Despite successes, lack of regulation raises concerns about medical devices

Despite successes, lack of regulation raises concerns about medical devices

Janice Berger is not a big fan of bowling shoes.

“Oh my God, who knows who’s got dirty feet in those shoes,” Berger said.

But sporting a pair at Signature Lanes in Elkhart, Berger is just happy to be able to lace them up on her own. Not so long ago, Goshen’s eldest couldn’t put on her own shoes. Much less bowl.

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

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

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

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

“I just thought I’ll 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 when Berger grabbed a bowling ball, rolled it down the lane, or watched his first gutter ball in years; but sitting at the base of its spine is a Nevro HFX. A spinal cord stimulator stopping the pain. She had it implanted in November 2021 after trying medication, therapy and other methods that never worked.

“The last time I spoke to her, she told me she was 100% relieved. She was smiling all the 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 has been used for diabetic neuropathy.

“I hope patients will get better, their quality of life will improve, their pain will decrease and they can be less dependent on medication,” 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 and Unregulated Medical Device Industry and One Man’s Battle to Survive Itworries some patients do not consider that medical devices have their own side effects which can be serious.

She has 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 have been at least 500 consumer complaints to the FDA over the past five years following the implantation of a Nevro Senza device. Reported problems include infections, sepsis, shock and numbness.

In these cases, no problem was found with the device. But it is the manufacturer himself who researches whether the device is in question.

” We have [implanted], between testing and everything else, almost 100,000 of these devices. And we follow up all reports of adverse events very carefully. We are obligated to do so,” said Nevro Chief Medical Officer Dr. David Caraway.

Dr. Caraway mentions an 18-month trial showing that Nevro’s spinal cord stimulators relieve pain in nearly three-quarters of patients.

“We are really focused on gathering evidence and delivering the safest and most effective therapies available,” Dr. Caraway said.

And the Nevro HFX has gone through the FDA’s stricter premarket 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 account for 97% of medical device recalls.

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

Patients considering a medical device can search the FDA database for reported issues. Lenzer recommends researching complaints, considering possible side effects and weighing them against the expected benefits. Patients should also ask their doctor how often they have implanted the device.

So far, Berger has had no problems.

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

And even if that doesn’t help her score on the lanes, she’s just happy to be back in the game.

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