Scandal of fruit netting ‘approved as surgical implant’20 March 2015
Carl Heneghan, Senior Tutor and Professor of Evidence-Based Medicine, joined an undercover investigation to expose how the regulation of medical devices is so lax that mesh packaging for fruit could be approved as a medical device to be implanted in people’s bodies. Carl Heneghan agreed to produce a fake report for Radar, a Dutch consumer television programme, about the advantages of netting used in mesh bags for mandarin oranges as a surgical aid. The dossier formed part of a secretly recorded presentation to TUV Austria, one of dozens of “notifying bodies” across Europe that administer safety regulations. Devices given Conformité Européenne (CE) accreditation by such bodies can be sold across the EU. Footage shows officials from TUV Austria examining Heneghan’s report, which was ostensibly compiled for representatives of a medical equipment firm, before declaring they can foresee “no problem” with the mesh being granted a CE mark for use in surgical pelvic repair procedures. TUV Austria has accused Radar of selectively editing the footage and insists the mesh would not have passed the CE approval process. Read more about the investigation in this article, which appeared in The Sunday Times on Sunday 11th January.