A new study warns metal-on-metal hip implants are much more likely to need repair or replacement. The study authors are calling on doctors to stop using the implants – which have also been linked to high levels of potentially toxic metals in the bloodstream – once and for all. For the study, British researchers looked at data for more than 400,000 hip replacements from the National Joint Registry of England and Wales between 2003 and 2011, one of the world’s largest databases on joint implants. More than 31,000 of the procedures were metal-on-metal devices, the researchers found. Most artificial hip joints are plastic or ceramic.
The metal-on-metal implants didn’t fare very well. After five years, almost 6% of people with the metal-on-metal variety needed surgery to fix or replace them. That compares with just 1.7% to 2.3% of people who had ceramic or plastic joints. Doctors usually expect hip joints to last at least a decade. The study was published online last month in The Lancet and funded by the National Joint Registry.
Study author Ashley Blom, head of orthopedic research at the University of Bristol, emphasized that most people with a metal hip haven’t needed a replacement. But with so many alternatives, he said there was no reason to take that risk. Dr. Blom said if he were a patient, he wouldn’t choose a metal-on-metal hip. He said the rates of failing metal hips were likely an underestimate since not all patients report symptoms or get surgery to fix the problem.
All metal hip joints were already under scrutiny over questions about how long they last. As we have reported, one major manufacturer recalled its product over a year ago. Last year, regulators in the U.S. asked makers to conduct safety studies on these medical devices. An investigation by the British Medical Journal and BBC News Night found that metal ions from this type of artificial hip could seep into surrounding tissue, destroying muscle and bone, and for some causing damage to the lymph nodes, spleen, liver and kidneys.
Those findings prompted a warning from the British regulatory group. The Medicines and Healthcare Products Regulatory Agency recommended patients with these joints should have yearly blood tests to make sure no dangerous metals are seeping into their bodies. It also advised patients with symptoms such as pain, swelling or reduced movement to get MRI scans to check for muscle damage in case the joints need to be removed. In 2010, DePuy, a division of Johnson & Johnson, recalled a metal hip implant after it was linked to high failure rates. Dr. Blom said the new analysis suggests the problem applies to all metal-on-metal hips, not just one brand. Doctors began using metal-on-metal implants after laboratory tests suggested the devices would be more resistant to wear and reduced the chances of dislocation. They aren’t sure why that isn’t the case once they are used in patients.
Last year, the U.S. Food and Drug Administration asked all manufacturers of metal-on-metal hips to conduct safety studies. Use of the devices has dropped dramatically in recent years worldwide. In the United Kingdom, only about 5% of patients are believed to be getting the metal hips. In the United States, it’s estimated that about 500,000 people have them. Some experts called for tighter regulation, warning there might be similar problems with other joint replacements, such as those for knees and shoulders. Dr. Art Sedrakyan, an associate professor of public health at Weill Cornell Medical College in New York, who authored an accompanying commentary in Lancet, stated:
I wouldn’t be surprised if this was just the beginning of the storm. A lot of products have been allowed onto the market without clinical evidence they work.
Hopefully, Congress will take action and pass the legislation needed in this area of concern. The approval process for all medical devices must be changed and made stronger. If you need additional information on any aspect of the metal hips litigation, contact Navan Ward at 800-898-2034 or by email at Navan.Ward@beasleyallen.com.
Source: CBS News
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