Posted on Jan 17, 2011

While we rely on the U.S. FDA to ensure that drugs and medical devices are safe to use we too often find that they are approve drugs and devices that are too soon recalled for dangerous side effects.  Recent hip joint recalls have highlighted a possibly dangerous loophole in the joint manufacturing approval process. 

The DePuy A.S.R., made by parent company Johnson & Johnson, was never approved by the FDA yet it was implanted in patients across the nation.  How was the now recalled artificial joint placed on the market, and inside patients, without FDA approval?   While drugs must go through multiple clinical trials before receiving approval, "critical implants" can be sold if the implant resembles an already approved device.  Though this loophole was created to help manufacturers make small changes quickly in order to improve a device, some worry that it has allowed defective, even dangerous medical devices to make it onto the market without proper approval. 

The ASR is one of the faulty, recalled devices that have caused pain, even permanent disability, without FDA approval.  While doctors were increasingly concerned about the higher than average failure rate of the device, DePuy refused to take the joint off the market.  Only "sluggish sales" convinced them to pull the artificial hip.

Now, DePuy is facing multiple class action lawsuits that center around the production and placement of the defective hip replacement parts.  Only time will tell if the FDA will take this serious matter into consideration and revise their policy on approving critical implants.