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July 10, 2012. Category: Product Liability, Unsafe Medical Devices

FDA Advisory Panel: More Warnings Needed for Metal-On-Metal Hip Implants

In late June 2012, a FDA Advisory Panel (consisting of orthopedic surgeons, medical experts, industry representatives, and patient advocates) convened a two day hearing to publically discuss safety data on metal-on-metal hip implants.  The deliberations led many of the panelists to conclude that labels for the implants should include warnings about pseudotumors and high levels of metal ions in patient’s blood.  Orthopedic surgeon Dr. Adolph Yates from the University of Pittsburgh Medical Center said these conditions have been found in recipients of the implants both with and without symptoms of device failure. 

The panel recommended that patients with a metal-on-metal implant who are experiencing signs or symptoms consistent with implant failure should be evaluated by a surgeon and undergo diagnostic testing, and possibly consider revision surgery.  Even without signs of failure, patients with metal-on-metal hips should make follow up visits at least every three to six months.  Even with the new recommendations, some of the panelists fear studies by the FDA will not provide sufficient evidence about the dangers caused by metal-on-metal hip implants.  Harvard University researcher Scott Evans said the data accumulated FDA is not of high enough quality, and suggested conducting more controlled studies.

Even though the panel didn’t discuss removing the devices from the market, panelists said there were few, if any, instances where they would recommend using metal-on-metal hip implants.  Dr William Rohr, the chairman of the panel, said “I do not use metal-on-metal hips, and I can see no reason to do so.”  The sentiments of these panelists is seen the yearly statistics.  In 2010, metal-on-metal hip implants accounted for 27% of all hip implants, down from 40% in 2008.

The panelists’ warnings are nothing new for those following the news on metal-on-metal hip implants.  Canadian officials issued a safety warning to surgeons about significant health problems being reported in patients with the implants.  In the UK, experts at the world’s largest artificial joint registry advised doctors to stop using the metal-on-metal hip implants.  The British officials cited a study where 6% of patients with the metal implants needed replacement within five years of the surgery, compared with just 2% of patients with ceramic or plastic implants. 

Metal-on-metal hip implants are another classic example of an unsafe medical product allowed on the market without adequate testing.  The FDA did not properly study the implant or require pre-market safety data, which allowed patients to receive a dangerous medical device.  Even as its own panelists recommend new warnings, the FDA refuses to heed their advice and many models of all-metal hips remain on the market today.  
 

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