DePuy Hip Implant Recall to be Featured at Senate Hearing on FDA Medical Device Approvals

Today, a Senate hearing into the oversight of medical devices will delve into the <"">DePuy ASR hip implant recall issued last year by DePuy Orthopaedics, a division of Johnson & Johnson. The hearing, entitled “A Delicate Balance: FDA and the Reform of the Medical Device Approval Process,” will be conducted by the U.S. Senate’s Special Committee on Aging.

The Senate hearing will examine the U.S. Food & Drug Administration’s (FDA) role in protecting patient safety in the medical device approval process, according to an announcement from the committee.

“Internal reviews by FDA officials and other outside sources have found troubling lapses in the procedures by which a number of medical devices were approved,” the committee wrote. “The results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months.”

A metal-on-metal device made of chromium and cobalt, the DePuy ASR Hip Implant System consists of a cup implanted into the hip with a ball joint that connects to the leg. In August, DePuy Orthopaedics issued a recall for the ASR XL Acetabular Hip Replacement System after data from the National Joint Registry of England and Wales showed that 1 out of 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving the surgery. A hip implant should last for roughly 15 years, but many DePuy ASR hip implant recipients have had to undergo new surgeries just a few years after implantation.

In 2009, DePuy had already announced it would be phasing out the ASR hip implant, ostensibly because of low sales. But by 2008, the FDA had received more than 300 reports of problems with the hip implant, most involving premature failure that required revision surgery.

The DePuy ASR Acetabular Cup System first came on the market in 2005. It was cleared by the FDA via a process known as 510(k) approval. This process allows a manufacturer to obtain market approval with very little clinical testing of the device – including no human testing – if a manufacturer can prove it is “substantially similar” to another product already on the market. In 2010, an internal FDA review – ironically released shortly after the DePuy ASR hip implant recall was issued – found numerous flaws with the 510(k) process, prompting the agency to consider changing it.

This past February, a study published in the Archives of Internal Medicine found that the majority of high risk medical device recalls over the past five years involved products subject to the streamlined 510(K) approval process. In addition to artificial hips like the DePuy ASR implant, other medical devices that fall into this category include knees replacements, external defibrillators, and infusion pumps.

The researchers found that of 113 Class I recalls issued from January 2005 through December 2009, 80 products – 70 percent – were given 510(k) clearance. Only 21 of those products, or 19 percent, were found to have been approved through the more stringent premarket approval process. Eight were exempt from regulation or were merely registered with the FDA.

According to the study, 12 percent of the high-risk recalled devices that got 510(k) clearance should have been subject to rigorous approval review because they were marketed for risky or life-sustaining purposes.

In addition to today’s Senate hearing, the House of Representatives Oversight & Government Reform Subcommittee on Health Care will conduct a hearing tomorrow “to study the FDA’s inconsistent application of reasonable standards for safety and effectiveness in approving medical devices, and the impact it has on American job creators.”

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