Washington, DCProposed legislation for a new patient safety bill couldn't come too soon for about 93,000 people (according to DePuy) who have received a DePuy Hip implant. The company recalled its defective ASR XL Acetabular hip replacement in August 2010, after acknowledging higher-than-average early failure rate.
This proposed safety bill, which was filed on December 14, 2011, by Senators Charles Grassley (R-Iowa), Richard Blumenthal (D-Connecticut) and Herb Kohl (D-Wisconsin), means that medical device makers such as DePuy Orthopaedics and Johnson & Johnson will be more accountable—they will be required to keep all recipients' records in a national database or implant registry.
The above senators sent letters to a number of medical device manufacturers, including DePuy (a subsidiary of Johnson & Johnson), requesting documents regarding how the companies currently track medical device and implant safety. Once legislation is passed, the manufacturers must keep records and track every medical device (e.g., pacemakers, hip and knee replacements, transvaginal mesh slings and more) that are implanted in recipients, thereby ensuring that performance and long-term safety concerns can be tracked.
Many countries have maintained such databases for decades, including Australia and New Zealand—where the DePuy metal-on-metal implant failure was first recognized. (In March 2010, DePuy sent a letter to US doctors saying recently analyzed data from Australia indicated a higher-than-expected failure rate than traditional hip replacement on certain types of patients.) Sweden established the first national database to track long-term performance of medical devices in patients back in 1976.
One reason why more than 4,000 lawsuits have been filed against DePuy is because the US lacks a national database. If a national registry were mandatory before the metal-on-metal hip implants were approved by the FDA, it is likely that countless patients who received DePuy ASR MoM implants would not require replacement surgery. Nor would there be so many patients diagnosed with metallosis, which is heavy metal blood poisoning and a very serious condition.
Under this new bill, the FDA will have the power to order companies to conduct safety studies on their devices after they have been approved. The 510(k) system currently in place allows medical device companies such as DePuy to market a hip replacement, for example, simply by showing it is similar to other devices already on the market.
Medical device manufacturers are likely not happy with this proposed legislation, believing that the 510(k) process is safe enough and does not require additional safeguards such as an implant registry. However, if the number of product liability lawsuits against DePuy is anything to go by, this current safeguard is not safe enough.
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