MHRA under scrutiny following implant scandal

Posted 18/01/2012

The MHRA, the body responsible for the safety of medicines and medical products in the UK, is coming under increasing scrutiny following the PIP implant scandal. It was the MHRA’s responsibility to act when safety issues surrounding implants emerged, but the Lancet medical journal says that, although surgeons began publicly to express doubts about PIP implants in 2006, the MHRA took a further two years to note concerns.Patient safety experts are also criticising the system for approving medical products. The PIP implants had a European CE mark of safety, but experts say the safety tests are not nearly as strict as those governing medicines and the approval process is not carried out by the MHRA but a number of organisations around Europe. In the case of PIP implants, approval was given in Germany.Sandra Patton, Head of Medical Injury at Ashtons Legal, says: “We can only hope that something positive does come out of this dreadful situation where thousands of women have been affected. If this scandal leads to an effective root and branch review of the regulation of cosmetic surgery and more generally to a review of how products are approved for use, patient safety will be very significantly improved.”