4/13/2005

FDA Can't Make Up Its' Mind

Tell me if this isn’t two-faced. A day after recommending against allowing silicone gel breast implants to be sold to the general public, a Food and Drug Administration advisory panel now says that a company called Mentor should be allowed to sell its product on the general market. Although they did say that there would be a number of conditions to be met. Sounds like the Food and Drug Administration is picking favorites. Sometimes I wonder if there are truly conspiracies when things like this happen. Or perhaps the new company had done more research than the previous.

1 comment:

Dr. Tufte said...

This is pretty bizarre. However, note that this is a preliminary ruling that has to be finalized in the next 6 months.

The facts are that two companies are in this market. Mentor went to the FDA first and was declined. They came back this year and were approved, along with Inamed who were declined. It is possible that Mentor just has a longer paper trail.

Having said that, it is a bad precedent when the FDA is picking winners and losers. They have just created a monopoly, and removed consumer surplus from future buyers of implants. In a very real sense they have factually hurt everyone who might be interested in buying implants, to prevent a potential hurt. That doesn't make much sense when you put it that way.