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.
This is perhaps not such an easy task as the government first thought. Take the Ombudsman idea. This is not revolutionary and exists in other areas of business. This could cover the whole of the private medical sector rather than just cosmetic surgery. To set up this office it would require premises, staff, processes and technology and all of this costs money. At a time when cuts are being made it is difficult to see how, without the support and funds of the private sector this could be achieved. Can the private sector be forced to contribute or would it be voluntary? When the practicalities are reviewed it is obvious that there are more questions than answers and perhaps this realisation has led to the delayed government response.
Data transparency is another interesting area. Again, this will require money and resources to setup an implant registry and to find ways to ensure that all cosmetic surgery companies feed data into the registers and that the data is accurate and robust. Can this be made compulsory? The good news is that there are many cosmetic surgery companies and private hospitals that are willing to work together to the spirit of the Sir Bruce Keogh review to find ways to further improve standards. There are meetings currently taking place to try and find a way to have transparency of data and it will be interesting to see if all cosmetic surgery providers are willing to supply their data. This way, at the very least, there is an understanding of what procedures actually take place in the UK and what type of procedures there are. This is something that the Sir Bruce Keogh Review did not establish whilst carrying out its investigations. It is also hoped that this will go further and be able to demonstrate return to theatre rates, revision rates and infection rates to allow the public to make an informed decision.
There really is a spirit of cooperation from many parties’ but unfortunately not all. This is likely to lead to a two tier cosmetic surgery sector. There are those who are not waiting for the government to make change but are trying to address the spirit of the review as best they can. This will have an impact on their business as it will take time and it will cost money but there is much pride in many of the specialist cosmetic surgery companies and private hospitals who wants cosmetic surgery to have a better reputation than it currently has. There are some excellent providers out there and in the main patient satisfaction is very high and so transparency should give people a real insight as to what cosmetic surgery is really like.
Unfortunately, there are some less robust practices out there and if those companies do not voluntarily adapt and follow a quality regime then we will be in a position where they incur less costs and therefore can charge lower fees to patients. This could mean that the most vulnerable patients who are drawn to the lowest possible prices are the ones least well protected. It is not always the case but it is likely that the lower price will result in a poor experience. If you were to look at the Care Quality Commission inspection reports of some of the lowest priced providers you would see this. But who is educating the public on where to look and how to measure quality?
Savings could be made not only through compromising on the quality of premises, ability of staff and the robustness of policies and procedures but in other ways that can affect results. This could be that the surgeons are less experienced or that the product used are not as well tested and controlled as other products or it could be just the way that complaints and complications are handled.
There can be a default assumption that a trained Dr can be trusted and that the quality will be high. It is perhaps based on the UK NHS culture whereby people expect a certain minimum level of service. Actually, as is now becoming evident in the NHS with better transparency, the variation in the quality of the service in the NHS can be significant. This is just the same in private practice. The only way to help people make informed decisions is by being transparent, by showing data, by being open and honest. At MYA cosmetic surgery publish our data and share our data with other organisations so that we can produce collective sector data. There are organisations out there that are willing to do more. This is maybe a naïve viewpoint but if the they were getting a positive reaction from patients through the public being educated as to what quality is then others will be forced to react otherwise without quality their business will not survive.
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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