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.
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.
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