UCL laboratory that made artificial implants breached safety rulesBMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j4572 (Published 03 October 2017) Cite this as: BMJ 2017;359:j4572
- Nigel Hawkes
Artificial implants produced at University College London and used in operations on patients abroad were in breach of manufacturing regulations and had not been properly tested in animals, an independent inquiry has found.1
Stephen Wigmore, professor of transplantation surgery at the University of Edinburgh, and his inquiry team found a catalogue of errors at UCL, where windpipes, arteries, and tear ducts made from polymer were supplied by a laboratory that was not licensed to make clinical grade devices. This breach should be reported to the Medicines and Healthcare Products Regulatory Agency “as soon as possible,” the report concluded.
The artificial organs were made of a polymer called POSS-PCU, a polyurethane modified to imitate natural materials. Before implantation the plastic scaffolds were clothed in cells taken from the patient. The medical research charity the Wellcome Trust awarded grants for the development of these …