Despite successes, lack of regulation raises concerns over medical devices

Janice Berger isn’t a big fan of bowling shoes.

“Oh my gosh, who knows whose dirty feet have been in those shoes,” Berger said.

But sporting a pair at Signature Lanes in Elkhart, Berger is just glad to be able to lace them up on her own. It wasn’t long ago the senior from Goshen couldn’t put on her own shoes. Much less bowl.

Chronic pain has kept Berger from bowling for the last seven years.

“I couldn’t bowl, I couldn't ride my bike,” Berger said. “I couldn’t enjoy my grandchildren. So it is frustrating when you are so tired of pain there is absolutely no joy in your life.”

She has diabetic neuropathy; nerve damage in her feet caused by diabetes. It affects 28% of all diabetic patients according to the National Library of Medicine.

Berger was at the point she was willing to do anything to stop the pain.

“I just thought, I'm going to start with a podiatrist and work my way up to God if that’s what it takes,” Berger said.

You couldn’t see it even while Berger grabbed a bowling ball, rolled it down the lane, or watched her first gutter ball in years; but sitting in the base of her spine is a Nevro HFX. A spinal cord stimulator stopping the pain. She had it implanted in November, 2021 after trying medications, therapy, and other methods that never worked.

“Last time I talked to her, she told me she had 100% relief. She was smiling the whole time. She was extremely happy,” said interventional pain specialist Dr. Jerry Grewal.

Dr. Grewal implanted Berger’s Nevro HFX, which is the first time it’s been used for diabetic neuropathy.

“Hopefully patients will improve, their quality of life will get better, their pain will decrease, and they can be less reliant on medications,” Dr. Grewal said. “And hopefully they don't have to be on opiates long term.”

Jeanne Lenzer, author of The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It, worries some patients don’t consider that medical devices have their own side effects which can be serious.

She's spent years studying the medical device industry.

“It's a wild west out there,” Lenzer said. “Devices are the wild west.”

About one in ten Americans will have a medical device implanted in their lifetime. But less than half a percent of these devices have been tested in rigorous clinical trials, according to the American Medical Association Journal of Ethics.

There are at least 500 FDA consumer complaints over the last five years following a Nevro Senza device implant. Reported issues include infections, sepsis, shocking sensations, and numbness.

In these cases, no issues were found with the device. But it’s the manufacturer itself investigating whether the device is at fault.

“We've [implanted], between the trials and everything else, almost 100,000 of these devices. And we very carefully track any reports of adverse events. We're required to,” Nevro chief medical officer Dr. David Caraway said.

Dr. Caraway points to an 18-month trial showing Nevro’s spinal cord stimulators leading to pain relief for nearly three quarters of patients.

“We're really focused on evidence building and providing the safest and most effective therapies that are out there,” Dr. Caraway said.

And the Nevro HFX went through the FDA’s more stringent pre-market approval process.

But 82% of devices go through 510(k) approval, which requires no clinical data. According to a study published in the Journal of the American Medical Association, 510(K)-approved devices make up 97% of medical device recalls.

“A lot of people think that the FDA actually tests things. They don't do any testing at all,” Lenzer said. “What they do is they ask the manufacturer to provide their information. And that's what they go on.”

Patients considering a medical device can look up reported issues on the FDA database. Lenzer recommends researching complaints, considering possible side effects, and weighing them against the intended benefit. Patients should also ask their medical provider how often they’ve implanted the device.

So far, Berger hasn’t had any issues.

“It’s a dream come true,” Berger said.

And even if it's not helping her score on the lanes, she is just glad to be back in the game.