Issue: June 2011
June 01, 2011
2 min read
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FDA orders post-market surveillance studies for metal-on-metal hip implants

Issue: June 2011
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The FDA has recently ordered 21 medical device makers of metal-on-metal hip systems to conduct post-market surveillance studies on these implants.

In a May 6 update to the FDA’s public health communication about metal-on-metal hips, the agency noted that the companies must submit research protocol to the agency that “addresses specific safety issues related to these devices. Data from the studies conducted will enable the agency to better understand these devices and their safety profiles.”

In all, the FDA sent 145 orders to the 21 manufacturers.

In the update, the FDA noted that the implants were on the market prior to a law that empowered the FDA with premarket authority regarding medical devices and were categorized as class III devices.

“The agency is currently reviewing all safety and effectiveness data related to these ‘preamendment devices,’ including metal-on-metal hip systems, in an effort to determine their proper risk classification and how these devices should be regulated in the future,” the agency noted in the update. “A decision on the proper classification of metal-on-metal hip systems is forthcoming but is unrelated to the post-market surveillance order.” – by Gina Brockenbrough, MA, and Robert Press

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Perspective

The FDA directive to implant manufacturers is not surprising; the orthopedic community and public have known for some time that metal-metal total hips are encountering more than their share of problems. This issue has been played out extensively in the media, and patients are rightfully concerned.

For industry, the research protocols mean that close collaboration with surgeons will be essential to capture the true extent of the problem. Hopefully, the data collected will shed scientific light on this problem and enable surgeons to understand whether or not metal reactions are related to specific factors or if they are a generic, unavoidable problem with all metal-metal total hips. The surgical community should stay ahead of this issue with the goal of understanding and addressing a problem that seems to be growing; while promoting patient safety and welfare.

Until the research protocols demanded by the FDA can enlighten the orthopedic community about the epidemiology of metal-metal adverse reactions in total hips, individual surgeons should exercise extreme caution in using or advocating the use of these products in any patient.

— B. Sonny Bal, MD, JD, MBA
Orthopedics Today Editorial Board member
Professor of hip and knee replacement in the department of orthopedic surgery
University of Missouri School of Medicine, Missouri
Disclosure: He has no relevant financial disclosures.