Senators Introduce Bill to Track Medical Devices Cleared Through FDA’s 510(k) Process

A bipartisan bill just introduced in the U.S. Senate would require the makers of some implantable medical devices to track their performance after they are approved for sale. The bill, sponsored by two Democrats, Herb Kohl of Wisconsin and Richard Blumenthal of Connecticut, and a Republican, Charles E. Grassley of Iowa, was introduced in response to the growing number of complaints linked to a class of medical devices that do not need to undergo human testing before they are brought to market.

According to a report from The New York Times, the bill targets devices, such as metal-on-metal hip implants, that are subjected to the U.S. Food & Drug Administration’s 510(k) clearance protocols. 510(k) approvals are permitted for medical devices that can be proven to be “substantially” equivalent to products already on the market, and don’t require human clinical trials. As we’ve reported previously, the 510(k) program is a frequent target of critics, who say it is too lax. Earlier this summer, the Institute of Medicine issued a report highlighting deficiencies with 510(k) clearances and recommended that the FDA scrap the program entirely.

Over the past year or so, several types of medical implants approved via 510(k) protocols have been the subject of complaints, safety reviews and lawsuits. Chief among these are metal-on-metal hip implants, including the now-recalled ASR hip implant manufactured by DePuy Orthopaedics. Just last month, an FDA sponsored study found that metal hip implants offer no advantages over older types hip implants, and may actually increase the likelihood that recipients will suffer premature failure or other side effects. In May, the FDA directed 21 makers of all-metal hip implants, including DePuy, Zimmer, Stryker, Biomet and Wright Medical, to conduct post-market studies of their devices to determine if they were shedding dangerous amounts of metallic debris in patients.

Concerns about the quality of 510(k) approvals have also been raised by the growing number of serious complications linked to transvaginal mesh devices used in pelvic organ prolapse (POP) repair. A multi-year review by the FDA has linked the transvaginal placement of surgical mesh in POP repair to hundreds of reports of serious problems, including mesh erosion, infection, pain, dyspareunia, vaginal scarring, urinary retention or urinary incontinence. Currently such devices are cleared via 510(k) protocols. However, in September an FDA panel of outside medical advisors backed a proposal that would place the devices in a higher risk category, thus making them ineligible for the 510(k) process.

The bill introduced by Senators Kohl, Blumenthal and Grassley would give the FDA the power to force makers of devices cleared via the 510(k) process to track their performance after they are brought to market. The bill would also tighten federal scrutiny of product recalls. In an interview with The New York Times, Senator Blumenthal cited problems with metal-on-metal hip implants as an example of why the proposed law is necessary.

“There is clearly a need for scrutiny once products are implanted or used on patients,” he said.

According to the Times, the bill does face an uphill battle in Congress. In fact, several other bills recently introduced would actually allow new medical products to come to market sooner, with less scrutiny. But it may serve as a negotiating chip in a Congressional debate next year over FDA device regulation, the Times said.

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