Are Medical Device Industry Dollars Funding Lax Oversight?

No one is unaware of the influence wielded by lobbyists during the sausage-making mess that is our federal legislative process. For these lobbyists, and especially medical industry lobbyists, what they can keep out of laws is just as important to them as what goes into the laws. And that spells Trouble with a capital T for patient safety.

Manufacturers of medical devices, like their Big Pharma brethren, boast a robust army against efforts to empower the FDA with greater oversight of their wares.

According to Public Citizen, the manufacture of high-risk devices such as heart and brain stents, artificial joints and implantable defibrillators is a $350 billion industry that, since 2006, has spent nearly $20 million in campaign contributions. The industry has spent $33.3 million overall to lobby the people who are considering at least 14 bills to hasten the introduction of their products to the consumer market, many by weakening the review process intended to protect patient safety.

Public Citizen reports that the average number of high-risk product recalls in 2011 was more than twice as many as recent years. The organization says that more than 200,000 injuries and malfunctions, and 2,000 deaths attributed to medical devices are reported annually to the FDA.

Medical device safety weighs heavily in this practice, and we vigilantly follow its checkered progress.

Some medical devices deemed high-risk reach the consumer market with virtually no testing required, thanks to an FDA process known as 510(k) fast-track approval. If a device is described as “substantially equivalent” to one already on the market, it qualifies for fast-track approval. The problem, of course, is how “substantially equivalent” is defined.

A recently story in the Minneapolis Star Tribune perfectly captured both the poignancy and difficulty of imposing responsibility on manufacturers reluctant to exercise what seems to many people is basic human decency.

Steven Baker testified last month as part of the Consumer Union Safe Patient Project. He lives with excruciating elbow pain from the FDA-approved medical device that he says never worked right.

Jim Shull testified about the constant pain from permanent nerve damage and the loss of his livelihood thanks to a malfunctioning 501(k)-approved surgical mesh that was implanted during his hernia operation. The FDA had issued a public health warning for a similar product, synthetic trans-vaginal meshes, which we reported last year, but there was no such notification for hernia meshes.

According to the Star Tribune, “[R]ules to create an identification system for medical devices to help recall unsafe products remains stalled, several months after they should have been published. The medical device industry has called the ID system burdensome.”

Medical device manufacturers claim that inefficient approval procedures unnecessarily delay the introduction of products that could cure or relieve medical problems. Still, as the newspaper reported, most of the testimony before the congressional committee was about getting medical devices to market faster. “There was little talk about protecting patients.”

If you find that unacceptable, if you have a story to tell about the harm caused by a device that wasn’t sufficiently reviewed, visit the Safe Patient Project’s website where you can make your experience and feelings known to authorities. It also keeps you apprised of the progress of oversight legislation, including committee testimony.

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