The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued a new warning advising doctors against using a specific combination of metal hip implant components. The MHRA issued the warning after it was determined that the patients who received the metal hips in question had an “unacceptably high” rate of revision surgery after undergoing the initial procedure.
Specifically, the MHRA advised that patients who had a combination of Mitch TRH cupheads manufactured by Finsbury Orthopedics, a unit of Johnson & Johnson and Accolade femoral stems made by Stryker should be monitored for signs of possible complications. Doctors were also advised against using the two products in tandem for future hip replacement surgeries.
All-metal hip implants were introduced over the last few years as an alternative to older types of artificial hips, which typically featured plastic or ceramic components. The metal-on-metal hips were intended to be a more durable alternative but numerous research studies have suggested that some of the metal hips are failing prematurely at alarmingly high rates. In addition, metal hip implant recipients have reported serious complications caused by one of these devices, including pain, swelling, tissue and joint damage and loss of mobility.
Earlier this year, researchers in the U.K. also suggested that the all-metal hips could potentially put thousands of patients at risk for metal poisoning. Research has indicated that as the metal head and cup components of the hip devices rub together, small pieces of chromium and cobalt are shed into the body. As the level of metal ions builds up in the blood, it can potentially lead to other complications, including a heart condition known as cardiomyopathy.
The primary focus of concern has been metal hip implants manufactured by Johnson & Johnson’ s DePuy Orthopedics division. Approximately 93,000 DePuy ASR hips were recalled in 2010 after data from joint registries in the U.K. and Australia indicated that the devices were failing at high rates. New reports have since indicated that Johnson & Johnson may have been aware of the problems with the ASR hips as early as a year before the recall was issued and that the company continued to market its ASR hip resurfacing system to doctors overseas after it was rejected by the U.S. Food and Drug Administration.
In the U.S., lawmakers and health industry experts are blaming a loophole in the FDA’s medical device approval process for the metal hip dilemma. Specifically, concerns have been raised over the FDA’s 510(k) rule, which allows medical device manufacturers to gain approval for a product without conducting additional safety testing if the product is substantially similar to a device that’s already on the market. In the case of the DePuy ASR hips, those devices were approved under the 510(k) system using the company’s Pinnacle hip as a predicate. It has since been determined that the Pinnacle hip is also responsible for numerous instances of patient injury.
Johnson & Johnson, DePuy and several other metal hip manufacturers currently face numerous lawsuits filed on behalf of patients who say they suffered complications caused by an all-metal hip replacement. Patients who experienced problems or required revision surgery in connection with a metal hip device are urged to seek the aid of an experienced personal injury attorney to discuss their legal rights.
NadrichCohenLLP