Retiro De Equipo (Recall) de Prefilled breast prostheses of hydrogel

Recall

2002-01-07

France

ANSM

https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/decision-suspendant-la-mise-sur-le-marche-et-l-utilisation-des-protheses-mammaires-internes-preremplies-d-hydrogel-fabriquees-par-les-laboratoires-arion

Decision annulled by the decision of the Council of State of May 28, 200. The Director General of the French Agency for Health Safety of Health Products. Vu. books II and III of the fifth part of the code of public health and in particular its articles L. 5312-1 and R.665-15. Vu. the decision of the Chief Executive Officer of Afssaps dated 22 December 2000 suspending the placing on the market and the use of prefilled internal breast prostheses of hydrogel manufactured by the Arion laboratories. Vu. the Communication on Community and national provisions for breast implants of the European Commission dated 15 November 2001. Vu. the letter dated 4 December 2001 to Arion Laboratories informing them of the intention of the Agency to suspend the placing on the market and use of prefilled breast prostheses of hydrogel manufactured by Arion Laboratories . Vu. the reply of Arion Laboratories dated 11 December 2001 to the above-mentioned letter. Considering. that by decision of 22 December 2000, Arion Laboratories were required to provide information regarding the safety of prefilled internal breast prostheses of hydrogel. Considering. that by meeting of 28 September 2001, the Arion laboratories were invited to discuss the additional elements provided and still to provide. Considering. that the elements transmitted by the Arion laboratories do not make it possible to guarantee compliance with all the essential requirements of Annex I to Directive 93/42 / EEC, as explained in the Communication on Community and national provisions applicable to breast implants of the European Commission dated 15 November 2001. Considering. thus, it is not possible to exclude a risk of danger to health under normal conditions of use. Decide. Art. 1. - The placing on the market and the use of prefilled internal breast prostheses of hydrogel manufactured by the Arion laboratories are suspended as of the publication of this decision in the Official Journal. of the French Republic. Art. 2. - The Director of Medical Devices Evaluation and the Director of Inspection and Establishments shall each be responsible for the implementation of this decision, which shall be published in the Official Journal. of the French Republic .. Done at Saint Denis, January 7, 2002