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Master Thesis

Les implants mammaires pré-remplis de gel de silicone : impact de la fraude de la société Poly Implant Prothèse sur la règlementation des dispositifs médicaux : analyse des explantations au CHU de Bordeaux du point de vue de la matériovigilance

Abstract : Breast implants have been developed in the 1960s and are used nowadays in the case of breast hypoplasia and reconstruction. European regulations concerning medical devices (MD) and the current MD vigilance systems were set up in the 1990s. In 2010, the Agence Française de Sécurité Sanitaire des Produits de Santé has revealed what appears to date as the biggest health scandal involving MD: the company Poly Implant Prothèse voluntarily prefilled her silicone breast implants with a inappropriate silicone gel. These implants have been distributed in 71 countries and implanted in 400,000 women worldwide, including 30,000 in France. This case revealed many shortcomings in the MD marketing, evaluation and vigilance systems. In France, the removal of implants is recommended to patients even in the absence of any adverse effects or malfunction. In CHU de Bordeaux, 55 patients were explanted, representing 99 implants. A questionnaire was sent to patients in order to identify prostheses dysfunction, the occurrence of the migration of silicone to the axillary lymph nodes and any problems concerning protheses of another brand. The data was analyzed in terms of medical device vigilance systems. No suspicion about the safety of prostheses reimplanted were found. However, a longer-term follow-up of these patients is absolutely necessary because of the rates of adverse events or malfunctions observed in nearly half of patients explanted preventively. More generally, the problematic faulty implants reinforces the imperative traceability concept.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01109479
Contributor : Bu Carreire Université de Bordeaux <>
Submitted on : Monday, January 26, 2015 - 2:05:26 PM
Last modification on : Wednesday, August 23, 2017 - 4:29:43 PM
Long-term archiving on: : Monday, April 27, 2015 - 10:26:20 AM

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Cécile Ribas. Les implants mammaires pré-remplis de gel de silicone : impact de la fraude de la société Poly Implant Prothèse sur la règlementation des dispositifs médicaux : analyse des explantations au CHU de Bordeaux du point de vue de la matériovigilance. Sciences pharmaceutiques. 2014. ⟨dumas-01109479⟩

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