By Armand Suicmez
Translation: Melissa Okabe
Passage au crible n°53
On January 4, 2012, the investigating judge of the city of Marseille led a search on the premises of the French PIP (Poly Implant Prosthesis) company located in the Var region, following the scandal over the breast implants manufactured by this company. Consisting of a non-compliant silicone gel, the PIP products would be responsible for several cases of cancer, even if the link between the implants and the pathology is not shown.
This affair extends beyond French borders because the firm exported throughout Europe, to the United States, and to South America. This incident also brings to light the absence of national and international rules concerning medical devices.
> Historical background
> Theoretical framework
> Analysis
> References
Established by Jean-Claude Mas in 1991, the French SME (Small and Medium Enterprises) PIP exports to 65 countries and sold 400,000 prostheses on the world plan. Its prosperous activity degraded with Asian competition in the 2000’s and with the decline of the dollar. The CEO decided to maximize profits by turning to an industrial silicone gel, seven times cheaper than the medical version. Thanks to this subterfuge, PIP was able to become the leader in this sector, in both production and in distribution.
In addition to being dangerous for health, the PIP products obtained a certification from the private enterprise TÜV Rheinland. This laboratory indeed validated the PIP serum as a physiological technology devoid of risk; Jean-Claude Mas having deliberately supplied a compliant implant sample at the moment of scientific testing. At the time of instruction, he declared to investigators: « I knew that this gel was not approved, but I deliberately made it because the PIP gel was cheaper ». Besides that, he had hidden the real composition of its articles to his customers, his suppliers but also to his own employees, by stating forged invoices.
Over 500,000 people across the globe are affected by this situation. In 2005-2006, the first patient complaints entailed a condemnation of PIP in the United States before cases of breaking prostheses multiplied over the next year in the United Kingdom, in Spain, and in South America. For one year and a half, a commercial ban was implemented and struck the company with a 1.4 million dollar global fine. Finally, the much mediatized fate of a woman who died of lymphoma provoked a collective panic. In 2011, Marseille’s public prosecutor department received nearly 2,400 complaints and opened a judicial inquiry for « involuntary wounds and manslaughter ». Today around 30,000 planned removals are anticipated in order to reduce the danger. The main person accused of the affair, Jean-Claude Mas, risks four years of imprisonment.
Let’s keep two main elements in mind:
1. Outsource labeling. Now essential, labels henceforth represent a pledge of sanitary safety. This mechanism became widespread in order to better protect the vulnerable consumer against numerous and sometimes meekly reliable information. This public authentication of national, community and international standards is now confined to private enterprises.
2. Medical expertise in the service of private interests. Often worshiped by commentators, expertise is valid when it is a question of estimating the quality of a product. However, it is advisable to remember that the process of scientific validation very often remains dependent on political and economic logic. Therefore, the neutrality of medical expertise is subject to query and must be questioned.
Nowadays, the value of expertise seems more and more important: it is almost made sacred, precisely when medical material is concerned, naturally in direct line with the questions of public health. Within this frame, the PIP implants – even before their ban – took on a double character: they remained the cheapest in the global market, all the while appearing to preserve medical qualities evaluated and confirmed by independent offices. Let us underline the fact that the AP-HP (Public Assistance- Paris Hospitals) furnished at that time three public cancer research centers in Paris with PIP devices.
A priori, the PIP scandal can appear as an isolated case of error due to the deceitful schemes of a single person: Jean-Claude Mas. However, in reality, the lack of international regulations has been underlined by the European governments as well as by non-state actors or individuals’ networks, groups of doctors or victim’s organizations such as the association for carriers of prosthesis PIP. Under the condition that silicone implants are considered as simple medical devices – that is low degree of risks and non-essential – they are regulated by the standard ISO 14607: 2007 « which specifies the requirements relative to the mammary implants intended for clinical purposes ». Now, this binding rule can allow the industrialist to label the performance evaluation of its own production.
In Europe, the sanitary materials vigilance subjects the manufacturer to a validation procedure by one of 70 certifying bodies, among which the independent laboratory TÜV Rheinland, plays an expert’s role symbolizing medical ethics. However, this does not in reality insure a detailed examination. Instead TÜV Rheinland is specialized in the installation of medical goods companies, with the objective of seeing their customers achieving maximum financial profits.
Governments made a commitment in favor of a preventive withdrawal of the product in the name of the precautionary principle. From then on, we indeed understand that their economic responsibility is implied by this scandal. If American justice demands a compensation from the French SME (Small and Medium Enterprises), on the other hand in France, financial participation from Social Security is expected. In return, health insurance lodged a complaint for « aggravated deceit and swindle » to be reimbursed for the likely 60 million euro in compensation granted to the victims. This transnationalized (prosthesis PIP) underlines, if need be, the heterogeneousness of governmental jurisdictions, which show themselves devoid in front of a health affair exceeding the strict frame of state sovereignties.
Xavier Bertrand, French Minister of Health, at the moment requires the implementation of a complete follow-up process for medical devices. However this normative watch, under public attentiveness, remains insured by private groups. Health therefore becomes « indissolubly bound to a system of market economy, based on the spontaneous strengths of the economic and political agents which intervene there ». In other words, the splendor of a non-falsified scientific objectivism hides an aggravated search for profit. Competition law (abuse of a dominant position) in the field of the health, already denounced in the plectrum affair, continues to constitute an endless risk ; especially when we know that more than 60% of the members of the AFSSAPS (French Agency of Sanitary Security of Health Products) hold interests within the pharmaceutical firms.
Behar-Touchais Martine, « Le Conseil de la concurrence et la santé », Les Tribunes de la santé, (15), fev.2007, pp. 63-77.
Demme Géraldine, « Le secteur de la santé face au droit de la concurrence », Regards sur l’économie allemande, (95), mars 2012, pp.27-32.
Paule Clément, « La Marchandisation mondiale de la santé publique, La stratégie entrepreneuriale des firmes pharmaceutiques », Passage au crible, Chaos International, (11), janv.2010, pp. 1-2.
Guelfi Marie-Claude, « Les dangers des lits médicalisés », Gérontologie et société, (116) jan.2006, pp. 77-83.
Kerouedan Dominique, Santé internationale. Paris, Presses de Sciences Po, 2011.
20min.fr, Santé ; « Prothèses mammaires PIP : Jean-Claude Mas admet la tromperie sans regrets »: http://www.20minutes.fr/sante/853770-protheses-mammaires-pip-jean-claude-mas-admet-tromperie-aucun-regret, dernière consultation : 8 janvier 2011
