In January 2012 the Department of Health set up two reviews into the PIP implant scandal. The first review, led by Health Minister Lord Howe, was tasked with examining the role played by the Department of Health (DoH) and the Medicines and Healthcare products Regulatory Agency (MHRA).
In March the Commons Health Committee criticised both the government and the MHRA for failing to raise public awareness of the PIP scandal with sufficient vigour. In his review Lord Howe concluded that although the DoH and MHRA had not completely failed in their roles, the whole incident highlighted several areas in which improvements must be made. He said there were “serious lessons” to be learned.
With reference to the way in which evidence is gathered, Lord Howe recommended that the MHRA “obtain evidence from a wider and more detailed set of sources” in order that it can identify potential problems sooner.
He also advised a review of the way in which reports about medical devices are analysed. According to reports in the media, more than 20 letters were sent from the MHRA to the French PIP Manufacturers between 2003 and 2010 raising concerns about the safety of the implants. With the benefit of hindsight Lord Howe opined that “this body of evidence could be seen as suggestive of a problematic manufacturer.”
He went on to say that EU regulatory agencies need to co-operate with each other in order to facilitate the early detection of problems and also maintain close links so that they can effectively share the information they gather. This would enable them to better inform patients about the risks and therefore provide them with better levels of protection.
According to the President of the British Association of Aesthetic Plastic Surgeons (BAAPS), Fazel Fatah, the issue at the very heart of the PIP implant scandal is the issue of “poor post-marketing surveillance.” Although PIP were required to monitor their implants post-operatively as part of the agreement under which they were allowed to continue manufacturing them, they did not comply with this and the requirement was not enforced against them.
Arguably, in an act of deliberate deception by the PIP manufacturer, a CE mark was fraudulently obtained and unfortunately regulation alone could not have prevented this. Nonetheless BAAPS is calling for “significantly more stringent monitoring of all medical devices” via “compulsory, regular reporting of adverse effects and mystery shopping”. They feel this is the only way to sufficiently safeguard the welfare of patients receiving medical devices such as breast implants.
In his review Lord Howe was also keen to identify the need for a “higher level of proactive public communication” and recommended that the MHRA should “review and further develop its communications capability”. He further suggested that they adopt a more creative approach to interacting with the public by making use of social networking sites such a Facebook and Twitter.
The second review will be headed by Professor Sir Bruce Keogh, NHS Medical Director and will consider the question of whether the cosmetic surgery industry needs to be more effectively regulated. Clearly there will be other serious lessons to be learnt in this regard as well.
Slee Blackwell solicitors have provided support to women affected by the scandal via Facebook and have kept people informed of the key developments at each stage in the litigation process. If you have concerns about PIP implants, or a failed cosmetic procedure, please contact Samantha Robson, Partner who heads up the PIP team, via her website www.cosmeticsurgerylaw.co.uk or on freephone 0808 1391592.