Were you harmed by a defective medical device?

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In an effort to improve the way medical devices are reviewed in the United States, the Food and Drug Administration (FDA) asked a panel of health experts to recommend ways to improve the review process. Nearly two years later, that panel has recommended the FDA do away with the system completely because it "fails to protect patients."

The recommendation came as a surprise to the FDA, which had used the system, known as the 510(k) system, for more than 30 years. 510(k) was originally created for devices that were already on the market but that had not been formally reviewed. Although this system was originally supposed to be phased out over time, it became the tool by which the FDA approved new devices.

501(k) review is for moderate-risk products like artificial hips, external heart defibrillators, and hospital pumps. This type of review is favored by manufacturers who argue that the quicker they can get the medical devices on the market, the more people will benefit. More high-risk products and first-of-a-kind devices, like implanted heart defibrillators, must undergo much more extensive testing, like prescription drugs do. The cost of this testing is about $800,000 per device.

About 90 percent of all the devices reviewed under 501(k) reach the market, totaling to between 3000 and 4000 new devices each year. Comparatively, under the more stringent form of review, only about 50 devices are approved.

Panel Worries about Dangerous Devices Slipping Through
The panel making the recommendation was composed of members of the Institute of Medicine (IOM), an independent non-profit organization, commissioned by the FDA for guidance. Although the panel's advice is not binding, it did get the attention of not only the FDA, but also the medical device industry and consumer advocates.

In recent years, products like the DePuy hip implant have shown the flaws of the 501(k) review process. In the case of defective artificial hip implants, nearly 100,000 American patients were affected.

Dr. Michael Carome of the patient advocacy group Public Citizen has said before that the devices under 501(k) review clear too quickly, allowing some unsafe devices to come to the market. "FDA's oversight and review process is too weak and needs to be strengthened," he said.

The medical device industry could not disagree more. In their opinion, the devices do not get out fast enough. They argue that the sooner the devices get to patients, the sooner the patients will have relief from their ailments. For these reasons, the trade group for the device industry has dismissed the report, noting that it does not deserve serious consideration from the U.S. government because it does a "disservice to patients and public health."

FDA Stumbles over Next Step
Although the FDA does not have to follow the advice of the panel, it has a long road ahead of it to try to determine how to fix the current system. FDA spokespeople have said that the 501(k) process should not be eliminated, but that the FDA is seeking alternative proposals to fix the current system.

As of now, the FDA is accepting public comments on the report put out by the IOM panel. Consumers and patients who are concerned about the safety of medical devices currently on the market should notify the FDA. Otherwise, you should write your congressperson to tell him or her that you want a more stringent review of medical devices before they reach consumers.

If you or a loved one have been injured by a defective medical device, call Dallas defective product attorney Kay Van Wey today at 800-489-5082.

Don't hesitate to contact Kay Van Wey at (800)489-5082 for a free, no obligation consultation.

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