Pharmaceutical

Consumer Reports warns of FDA’s fast-track medical device approval process

In an email blast to one million subscribers, Consumer Reports President Jim Guest wrote that medical devices that receive U.S. Food and Drug Administration (FDA) approval through its fast-track process have created a “nightmare scenario” for public safety. The fast-track approval process, or 510(k), is a shortcut designed to speed low- and moderate-risk medical devices to market when their designs are similar to already approved devices, bypassing costly and time-consuming clinical safety trials.

The majority of Class I and Class II medical devices, including DePuy Orthopaedic’s ASR hip implants, gained FDA approval through the 510(k) process. The ASR XL Acetabular System and ASR Hip Resurfacing System were recalled by DePuy in August 2010 after studies revealed 12-13 percent of the implants failed within five years.

“This isn’t science fiction,” Mr. Guest warned in his email. “Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled — 700 different products a year. And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were ‘similar’ to products already on the market.”

DePuy’s ASR hip devices were implanted in some 93,000 patients worldwide, including about 37,000 in the United States, before they were recalled. Thousands of ASR hip implant recipients have filed lawsuits against DePuy for injuries ranging from device failure, fractured bones, muscle and tissue decay, chronic pain, and immobility. Some ASR hip recipients suffer more systemic damage to the central nervous system, thyroid, and heart as a result of excessive levels of cobalt and chromium in the blood, a condition known as metallosis, which may cause tumors, cancer, and other serious problems.

Carol Kochhar-Bryant, a 62-year-old professor and senior associate dean at George Washington University, received a DePuy ASR implant in 2009. She also received the Consumer Reports alert from John Guest warning about the FDA 510(k) approval process. Professor Kochhar-Bryant told Reuters that her DePuy implant failed after just two years, leaving her with elevated levels of cobalt and chromium in her blood.

According to Reuters, “She continued to have pain and recently underwent a second, more extensive surgery to scrape out metal shavings embedded in the surrounding tissues of her hip and replace the entire ball and socket with a new device.”

Professor Kochhar-Bryant told Reuters that she was surprised the implants went through minimal review before the FDA approved them. “I was assuming there was a much more rigorous process,” she told Reuters. “I did not quiz my doctors on how these things come to the market. They gave me a lot of pamphlets on it. I went back to look to see what adverse events were listed, but there’s nothing in there.”

Last month, a new bill introduced by Democrats to the House Energy and Commerce committee for review aims to close loopholes in the FDA’s 501(k) process and thus prevent potentially dangerous devices from going to market without the appropriate safety trials.

Source:

Consumer Reports

Reuters

Bloomberg