Research Finds Hip Device Regulatory Review “Entirely Inadequate”

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hip-device-regulation-oversight--inadequateA recent study has found that some hip implants released to market received clearance with minimal or no proof of their safety or effectiveness.

The study revealed that some 8 percent of hip devices available on the market today are involved. The researchers are looking for changes in the way in which orthopedic hip implant devices are regulated, noting that many of these devices are released with inadequate efficacy and safety studies, according to MassDevice.com.

The researchers, from the University of Oxford, state that today’s hip implant regulation is “entirely inadequate,” and point out that growing controversy over high failure rates and injuries tied to metal hips is indicative of a need for an overhaul of today’s processes, MassDevice.com reported.

The researchers analyzed National Joint Registry of England & Wales data, specifically looking at the way in which devices described as “unclassified” or “pre-entry” by the Orthopaedic Data Evaluation Panel, were utilized. The panel is a group that “rates implants based on their levels of evidence,” according to MassDevice.com.

“Unclassified” implants were described as those devices that have no evidence submitted by their manufacturers, while “pre-entry” implants are associated with less than three years of evidence, according to MassDevice.com. Unclassified and pre-entry devices are on the market and available for use in procedures, MassDevice.com noted.

The team found that, of more than 136,500 components used in hip implants in 2011, about 7.6 percent were used “without readily identifiable evidence of clinical effectiveness.” The researchers also noted that these findings likely underestimate the true number of under-studied devices, according to MassDevice.com.

“This study shows that the need still exists for an improved and more rigorous approach to regulation of devices to avoid devices with no available evidence being used in a widespread and uncontrolled manner,” the researchers wrote, MassDevice.com reported. “Physicians who adopt new technologies that have little or no evidence of superiority over existing products need to be educated about the implications of their choices. They should also ensure that their patients know about the benefits and risks of the new—but often unproved—medical devices that they are receiving.”

We have long written that not all medical devices undergo safety testing prior to being released to market, which has given rise to increased controversy, especially concerning metal-on-metal hips. In the United States, device makers may seek U.S. Food and Drug Administration (FDA) clearance through a 510(k) application should a device be substantially similar to a previously approved device. Using this clearance route, device makers need only file paperwork with the agency and pay a $4,000 fee, according to Newsmax Health. It is only after a device is on the market and has been tied to increased injury reports—so-called “post-market surveillance”—does the agency become involved.

Metal-on-metal hip device implants, such as the DePuy Orthopaedics’ ASR devices, were marketed to last for at least two decades, as well as to provide increased range of motion, when compared to traditional hip replacements constructed with plastic or ceramic components. Instead, metal-on-metal hips have been associated with high and premature failure rates; an array of alleged, adverse medical reactions, including increased blood metal ion levels and metal poisoning; and mounting litigation. Injury reports also allege dislocations; pain; fracture; difficulty ambulating, rising, standing, and balancing; noise emanating from the joint; and pseudotumors, to name just some.

Johnson & Johnson, DePuy’s parent company, faces some 12,000 lawsuits filed in federal and state courts in Ohio, California, and New Jersey, according to a recent Bloomberg.com report. The device maker also recently reached a $2.47 billion settlement to resolve thousands of these lawsuits; that amount may reach as high as $4 billion.