The FDA will hold a two-day hearing to determine strategies to help physicians monitor the risks associated with all-metal hip replacements, according to a New York Times report. In recent years, the medical device industry has come under intense scrutiny for the failure of several all-metal hip implants, which have led to complications, repeat surgeries and numerous lawsuits.
According to the report, a number of factors led to the widespread use and implantation of this type of device, including lack of FDA regulation on clinical trials, lack of data and knowledge on the risks related to the devices as well as lack of an orthopedic registry to assess outcomes following the implantations.
The hearing will start today where experts will be faced with difficult questions surrounding the lack of data and clinical trials for all-metal hip implants.
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According to the report, a number of factors led to the widespread use and implantation of this type of device, including lack of FDA regulation on clinical trials, lack of data and knowledge on the risks related to the devices as well as lack of an orthopedic registry to assess outcomes following the implantations.
The hearing will start today where experts will be faced with difficult questions surrounding the lack of data and clinical trials for all-metal hip implants.
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