New Reports Cite Dangers In Speedy FDA Medical Device Approval Process

Feb 5, 2019 | Product Liability

When you’re hungry for a burger and in a hurry, “fast and cheap” might be an acceptable option. But if you’re facing the prospect of a medical device being surgically implanted in your body, such as a joint replacement, pelvic mesh, or pacemaker, you want something that’s been rigorously tested and proven to be safe and effective.

Is the FDA Medical Device Approval Process Safe?

We’ve written before about how theFood and Drug Administration (FDA) medical device approval process for new medical devices may be more flawed than most consumers realize. Recent reports about the inadequacies of the FDA fast-track process for approving such devices have raised fresh concerns about whether the shortcuts that have been adopted are jeopardizing patient safety.

A blockbuster investigation by a nonprofit news organization, the International Consortium of Investigative Journalists, found a disturbing rate of failure among a wide array of medical devices across the globe, including close to 83,000 deaths and more than 1.7 million injuries in the United States linked to such devices since 2008. The report makes the case that inadequate review and spotty enforcement of regulations in numerous countries, including the US, has led to patients becoming unwitting guinea pigs for new technology.

How did we get here?

A complementary report published by the Associated Press a few weeks ago traces how the FDA, under intense pressure from lawmakers and lobbyists for the $400 billion medical device industry, came to “streamline” the approval process over the past several years so that new products could reach the marketplace faster — in part by minimizing clinical trial testing.

The result? New device approvals have more than tripled, while warning letters to device makers about safety and quality issues have fallen 80 percent. Yet the streamlined products have generated what the report describes as “tens of thousands of injury and death reports.”

In response to criticisms from public health advocacy groups, FDA officials have vowed to sharpen its approval process and improve the ways that problems with devices are detected and reported back to the agency. But while the FDA posted recall notices on 2000 medical devices last year, the AP reports that the agency has banned only two products in the last forty years — powdered surgical gloves (which cause allergic reactions in some patients) and fake hair implants.

That track record raises other questions. The FDA’s current system for detecting defects and critical failures in medical devices relies heavily on reports from the manufacturers themselves. In many instances, the push for a recall or more stringent standards comes only after enough patients have pursued lawsuits, seeking compensation for their injuries, that the problem can no longer be ignored. A few more steps toward prevention could prove to be a lot less costly than the cure.


If you or a loved one have suffered injuries as a result of a dangerous prescription drug or a failed medical device, you may be entitled to compensation. The product liability attorneys at Franklin D. Azar & Associates have helped thousands of people who have been harmed by defective pharmaceuticals and medical devices. We are currently investigating several products associated with recalls, adverse events, and dangerous side effects, including Depuy Attune Knee Replacements, St. Jude Defibrillators, Xarelto, and Eliquis. Call us or contact us here for a free, no-obligation consultation.