PIP Breast Implants: Who is responsible?

The manufacture of breast implants using a non-medical grade silicone is a saga that runs on and on, not only for the victims who received PIP devices but also for the companies in the supply chain, the surgeons, the regulators and (of course) the lawyers who are arguably the only beneficiaries of this disaster.  Today a French court appears to have determined that a German "Notified Body" (a legal entity who is considered competent to recommend whether or not a CE mark should be awarded) shares some of the blame for this disaster.  You will need to note here that a CE mark is necessary to place a medical device on the open market in Europe.  It is not a "safety certificate", it is simply a mark of compliance with European law (albeit European law that was implemented as a risk reduction measure).

For the lay person, this is a very confusing subject, and the BBC have tried hard but probably failed to make this story easier to follow (see: BBC story on the recent legal case.).  Why is this story so confusing, and why then is it so difficult to determine precisely who is to blame?  To answer these questions, you have to find the answers to a number of other related questions that are being scrutinised by lawyers and regulators throughout Europe.  These include (1) Was the PIP breast impact actually a medical device or instead a mad-made component to be used in a purely cosmetic and non-medical procedure, (2) Were the regulators to blame for not having strong enough definitions to answer question 1, (3) Was the "Notified Body" to blame for incorrectly recommending the award of a CE mark on the basis of their inspection (if indeed this is what they did, and as an appeal has been launched we need to be careful not to assume), and even (4) Were the private clinics, hospitals and surgeons to blame for not wondering why these French implants were cheaper than the majority of devices on the market.  These are all important questions, but given the legal result reported today, I want to comment mainly on number (3), was the "Notified Body" TUV Rheinland really responsible?

As a Notified Body, this company had the job of checking the documentation regarding design and specification for a medical device, as well as the quality of the manufacturing environment (including quality assurance processes).  The nearest analogy that a lay person might understand - at least in the UK - is the garage that checks the safety of your car before awarding an MOT certificate.  If you were to use low quality brake components - perhaps purchased off eBay - that did not work properly, you would expect a diligent mechanic to detect this and your vehicle would fail the MOT.  If the mechanic did not test the breaks, and you were awarded an MOT shortly before killing a pedestrian because you failed to stop at a crossing, it could be construed that the mechanic and his/her employer were in some way responsible.  My view though is that the vehicle owner who fitted the "dodgy" components is really responsible, and all the more so if they deliberately fitted the parts knowing they were sub-standard. 

In the case of the PIP breast implants though, I expect that TUV Rheinland will claim that the French manufacturer deliberately lied in their documentation and hid the malpractice from them.  In this case, it is as if you re-fitted high quality brake components for the purposes of passing your MOT, but then took them off immediately after obtaining your certificate.  It would be very unfair to hold the garage responsible if you then caused an accident, but this appears to be the decision of the French court. Of course this comes to whether or not the German Notified Body did its job properly, and also what the law says about responsibility in this case.  Perhaps at appeal we will find out.

The only other comment worth making is on my first question, are PIP breast implants medical devices?  This is very important, because in this context only medical devices need CE marks.  The fact that the manufacturer applied for a CE mark suggested that - at least in some cases - they expected the device to be used in a medical procedure (for example, in a breast reconstruction following mastectomy).  However, if the device was for purely cosmetic enhancement of breast shape and size, this was arguably a purely cosmetic procedure and it is probably the case that the medical devices directives would not apply.  Now the average person might think the same quality and manufacturing standards should apply, but the fact is that they do not (at least not in any legal sense), and a short visit to eBay shows that people may be surprisingly relaxed when it comes to the purchase of so-called cosmetic materials such as powerful tooth bleaches from Hong Kong, "Botox effect gels", and home made cosmetics, none of which come with any safety or quality checks.  If the manufacturer used medical grade silicone for the implants to be used in medical procedures, and a lower grade filler only for cosmetic implants, then he may yet deflect the full force of justice.

I have written another article on this subject that questions the role of the purchaser in this debacle (usually a private clinic, but also NHS hospitals), and even ponders whether or not clinicians should today take a keener interest in the provenance of the medical devices that they use?  All of these questions and more are difficult to answer, the only certainty for now being that lawyers will be reaping the benefits of this uncertainty for many years to come.


 

Ethics Abandoned: What do shameful practices among some military medical personnel have to do with innovation?

