Metal Hip Replacements Under Increased FDA Scrutiny

An Ohio hip replacement attorney notes that the U.S. Food and Drug Administration (FDA) is now requiring some hip replacement manufacturers to submit their products to a strict pre-market approval (PMA) process. Patients who have suffered severe complications from metal hip replacements may be eligible to seek compensation with the assistance of an Ohio metal hip replacement lawyer.

For more information, contact Attorney Group for Ohio today. Our consultations are free, confidential and without any obligation on your part. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated Ohio hip replacement attorney who can assist you throughout the legal process.

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FDA: PMA Applications Now Required For Some Metal-On-Metal Devices

Hip replacement manufacturers who plan to continue to sell certain models of metal-on-metal hip replacement devices must take additional steps to prove safety and effectiveness, according to a new decision by the FDA. Concerns over the safety and effectiveness of certain metal-on-metal hip replacement devices are spurring a number of important changes at the federal level. According to the Regulatory Affairs Professionals Society, the changes come in the wake of a finding by the FDA that these hip replacement devices can cause metal debris to break off and disperse within the body.

The two hip replacement devices under increased scrutiny are the hip joint metal/metal semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an un-cemented acetabular component. Because of device concerns, the FDA will now require all manufacturers to submit premarket approval applications prior to May 18, 2016, if the companies intend to market new versions or continue to sell existing ones.

In addition, the agency will continue to track reports of adverse reactions involving the two metal-on-metal hip replacement devices in an effort to ensure they are safe for patient use. This new directive from the FDA comes as a Texas jury returned a $498 million metal hip replacement verdict against device maker Johnson & Johnson and its DePuy Orthopaedics subsidiary in favor of five plaintiffs who claimed that their metal-on-metal Pinnacle hip replacement was defective and caused them significant injury.

How an Ohio Hip Replacement Attorney Can Help

Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

Patients who are injured by metal-on-metal hip replacements may be entitled to compensation for damages, including:

  • Medical expenses
  • The permanency of the injury
  • Pain, suffering, and mental anguish
  • Loss of income or ability to work

If a patient dies from complications related to a defective metal-on-metal hip replacement, family members may be entitled to compensation for the wrongful death of their loved one, including:

  • Conscious pain and suffering of a loved one prior to death
  • Pain, suffering, and mental anguish from the loss of a loved one
  • Funeral expenses

Patients who have suffered severe complications from metal-on-metal hip replacements, as well as the families of those who have died as a result of complications with the device, are encouraged to seek the advice of an Ohio hip replacement attorney to learn more about their rights and remedies.

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