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As better tracking finally becomes available for medical devices, patients are experiencing a number of problems related to a range of devices.

Spinal-cord stimulators

For years, medical device companies and doctors have touted spinal-cord stimulators as a panacea for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry.

Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S., and as a treatment for an aging population in need of chronic pain relief.

But the stimulators — devices that use electrical currents to block pain signals before they reach the brain — are more dangerous than many patients know, an Associated Press investigation found. They account for the third-highest number of medical device injury reports to the FDA, with more than 80,000 incidents flagged since 2008.

Patients report that they have been shocked or burned, or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows.

Breast implants

To all the world, it looked like breast implants were safe. From 2008 to 2015, the FDA publicly reported 200 or so complaints annually — a tiny fraction of the hundreds of thousands of implant surgeries performed each year.

Then last fall, something strange happened: Thousands of problems with breast implants flooded the FDA’s system. More than 4,000 injury reports were filed in the last half of 2017. Another 8,000 in the first six months of 2018.

Why had it taken so long for complaints to see the light of day?

Makers of breast implants were required to track patients and their health. But for more than a decade, manufacturers with high numbers of recurring problems — in the case of implants, ruptures that required surgery to remove — were allowed to report issues in bulk, with one report standing in for thousands of individual cases, and no way for the public to discern the true volume of incidents.

That agreement stood even as the FDA began closely monitoring a rare type of cancer, and acknowledged in 2011 that it might be linked to breast implants.

Insulin pumps

When it comes to medical devices, none have had more reported problems over the last decade than insulin pumps, a product that’s used by hundreds of thousands of diabetics around the world, many of them children.

Collectively, insulin pumps and their components are responsible for the highest overall number of malfunction, injury and death reports in the FDA’s medical device database, according to an Associated Press analysis of reports since 2008.

In terms of injuries alone, insulin pumps were second only to metal hip replacements, whose problems with metal shavings in the body causing damage to bone and tissue and other issues, have been well-documented and widely reported.

By contrast, problems with insulin pumps largely have flown under the radar.

Medical device companies and many experts say insulin pumps are safe devices that can help diabetics lead more normal lives. They blame user error for most reported problems, noting that the pumps are complicated devices requiring special training for patients.

For more stories on these issues and others related to implanted medical devices, see the following links on the Beacon’s

website:

Breast implants reveal problems in tracking device safety

At FDA, a new goal, then a push for speedy device reviews

Insulin pumps have most reported problems in FDA database

Spinal-cord stimulators help some patients, injure others

— AP