This week saw the release of a long-awaited report on doctors in the US military, and it concluded that some had been complicit in the torture of detained suspects.  This report makes interesting and at times depressing reading, but it should be noted that these are a tiny tiny minority of healthcare professionals, and this is certainly not an indictment of modern medicine as a whole.  You can read more here, with a link to the report itself at the bottom of the post: http://www.theguardian.com/world/2013/nov/04/cia-doctors-torture-suspected-terrorists-9-11

While this failure to adhere to ethical codes and professional standards was probably a greater problem in the USA, the UK profession has not been immune (the best example being Derek Keilloh, struck off for his complicity in seeking to cover up the fatal injuries of Baha Mousa received while detained by the British Army).  There is much written on these emotive subjects, and those who are interested can find plenty to digest and debate elsewhere.  This did, however, make me think more broadly.  The interesting questions here then are do professional standards and ethical codes for doctors and dentists matter in the world of health technology innovation, and if they can be eroded in a military setting could they also be undermined when working with businesses or even universities? 

In my dealings with healthcare professionals, I am always impressed by the strong emphasis of what is in the best interests of the patient above all other considerations.  This strong moral foundation is not new, it can be traced back to (among others) Hippocrates and the oath that is still taken by many physicians today (including in the UK and USA).  Clinicians and their professional bodies take a dim view of colleagues who fall short of these high standards, and thankfully the available evidence shows that very few doctors do transgress.  That said, this tiny minority includes a number of clinicians who were perhaps overly influenced by commercial factors, or who at least paid insufficient attention to the of the medical devices they were using.  One example was the use of poor quality PIP breast implants by countless surgeons, where the major determinant of implant selection appeared to have been (low) price.  This may not be a fair example, it is unlikely that the surgeons themselves were involved in procurement, but I have argued in a previous article (The PIP breast implant scandal: lessons for dental implantology Faculty Dental Journal volume 3 pages 68 to 72) that perhaps surgeons should concern themselves more with the quality of medical devices being purchased by their hospitals, and if purchasing decisions are made solely on the basis of the lowest price then quality will fall and ultimately patients will suffer (if you disagree, just think about the contents of Tesco's value lasagne).  Of course this is not wilful disregard for professional standards or even dishonesty, and where new health technology innovations go wrong it is very unlikely that deliberate clinical malpractice is to blame.  What the behaviour of a few US military doctors, Derek Keilloh, and some surgeons associated with the PIP scandal, tells us is that working environment and prevailing culture can have a subtle but sometimes very negative impact on personal and professional ethics.  Society would be wise to consider this risk when we place medical professionals in places where their training may not have prepared them fully for the new environment.

If this subject attracts some interest and comments, then I would be happy to follow up with some more detailed analysis of medical device disasters, ancient and modern, and we can look at the roles of the professional and the industry.  For now though, I remain very confident that the vast majority of clinicians engaged in the development and evaluation of new healthcare technologies do so because that are motivated by the highest values of the caring professions, and therefore what is in the best interest of the patient.

Link to the IMAP report: http://www.imapny.org/medicine_as_a_profession/interrogationtorture-and-dual-loyalty

The Witty Report: Are SMEs more important than large companies to exploit innovation in health technology?

This is the 3rd of my blogs on the Witty Report, and I want to visit the complex issue of where and how precisely does healthtech innovation happen, and are SMEs really more important than large multinationals?  OK, to be this is not exactly what Sir Andrew says, but he does emphasise the role of SMEs in innovation, and says relatively little about large companies and whether or not universities should continue to focus their attention on multinationals.

I agree with the Witty Report that compelling evidence suggests that innovation now takes place mainly in SMEs.  I have experience of collaborating with innovative SMEs, and I have witnessed at first-hand how academic support can be instrumental in growth and job creation.  While I am therefore a convert to argument that significant benefits will come from improving opportunities for SMEs and universities to work together, it is probably the case that not all academic staff share this view.  The reasons are complex, but one contributory factor is the relative small scale (and perhaps a lack of kudos) associated with working in partnership with a very small SME compared to a global multinational.  Much thought needs to be given to communicating the value of working with SMEs, and the development of incentives and instruments to drive this collaboration.  Indeed, the Witty Report makes a number of recommendations that - if implemented - could change the collaboration landscape in the UK and make a real difference to our economy.

But is it only SMEs that are important in health technology and medical devices innovation?  Obviously not, and again especially in these sectors. Large multinationals (and indeed the largest SMEs) are still very important drivers of innovation, but this is increasingly because of their role in maximising the impact of de-risked innovative technologies developed by SMEs, and by providing greater opportunities for economic growth on the basis of their exploitation. Larger companies have the maturity, expertise, and infrastructure (including specialist knowledge of regulatory affairs, market needs, reimbursement, marketing, and distribution networks) necessary to respond quickly to opportunities created by SMEs.   The supply chains in health technology and medical devices are sophisticated, and the expertise embedded in UK-based multinationals is a critical determinant of our ability to exploit innovation, generating prosperity as well as providing more general socio-economic benefits.  Perhaps even more importantly, large companies are frequently “cash rich” and/or have access to sizeable capital that is necessary to scale up innovation, even those innovations that have already been de-risked by SMEs. 

