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FDA Issues Safety Communication Regarding Metal-On-Metal Hips
The Food and Drug Administration (FDA) issued a Safety Communication on January 17, 2013 to the medical community and patients who are considering or have received a metal-on-metal hip implant, warning of the unique risks of all-metal implants.
All metal implants have unique risks in addition to the general risks associated with hip implants. The metal ball and the metal cup slide against each other during walking and running causing metal to be released from parts of the implant when the two components connect. This can cause tiny metal particles to wear off which may cause damage to bone and/or soft tissue surrounding the implant and joint. Soft tissue damage can lead to implant loosening, device failure and the need for revision surgery. Additionally, metal ions may enter the bloodstream where they may cause systemic damage to other organs within the body. The FDA recommends that orthopedic surgeons use metal-on-metal implants only after determining the risks are necessary for the patient, inform patients regarding all of the unique risks with the all metal implants and be especially aware of patients where all metal hips are contraindicated.
The FDA also made patient recommendations including patient follow-up and monitoring for patients with all-metal hips. The FDA further noted the certain patients are at risk for increased device wear and/or adverse local tissue reaction and should be followed more closely. These patients include: patients with bilateral implants, female patients, patients receiving high doses of corticosteroids, patients with renal insufficiency, patients with suppressed immune systems, patients with metal sensitivity, patients who are severely overweight and patients with high levels of physical activity. The FDA advises patients who receive all-metal hips to pay close attention to symptoms which indicate adverse reactions including: hypersensitivity, loosening, infection, bone loss, soft tissue mass, cardiomyopathy, neurological changes, renal function impairment and/or thyroid dysfunction. If symptoms appear, the patient should undergo metal ion testing. The FDA recommends those with symptoms be evaluated every six months and even asymptomatic patients should follow-up with their orthopedist every 1-2 years.
Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who received any metal-on-metal hip device including the DePuy Pinnacle, DePuy ASR, Stryker Rejuvenate, ABGII and Accolade, Wright Conserve and Profemur and Biomet M2A Magnum by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.