Metal-on-metal (MOM) hip implants have had a rough go lately. In the last few years, this market has been largely decimated due to a number of complaints of implant failure and complications. Now, in January 2013, the industry was dealt another blow as the FDA requested that all manufacturers selling MOM hip implants go through a lengthy, expensive, PMA process?even those already selling these products. The FDA also made some recommendations regarding the ideal patient type?with the conclusion being that these implants are best in young males with large femoral heads?and suggested follow-up monitoring every 6 months if a patient is symptomatic. Additionally, J&J has been facing some negative press because it recently came to light that the company has been aware of the high failure rate of its recalled ASR MOM hip implants since 2011.

But how much of an impact will any of this have in an already dying market? The recommendations regarding the ideal patient type are already known, and those regarding follow-up are already somewhat weak and behind the times. The UK NHS initially requested follow-up with MOM implant patients every year for 5 years, regardless of whether or not the patient is symptomatic, and then in early 2012 updated these recommendations to be every year for life. Similarly, the Australian Therapeutic Goods Administration recommended in September that patients with MOM implants have regular follow-up visits including soft tissue imaging and blood tests. And all of this matters little because US doctors are largely already avoiding these products due to all of this controversy and a very real fear of being sued.
So really, all the FDA is doing here is formally communicating guidelines that people are already following, and making it more difficult to be in a market no one wants to be in. The worst blow has already been dealt?now we?re just waiting for the market to bottom out.

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