Im­plant launched with­out clin­i­cal trial

Vagi­nal mesh de­vice was mar­keted for years de­spite high fail­ure rate

The Guardian Weekly - - International News - Han­nah Devlin

A vagi­nal mesh im­plant made by John­son & John­son was launched with­out a clin­i­cal trial, and mar­keted for five years af­ter the com­pany learned it had a higher fail­ure rate than its two ear­lier de­vices.

In­ter­nal com­pany emails dis­closed in a US court case, in which a woman was awarded a record $57m in dam­ages last week, also show se­nior ex­ec­u­tives even briefly con­sid­ered sup­press­ing un­favourable data that “could com­pro­mise the fu­ture” of the de­vice.

J&J’s Ethicon unit was found by the court to be li­able for in­juries suf­fered by Ella Ebaugh, 51, af­ter she was given a mesh im­plant. Ebaugh said she was left with a man­gled ure­thra, blad­der spasms and con­tin­ual pelvic pain af­ter an un­suc­cess­ful pro­ce­dure that led to three re­vi­sion surg­eries to re­move mesh that had cut into her ure­thra and mi­grated to her blad­der.

But doc­u­ments sub­mit­ted to the court show J&J staff had raised con­cerns about the “spin­ning of data” in emails. In ad­di­tion, a male ex­ec­u­tive ban­tered about a sug­ges­tion that sex with an ear­lier pa­tient with mesh com­pli­ca­tions was “like screw­ing a wire brush”.

When it emerged from ini­tial data that the suc­cess rates for a new de­vice looked to be “way be­low” those seen for pre­vi­ous prod­ucts, Ethicon’s direc­tor of sales, Xavier Bu­chon, sug­gested in an email “stop[ping] for a while such pub­li­ca­tions that could com­pro­mise the fu­ture”. In the event, the find­ings were pre­sented at a ma­jor in­ter­na­tional con­fer­ence.

The J&J ten­sion-free vagi­nal tape (TVT) im­plant was launched in 2006. De­spite the early signs it had a higher fail­ure rate, it was only with­drawn in 2012 af­ter be­ing used in thou­sands of op­er­a­tions in the US, the UK and Aus­tralia. The doc­u­ments raise ques­tions for the man­u­fac­tur­ers of vagi­nal mesh prod­ucts, which are the subject of grow­ing con­tro­versy.

The im­plants, which re­in­force tis­sue around the ure­thra, are widely used to treat in­con­ti­nence and for most women the pro­ce­dure is quick and suc­cess­ful. How­ever, some have suf­fered de­bil­i­tat­ing com­pli­ca­tions, in­clud­ing se­vere pelvic pain, and the mesh erod­ing through the vagi­nal wall or per­fo­rat­ing or­gans. Class ac­tion law­suits are un­der way in Aus­tralia and the US. In Eng­land, NHS data sug­gests as many as one in 15 women re­quire full or par­tial re­moval of the im­plant.

Ebaugh, whose case was heard in Philadel­phia, said her com­pli­ca­tions had left her with con­stant pelvic pain. “I feel like I’m on fire down there,” she told CBS.

The doc­u­ments, re­vealed in the trial, high­light ten­sions be­tween Ethicon’s com­mer­cial and clin­i­cal di­vi­sions at the time it launched its “minia­ture” mesh product, the TVT-Se­cur, in 2006. It hoped the de­vice, which was smaller and re­quired fewer in­ci­sions, would re­duce com­pli­ca­tions seen with its ear­lier de­vices. But get­ting to mar­ket be­fore com­peti­tors, who had sim­i­lar of­fer­ings in the pipe­line, was de­scribed as “price­less” in com­pany pa­pers. It was ap­proved for use with­out a trial un­der US and Euro­pean equiv­a­lence rules, which al­low this when a new de­vice is sim­i­lar to ex­ist­ing ones.

Carl Heneghan, pro­fes­sor of ev­i­dence-based medicine at the Univer­sity of Ox­ford, has called for a pub­lic in­quiry into the use of mesh and crit­i­cised the de­ci­sion to launch a de­vice be­fore a trial, say­ing this “led to di­rect pa­tient harms”. “It has made it im­pos­si­ble to pro­vide in­formed choice to women, and points to a reg­u­la­tory sys­tem that is fail­ing pa­tients,” he said.

Prof Bernard Jac­quetin, an em­i­nent French gy­nae­col­o­gist whose early study on TVT-Se­cur had led to mis­giv­ings among J&J man­age­ment, said the com­pany had acted “ir­re­spon­si­bly” by launch­ing the de­vice with­out ad­e­quate ev­i­dence.

His team’s study of 40 pa­tients found suc­cess rates of 77% two months af­ter surgery, com­pared with roughly a 85%90% suc­cess rate com­monly re­ported for Ethicon’s orig­i­nal TVT de­vice. In 2012, TVT-Se­cur was with­drawn from the mar­ket, along with three other mesh prod­ucts. J&J de­clined to pro­vide ex­act fig­ures on how many women had re­ceived the im­plants.

The com­pany said it planned to ap­peal against the ver­dict.

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