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DePuy ASR XL 4 articles

FDA Cleared Metal-on-Metal Hip Implants without Clinical Testing

When Consumer Reports did an investigation regarding the FDA and approved medical devices designed to be implanted into the body, what they found was disturbing to say the least. “Medical devices often aren’t tested before they come on the market,” Consumer Reports says. That was the case for the DePuy ASR XL metal-on-metal hip that has allegedly injured thousands of patients, including Stephen Tower, M.D., a 55-year-old orthopedic surgeon. About a year after receiving his hip implant, Tower could tell that something was wrong. He experienced pain from his hip “pretty much constantly”, his chromium and cobalt blood levels were through the roof, ... Read More

FDA increases fees in hopes of improving medical device approval process

Medical device manufacturers will have to double the fees they pay to the Food and Drug Administration (FDA) in order to have their products reviewed over the next five years as part of a plan to provide faster, more thorough evaluations. The increase would allow the FDA to hire 200 new full-time employees within five years to assist with medical device evaluations. As part of the approval process, evaluators would be required to meet with device applicants midway through the review process in order to address concerns. Medical device makers are in favor of a plan that would allow for ... Read More

Artificial hip makers pay less to surgeons after settling lawsuit

A 2007 lawsuit charging manufacturers of artificial hips with providing kickbacks to orthopedic surgeons for using their products, has resulted in fewer payments to surgeons the year following the lawsuit, according to a report released today by the Archives of Internal Medicine. Researchers reviewed data from Biomet Inc., Johnson & Johnson’s DePuy unit, Smith & Nephew Plc, Stryler Corp, and Zimmer Holdings Inc. for the years 2007 and 2008. They found that a total of 939 orthopedic surgeons received $198 million from the medical device companies in 2007. A year later, 568 payments were made worth $119 million, plus $109 ... Read More

Identifying patients with recalled DePuy hip implant imperative

The National Joint Registry for England and Wales reveals that a type of metal-on-metal hip replacement is failing at an alarmingly high rate, making it imperative that all recipients of these faulty devices be identified before their injuries get worse. The British registry of artificial joints was the first to identify the troubling trend with the DePuy Orthopaedics ASR XL hip replacement system. Data from the British registry ultimately led to the worldwide recall of all DePuy ASR XL hip resurfacing and hip replacement devices, a recall that affects approximately 93,000 people around the world. The British registry makes it ... Read More