FDA Issues Updated Metal-on-Metal Hip Implants Advisory
The U.S. Food and Drugs Administration have issued new safety guidelines for metal-on-metal hips, including a proposal to require hip manufacturers to prove that the implants are safe and effective before allowing them to go to market, after extensive review of metal hip replacement risks and dangers.
Metal-on-metal hip implants have been linked to high revision surgery rates and increased risks of complications. The metal components of the hip implants may shed toxic metal debris to the surrounding tissue, causing tissue damage, pain, implant loosening, hip replacement failure, and metallosis, which can even manifest symptoms in other parts of the body.
After numerous previous advisories, and receiving nearly 17,000 metal-on-metal hip implant adverse event reports, and an expert panel that convened in June last year, the FDA has finally issued a complete set of updated guidelines regarding metal-on-metal hip implants, including regular monitoring of patients with metal hip implants.
FDA Recommends Regular Monitoring for Metal-On-Metal Hip Side Effects
FDA advised orthopaedic surgeons to use metal-on-metal hip implants only after evaluating the devices against hip replacements using other materials, and carefully evaluating patient risks factors, which include age, sex, weight, and diagnosis and activity level. Doctors are also advised to inform patients about the risks associated with metal hip replacements, including the potential need for revision surgery. In addition, the agency suggested follow-ups for asymptomatic patients every one to two years, and follow-ups once every six months for symptomatic patients with metal-on-metal hip implants. Doctors are advised to monitor and evaluate metal ion levels to determine whether patients will require revision surgery.
The agency also told health care providers to be alert for signs of systemic symptoms from metal hip replacements. Patients are encouraged to carefully evaluate the risks and benefits of metal hip implants with their doctors, and see a doctor immediately if they experience problems.
The FDA has also issued a proposal to require metal-on-metal hip manufacturers to submit premarket approval applications (PMA), instead of allowing them to be approved through the 510(k) program. Most of the metal hip systems on the market were allowed to be sold without clinical testing through the 510(k) program despite being classified high-risk devices.
Metal Hip Implant Lawsuits Filed by Patients Who Suffered Injuries
Many victims of defective metal-on-metal hips are now filing lawsuits seeking compensation for their injuries. The hip replacement lawyers at Bernstein Liebhard LLP are currently filing and investigating cases related to the following metal hip systems:
- DePuy ASR hip implant
- Metal-on-metal DePuy Pinnacle hip system
- Biomet Magnum M2a hip replacement
- Wright Profemur and Conserve hip systems
- Stryker Rejuvenate and ABG II modular-neck stems
If you suffered complications or had revision surgery because of a defective metal hip implant, consider joining the thousands of other patients filing metal hip replacement lawsuits and seek the compensation you deserve. Learn more by calling (877) 779-1414 today.