De­vices to treat pain bring it

AP: Many hurt by hyped, ill-reg­u­lated med­i­cal im­plants

Baltimore Sun Sunday - - NEWS - By Mitch Weiss and Holbrook Mohr

COLUMBIA, S.C. — Des­per­ate for re­lief af­ter years of agony, Jim Taft lis­tened in­tently as his pain man­age­ment doc­tor de­scribed a med­i­cal de­vice that could change his life.

It wouldn’t fix the nerve dam­age in his man­gled right arm, Taft and his wife re­called the doc­tor say­ing, but a spinal-cord stim­u­la­tor would cloak his pain, mak­ing him “good as new.”

But Taft’s sur­gi­cally im­planted stim­u­la­tor failed when a wire along his spine broke. Af­ter an op­er­a­tion to re­pair it, he said the de­vice shocked him so many times that he couldn’t sleep and even fell down a flight of stairs. To­day, the 45-year-old Taft is a pris­oner in his own bed, barely able to get to the bath­room by him­self.

“I thought I would have a won­der­ful life,” he said. “But look at me.”

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 U.S. Food and Drug Ad­min­is­tra­tion, 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 show. Among the 4,000 types of de­vices tracked by the FDA, only metal hip re­place­ments and in­sulin pumps have logged more in­jury re­ports.

The FDA data con­tain more than 500 re­ports of peo­ple with spinal-cord stim­u­la­tors who died, but de­tails are scant, mak­ing it dif­fi­cult to de­ter­mine if the deaths were re­lated to the stim­u­la­tor or im­plant surgery.

Med­i­cal de­vice man­u­fac­tur­ers in­sist spinal-cord stim­u­la­tors are safe — about 60,000 are im­planted an­nu­ally — and doc­tors who spe­cial­ize in these surg­eries say they helped re­duce pain for many of their pa­tients.

Most of these de­vices have been ap­proved by the FDA with lit­tle clin­i­cal test­ing, how­ever, and the agency’s data show that spinal­cord stim­u­la­tors have a dis­pro­por­tion­ately higher num­ber of in­juries com­pared to hip im­plants, which are far more plen­ti­ful.

The AP re­ported on spinal stim­u­la­tors as part of a nearly year­long joint in­ves­ti­ga­tion of the global med­i­cal de­vices in­dus­try that in­cluded NBC, the In­ter­na­tional Con­sor­tium of In­ves­tiga­tive Jour­nal­ists and more than 50 other me­dia part­ners around the world. Re­porters col­lected and an­a­lyzed mil­lions of med­i­cal records, re­call no­tices and other prod­uct safety warn­ings, in ad­di­tion to in­ter­view­ing doc­tors, pa­tients, re­searchers and com­pany whistle­blow­ers.

The me­dia part­ners found that, across all types of med­i­cal de­vices, more than 1.7 mil­lion in­juries and nearly 83,000 deaths were re­ported to the FDA over the last decade.

The in­ves­ti­ga­tion also found that the FDA pushes de­vices through an ab­bre­vi­ated ap­proval process, then re­sponds slowly when it comes to forc­ing com­pa­nies to cor­rect some­times lifethreat­en­ing prod­ucts.

De­vices are rarely pulled from the mar­ket, even when ma­jor prob­lems emerge.

The FDA ac­knowl­edges its data have lim­i­ta­tions, in­clud­ing mis­takes, omis­sions and un­der-re­port­ing that can make it dif­fi­cult to de­ter­mine whether a de­vice di­rectly caused an in­jury or death. But it re­jects any sug­ges­tion of failed over­sight.

“There are over 190,000 dif­fer­ent de­vices on the U.S. mar­ket. We ap­prove or clear about a dozen new or mod­i­fied de­vices ev­ery sin­gle busi­ness day,” Dr. Jef­frey Shuren, the FDA’s med­i­cal de­vice di­rec­tor said at an in­dus­try con­fer­ence in May. “The few de­vices that get at­ten­tion at any time in the press is fewer than the de­vices we may put on the mar­ket in a sin­gle busi­ness day.”

In the last 50 years, the med­i­cal de­vice in­dus­try has rev­o­lu­tion­ized treat­ment for some of the dead­li­est scourges of mod­ern medicine, in­tro­duc­ing de­vices to treat or di­ag­nose heart dis­ease, can­cer and di­a­betes.

Pete Corby, who in­jured his back work­ing as a movie stunt­man, said a spinal-cord stim­u­la­tor helped him deal with his con­stant pain and stop us­ing the opi­oids he’d be­come de­pen­dent on.

Med­i­cal de­vice com­pa­nies have “in­vested count­less re­sources — both cap­i­tal and hu­man — in de­vel­op­ing lead­ing-edge com­pli­ance pro­grams,” said Janet Trunzo, head of tech­nol­ogy and reg­u­la­tory af­fairs for Ad­vaMed, the in­dus­try’s main trade as­so­ci­a­tion.

At the same time, med­i­cal de­vice mak­ers also have spent bil­lions lob­by­ing reg­u­la­tors, hos­pi­tals and doc­tors.

Taft’s neu­ro­sur­geon, Ja­son High­smith of Charleston, S.C., im­planted the de­vice in April 2014. But Taft and his wife say the de­vice never worked.

In Oc­to­ber 2014, High­smith said he op­er­ated on Taft to in­stall a new lead, tested the bat­tery and rein­serted it. Still, Taft’s med­i­cal records show that he con­tin­ued to re­port numb­ness, tin­gling and pain.

The stim­u­la­tor was sur­gi­cally re­moved in Au­gust 2015.

High­smith said the over­whelm­ing ma­jor­ity of his spinal-cord stim­u­la­tor pa­tients gain sig­nif­i­cant pain re­lief.

That’s lit­tle com­fort for Taft.

“This is my death sen­tence,” Taft said, stretched out be­neath his bed’s wooden head­board on which he’s carved the words “death row.”

“I’ll die here,” he said.

SEAN RAYFORD/AS­SO­CI­ATED PRESS

Jim Taft is vir­tu­ally bedrid­den at his home in West Columbia, S.C., af­ter ex­pe­ri­enc­ing de­bil­i­tat­ing health is­sues fol­low­ing a spinal cord stim­u­la­tor im­plant.

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