One of the topics discussed by orthopedic surgeons at an annual conference held in Chicago, IL on March 19, 2013, centered on the subject of whether MRIs could potentially predict soft tissue problems in metal-on-metal hip recipients. Pain and swelling in the hip region following implantation of an all-metal implant—or an implant with some metal components, such as the Stryker Rejuvenate—is an early indication of implant failure. Physicians at this meeting discussed recent research involving seventy patients who were forced to undergo revision surgery to replace a defective hip implant device. An educational session involving seven orthopedic experts was also featured at the meeting entitled “Optimizing Management of Patients with Metal-on-Metal Hips.”
This particular research definitively showed that an MRI, with its superior imaging capabilities, is able to more readily identify tissue damage from defective hip implants. What this may mean for recipients of hip implants is that problems can be identified much earlier. This early identification allows revision surgery prior to extensive bone and tissue loss which renders the procedure much riskier for the patient and more complex for the surgeon. The American Academy of Orthopedic Surgeons issued an informational statement this past December regarding metal-on-metal hip devices.
The statement recommended a “low threshold for commencing the evaluation of a patient with a metal-on-metal hip replacement, as early recognition and diagnosis will facilitate the initiation of appropriate treatment prior to significant adverse biological reactions.” The AAOS also detailed specific treatments and diagnostic methods used when patients with all-metal implants suffered pain or discomfort. The time frame for initiating treatment and performing revision surgery are also set forth in this statement. In the interests of ensuring those with defective hip implants receive timely diagnosis and treatment, the surgeons at the March meeting discussed various methods of early identification.
Physicians at the AAOS meeting recommended that any patient implanted with a metal-on-metal hip implant—or a newer design with partial metal components such as the Stryker Rejuvenate and ABG II—be conscientious regarding after-care. Any unusual symptoms such as pain or inflammation or symptoms related to metal toxicity could suggest implant failure. Regular physician visits with appropriate diagnostic tests—including an MRI—can potentially identify problems with the implant before irreparable damage is done. Blood tests should be done regularly to determine whether levels of cobalt and chromium are above the levels considered “safe.”
The metal-on-metal implant devices were intended to provide greater durability and longevity due to the metal components which, in lab tests, had exhibited superiority over their ceramic and polyethylene counterparts. Unfortunately metal implants have come under fire for early failure rates as well as for the potential to leave implant recipients with long-term or even life-threatening injuries and illnesses. In the wake of recalls and thousands of lawsuits, some believe manufacturer profits were place ahead of patient safety. Recently the FDA issued updated guidelines to those with all-metal or partial metal hip implants. The agency advised patients to undergo regular physical exams, MRIs and blood testing. Further, the FDA is now proposing regulations which would require manufacturers to conduct clinical trials and to provide proof the implants are safe and effective prior to marketing. These steps are considered to be significant in holding manufacturers responsible for product deficiencies and dangers.