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Congress To Require Companies To Track Artificial Hips, Knees, Other Implants

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DePuy Hip RecallMuch has been learned about the medical device industry since problems surfaced regarding DePuy Hip implants and Zimmer knee implants. DePuy – a division of Johnson & Johnson – has recalled its ASR XL Acetabular and ASR Hip Resurfacing Systems and independent testing agencies have identified growing problems in other metal-on-metal artificial hips. Zimmer has also experienced problems in a number of its high flex artificial knees.

It turns out that these – and many other critical medical implants – were approved without any human testing under a controversial FDA provision known as the 510(k) approval process. The 510(k) approval process rests on the notion that if one device has been cleared by the FDA, then similar devices need little or no testing on actual patients. If a new medical device is "substantially equivalent" to an already-marketed device, then clinical testing is not required.

The New England Journal of Medicine found that the 510(k) process was "unfixable" and recommended that the FDA immediately stop using the 510(k) program for Class III medical devices.

Moreover, even though thousands of DePuy hips have either failed or have been recalled, DePuy failed to keep accurate records and did not maintain a list of patients who received its defective ASR artificial hip. DePuy was therefore unable to warn its customers directly about the recall and hip defects.

Not only were the artificial knees not tested in humans before the devices were put on the market, but DePuy paid doctors more than $80 million to promote and use its artificial hips — including defective artificial hips that were eventually recalled.

Against this backdrop, bipartisan legislation was introduced in the US Senate that would force medical device manufacturers to track the performance of implants after they were approved for sale.

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.

Source: NY Times

Sen. Richard Blumenthal (D-Conn.) called metal-on-metal hips a "classic example" of why this type of monitoring is needed.

Following the bill's introduction, three senators – two Democrats and a Republican – sent letters to five major medical device manufacturers – Johnson & Johnson, Zimmer Holdings, Medtronic, Boston Scientific, and C.R. Bard – asking for documents showing how these corporations track product safety and recall defective medical implants.

The medical device industry is pushing back and calling for less regulation rather than increased scrutiny. Some members of Congress have introduced a number of industry-backed bills to further "streamline" FDA rules to get new products to the market even faster.

[More on the DePuy Hip Recall]

[More on Zimmer Knee Problems]

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(c) Copyright 2011 Brett A. Emison

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2 Comments

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  1. mike says:
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    saw this debate a little while ago… http://www.mcminncentre.co.uk/research-lectures-debate.html talking about the differnce between the manufacture of artificial hips – hip resurfacing to be precise. It’s amazing that similar products can get through FDA approval on a 510(k) and be so fundamentally different… the mind boggles! This whole metal-metal fiasco could have been avoided if this advice was heeded back in 2005!!

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    The #1 expenditure of Medicare is joint replacements. Failed medical device “innovations” place patients and their families in medical and legal purgatory. An independent, transparent registry (similar to Consumer Reports for automobiles) would provide patients/clinicians with real-time information about safety/effectiveness. Legislation at the federal level must change the charter of the FDA to allow Patient Representatives to vote as stakeholders in medical device panels. Medical device companies must define the life of the product and warranty a portion. Congress can act to rescind the medical device industry entitlement given in 2/2009 by the Supreme Court “Riegel v Medtronic” with preemption from state court.