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FDA Allowed Doctors to Implant Untested Hip Replacements into Human Bodies

Posted on 2nd May, 2019

by Legal Staff

It is the experience of many patients that when their hips started hurting, doctors suggested they get metal-on-metal joints implanted. That's when things went downhill for them. Their experience gives insight into the Food and Drug Administration's faulty testing process of medical implants. Seven million people have some type of medical implants, be it a joint, a pump, a piece of mesh.

Our expectation is that medical devices undergo meticulous testing and approval.

But the truth is the FDA does not have the same type of approval procedures for implants as it does for prescription medication. In many cases when medical professionals recommended hip replacement surgery, they suggested the state of the art metal-on-metal hip implant Pinnacle with Ultamet liner made by Johnson and Johnson Depuy.

Patients were told they will be back on their feet in a few months but many never got out of pain. Many of those who have had the defective metal-on-metal Pinnacle implant in their bodies have had an extensive range of painful experiences. Some of the side effects, as that metal debris moved throughout the body, included suffering tinnitus, hearing loss, heart issues or memory issues. Most experienced a loss of muscle and ligaments and pain around the implant.

A State of the Art Hip Replacement Causes Crippling Pain

On their website, the FDA warns patients of the concerns of metal-on-metal hip devices:

  • Release of metal particles in the bloodstream
  • Damage to bone or tissue surrounding the implant and joint
  • Device loosening or failure, pain and the need for revision surgery
  • Extensive damage to bone, muscle and nerves

Frustrated, patients search for answers. However, the U.S. has no medical device registry, so you can't easily obtain information about implants. Much of the available data regarding hip implants involve registry data from countries outside the U.S.

Growing Number of Metal-On-Metal Hip Replacement Claims

The metal-on-metal hip implant Pinnacle with Ultamet liner was pulled off the market in August 2013.

The makers of the implant were fully warned by their development team that this product was not safe. In 1997, before patients started getting these medical devices, the head of Johnson and Johnson Depuy's development team warned company leaders of issues with the metal-on-metal implants.

A memo filed in court showed that wear was a major problem and metal on metal was a bad engineering design. The implant was shown to work well only for a period before suffering a sudden catastrophic failure including the release of a large volume of wear particles.

Across the U.S, J&J Depuy faces more than 10,000 claims. In 2019, J&J Depuy agreed to pay about $1 billion to resolve claims of deceptive marketing in metal-on-metal hip implants. As metal-on-metal devices are still currently in use, many patients may be at risk and more claims are likely expected.

If, due to side effects from metal-on-metal hip implants, you or a loved one suffered complications and required revision surgery, please contact Atraxia Law so that we may help you understand if you are eligible to file a claim.

Patients who have been injured by hip implant devices may receive compensation for past and future medical expenses, lost income, pain and suffering. Each claim is different and eligibility must be evaluated separately, so don't hesitate to contact us.