FDA: Some Hip Implant Devices Now Need Premarket Approval

A North Carolina hip replacement attorney notes that, following years of controversy and lawsuits surrounding claimed complications with metal on metal hip replacements, the FDA is now requiring some hip replacement manufacturers to submit their products to a stringent pre-market approval process. Patients who have suffered severe complications from the metal hips may be eligible to seek compensation by filing a North Carolina metal hip replacement lawsuit.

For more information, contact Attorney Group for North Carolina 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 attorney who can assist you throughout the legal process.

The time you have to pursue a claim is limited. Contact us for more information.Get Help Now.

Report: FDA Raising Metal-on-Metal Safety Standards

According to raps.org, manufacturers of certain metal-on-metal hip implant devices are going to have to take some extra steps if they intend to introduce new products to the market or continue selling existing ones. According to the U.S. Food and Drug Administration (FDA), the agency has taken numerous strides recently to ensure device makers properly assess these devices, which some have been shown to release potentially harmful metal debris into the human body.

Among the new mandates released by the FDA is the fact that device makers of the two types of hip implants must now submit premarket approval applications detailing the devices they plan to sell. These applications must contain comprehensive information about their safety and effectiveness, and they also must fully detail any risks faced by patients who are fitted with them. This is the latest in a long line of agency efforts to ascertain more about the safety risks these devices pose. The premarket approval application requirement applies to the makers of the hip joint metal/metal semi-constrained model with a cemented acetabular component and the hip joint metal/metal semi-constrained model with an un-cemented acetabular component, the website reported.

How a North Carolina 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 a North Carolina hip replacement attorney to learn more about their rights and remedies.

The Time You Have to Pursue a Claim is Limited. Contact Us Today.

For more information, contact Attorney Group for North Carolina. You can fill out the form on this page, call us at the number listed at the top of the page, or email us at [email protected].

When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.

Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.

See our Frequently Asked Questions page for more information, and contact Attorney Group for North Carolina today.

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