Between 2001 and 2010 (possibly even before that period), a former salesman, the owner of a business in the south of France, engaged in a fraud. He did it because of a crisis, a money crisis, in his business. His business was the manufacture of a particular form of “medical device”. His speciality was the manufacture of “prostheses”, artificial body parts. The name of his company was Poly Implants Prothèses, PIP for short and he was particularly focused on the manufacture of breast implants.
His crisis had arisen in 2000. That year, the Food and Drug Administration of the USA (“FDA”) had inspected his French factory and revoked his license to sell, in the USA, a breast implant he was manufacturing. The breast implant had saline as a filler. Being an American public body, the record of (and reasons for) this revocation were publicly accessible, under Freedom of Information laws, to any person making inquiries.
His American licence had a corresponding European licence or licences because the manufacture and distribution of medical devices is closely regulated in law. Not only ought a manufacturer to comply with legally established standards, it must also submit to inspection from a certifying body. In the USA, the FDA, the certifying body, is both the certifier and the government regulator. This is not necessarily the case in Europe and in the case of France was not the case. There, the French regulator left the function of certifying the production process to private bodies. PIP used the services of a German company to certify its production process and compliance with standards. The German company would inspect the PIP factory by appointment.
This arrangement gave the PIP owner an idea. He would ramp up his sales figures outside the USA and increase his profit margins in those markets. That way he would offset the loss of the USA as a market for his breast implants and save his company. The key to this plan required that he avoid compliance with legal standards in his manufacturing process.
He decided to do this with respect to a silicone filler for his breast implants. Silicone was an alternative to saline as a filler. It was widely manufactured but was relatively expensive when required to meet the standard for use as a filler in a medical device. That use dictated that it have a certain consistency, for instance. Speaking loosely, it had to be closer to a jelly than to a soup.
The PIP owner could buy soup-like silicone at one fifth the price of jelly-like silicone, so he did and made his own mixture.
This was a radical deviation from standards and required that he conceal what he had done from the regulator and the German certifier.
He also concealed it from his customers. His customers were doctors and hospitals. They were the people who delivered the breast implants to the ultimate consumers. Some, possibly many, of his customers were heavy buyers of breast implants; they were in the business of promoting their use in a “cosmetic” context rather than a “medical” context. They were quite price conscious. The owner of PIP could and did undercut his competitors in price in selling his breast implants to his customers.
His breast implants were, potentially, lethal. Desirable consistency was not the only attribute of medical-grade silicone; it also had to be free of impurities. The industrial silicone the PIP businessman had bought was manufactured without regard to impurities; why worry about impurities if the silicone is destined for use in mattresses, say?
The danger arises from a simple fact; accidents happen. If a breast implant is inserted into you it may rupture.
Inevitably, that did happen to PIP implants. In 2006 Ms. Rachel Walters, a UK plastic surgeon encountered such a case. Because of the unusual and unexpected consistency of the silicone in the PIP implant, the rupture and its consequences presented Ms. Walters and her patient with serious and difficult problems. She was so concerned that she wrote a letter to the British Journal of Plastic Surgeons recording the problem and alerting the profession and anyone interested or concerned.
The following year, in 2007 another UK plastic surgeon, Mr. Brook Berry, encountered another case. He also wrote a letter to the British Journal of Plastic Surgeons recording the problem and alerting the profession and anyone interested or concerned.
The British Journal of Plastic Surgeons is published in English. It was available to be read by any doctor or regulator or hospital/clinic proprietor in the UK and Ireland.
It would appear not to have been read, because the use of PIP implants continued.
In 2010 the French medical devices regulator received an anonymous tip-off about PIP. It launched an investigation and discovered the fraud. It then notified other government regulators, including the British and Irish regulators. They issued a medical alert and a “recall”.
What was recalled was the stock of PIP implants in the hands of any doctor or regulator or hospital/clinic proprietor in the UK and Ireland.
The stable door was now shut but the horse had bolted.
In Ireland the authorities are in denial. The Irish Medicines Board is the regulator for medical devices. It recommends that women fitted with PIP breast implants consult the doctor that fitted them, presumably to privatize the decision to take them out or leave them in. Its recommendation ignores the clear potential for a conflict of interest resting with such a doctor. Did the doctor not know of the FDA licence revocation and if not, why not? Did the doctor attend any continuous professional development courses since 2006 or 2007? If not, why not? Why did such a doctor not read a, presumably, leading professional journal in his/her specialised field?
The same questions can be directed to the Irish Medicines Board and the hospital/clinic proprietors or managers fitting PIP breast implants.
No doubt the hospital/clinic proprietors feel they are between a rock and a hard place. In Ireland, almost universally, the PIP breast implants were fitted pursuant to a contract with the patient. Those contracts contained some implied terms. The terms are implied by law; that means that the parties making the contract don’t have to express the terms, for them to form part of the contract. Firstly, it was a term that the person or persons fitting the implants would have the required skill and knowledge to do so properly. Secondly, it was a term that the implants would be merchantable. “Merchantable” means that they were fit for their purpose.
At a minimum PIP breast implants were not merchantable. Consequently the hospitals/clinics breached their contracts and the patients are entitled to be compensated for any losses arising from that breach.
Currently, only some lawyers are using language like this. The hospitals/clinics are, effectively demanding that patients produce, at their own expense, a scan. The scan is presumed to show if there is a rupture or not. (It has been suggested that it does not, necessarily).
The hospitals/clinics are, by implication, defining “breach of contract” to mean “rupture”. Probably, if pressed they would even deny that a PIP breast implant rupture is evidence of a breach of contract. They could cite the fact that all breast implants are at risk of rupturing, and argue that a ruptured implant is also a merchantable implant.
These ideas ignore the fact that the evidence of lack of merchantability is in the “recall”. Why recall merchantable goods? If a PIP implant ruptures nobody knows what the consequences will be, save that they will constitute a medical emergency, the same medical emergency that Ms. Rachel Walters and Mr. Brook Berry wrote about in the British Journal of Plastic Surgery.
But there will be a difference; those doctors did not know that the silicone that leaked into their patients was not pure. Now, the profession does know that. The regulator knows that. The patients know that.
Only the patients, some of them, are acting to deal with this crisis.
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