why did the DePuy ASR MetalonMetal hip implants fail and wha

why did the DePuy ASR Metal-on-Metal hip implants fail, and what FDA precedent allowed this device to be approved without any clinical trials?

Solution

DePuy Orthopaedics recalled its ASR Hip Resurfacing System and ASR XL Acetabular System in 2010 after studies showed high failure rates in the hip implants. People who received the hips may have legal options.

No, when a physician uses a legally marketed device outside its labeling to treat a patient and no research is being done, IRB review is not required. Note: Although not required by FDA, an IRB may still decide on its own initiative to review such use. Yes, when the off-label use of a legally marketed device is part of a research study collecting safety and effectiveness data involving human subjects, IRB review and approval is required .