Mesh pain risk from her­nia high, sur­geon says

The Press - - News - CATE BROUGHTON

A lead­ing Cana­dian her­nia sur­geon says the risk of com­pli­ca­tions from sur­gi­cal mesh is too high and its use in New Zealand should be re­stricted.

Sur­gi­cal mesh made with polypropy­lene is used rou­tinely in New Zealand her­nia pro­ce­dures to strengthen weak­ened ab­dom­i­nal walls. About 5000 pro­ce­dures take place each year.

How­ever, hun­dreds of Ki­wis have suf­fered se­vere in­juries af­ter be­ing im­planted with the prod­uct.

Robert Ben­david, a past pres­i­dent and a found­ing father of the Amer­i­can Her­nia So­ci­ety, said the in­ci­dence of chronic pain fol­low­ing all types of her­nia re­pairs had in­creased sub­stan­tially since the use of sur­gi­cal mesh from the mid-1990s.

The sur­geon has per­formed thou­sands of non-mesh her­nia re­pairs at the only hos­pi­tal in the world ded­i­cated to such pro­ce­dures, the Shouldice Her­nia Hos­pi­tal in On­tario, Canada.

He said the most re­li­able stud­ies put the post-her­nia surgery com­pli­ca­tion rate at 12 per cent, but some found the risks were ‘‘un­ac­cept­ably high’’ at up to 20 per cent.

Ben­david took is­sue with Christchurch sur­geon Steven Kelly’s de­fence of mesh in a let­ter to the New Zealand Med­i­cal Jour­nal pub­lished in Novem­ber.

Kelly had said me­dia had been scare­mon­ger­ing over the is­sue: ‘‘The pub­lic needs to be in­formed that mesh for ab­dom­i­nal wall her­nia re­pair is safe and ef­fec­tive,’’ he wrote.

Ben­david’s re­sponse was pub­lished in a let­ter in the De­cem­ber is­sue of the jour­nal.

He said that de­spite the risks, mesh was used in most her­nia pro­ce­dures as sur­geons had been ma­nip­u­lated by the med­i­cal de­vice in­dus­try and were not trained in non-mesh tech­niques.

Much of the re­search used to gain reg­u­la­tory ap­proval for mesh prod­ucts was paid for by mesh man­u­fac­tur­ers, he said.

‘‘If the var­i­ous meshes were as safe as the in­dus­try claims them to be, why are there hun­dreds of thou­sands of pa­tients in­volved in class ac­tions, re­sult­ing in bil­lions of dol­lars in fines?’’

Reg­u­la­tory au­thor­i­ties, in­clud­ing the Un­tied States Food and Drug Ad­min­is­tra­tion (FDA), had failed to en­sure ad­e­quate safety checks or even mon­i­tor­ing of the de­vices, he said.

‘‘Nei­ther the in­dus­try, nor the FDA nor any world or­gan­i­sa­tion that I am aware of, is keep­ing track of such com­pli­ca­tions.’’

At­tempts by the in­dus­try to fix prob­lems with mesh by in­tro­duc­ing lighter prod­ucts and new coat­ings had failed to ad­dress the risks:

‘‘In fact noth­ing new has been in­tro­duced since it is, and al­ways will be, polypropy­lene once its added coats have been di­gested away.’’

Ben­david said polypropy­lene used to make the mesh prod­ucts was a for­eign body which could erode into tis­sues and nerves.

De­spite his views, Ben­david did not want sur­gi­cal mesh banned for her­nia re­pairs, but re­stricted for use in up to 2 per cent of cases.

Gov­ern­ments should make it manda­tory for sur­geons to fol­low up her­nia pa­tients treated with mesh for at least four years and ide­ally for up to 10 years af­ter­wards as stud­ies showed com­pli­ca­tions could ap­pear years af­ter the pro­ce­dure, he said.

A manda­tory reg­istry to record all mesh pro­ce­dures should be a min­i­mum re­quire­ment of gov­ern­ments, to en­able fol­low up of pa­tients with com­pli­ca­tions, he said.

Af­ter a two-year in­quiry into mesh prod­ucts, New Zealand’s health se­lect com­mit­tee pro­posed the de­vel­op­ment of a na­tional mesh reg­istry in 2016.

Min­is­ter of Health David Clark, who had promised to im­me­di­ately be­gin work on the reg­istry if elected, last month said the Min­istry of Health had com­mit­ted in Oc­to­ber to look­ing at a cost-ben­e­fit anal­y­sis for a pelvic sur­gi­cal mesh reg­istry.

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