Imperfect regulation of implants
Towards the end of last year, a prominent UK newspaper carried a leading article ‘Revealed: faulty medical implants harm patients around the world’.1 This was followed shortly after by a BBC News article on the same subject.2 The Implant Files Project, an international group coordinated by the International Consortium of Investigative Journalists, published some impressive statistics about implant problems. The main targets were meshes for pelvic floor and hernia reconstruction, breast implants, cardiac pacemakers and a contraceptive, but orthopaedics did not escape unscathed. Problems with total hip, knee and intervertebral disc replacements also featured prominently. Even allowing for journalistic dramatisation and over-simplification, the figures quoted are worrying. Between 2015 and 2018, 62 000 adverse events with implants were reported in the UK alone, a third of them causing serious complications, including 1 004 deaths. In the USA the FDA recorded 5.4 million events over the past decade, with 500 000 implants requiring removal, and 83 000 deaths.