Scandal of fruit netting ‘approved as surgical implant’

http://www.thesundaytimes.co.uk/sto/news/uk_news/Science/article1505669.ece

A fake report saw mesh netting on the brink of medical approval
Lois Rogers Published: 11 January 2015
A fake report saw mesh netting on the brink of medical approval

AN OXFORD scientist 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, professor of evidence-based medicine at Oxford, 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