Big pharma and how they operate
Zimmer-Biomet shoulder recall & More
The lawyers at TheLawFirm.com have long complained that the 510(k) process allows Big Pharma to use the American people as guinea pigs. This process basically allows a company to short circuit the regular FDA requirements if it can convince the FDA that a new medical device is ‘substantially equivalent’ to a previously approved device.
Using the Zimmer-Biomet Comprehensive Reverse Shoulder as an example, we can see how Big Pharma games the system. This device was approved by the FDA as substantially equivalent to five other shoulder devices. One of those was made by Biomet, but the other four were made by Zimmer (which was a separate company then), Exacttech and Encore Medical. Biomet told the FDA in the July 8, 2008 letter that the Comprehensive Shoulder has “similar technologies” as the predicate devices. No clinical testing was done as a basis for substantial equivalence. That letter can be found here.
Once Biomet was approved, they began to market this reverse shoulder device. The page for this device is here.
Notice that the device is described as having “unmatched intraoperative flexibility and clinically proven technologies”.
Really? How is ‘unmatched technology’ the same as ‘substantially equivalent’? To the FDA, the reverse shoulder should be approved because it ‘substantially equivalent’ to other products. But when marketing to doctors and the public, the device is unmatched and clinically proven (remember that NO clinical testing was done as part of the 510(k) application process).
Do you see the problem? This is how Big Pharma continues to get away with pushing defective devices on Americans year after year. Why would they really spend the money just to make a product that everyone else has? No. They do something different, lie to the FDA, fail to do clinical testing and then, years later the device has to be recalled.
If you have been injured by a defective medical device, call The LawFirm.com for a free consultation.
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