Study: Hip Device Regulatory Review Found to be “Entirely Inadequate”

hip-device-regulation-inadequateEmerging research reveals that some hip implants on the market today received clearance with little or no proof of efficacy or safety.

The researchers indicate that about 8 percent of the hip devices on today’s market are involved and that they seek a significant change in how orthopedic hip implants are regulated. They note that many of these devices are released to the market without much efficacy and safety studies, according to MassDevice.com.

The University of Oxford research describes current hip implant regulation as “entirely inadequate,” adding that the growing controversy concerning high failure rates and injuries associated with metal hip devices points to a need for an overhaul of current processes, MassDevice.com reported.

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

“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.

According to the team, of more than 136,500 components that were used in hip implants in 2011, some 7.6 percent were used “without readily identifiable evidence of clinical effectiveness.” The researchers pointed out that these figures likely underestimate the actual 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 pointed out that not all medical devices are tested for safety before they are released to market, a long-discussed issue that 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 device that has already been approved. Under this clearance route, device makers are only required to file paperwork with the FDA and pay a $4,000 fee, according to Newsmax Health. 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.

All-metal hip device implants, such as the DePuy Orthopaedics’ ASR devices, were marketed to last for at least 20 years, as well as to provide increased range of motion, when compared to traditional hip replacement devices that are constructed with plastic or ceramic components. Instead, metal-on-metal hips have been tied to 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.

Today, Johnson & Johnson, the parent company of DePuy, 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.

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