Heart Ring Slips Through FDA Loophole

Merrill Goozner

First published 5/23/11 on GoozNews

The Chicago Tribune had an important series over the weekend exposing conflicts of interest in the cardiovascular medical device industry, and the loopholes in regulatory oversight that allowed what appears to be a dangerous heart valve replacement part to escape Food and Drug Administration scrutiny. The latter story is by far the more important one. Here’s the details, from the Trib website:

Instead of being grouped with heart valves and implantable pacemakers, annuloplasty rings were put into a class with most catheters, sutures and hearing aids, which allows the medical device industry to gain approval for new rings without clinical studies.

“It’s absolutely ridiculous. How could something that is permanently implanted in the heart be regulated this way?” said Diana Zuckerman, president of the National Research Center for Women & Families, a think tank that has fought for stricter oversight of medical devices. “The first question is: Who petitioned this change and what financial interest did they have?”

The answer, buried in federal records: the Advanced Medical Technology Association, or AdvaMed, which represents medical device companies.

A Tribune investigation found that the FDA rubber-stamped the group’s petition, allowing the invasive devices to make their way into the hearts of thousands of patients with virtually no scrutiny.

Today, annuloplasty rings have had more deaths associated with them during the past five years than any other device in their class, according to a Tribune analysis of FDA data on adverse events. Although there are many flaws in the way the FDA gathers its data and there is no way to tell if the deaths are directly related to the rings’ performance, the analysis raises questions about whether the agency erred in reclassifying the device.

The FDA’s overhaul of its medical device rules is awaiting an Institute of Medicine report on the so-called 510(k) clearance process, which allows some devices deemed comparable to previous devices to enter the market without clinical trials. Since the brouhaha over the Menaflex scandal has quieted down, Jeffrey Shuren, the director of the Center for Devices and Radiological Health, has been under intense pressure from industry to avoid any major changes in the rules. At issue is an FDA proposal to create a new class of products that may be similar to previous products, but since they pose a risk to health if they malfunction, will require clinical testing before marketing. One can only hope the IOM gives a ringing endorsement to this proposal. Their report is due next month.

Hat tip to Gary Schwitzer’s HealthNewsReview for alerting me to the Trib series.

Merrill Goozner is an independent health care journalist. He blogs at Gooz News.

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