Faulty Medical Devices Part I: Thousands of Deaths Yearly

January 29th, 2019
FDA approval stamp

According to the United States Food and Drug Administration (FDA), a new report indicates that faulty medical devices have led to 1.7 million injuries, and more than 83,000 deaths throughout the world within the last decade. Details on the report and its findings are available here.

Devices in Question

Advances in medical-device technology hold tremendous promise for patients who may benefit from surgical implants and other devices. Unfortunately, the added complexity of such technologies can significantly complicate the FDA review process, which leads to ongoing concerns regarding a device’s safety and effectiveness.

Every year, thousands of patients across the U.S. lodge complaints regarding potentially faulty, defective, or malfunctioning medical devices. These include artificial hip implants, surgical knee replacements, mesh implants, spinal cord stimulators, and Intrauterine Devices (IUDs).

One Painful Example

Spinal cord stimulators—according to the International Consortium of Investigative Journalists (ICIJ)—have a particularly poor safety record. These devices are marketed as a safe alternative to opioid pain medication, with nearly 60,000 implanted annually. Sadly, the FDA has recorded 80,000 injuries and 500 deaths involving spinal cord stimulators since 2008.

Problems with the Process

After a year-long investigation, the ICIJ and its partners have discovered many faulty medical devices have received FDA approval with little clinical testing—and few devices are pulled from the market once they prove defective. This presents a serious risk to public confidence and patient safety.

FDA sources indicate approximately 20% of medical devices are based on technology over 10 years old—and the agency may publish a list of such devices in an attempt to encourage technological advancement. In the face of growing complaints, the agency intends to update the now-40-year-old process to review medical devices.

Next Time

In our next installment on this topic, we will examine the FDA’s evolving position—as well as the changes they intend to bring to the review process. In the meantime, the ICIJ has published a searchable database that includes more than 70,000 notices, alerts, and recalls, allowing patients to view the safety record of a particular device.

Graves McLain is Here to Help

If you or a loved one has been injured by a Dangerous Drug or Defective Medical Device, call Graves McLain right away at 918-359-6600 or fill out a free consultation form online. When you call one of our experienced Tulsa, Oklahoma Product Liability Attorneys, we will speak with you for FREE and determine the best course of action.

We review every detail of your situation at no cost to you—and fight hard to protect your rights. Trust our team, we are here to help. At Graves McLain, you will never pay an attorney’s fee up front—and you owe us nothing until we win your case. At Graves McLain, we don’t get paid until you do.

Graves McLain, Serious Lawyers for Serious Injuries