Following pushback from medical device manufacturers over a move to revamp the existing medical device approval process, the U.S. Food and Drug Administration (FDA) has stepped back and is requesting more comments from the industry.
A government-commissioned report was unveiled last week that reviewed the regulation of medical devices and recommended that the existing FDA approval process be scrapped and a new screening process be established in its place. Also, the panel recommended developing a new way to track the performance of implanted devices.
According to a story this week in the Star-Tribune, the FDA held a town-hall meeting in St. Paul to discuss the implications of wide-sweeping changes to their process and to request feedback. Minnesota is home to Medtronic, Inc., the world’s largest med-tech company, which organized and hosted the meeting.
Dr. Jeffrey Shuren, head of the FDA’s device division, opened the session by stating, “If there are any recommendations that make sense, we’ll [the FDA] consider them,” Shuren said.
While the medical device industry has already voiced criticism of many of the recommendations, hip replacement patients, their doctors and their lawyers question how certain devices won approval in the first place. Artificial metal-on-metal hip replacements made by DePuy Orthopedics, Inc., passed FDA approval but then failed in many patients. The failure rate was so high that in 2010 DePuy warned doctors to stop using the devices and issued a recall.
Some patients with the replacement parts experienced pain, swelling around the hips, difficulty walking and a sensation that their hip was dislocated. These patients are now at greater risk of health complications. Many of these patients will need another surgery to have the artificial joint removed and replaced with another.
We reiterate that patient safety should come before profit in the regulation of medical devices. We support the methodical process the FDA is taking to review its own procedures.
If you suspect that you or a loved one has been harmed by a medical device, including a metal-on-metal joint replacement, turn to a South Florida medical products attorney with more than 36 years of experience evaluating cases of medical malpractice and defective medical devices.
I am attorney Philip DeBerard, and I protect the rights of medical malpractice victims by getting the insurance companies to pay what is fair. We represent victims of defective medical devices and medical malpractice in Stuart, Port St. Lucie, Okeechobee, Fort Pierce, Jupiter, Palm Beach and Vero Beach.
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