The Wall Street Journal published an article recently regarding the conversation going on between the FDA and Congress over the review of medical devices.
Some Republicans in Congress criticize the FDA and say that the long review process delays products coming to market which causes the device manufacturers to move Europe, taking jobs with them.
Dr. Jeffrey Shuren, director of the FDA’s medical device devision, said that if the process is speeded up then more patients will get hurt.
One physician, Cardiologist Steven Nissen, who testified at the Congressional hearing, said that most of the medical devices that seriously injured patients in the past few years were cleared using the 510(k) program, a “fast track” through the FDA which does not rely on clinical trials which are costly to the manufacturer.
This is certainly true of DePuy Orthopaedic, Inc., ASR XL Acetabular and Hip Resurfacing Systems which were recalled on August 24, 2010. The ASR hip implants have shown to have a 1 in 8 patient failure rate requiring revision or second surgeries in patients. There are also studies that show that the device may cause metallosis or cobalt/chromium poisoning which has a potential for serious side effects including cancer, heart disease, tissue necrosis and brain disease.
The Wall Street Journal FDA Criticized Over Device Approvals
By Alicia Mundy February 17, 2011
This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are Bellevue personal injury law firm with more than 30 years experience representing people in their product liability lawsuits. We welcome inquiries from people who have a DePuy hip implant and we provide a FREE and confidential case evaluation. Call us TOLL FREE at 1-800-244-9087 or use our CONTACT FORM.
DePuy hip implant recall shows the need for National Joint Registry in the U.S.
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