I will now be taking a short break from blogging, and hopefully people will have time then to digest and comment on my thoughts stimulated by Sir Andrew Witty's Report.  More in the week beginning 4th November. Don't forget you can read the Witty Report for free: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/249720/bis-13-1241-encouraging-a-british-invention-revolution-andrew-witty-review-R1.pdf

The Witty Report: A Role for Large Companies?

After 24 hours, I still believe that the Witty report is welcome and timely, focussing on the opportunities for growth that would be generated if the academic power of UK universities were even more effectively coupled to innovation and wealth creation in the private sector. The report is very perceptive, recognising I think all of the key issues including the “granularity” of business and academic activities, the special role of SMEs in driving innovation, and the challenges faced by government in determining the best strategies for effective deployment of precious resources to maximise benefits for the UK.  These challenges are significant, for example the relative immaturity of the LEPs, but they are not insurmountable and many of these new challenges have arisen precisely because of steady progress over the past decade.

One area of debate raised by Witty is the potential value of sectoral (and specifically regional sectoral) strengths that are mapped against available academic expertise, i.e. is it a good thing to invest tax payers money where University expertise is co-located with an innovative industrial base?  The easy answer is "yes", but I think Sir Andrew is correct to caution against this being seen as the only factor that should determine funding (not least because the greatest added value is often found with wider national or even international partnerships).  Does this mean that I think city regions and larger geographical clusters are a distraction?  No, I and Sir Andrew I think agree that regional strengths are often very important determinants of future growth potential.  One example of this is the tendency of established companies (and their supply chains) to gradually embed skills and knowledge in a region.  

My long experience of working with industry in the medical devices and health technologies sector, and the additional experience of coordinating an S&T mission to Texas and Minnesota to investigate the impact of converging technologies on medical devices, together confirm for me the value of geographical clusters.  In brief, one key reason for their importance is the creation of a regional community who populate all parts of the supply chain and who frequently interact for mutual benefit (the creation of LEP sectoral groups being a logical evolutionary step).  For example, in Minnesota I frequently met entrepreneurs and employees of local companies who had originally worked for - and been professionally developed by - Medtronic.  The same is true in Yorkshire, where many talented people in the medical devices and health technologies sector either work for or used to work for our large companies (such as Smith & Nephew and J&J Depuy Synthes).  Despite recent structural changes in many of our larger companies, their impact on the region remains significant, and the value of the experienced staff they generate should not be understated.  This is particularly true in the medical devices and health technology sector, where the supply chains are sophisticated and the regulatory environment is complex (and rarely fixed). I will say more about this tomorrow, and consider whether or not the Witty Report has underestimated the value of large companies versus SMEs in driving innovation and growth.

An evening with Sir Andrew Witty

I have been eagerly anticipating the release of the final report "Encouraging a British Invention Revolution: Sir Andrew Witty's Review of Universities and Growth" since the preliminary report came out in the summer.  Was I disappointed?  No, most definitely not.  This is a superb report, beautifully written (indeed, crafted), and where every sentence conveys precise meaning and insight.  Will it therefore be welcomed by all academic staff throughout the land? Probably not, but if it is understood by academic leaders and government then it will become the principal force that shapes our academic landscape over the next decade.  Over the next few weeks, I plan to critically evaluate the potential impact of this report on both my own academic discipline and health technology-based  businesses that include the UK's relatively mature medical device sector as well as emerging fields ranging from regenerative medicine to telehealth.  In the meantime, I urge all people with an interest in how universities can help to drive economic growth in the UK by partnership with business to read this report from Sir Andrew (link at the bottom of the blog).

While I am excited about the opportunities for academics to become even more involved in supporting industry, I am also aware that some of the recommendations are radical and will not necessarily be welcomed by all staff, at least not initially.  Of course universities already work extensively with the non-academic world including businesses, and through this and other activities we already make a substantial contribution to economic growth and recovery.  It is my opinion though that the thinking in the Witty report offers an even greater opportunity to harness the intellectual power of the UK academic base, generating benefits on an unimaginable scale while driving societal changes by establishing new ways of working in partnerships.

You can download the report here: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/249720/bis-13-1241-encouraging-a-british-invention-revolution-andrew-witty-review-R1.pdf