May 15, 2012 – The UK Health Minister Lord Howe has published a report looking into the actions of the Medicines and Healthcare Products Regulatory Authority (MHRA) relating to the Poly Implant Prothèse (Pip) implant scandal.
The report found that the agency started to receive reports related to the Pip implant scandal as early as 2002. In 2006, surgeons contacted the agency, concerned that the implants were breaking more frequently than other brands. MHRA brought these concerns to the attention of the notified body TUV Rheinland, which was responsible for assessing the implants, and continued to analyse Pip incident data afterwards. Ultimately, the blame “lies squarely with the fraudulent manufacturer”, the report found.
While the review found that the MHRA acted reasonably, it also calls for several improvements to the agency. MHRA needs to improve its procedures for gathering evidence related to device safety and analysing reported problems, according to the report. It also needs to find better ways of communicating with the public. In addition, the report calls for changes to the European regulatory system, stating that EU countries must work more closely together and become better at sharing information on medical devices.
However, the report rejects the need for a premarket authorisation system, something the European Parliament called for in its Pip resolution. “Nothing about this case provides evidence to suggest the system for regulating medical devices is fundamentally unsound and that there needs to be a shift to a system like that used to regulate pharmaceuticals in the EU, or the system used to regulate higher risk devices in the United States…Putting in place even the most exhaustive testing regime before market authorisation would not have prevented this deliberate fraud taking place once the product was on the market,” the report says.