subject: Loose Regulation Put Zimmer NexGen Patients At Risk [print this page] Loose Regulation Put Zimmer NexGen Patients At Risk
Zimmer, one of the world's largest manufacturers of medical devices, introduced its NexGen knee replacement system in 1994, and the long line of models has largely been successful. However, the Zimmer NexGen CR-Flex in particular has been the subject of some scrutiny of late. There has recently been a rash of reports of loosening, pain, and patients requiring revision surgery on their NexGen CR-Flex knee replacement systems. The model that is causing problems is a cementless model, meaning that it attaches to the thigh bone through natural bone ingrowth rather than with an adhesive.
While a defective medical device's manufacturer must be held accountable for such defects, there are problems with the U.S. Food and Drug Administration's (FDA) approval and oversight systems. The Section 510(k) approval process, by which the NexGen CR-Flex was approved for sale to the public, allows medical devices that are "substantially similar" to an already-approved device to pass through the FDA's offices and gain approval with no pre-market testing.
The FDA's rationale for such a lax approval process is that it encourages companies to innovate and bring new products to market without unnecessarily restrictive overregulation. While this reasoning has some merit, there are other flaws with the FDA's regulation of the medical device industry that cannot be excused. The United States Government Accountability Office released a report in 2009 finding that the FDA's post-market surveillance is inadequate and the department has not regularly made the appropriate inspections of medical device manufacturing facilities. Surely, if the FDA is going to loosely regulate pre-market approval of certain medical devices through the Section 510(k) process, then it must actively oversee those devices once brought to market.
The aforementioned Zimmer NexGen CR-Flex was approved through this very process. Dr. Richard Berger, who worked as a consultant with Zimmer for roughly a decade, believes the product should not be used in patients who require knee replacement surgery. In fact, he has spearheaded much of the research into the alleged defectiveness of the product. The study he conducted with his colleagues at the Rush University Medical Center in Chicago found that the product was failing at rates well above established industry standards. As a long time consultant to Zimmer and an experienced knee replacement surgeon, Dr. Berger has a level of understanding of the NexGen CR-Flex that few others do.
If you have experienced a failure in your Zimmer NexGen CR-Flex knee replacement system, you might be able to file a claim. To determine whether or not you should bring a Zimmer lawsuit, contact the Rottenstein Law Group. RLG has the know-how and experience necessary to effectively take on an industry giant like Zimmer.
