CPA & Business Advisory Blog

Possible New Legislation Governing Hip Replacement

One of the most common surgeries affecting our aging population is the hip replacement. However, from reading the news lately it seems like a risky fix for someone’s aches and pains. Especially when it comes to all-metal hips. Over the past year the FDA has had over 5,000 complaints related to all-metal hip replacements, the devices have a 12 to 13% failure rate, and corporations selling these devices have been issuing voluntary recalls and experienced lawsuits. 


Part of the problem may stem from the fact that these implants don’t have to go through human testing for FDA approval, but instead can use the 510(k) to obtain market approval. According to the FDA’s website, “A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.” Basically, if there’s a similar product already out on the market, then the new product is also deemed to be safe. 


However, there is new legislation on the table that would not add any premarket requirements to the approval process for a 510(k), but would increase the FDA’s oversight for tracking the performance of these devices. It seems like a good idea since the United Kingdom has already established a registry (since 2002) that collects data on hip, knee and ankle replacements and was responsible for providing the data that led to a large corporation recall of the all-metal hip devices. 


The problem is in the details. What type of oversight would this entail? Can the FDA manage additional responsibilities when corporations going through the PMA (Premarket Approval) process already complain about the lack of efficiency? Which products would be tracked and how will these be determined? I’ll be interested to hear the results as it will affect our grandmothers, fathers, uncles, cousins and perhaps ourselves. 


Please feel free to leave a comment below or to contact one of our contact our Life Sciences and Innovation Group by calling 440-449-6800.


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