13 July 2012

The Harley Medical Group has released its recommendations for the regulation of medical implants following the recent PIP crisis. At the end of last year, it emerged that the implants contained industrial silicone instead of medical-grade fillers, which means they could be more likely to leak or rupture than other products.The Harley Medical Group, which was one of the largest single users of the implants in Britain, trusted the safety of the products because they carried the CE mark – which it assumed meant they had been thoroughly tested. However, it was discovered that testing was undertaken after the product had already been commercialised. As a result, the Harley Medical Group has recommended that testing takes place before commercialisation. Furthermore, a compulsory breast implant register managed by the Medicines and Healthcare products Regulatory Agency (MHRA) should be introduced. Under the recommendations, this would be complemented by an improved insurance system so that regulatory bodies would be able to take financial action in the event something similar should reoccur, enabling them to manage the situation appropriately. Similarly, authorities such as the MHRA should be made accountable. According to the Harley Medical Group, these actions would help to ensure authorities are completely transparent to the public, ensuring breast surgery patients are fully aware of the situation. Please click here to see the full recommendation by The Harley Medical Group and published by the British Parliament