Leading up to 2010 unusual levels of ruptures started to occur with the silicone gel filled breast implants manufactured by Poly Implant Prosthèse (PIP). In many cases they were fraudulently filled with a non-clinical grade and unapproved silicone gel. This inferior implant quality was starting to create complications.
The founder of PIP, Jean Claude Mas, was found guilty in France for aggravated fraud along with other senior staff members. It emerged that 75% of the implants manufactured had sub-standard gel and that when inspectors visited his factory he hid the unapproved gel implants and just presented the authorised gel. The inspections were with notice and so they had time to cover up their activity.
In March 2010 the MHRA was informed by AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé, the French regulator of medicines and medical devices) that it had suspended the marketing, distribution, export and use of PIP implants. It was not until 23 December 2011, that the French Government announced that it was recommending that all women who had been implanted with PIP breast implants should have them removed as a preventative measure. This created much alarm across Europe and was widely reported leading to significant public interest.
On 31 December 2011 Professor Sir Bruce Keogh, the NHS Medical Director, was asked to carry out a detailed review into PIP implants. He was tasked with providing advice about what steps needed taking and what lessons could be learnt regarding cosmetic surgery generally.
Public tensions were growing as it was estimated that tens of thousands of women had been implanted with PIP implants and thousands of others were just not sure what implants they had. Sir Bruce Keogh led an Expert Group who quickly published an interim report on 6 January 2012. The report concluded that PIP implants were not associated with a higher risk of breast cancer or other forms of cancer than other breast implants but that further testing should be carried out.
On the 15th August 2012 the Review of the Regulation of Cosmetic Interventions called for information from patients, members of the public, private healthcare providers, Royal Colleges and any professional bodies. The series of questions were to be answered within two months and the information would then be considered by a varied panel leading to a series of recommendations. MYA submitted a 100 page report offering an insight into the sector and ways to improve standards. The Review Panel published an interim report on 31st December 2012.
In January 2013 the MHRA published the final toxicology test results, which confirmed previous testing and concluded that there was no evidence of cytotoxicity or genotoxicity of the PIP breast implant filler.
In April 2013 the final Review of the Regulation of Cosmetic Interventions report was published with 40 Recommendations.
The review can be broken into several categories. Business changes such as making sure that there is business failure insurance in place, complaint handling with the recommendation of putting an Ombudsman in place, having an improved Care Quality Commission (although they’re facing many difficulties in not only the private sector but also the NHS). We were delighted that one of the main areas we have been pushing for, transparency of information was included. Some organisations publish headline data for marketing purposes but not clinical quality data. Hopefully, organisations will now go that step further like MYA do. It is important for the UK cosmetic surgery sector to collect accurate and consistent data and to combine this information so that trends and patterns can be seen and people can make an informed decision as to the quality of the provider. Better control of advertising is included ensuring that it is socially responsible whilst accepting that advertising should not be stopped as this would compromise freedom of choice. Non-surgical practices needed to be made more robust including uniform training for practitioners, registers of suitable practitioners and also re-classifying fillers as prescription only drugs which would put them in a similar category to Botox and require greater medical involvement. There were also many suggestions around improving professional standards which was to be led by the Royal College of surgeons. Finally, there was the surgeons themselves and minimum requirements of training, mandatory need to be on a relevant register and ensuring more uniform and robust insurance.
At the end of December 2013 the government confirmed that it would provide its formal response in January 2014. Two years will have passed since the PIP scandal first hit the news. So what has happened in those months since the review?
The MP Dr Dan Poulter is leading the government implementation team and it has been acknowledged that primary and secondary legislation will be required to make many changes. This complicates matters and creates time and cost issues. In times of austerity it will be interesting to see the government’s appetite for change.
Arguably one of the simplest changes would be to change fillers to a prescription only drug but this requires legislation meaning it could take until 2016 which is after the next general election in 2015.
John Ryan, MYA’s Chairman commented “I have been in the cosmetic surgery business since the 1970’s and there is no doubt that these developments will make a difference although the devil will be in the detail. I agree with Dr Dan Poulter MP that cosmetic surgery has gone from a niche market to a popular norm and that certainly, in terms of surgery, improvements have been made over the years although in some quarters more can be done. We now need one big push to tidy up the detail and find a mechanism to enforce it. We also need to set aggressive but realistic timeframes for action. I would like the UK to be seen as the safest provider of cosmetic surgery in the world and hope that between the GMC and CQC they can feel empowered to enforce standards. I believe that MYA set a standard in terms of the quality of surgical results, transparency of information and the quality of patient care and experience. We are the only major cosmetic surgery provider who has an online forum and publishes not only numbers of procedures carried out but also details around any complications. We are a pure cosmetic surgery specialist and I believe that we are the model of quality and transparency and we will happily work with the RCS, GMC, CQC, HQIP, CSIC, NHS choices and any other relevant party to show what is possible”.
Simon McMillan, MYA’s Nominated Individual, commented “If an organisation the size of the NHS is publishing more and more clinical data then there should be no excuse for the private sector not to do so. This is important in terms of monitoring quality and allowing patients to objectively assess quality. We collect data at provider and surgeon level and use this as an indicator of performance. Our figures are excellent and we are so confident with the quality of our surgery that we publish our clinical data on our website www.mya.co.uk. We are not aware of any other organisation in the UK that has this level of transparency but we hope they will now follow our lead and not wait for the government to force the issue”.
MYA ( www.mya.co.uk ) is one of the largest specialist cosmetic surgery providers in the UK with a network of 10 clinics across the country including in London, Manchester and Birmingham. MYA was one of the few companies to remove and replace PIP implants free of charge and is the only major cosmetic surgery provider to have a forum /mya-space, to publish clinical data online and to link ‘real time’ to the CQC findings following clinic inspections. MYA is committed to improving quality and transparency within the cosmetic surgery sector.
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