Metal-on-Metal Hip Implants Come Under Greater Scrutiny, as First DePuy ASR Trial Takes Place and FDA Officially Recognizes Dangers

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Metal-on-Metal Hip Implants Come Under Greater Scrutiny, as First DePuy ASR Trial Takes Place and FDA Officially Recognizes DangersOverview: Metal-on-metal hip implants are a type of hip replacement in which all of the components are made of metal. These devices were once highly popular, as thousands of patients received them with the promise that the implant offered greater durability and a better range of motion compared to older hip replacements. However, these sentiments began to change in 2010, when Johnson & Johnson recalled 93,000 DePuy ASR all-metal hip implants worldwide due to a high rate of failure. The recall is considered one of the biggest medical device failures in recent history. Since then, data has only continued to confirm that all-metal hip implants fail at higher rates and can cause complications through the release of metal ions. Now, as the first DePuy ASR trial takes place and the U.S. Food and Drug Administration (FDA) takes actions to recognize metal hip dangers, metal-on-metal hips are under more scrutiny than ever.

  • Metal-on-metal hip implants release metal debris, which can cause soft tissue reactions and other complications leading to early failure
  • The first trial over the DePuy ASR hip implant began last week; court documents suggest that J&J knew about the defects for years before the recall
  • The FDA recently updated guidelines for patients with metal-on-metal hips

Product & Manufacturer

Johnson & Johnson/ DePuy Orthopaedics Biomet Smith Nephew Zimmer Wright Medical Technology
ASR (recalled) M2a Magnum Oxinium Durom CONSERVE Hip Systems
Pinnacle   Birmingham BHR   Profemur

Side Effects & Complications

  • High failure rate
  • Necrosis (tissue death)
  • Increased levels of cobalt and chromium ions
  • Pain at the implant, sometimes spreading to the groin and back
  • Osteolysis (bone loss)
  • Fluid collections/solid masses around the hip joint

DePuy ASR Bellwether Trial

Last week, the first DePuy ASR trial began in California state court. The Plaintiff is Loren Kransky, a retired corrections officer who had his hip replaced last year. Kransky is suing DePuy and parent company Johnson & Johnson for, among other things, failing to warn about the risks of using the metal-on-metal hip implant. Johnson & Johnson has repeatedly said it acted responsibly, but evidence suggests otherwise. Court documents and a witness testimony suggest that the company knew about the flaws of the implant long before the recall. One witness said that the ASR hip cup failed a test established J&J itself. Instead of redesigning the hip component, the company changed the protocols of the test.

There are some 2,000 other cases pending in California state court and other 8,000 filed elsewhere around the country, most of them in the MDL in federal court. The outcome of this trial will help give both parties a better idea of how future trials will proceed.

Recent FDA Actions

Recently, FDA has taken action to address the risks of metal-on-metal hip implants. The agency has proposed stricter guidelines for approving the devices. Currently, they go through 510(k), meaning that device makers do not need conduct clinical tests before selling the implants. The new regulations would require manufacturers to prove that their metal hips are safe and effective before obtaining approval. The FDA has also issued new guidelines for patients with metal-on-metal hip implants, recommending physical examinations, diagnostic imaging and metal ion testing as needed.