This is the beginning of a victory for the many women who have been fighting for years against the Bayer laboratory and its Essure implant.
The German manufacturer has announced, via a statement published on September 18, 2017, its decision "to stop the commercialization of the medical device definitive contraception in all countries except the United States", while it is the same. suspended from its CE marking since last August 3rd.
Bayer clarifies that this is a choice taken "for commercial reasons" and not motivated by "a problem of safety or quality of the product". According to him, it is directly attributable to the controversy surrounding the device, which for several months causes "a steady decline in demand."
No questioning of the safety and effectiveness of the implant
For its part, the National Agency for the Safety of Health Products and Medicines (ANSM) "wishes to reassure the wearers of the Essure implant on the benefit / risk ratio of the device".
The health authority and the laboratory agree that it has been evaluated by a committee of experts and therefore presents no danger for patients: "The safety and efficacy of 'Essure remains underpinned by more than a decade of real-life scientific research and clinical experience, and the safety, efficacy and proper use of the Essure medical device have always been our highest priority, "says Bayer.
In addition, the ANSM invites women with symptoms "to consult their doctor not to ignore an underlying pathology." And to specify that "in the absence of such a diagnosis, the interest of a withdrawal can be considered between the woman concerned and the doctor. "
According to the health agency, "a meeting on these topics will be held very soon at the Ministry of Solidarity and Health with representatives of associations, health professionals and the various institutional actors concerned."
A decision that does not put an end to the actions of victims' associations
The RESIST patient association, which announced a few months ago its intention to launch a collective action against the laboratory, "welcomes this decision which will limit the number of victims in the future", but "certainly does not no end to (their) action, "says Marielle Klein, its president in a statement.
The latter remains convinced "that other reasons, directly related to product safety, are not unrelated to this decision". Adding that "it is unacceptable that the health of women passes after the profit of a pharmaceutical giant". A decision that does not call into question the judicial procedures provided. As such, she wants to quickly organize a hearing with Agnès Buzyn, Minister of Solidarities and Health.
At the same time, the Paris prosecution has just decided to dismiss the case concerning the 3rd and 4th generation pills, accused of causing serious sequelae such as stroke or pulmonary embolism, after four years of investigation.
Sources:
https://www.bayer.fr/actualites_Bayer_arret_commercialisation_Essure_France
https://ansm.sante.fr/S-informer/Actualite/Information-suite-al-arret-de-la-commercialisation-en-France-par-la-societe-Bayer-Pharma-AG-du-dispositif- de-sterilization-final-Essure-Communicates
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