Kansas City, Missouri

HomeMissouriKansas City

Email Mark Emison
Mark Emison
Mark Emison
Attorney • (800) 397-4910

Lax Medical Device Regulations Pose Threat to Public Health


After an exhaustive study of the safety and efficacy of artificial hip implants, The New York Times has published an article that examines the risks of metal hips and other medical devices that go untested and largely unregulated.

Thousands of Americans have filed lawsuits against manufacturers of hip implants for failing to warn doctors and patients about their dangers. According to The New York Times, the medical device industry is ripe with loopholes that allow hip implants and other medical devices to be rushed to market, bypassing critical testing that would protect consumers.     Injured Hip (iStockPhoto)

“Many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs.  In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.”  – New York Times, 1/13/18

An abbreviated approval process known as 510(k) 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, even for the highest risk devices.

A 2011 editorial published by The New England Journal of Medicine noted that the DePuy ASR hip implant is a Class III medical device—the highest risk classification—and approval through the 510(k) process is especially inappropriate for devices that pose the highest potential risk to patients.

According to The New York Times, about 32 million Americans—or about one in 10—have at least one medical device implanted. Many patients and their physicians are not fully aware of the health risks these products pose.

The article, authored by Jeanne Lenzer, attributes loose oversight of medical devices to the increase in device recalls over the years. Medical interventions are the third leading cause of death in the U.S., and devices, she says, plays an increasing role in that statistic.

Read More:

Leave a Comment

Have an opinion? Please leave a comment using the box below.

For information on acceptable commenting practices, please visit Lifehacker's guide to weblog comments. Comments containing spam or profanity will be filtered or deleted.