Spinal-cord stimulators rank 3rd in injury reports to FDA over past decade

Spinal-cord stimulators accounted for the third-highest number of medical device injury reports to the Food and Drug Administration since 2008, an Associated Press investigation found.

The AP investigated the global medical devices industry for nearly a year in partnership with NBC, the International Consortium of Investigative Journalists and more than 50 other media organizations around the world. They analyzed millions of medical records, recall notices and product safety warnings and conducted multiple interviews.

Here's what you should know:

1. The FDA tracks 4,000 types of medical devices, and only metal hip replacements and insulin pumps had more injury reports than spinal-cord stimulators. The number of spinal-cord stimulator reports are "disproportionately higher" compared to hip implants, which are more common, according to the investigation.

2. The stimulators use electrical currents to block pain signals before they reach the brain. Each year, about 60,000 are implanted — meaning an estimated 600,000 have been implanted since 2008.

3. More than 80,000 incidents reported to the FDA in the past decade involved spinal-cord stimulators (comprising about 13 percent of all spinal-cord stimulator implants). The agency received more than 500 reports of death in people who had spinal-cord stimulators, but it's difficult to determine whether the deaths were linked to the stimulator or implant surgery due to data limitations.

4. Medical device companies have "invested countless resources – both capital and human – in developing leading-edge compliance programs," Janet Trunzo, head of technology and regulatory affairs for AdvaMed, told the AP. AdvaMed is the medical device industry's main trade organization.

5. Patients reported spinal-cord nerve damage ranging from muscle weakness to paraplegia, as well as being shocked or burned. However, physicians say the stimulators have still helped reduce pain for many patients.

6. Out of all the medical devices included in the FDA's data, six accounted for 25 percent of device injury reports since 2008:

  • Hip prosthesis: 103,104
  • Insulin pump with sensor: 94,826
  • Spinal stimulator: 78,172
  • Surgical mesh: 60,795
  • Insulin pump implanted: 60,561
  • Defibrillator: 59,457

Read the full report here.

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