(theguardian.com)–A UK company’s spinal implants that allegedly moved and eroded in patients, and which are at the centre of legal action, have highlighted potential weaknesses in the way in which some medical devices enter the market, an investigation has revealed.Documents seen by the Guardian show the plastic discs were approved for sale by the British Standards Institution (BSI) after tests on 30 people over six months
A customised version was also implanted in nine baboons, according to a paper by members of the company’s own scientific advisory board.The devices, made by the now-defunct Ranier Technology, which was based in Cambridge, are the focus of legal action brought by prosecutors in Germany against a doctor who implanted them, allegedly without first obtaining fully informed patient consent.
Many of the patients who received them are undergoing surgery to have them removed, with doctors finding some had completely disintegrated, according to an investigation coordinated by the International Consortium of Investigative Journalists, involving the Guardian and BBC’s Panorama.
Ranier Technology was granted CE (Conformité Européenne) safety marks for two implants, Cadisc-L and Cadisc-C. The devices were certified by the BSI in 2010 and 2011 respectively, and once approved were marketed to hospitals across Europe.The firm gained millions of pounds in backing from investors impressed by its work in developing artificial spinal discs, which it said would bring relief and a normal quality of life to patients suffering degenerative disc disease.Read the complete Article https://www.theguardian.com/science/2018/nov/26/uk-firm-sold-spinal-implants-disintegrated