FDA Releases 20 Years of “Hidden” Data Related to Medical Device Injuries and Deaths 

Serious medical complications and lifelong injuries, and even death, can result from a risky or wrong medical device. But a March 8, 2019 Kaiser Health News investigative report has led to the recent Food and Drug Administration (FDA) release of two decades worth of previously hidden data containing millions of malfunctions by medical devices and allowed some manufacturers to keep potential safety issues quiet.

Some of the FDA’s public reporting of adverse device outcomes were previously filed as an “alternative summary,” and included more than 5.7 million incidents hidden from the American people. This is risk information that could have been (and now will be) helpful for device prescribing doctors, medical researchers and life-saving knowledge for consumers and patients.

KHN’s Most Shocking Revelations Found Through Hidden Reports

  1. Blood Glucose Meters: Nearly all blood glucose meter products made by LifeScan (previously a Johnson & Johnson company before 2018) for patients with diabetes had more unique incidents than any other device in the database, logging 2.4 million reports over the past 20 years.
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  3. Dental Implants: There were 2.1 million reports for commonly used dental implants, used to connect bone to an artificial tooth or implant. In 2018, 114,200 were noted.
  4. Fatal Devices: KHN reviewed most fatalities were associated with two kinds of pacemakers, an insulin pump, a breast implant, an intra-aortic balloon pump, and a ventilator.
  5. Surgical Staplers: Surgical stapler-related malfunctions accounted for more than 66,000 previously hidden incidents since 2001. The most common problems were staplers that failed to fire or fired malformed staples. Nearly 4,700 stapler problems were reported through the hidden database in 2017 alone. Our attorneys covered this issue in an April 3, 2019 blog post.
  6. Breast Implants: Nearly half a million reports included breast implant injuries and malfunctions, implants that leaked, deflated, or migrated, with the most common being rupture. More than 6,600 of these incidents have been reported so far in 2019 by manufacturers Allergan, Mentor, and Sientra.

The once poorly filed MDR (medical-device reporting) data is now available for public review on the federal database, Manufacturer and User Facility Device Experience, or MAUDE.

Thousands of injured consumers will likely require help in pursuing legal support after this news has emerged. Successful litigation requires detailed medical explanations and an understanding of product liability law but also evidence. This transparency in reporting may provide the information necessary to prove a device faulty but hiring a personal injury attorney will still be critical in securing fair compensation.

Understanding Your Rights as an Injured Consumer

Risky or faulted medical devices can cause significant physical injuries and mental health complications to patients. If you or a loved one has suffered because of a medical device, contact Levin & Perconti for a free consultation.

Call us at 877-374-1417 or 312-332-2872 to speak with a lawyer. You may also contact us online to set up a case evaluation consultation. We work on a contingent fee basis, so there are no fees for our services unless we successfully resolve your case.

Also read: FDA Says Surgical Mesh Manufacturers Must Stop Selling Unsafe Devices