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FDA Proposes Stricter Guidelines on Metal-On-Metal Hip Implants

Written by Ankin Law Office

Metal-on-metal hip implants could soon be a thing of the past, if the U.S. Food and Drug Administration (FDA) has its way. Last summer, the FDA issued a report indicating that data revealed that metal-on-metal hip replacement systems are more likely to fail than other hip implant devices. Although the FDA stopped short of banning metal hip implants at that time, the agency is now proposing regulations that would require makers of metal-on-metal hip implants to file approval applications that meet the strictest level of review for medical devices.

Even though the FDA’s proposed legislation isn’t an outright ban on all-metal hip implants, the stricter requirements could prevent more metal hip implants from coming to market. In fact, many popular metal-on-metal him implants have already been recalled, including Stryker’s recall of its Rejuvenate and ABG II Modular-Neck Hip Implant Systems in July 2012 and DePuy Orthopedics’ recall of the DePuy ASR XL Acetabular System and the ASR Hip Resurfacing System in August 2010.

Metal-on-metal hip implants, like the Stryker Rejuvenate and ABG II hip implants, have been associated with significant risk of developing serious complications including the following:

  • Tissue damage
  • Device failure
  • Bone and muscle deterioration
  • Necrosis
  • Hip and groin pain
  • Swelling and inflammation
  • Numbness
  • Metallosis, or the buildup of metallic ions in the tissues of the body
  • Dislocation of non-cemented implants
  • Pseudotumors
  • Gait issues and inability to walk
  • Adverse affects to nervous system, heart, and thyroid gland

Some patients may require a subsequent corrective surgery to remove and replace the recalled Stryker hip product.

As we recently reported, the FDA received more than 5,000 complaints between January and August about metal-on-metal hip implants, which is more complaints than the FDA had received about metal-on-metal hip implants in the previous four years combined. Most of the reports involved patients who have had their metal-on-metal hip implant removed, or will do so in the near future. Although the implants are designed to last up to 15 years, early replacement is a common problem for many metal-on-metal hip implants, which can cause dangerous complications for elderly patients.

Patients who have received the recalled a metal-on-metal hip implant should consult with their doctor immediately. According to Bloomberg, the FDA recommends that patients receive radiographs at least every two years even if they aren’t experiencing any symptoms that would indicate that the metal-on-metal hip implant is failing.

You may also wish to consult with a skilled hip implant attorney since you may be entitled to compensation for your injuries, including medical expenses, lost wages, and pain and suffering, in a product liability or medical malpractice lawsuit. Contact the Chicago product liability lawyers at Ankin Law Offices, LLC at (312) 600-0000 to learn more about the dangers of all-metal hip implants.

Categories: Hip Implant Recalls