PIP rupture data back French call for explantation and entrench EU regulatory response gap
This article was originally published in Clinica
Executive Summary
Over a fifth of the 8,500 purely precautionary PIP explantations conducted in France up to July 2012 revealed undetected ruptures, according to a report by the national regulatory agency, ANSM. These and other findings further vindicate the agency’s much-criticised preventive explantation policy – which pitted the agency against other countries, such as the UK and Australia – the report concludes.