People living in the U.K. appear to be susceptible to many of the same faults of their healthcare regulation as those living in the U.S., and like here, the fallout from a high volume of injuries caused by defective metal-on-metal hip implants has drawn a thick underscore on the issue.
In a follow-up to a report earlier this week appearing in U.K.’s The Telegraph, the Royal College and British Orthopaedic Association say that faults with medical device regulation likely allowed this dangerous class of metal hip implants on the market, putting tens of thousands of its citizens at risk of serious and life-altering injuries.
Together, the groups addressed a Letter to the Editor of The Telegraph in which they stressed the “urgent need to address the regulatory flaws” that are putting millions, potentially, at risk of serious injuries that could be avoided.
Most troubling in Europe, and the U.K. specifically, is the alleged subcontracting of regulatory powers governing medical devices used across the European Union, using “questionable Asian firms” to approve medical devices for use in the E.U., the same firms that tout their record of never rejecting a new device’s approval.
No matter the circumstance, leading health authorities appear together in stressing the need for reform.
The same problems exist in the U.S., where medical device companies seemingly have power over the regulatory agencies and can get new products like metal-on-metal hips on the market without much, if any, pre-market safety testing conducted to ensure it won’t cause serious injuries to a wide group of people.
Metal-on-metal hip implants have drawn sharp criticisms of the Food and Drug Administration here. More than 30 companies have gotten their version of these hip implants approved in the last decade, many through the questionable 510(k) “fast-track” approval system that allows new devices on the market based on their being similar in design to a previously-approved device.
The 2010 recall of the DePuy Orthopaedics ASR hip implant triggered a chain reaction of reports linking these hip implants to thousands of serious injuries.
Soon, tens of thousands of recipients of metal-on-metal hip implants like the recalled DePuy ASR came forward with reports linked to their defects. These devices suffer from a faulty overall design. Many implants cause severe pain just months after they’re implanted. Recipients are at greater risk of pain, inflammation, decreased mobility, and serious infections due to this design. The all-metal components of the devices put recipients at risk of metal poisoning, too.
All these potential flaws with all-metal hip implants were not discovered during the approval process because the FDA and apparently other regulatory agencies around the world did not require them.