Recently, the FDA has issued a letter to the manufacturers of metal-on-metal hip replacements. The letter states that the FDA will require the medical device companies to report hip replacement failures as well as test the level of metal in hip replacement patients, among other things.
The letter was issued because so many of these types of hips such as the DePuy ASR XL, the DePuy Pinnacle, Smith & Nephew’s Birmingham hip replacement to name a few, were fast tracked to the marketplace without having to undergo rigorous pre-market screening and testing. The logic behind the decision was that these metal-on-metal hips were substantially similar to previously approved hip replacements. Obviously, that logic was flawed and as a result many metal-on-metal patients will have to undergo painful and complicated revision surgeries.
Hip replacement patients have to rely on their doctors for guidance as to the type of hip replacement they receive. Doctors, in turn, rely on agencies such as the FDA to know which hips are appropriate for the individual hip replacement candidate. When the system breaks down as it has in this case, doctors are left in the dark and the patients suffer.
Hip replacement manufacturers want to make a profit and the faster they receive approval to move a product to market, the better. However, such short-sightedness comes at a cost, a cost borne by the patient and the medical community. It’s time that all such medical devices undergo rigorous and thorough scientific review PRIOR to their approval for market. Patients deserve it and so does the medical community.