In 2013 an estimated 346,000 women in France had breast implants. Some 30,000 of these are thought to have received an implant produced by the company PIP (some of which have since been removed). Beyond determining that these breast implants are defective, it appears that the only way to document their potential adverse effects is to conduct a large-scale epidemiological study. At the request of the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) [French National Agency of Medicine and Health Products Safety], a group of researchers managed by Florent de Vathaire in Inserm Unit 1018 “Centre for epidemiology and population health research” is launching a study entitled LUCIE. The aim of this 10-year study is to monitor some 100,000 women who have or have had breast implants of any brand. The results will enable conclusions to be drawn with regard to the potential medium and long-term adverse events in women with PIP implants.

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The report gives an overview on 3 areas:

- For evaluation and recommendation, HAS especially recalls that 620 opinions of the Committee for transparency were delivered with 85 days of instruction median of applications for registration and 7 recommendations of good practice;

- In terms of certification, indicators and medical information, HAS finds that 1997 institutions have been certified and 130 medical visits exploitative pharmaceutical companies were made.

- In terms of tools, guides and methods for quality and safety of care, 11 cooperation protocols between professionals have been validated and 12270 accreditation certificates were issued. Finally, the report emphasizes on the development of international relations with 9 international projects including 2 new in the field of health technology assessment.

The ANSM (French National Security Agency of Medicines and Health Products) is organizing its first Meetings September 26, 2014 in Paris. This meeting will be an opportunity to discuss future challenges in health security: What is the role of innovation in health? How are scientific advances changing the regulation of health products? What impacts do new technologies have on our behavior? What vigilance, monitoring for tomorrow? Many lines of inquiry that will be addressed during this day.

Registration is free but mandatory.
Online registration form here.
Registration Deadline: Friday, September 12, 2014
Contact: Gwénaëlle Levaché

The ANSM (National Security Agency of Medicines and Health Products) publishes an analysis report of medicine sales in France.

The data for 2013 shows, as in the previous year, a slowdown in growth in value of the pharmaceutical market. Every person has consumed an average of 48 boxes of medicine in 2013, in the same way as for the previous two years. The generics market has continued to grow, more than 3 drugs reimbursed 10 in 2013 are generic.