The French National Agency for Medicines and Health Products Safety (ANSM) decided on Thursday to suspend the permanent contraception device FemBloc, concluding that the available data do not sufficiently demonstrate its efficacy or safety.
According to the ANSM, the studies provided by the American manufacturer Femasys involve too few women and a follow-up period that is too short to guarantee that this non-surgical sterilization method is reliable in the medium and long term. The agency is therefore blocking its marketing, distribution, and use in France, except within the framework of a potential clinical trial.
FemBloc involves injecting a polymer into the fallopian tubes to cause permanent blockage after healing. The device is already sold in Spain, where a post-marketing study of 100 patients is underway, and it has received authorization in the United Kingdom and New Zealand. In France, only four women have used it since March.
This decision comes in a context marked by the precedent of Essure implants, another non-surgical sterilization method withdrawn from the market at the end of the 2010s after numerous adverse effects and legal actions.
Sophie de Duiéry
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