Give Me a Crash Course In . . . Med­i­cal im­plants

The Irish Times - Weekend Review - - NEWS REVIEW - COLM KEENA

What’s this fuss about med­i­cal de­vices?

The In­ter­na­tional Con­sor­tium of In­ves­tiga­tive Jour­nal­ists (ICIJ) this week pub­lished a new project, the Im­plant Files, which con­sisted of a se­ries of sto­ries about im­planted med­i­cal de­vices that have gone wrong, or may be caus­ing prob­lems, or were not prop­erly tested be­fore they were al­lowed on to the mar­ket for im­plan­ta­tion into peo­ple’s bod­ies.

What type of med­i­cal de­vices?

Metal hips that shed ions, caus­ing peo­ple’s flesh and bones to soften and die; a per­ma­nent con­tra­cep­tive, Es­sure, that doc­tors say in some cases turn into a “cal­ci­fied nail”; vag­i­nal meshes that cut through in­ter­nal walls; breast im­plants that may be linked to rare can­cers; and pace­mak­ers that turn faulty. The de­vices are very dif­fi­cult to re­move, and pa­tients can be left with a de­vice in­side their bod­ies that is caus­ing se­ri­ous pain and may even be a threat to their lives, but which is too risky to take out, or “ex­plant”.

Who broke the story?

The Ir­ish Times took part in the ICIJ project, along with the Guardian, the BBC, Le Monde, Süd­deutsche Zeitung and me­dia or­gan­i­sa­tions around the globe. Ir­ish cov­er­age con­cen­trated on the DePuy metal hip, which on a per capita ba­sis was more pop­u­lar here than in any other mar­ket. The de­vice was with­drawn in 2010 and since then more than 1,000 Ir­ish peo­ple have ini­ti­ated High Court pro­ceed­ings against DePuy, seek­ing dam­ages.

The ICIJ, which has pre­vi­ously pro­duced projects based on leaked data, such as Luxleaks and the Panama Pa­pers, de­cided to have an in­ten­sive look at med­i­cal de­vices be­cause of their in­creas­ing im­por­tance in health­care, the size and power of some of the multi­na­tion­als in­volved, and con­cerns about the ad­e­quacy of the sec­tor’s reg­u­la­tion.

Is reg­u­la­tion that bad?

Maybe not any more. Aris­ing from the metal hip con­tro­versy and a scan­dal in­volv­ing in­dus­trial sil­i­cone be­ing used in breast im­plants, the EU de­cided some years ago to re­form its med­i­cal de­vice reg­u­la­tion regime, with the new ar­range­ment now be­ing rolled out. In the US there is some con­cern that the po­lit­i­cal regime there, as part of its gen­er­ally anti-reg­u­la­tion phi­los­o­phy, may be soft­en­ing the role played by the Food and Drug Ad­min­is­tra­tion.

So, should we avoid med­i­cal de­vices?

No. Med­i­cal de­vices have trans­formed health­care in re­cent decades and the pace of in­no­va­tion shows lit­tle sign of let­ting up. Con­di­tions that were un­treat­able or in­volved ma­jor, risky surgery two decades ago, can now be sub­stan­tially ad­dressed us­ing in­ge­nious de­vices, many of which can be im­planted with rel­a­tive ease. All around the globe peo­ple are liv­ing ac­tive, pain-free lives be­cause of the won­ders pro­duced by the med­i­cal de­vice sec­tor. It is be­cause of the sec­tor’s im­por­tance to peo­ple’s lives that it re­quires best-in-class reg­u­la­tion, some­thing many ob­servers be­lieve is not cur­rently the case.

The sec­tor is also of enor­mous im­por­tance to the Ir­ish econ­omy, mak­ing up al­most 10 per cent of our ex­ports. Eight out of ev­ery 10 stents pro­duced in the world, are pro­duced in Ire­land.

What can be done to make things bet­ter?

The DePuy metal hip was with­drawn from the world mar­ket when it was dis­cov­ered that it was not per­form­ing as well as other types of hip. Key data came from the UK’s Na­tional Joint Reg­is­ter, which mon­i­tors the per­for­mance of all orthopaedic im­plants. A sim­i­lar registry has since been es­tab­lished in Ire­land and this week the Royal Col­lege of Sur­geons in Ire­land (RCSI), and the Na­tional Of­fice for Clin­i­cal Au­dit, which op­er­ates the registry, re­sponded to the Im­plant Files by sug­gest­ing that fund­ing be pro­vided so that the registry would mon­i­tor the per­for­mance of all im­plants, and not just orthopaedics.

An X-ray im­age shows the DePuy ASR re­place­ment hip sys­tem. PHO­TO­GRAPH: BRYAN O’BRIEN

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