Senate Introduces Implant-Monitoring Bill

Senator Kohl
Senator Kohl (D-Wisc.) sponsored the implant-monitoring bill with two other senators.

Hip replacements are supposed to relieve pain, improve mobility, and last about 15 years. However, pain is rampant as all-metal hip implants are failing widely within a couple of years. As lawsuits pile up, researchers are trying to compare implants made from various kinds of materials, but incomplete tracking and performance records make it difficult.

Now, three senators have introduced bipartisan legislation that would force implant manufacturers to keep tabs on the implants after approval for sale. Barry Meier reports for The New York Times:

The bill would allow the Food and Drug Administration to compel companies to track implants, such as replacement hips, that belong to a category of products that do not require human testing for approval.

The proposal is an effort to address longstanding complaints by patient advocates and others like the Institute of Medicine about a system known as the 510(k) process that the F.D.A. uses to clear the sale of certain implants like artificial joints. To sell a new product under that system, a producer need only show that it is ‘substantially similar’ to a product already on the market.

Democrats Herb Kohl of Wisconsin, Richard Blumenthal of Connecticut, and Republican Charles E. Grassley of Iowa sponsored the bill. They also sent letters to five manufacturers of medical devices asking for documentation about how the companies track product safety and handle device recalls. The companies were Johnson & Johnson (J&J), an artificial joint maker; Zimmer Holdings, another producer of artificial joints; Medtronic, a heart and spinal implant producer; Boston Scientific, a heart device maker; and C. R. Bard, a surgical implant maker.

Meier writes that Congressional investigators are particularly interested in learning when J&J was warned that ASR, one of its all-metal hip replacements, was failing “and how it tracked those problems.” J&J recalled its implant last year, after it had been implanted in 93,000 patients around the world.

Legislators from across the globe are also questioning the companies. Meier writes:

Last month, a legislative panel in Australia issued a report that concluded that Johnson & Johnson was probably aware of serious problems with the A.S.R well before recalling it. The panel also characterized the company’s responses to its questions as ‘decidedly opaque.’

The bill’s fate likely won’t be decided until next year, and it may become a bargaining chip in Congress’s debate over FDA regulation. The bill joins several other bills that were recently introduced and are backed by the medical industry to usher new products to market more quickly.

Source: “Bill Would Require More Monitoring of Implants,” The New York Times, 12/14/11
Image by @jbtaylor (John Taylor), used under its Creative Commons license.

Rachel Petkewich is a freelance science writer and editor. She has worked as a research scientist in the chemical industry and spent eight years as a staff writer and editor at various science journals and magazines, including Chemical & Engineering News.

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