Regulators of European medical devices have released a fact sheet detailing the pros, cons and potential health risks for patients who choose to receive so-called metal-on-metal hip implants.
The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks compiled the fact sheet to address concerns about premature failures and injuries caused by the all-metal devices.
Traditional hip replacement systems are made of ceramic or plastic parts, and can last up to 20 years or longer. But in recent years manufacturers have produced hip implants made with metal parts under the guise that all-metal hip implants would be more durable and a better option for younger or more active patients. However, soon after the devices hit the market, complaints flooded the market.
The metal-on-metal hip implants were failing at a higher than expected rate, in five years or less. Not only were the devices fracturing, loosening or dislocating, the metal parts were also corroding inside the body, inflaming tissue causing immense pain and limiting mobility. Many patients were forced to undergo revision surgery to remove and replace their defective device – a more invasive procedure that requires longer recovery.
Health authorities around the world including Europe and the United States began to crack down on manufacturers of these all-metal hip implants. Recalls were issued and lawsuits were filed against medical device manufacturers including Johnson & Johnson’s unit DePuy Orthopaedics and Stryker. Patients and surgeons were advised to consider the potential harm the all-metal devices could cause.
The European Commission’s fact sheet is designed to better inform patients of the risks associated with metal-on-metal hip implants and advises physicians and patients to consider a patient’s age, gender, body size and physical fitness level before choosing an implant. The commission also said that the all-metal devices should not be used in at-risk individuals such as women of child-bearing age, small-boned patients, and those allergic to the metals.