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FDA posts public health communication about metal-on-metal hips
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The FDA released a public health communication on metal-on-metal orthopedic hip implants, which details concerns and effectiveness regarding these devices and offers information for patients and health care professionals who provide their treatment.
In the posting on its website, the FDA cited a 2010 report from the Australian Orthopaedic Association’s National Joint Registry which found 92% implant survivorship at 7 years in patients with primary osteoarthritis who were treated with total hip replacement (THR) using metal-on-metal (MoM) components. However, the FDA also noted that MoM replacement systems have “unique risks in addition to the general risks of all hip implant systems.”
Concerns
One noted risk of MoM systems — the potential release of metal particles into the bloodstream due to wear. “Different people will react to these metal particles in different ways,” the FDA wrote. “At this time, it is not possible to know who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be. However, it is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint.”
In addition to adverse local tissue reactions or reactions to metal debris, the agency noted that some studies have reported a small number of patients with high metal-ion levels in the blood which may have impacted the heart, nervous system and thyroid gland.
The federal posting also highlighted a recent medical device alert issued by the Medicines and Healthcare products Regulatory Agency in the United Kingdom which detailed follow-up recommendations for patients with MoM hips, and voluntary company recalls of the DePuy ASR total hip system and Zimmer Durom cup.
For health care professionals
In its information for health care professionals treating patients with MoM hips, the FDA noted that “the true incidence or prevalence of adverse systemic effects from MoM hip implants is not known at this time, but is believed to be rare.”
They advised clinicians to be aware of the potential role of metal ions when evaluating symptomatic patients and noted that no threshold value of metal ions in the bloodstream exists to confirm the etiology of symptoms. The agency also instructed physicians to report adverse systemic events using MedWatch.
AAOS response, efforts
In a response to the FDA posting, the American Academy of Orthopaedic Surgeons (AAOS) highlighted the benefits of MoM THR and said that they will continue to share information about the systems.
 John J. Callaghan |
“The FDA is a partner in patient safety and education,” AAOS President John J. Callaghan, MD, stated in a press release. “We believe that a significant majority of metal-on-metal hip replacement implants have successfully relieved pain and improved function without any problems for the patients who have received them, but there have been some concerning exceptions. We are working together to investigate and report these concerns and will continue to communicate with our 36,000 members, the medical community and the public.”
The group stated that it has notified its members about the potential side effects of these devices, updated patient education information on its website and asked physicians to help them identify patients who have adverse reactions to MoM implants.
“We recommend all patients tell their physicians about their metal-on-metal implants, because if they are experiencing new symptoms or new pain, that can indicate a complication,” Joshua A. Jacobs, MD, spokesperson for the AAOS and an orthopaedic surgeon and researcher in Chicago, stated in the release.
References:
- www.aaos.org
- www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/default.htm
Disclosures: John J. Callaghan, MD, receives royalties from DePuy, A Johnson & Johnson Company.
Joshua A. Jacobs, MD, is a consultant for Zimmer, Johnson and Johnson, Medtronics and Implant Protection. He receives research funding from Zimmer, Medtronics Spinal Motion.
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