Tuesday, April 12, 2005

FDA committee's rejection of silicone breast implant product

An FDA advisory panel came down against one of two manufacturers seeking to market silicone breast implants today. The panel rejected Inamed's application. Mentor will be presenting data in support of its product for the next day or so.

Interestingly, the panel's rejection (which is not binding to the FDA) seemed more concerned about the risk of rupture of the product then of concerns specifically related to the silicone inside. Their position was that Inamed only presented data that went out three to four years.

I wonder how long a follow-up period the panel wants. These implants presumably will have to last a lifetime. No product requires that length of testing before acceptance. If the problem is merely one of structural engineering, there are provocative tests that simulate a lifetime of use. Remember that commercial for a bed mattress that showed a machine pounding it over and over again to demonstrate its durability?

If the reason for rejection was as stated, then I see little chance of Mentor's data being any more compelling than Inamed's.

This is a shame because as one who has examined patients with both the saline and the silicone products (post-mastectomy and purely cosmetic implants) I can state with some certainty that the silicone ones have a much more realistic feel.

At any rate, it appears that the final decision will ultimately be based on the mechanics of the implants rather than a concern for imagined disease associations that have never truly been proven. Purely mechanical concerns are obstacles that will eventually be overcome. Imagined, speculative disease associations might not be. See my previous post on this.



Post a Comment

<< Home