FDA seeks more advice on metal hip implants
Key points
- The Food and Drug Administration said on Thursday it is considering whether to make so-called metal-on-metal hip implants subject to more rigorous testing and said it will discuss the issue at a two-day expert advisory panel meeting on June 27-28.
- The announcement follows several years of controversy over these implants, which appear to fail at a higher rate than systems that use other materials.
- A recent study from the National Joint Registry of England and Wales conducted between 2003 to 2011 showed that after five years, about 6 percent of people with the metal-on-metal variety needed additional surgery to replace or repair them, compared with 1.7 to 2.3 percent of people who had ceramic or plastic systems.
- In May last year, the FDA issued an order for manufacturers of metal-on-metal implants to collect more safety data on the devices, including data related to metal ion concentrations in the blood stream.
The Food and Drug Administration said on Thursday it is considering whether to make so-called metal-on-metal hip implants subject to more rigorous testing and said it will discuss the issue at a two-day expert advisory panel meeting on June 27-28.
The announcement follows several years of controversy over these implants, which appear to fail at a higher rate than systems that use other materials.
A recent study from the National Joint Registry of England and Wales conducted between 2003 to 2011 showed that after five years, about 6 percent of people with the metal-on-metal variety needed additional surgery to replace or repair them, compared with 1.7 to 2.3 percent of people who had ceramic or plastic systems.
In May last year, the FDA issued an order for manufacturers of metal-on-metal implants to collect more safety data on the devices, including data related to metal ion concentrations in the blood stream.
(Reporting by Toni Clarke; Editing by Gerald E. McCormick)
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(Reuters)
Written and revised by
David Cohen, M.D.
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