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FDA allowed doctors to implant untested hip replacements into human bodies

Many patients experience that when their hips started hurting, doctors suggested they get metal-on-metal joints implanted. But, unfortunately, that's when things went downhill for them. Their experience gives insight into the FDA's faulty testing process of medical implants.

Seven million people have some medical implants: joints, pumps, or a piece of mesh, and it's to be expected 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 would 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.

As that metal debris moved throughout the body, some of the side effects included suffering from tinnitus, hearing loss, heart issues, or memory issues. In addition, 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.

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

Their development team fully warned the implants that this product was not safe.

In 1997, before patients started getting these medical devices, the head of J&J Depuy's development team warned company leaders of MoM implant issues.

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 releasing many wear particles.

Across the U.S, J&J Depuy faces more than 10,000 claims. In addition, in 2019, J&J Depuy agreed to pay about $1 billion to resolve deceptive marketing claims 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 expected.

A growing number of metal-on-metal hip replacement claims

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 to see 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.