Artificial hips that fail, surgical mesh that injures – the New York Times reports (here) on December 14, 2011, that amid the growing number of problems with medical devices a bipartisan bill was introduced in the U.S. Senate that would require device makers follow the life of their products after they’re approved for sale. As it now stands, tracking of implantable medical devices is not required of the manufacturer. The U.S. Food and Drug Administration’s 510(k) clearance process allows products onto the market after an exchange of paperwork and a claim of equivalence to a device already on the market. There is no requirement for human testing.
The Institute of Medicine found this system to be “fatally flawed” this year and suggested it be overthrown (here).
Under The Medical Device Patient Safety Act (here), the agency would still not require any monitoring of clinical studies before a device is approved under 510 (k), which is what critics say is needed, but the FDA would be able to require post-market safety evaluations including data collection, post-market studies and labeling information. The clearance could be rescinded if the manufacturer does not perform the required post-market studies.
As the FDA Law blog points out (here), the bill doesn’t give the FDA the ability to remove defective or unsafe devices from the market based on the outcome of its tracking and trending.
Two Democrats sponsored the bill- Herb Kohl of Wisconsin and Richard Blumenthal (news release here) of Connecticut along with Republican, Charles Grassley of Iowa, the third sponsor. Blumenthal told the NYT that the Johnson & Johnson all-metal hip recall is a prime example of why this level of scrutiny is needed. The DePuy division of Johnson & Johnson recalled the A.S.R. hip implant last April after it was used in about 93,000 patients worldwide.
Medtronic’s Infuse product, Boston Scientific’s Guidant defibrillator, CR Bard’s vaginal and hernia mesh, and Zimmer Holding’s knee replacements have all caused patient injury and recalls. All were cleared under the 510 (k) process as compared to premarket review approval (PMA) process, intended for high risk devices.
How Do You Track Devices?
The three sent letters to five manufacturers of medical devices to determine how they track medical devices now. The five are C. R. Bard, Boston Scientific, Medtronic, Zimmer Holdings, and Johnson & Johnson. There is no mention of surgical mesh specifically in the article but Bard, Boston Scientific and Johnson & Johnson all produce synthetic mesh.
“This reform legislation should be part of the reauthorization of the medical device user fee law next year,” Grassley said in his news release (here). “The reforms incorporate well-founded recommendations from the Government Accountability Office and reflect the value of having a robust post-market surveillance operation in the FDA. Important information can be learned about product safety after a device is on the market, and when there are problems, the sooner the response, the better.”
510 (k) Remarkably Safe
An industry spokeswoman for the Advanced Medical Technology Association told the Times that the 510(k) process works fine and is “remarkably safe.”
The Government Accountability Office in June issued a report, MEDICAL DEVICES – FDA Should Enhance Its Oversight of Recalls to Congress (here).