommendation requires that they
  • Require patients to sign an informed consent stating that they understand that the implants can rupture.
  • Maintain an accurate registry to track patient outcomes.
  • Perform continuing ongoing long-term safety studies.
  • Require surgeons using the implants to have taken a special course in their use.

Each of these requirements appear quite reasonable although I'm sure that had the requirements not been made, any surgeon using this or any such problem would have required the informed consent anyway.

There was one other requirement I found rather puzzling: The surgeon would have to be board certified in plastic surgery. I'd have to look into it but I'm not aware of any medical products where the federal government requires board certification in order to use them.

The issue of requiring board certification for various medical procedures is generally left up to individual hospitals and facilities. If I wanted to perform brain surgery at my institution, there's no law that I'm aware of to prevent me from doing so. On the other hand, Harbor-UCLA Medical Center (or any other hospital in the U.S.) would have a problem with it considering that I'm an internist!

The panel's recommendations are suggestions and the FDA can still decide one way or the other. Personally, I'd be surprised if they mandated board certification per the panel's recommendation. But that's a another topic.

As an aside, look at the article I've linked. Three column inches are spent on the completely unsubstantiated claims of one self-reported "victim" including allegations of "Incident after incident of quality control problems, contamination issues, documents being destroyed," on the part of Mentor. No opportunity for rebuttal from the company was offered.

Is this quality journalism?



Anonymous Anonymous said...

I am not satisfied with the Mentor silicone breast. Even though it is my wife that has them, she is a breast cancer surviver so far, and to see her in this much pain must be a result of a bloched surgery or defective implants.

February 10, 2008 11:16 AM  

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