Recalled Hip Implants: An International Trend

The companies that sell metal-on-metal hip implants in the US sell the same implants in foreign countries. By the time the US government determines an implant is hurting patients, and recalls it, the same thing has usually already happened in multiple foreign countries. Hip-implant manufacturers know their implants are hurting patients. And they know that foreign governments are recalling their implants for that very reason. But they keep selling them anyway here in the US.

Hip Implant Failure in the United Kingdom

The UK government has issued four safety alerts about metal-on-metal hip implants because those implants are hurting their patients.

1.      Metal Hip Implants Cause Adverse Tissue Reactions and Pain

  • The UK government issued the first safety alert on April 22, 2010.
  • Metal-on-metal hip replacement patients were experiencing adverse soft-tissue reactions and hip pain.
  • Required patients to undergo blood metal-level testing, and get follow-ups for five years.

2.      No More DePuy ASRs

  • The UK government issued the second safety alert on September 7, 2010.
  • DePuy voluntarily recalled the ASR in the UK because it was experiencing higher-than-expected failure rates after 5 years.
  • Although the UK government didn’t require patients with ASRs to get revision surgery, it did prohibit surgeons from implanting them in the future, require surgeons to return all un-implanted stock to DePuy, and require doctors to schedule appointments with ASR patients in order to test their blood metal levels.

3.      Metal Hip Implants Cause Metallosis

  • The UK government issued the third safety alert on February 28, 2012.
  • Concluded that some patients get metallosis from the metal wear caused by hip implants.
  • Recommended that most patients with metal-on-metal hip implants should get them removed if they show signs of rising metal blood levels, or other abnormal results.

4.      If Blood Metal Levels Rise, Then Get Implant Removed

  • The UK government issued the fourth safety alert on June 25, 2012.
  • Patients with metal-on-metal hip implants should get blood tests, and if they show signs of rising metal blood levels or other abnormal results, then they should get their hip implants removed.

Even though the UK government has only officially banned the implant of DePuy ASRs, some British surgeons have been calling for a total ban on metal-on-metal hip implants since 2012.

Hip Implant Failure in Canada

The Canadian government issued a health alert on April 11, 2012. It said that some patients with metal-on-metal hips were suffering from pain, implant loosening, and significant soft tissue damage. The alert stated that patients with any of the following attributes have an increased risk of harm:

  • Female
  • Misaligned components
  • Very active
  • Very overweight
  • Bilateral implants (both hips are implants)

The Canadian government told doctors to test patients for these symptoms, and to follow up with patients if they exhibit the following:

  • Groin, hip, or leg pain
  • Swelling at or near the hip joint
  • A limp or change in walking ability or range of motion

Further, the Canadian government said that if patients have any of the above symptoms, then revision surgery (removal of the implant) should be “seriously considered.”

Hip Implant Failure in Australia

The Australian government has been an international leader as a watchdog for metal-on-metal hip implant patients. It recalled the DePuy ASR metal-on-metal hip implant, and issued three warnings about metal-on-metal hip implants in general.

Australia was the first country to recall the DePuy ASR. It recalled the ASR in December 2009, because it said that patients with ASRs needed revision surgery (removal of ASR and replacement with a new implant) at a much higher than anticipated rate.

Its warnings had less bite than its recall, but they were also broader, and applied to more implants.

1.      If Blood Metal Levels Rise, Then Get Implant Removed

  • The Australian government issued the first warning on September 20, 2012.
  • If patients have increasing metal ion levels, then they should undergo revision surgery.
  • Patients without symptoms should undergo monitoring at a minimum of once per year.

2.      If 36 mm or Larger, Then Get Implant Removed

  • The Australian government issued the second warning on April 14, 2014.
  • If the patient has increased blood metal levels, or the patient got a total hip arthroplasty and the patient’s femoral head is 36 mm or larger, then they should undergo revision surgery.

3.      Consistency with the EU

  • The Australian government issued the third warning on March 12, 2015.
  • This warning is just a link to the EU’s recent report on metal-on-metal hips. The main point of that report is that metal-on-metal hip implants conclusively do cause metal poisoning.

Hip Implant Failure in the European Union

The Scientific Committee on Emerging Newly Identified Health Risks issued an opinion on metal-on-metal hip implants in March 2014. The Committee concluded that all types of metal-on-metal hip implants release metal particles into the bloodstream, and that the process is even more severe in implants with large femoral heads. The Committee did not ban metal-on-metal hip implants outright. Rather, it suggested that their use should be “carefully considered” on a case by case basis.

Why are other countries noticing the failure problems before the US?

Generally, foreign governments warn about and recall metal-on-metal hip implants before the US government. The reason why it works that way is because other countries have joint registries. A joint registry is a list of every patient who has received a certain implant in a certain country. It has each patient’s name, the type of implant they received, the date they received it, and among other things, whether they had to get the implant replaced. It takes lots of data to identify a pattern of failure. Joint registries help countries spot malfunctioning implants faster, because it puts more data in front of them, faster.

Foreign governments have been telling hip implant manufacturers that their implants are harming patients for more than 5 years (Australia in 2009), (UK in 2010), (Canada in 2012). Manufacturers keep selling their hip implants in the US even though multiple governments worldwide are recalling those same implants. Hip implant manufacturers need to be held accountable.

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