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