A Ban on Metal-on-Metal Hips Likely in the U.K.Nov 1, 2013
Health regulators in the United Kingdom are considering a ban on metal-on-metal hip implant devices following their review of 17,000 cases that revealed excessive and premature failure rates in patients who had been implanted with these hip systems.
The proposed ban would impact all National Health Service (NHS) hospitals in the U.K., and comes after a National Institute for Health & Care Excellence (NICE) review that found some implants experienced failure rates as high as 43 percent, The Telegraph reported.
NICE recommended that NHS hospitals cease using all-metal hip implant devices that have failure rates greater than 5 percent, which means that just about every metal-on-metal implant used in the U.K. would be banned. In fact, only two all-metal hip devices could be used and both of them just barely meet the proposed requirement, according to The Telegraph report.
Dr. Stephen Cannon of the U.K.’s Royal National Orthopaedic Hospital told The Telegraph. "I think there is a question about whether [the proposed ban] goes far enough, but this is definitely a step in the right direction—it amounts to a ban on most of them…. The figures speak for themselves—even the best metal-on-metals have four times the failure rate of the rest. This is a really significant problem because these were given to an awful lot of people."
The NICE audit found that the DePuy ASR failed 43 percent of the time within nine years and also indicated high failure rates in metal-on-metal hip resurfacing systems. The headline-making August 2010 recall implemented by DePuy Orthopaedics involved over 93,000 of its ASR XL acetabular and ASR hip resurfacing systems due to higher-than-anticipated failure rates. Soon, all metal-on-metal hip devices became the focus of increased controversy.
When a device fails, revision surgery to remove and replace that device is generally required. The surgeries are not always conducted on the same day and are typically longer and much more complex, painful, and costly than the original implant surgery. Surgeons are then working with reduced bone mass and must also remove damaged tissue and bone. Often, patients are left with life-long injuries.
Hundreds of thousands of patients may have been exposed to dangerous and toxic compounds that are released from the devices, leading to staggering potentials for future revision surgeries and device failures.
When the metal components rub against one another—which is seen in normal activities, such as walking—tiny shards of metal are released into patients’ tissues and bloodstreams. Some reports have indicated that all-metal hip implant patients are at risk for an array of adverse reactions including cancer, cardiomyopathy, muscle and bone damage and destruction, and DNA changes due to this metal release.
Mounting injury reports have also alleged injuries that include swelling, infection, metallosis (metal poisoning), synovitis (inflammation of the joint lining), difficulty ambulating, rising, and balancing, high blood metal levels, tissue and bone damage, tissue necrosis, pain at the implant site that sometimes spreads to the groin and back, osteolysis (bone loss), fluid collection/solid masses (pseudotumors) around the hip joint, rash, renal function impairment, and other injuries.
The increase in injury reports has also led to an increase in litigation against DePuy and a host of other metal-on-metal hip implant device makers that also include Smith & Nephew, Zimmer, Biomet, and Stryker. DePuy Orthopaedics, which is a unit of health care giant, Johnson & Johnson, faces nearly 11,000 lawsuits. Meanwhile, many devices have yet to be recalled.
In the United States, many metal-on-metal hip devices received clearance under the U.S. Food and Drug Administration’s (FDA) 510(k) route, which enables device makers to bypass clinical testing of their products if a device is shown to be substantially similar to an already-approved device. Medical device makers must simply demonstrate that a devices does what the device maker says it does and that it poses no undue safety risks. A device cleared under the 510(k) does not have to be shown to be effective.
Congress gave the FDA authority over medical devices in 1976, allowing the expedited review process now known as the 510(k) review. In 1976, medical devices played a much smaller role in medicine and, in recent years, the 510(k) has been criticized over the complexity of the thousands of devices on the current market, which have rendered the expedited process inadequate. Metal-on-Metal hip devices are among some of the more controversial devices approved under the 510(k) process.
Ironically, metal-on-metal hip devices were created to provide increased durability and longevity. The belief was that the devices’ stronger components would provide increased benefits over traditional all-metal devices manufactured with plastic or ceramic elements. Instead, the all-metal hips have led to a massive debacle involving serious adverse reaction reports, global recalls, and regulatory and medical probes. Some experts have accused both European and American regulators of concealing risks tied to metal-on-metal hip devices from consumers, according to Medscape Medical News, and many have criticized device makers of putting profits over patient safety.
For its part, in response to mounting adverse event reports, litigation, and recalls, the FDA has said that the devices can lead to pain, soft tissue damage, and metal shedding in the area where the device’s components meet—typically at the ball and cup junction, according to a FoxNews report. The FDA also issued new guidelines for patients who have been implanted with all-metal hip devices and advised that physicians should conduct physical examinations, diagnostic imaging, and metal ion testing, as needed, in patients experiencing symptoms of device failure.
This January, the FDA proposed more stringent regulations mandating metal-on-metal hip device makers prove implant safety and efficacy prior to releasing their devices to the market, according to a Health Point Capital report. The FDA also cited a “renewed concern of wear and corrosion of conical head/stem taper junctions in modern modular total hip replacements,” and commissioned research to better understand the association between the devices’ “volumetric” wear and corrosion in total hip replacement surgeries, and potential links to clinical outcomes, Health Point Capital wrote.
The agency’s statements are significant in context of holding manufacturers responsible for dangers allegedly tied to their products.