Essure : the MSNA request to Bayer to withdraw the implants from the sale.
Published the 06.08.2017 at 19: 19
The decision comes adding a bit of blur in the case of Essure. In a press release published this Friday, the national Agency of health of the drug (MSNA) has ” asked the company Bayer Pharma AG to proceed with the recall of products in stock at all health institutions may hold “. This request is due to the temporary suspension of the CE marking.
An expert committee convened in April by the agency for French food was, however, concluded ” that the data of the literature, of the monitoring and the results of the epidemiological study, involving more than 100,000 women, did not call into question the balance between benefit/risk of the implant “, says the MAN.
The agency would therefore have probably not made the suspension itself. But the National standards authority of Ireland (NSAI) does not have sufficient elements to renew the marking. For the marketing of a medical device in Europe, it is essential and certifies compliance with european legislation.
Issued by the irish authorities for Essure, it was valid for the other countries of the European Union. By this suspension, the NSAI therefore prevent the marketing in all countries of the continent. The measure took effect on 3 August last.
No danger to the carriers
The MAN invites the women waiting for an implementation to consider an appropriate alternative in consultation with their gynecologist.
She adds, however, that ” the decision of temporary suspension of 3 months of the CE marking made by the notified body is not of a nature to question, at this stage, the recommendations of the committee of experts relating to the care of women who are carriers of an implant Essure “.
In summary : “despite some reports of adverse effects, we do not believe that the implants Essure to be dangerous ; but the body which had validated his certification at european level is not safe ; so we didn’t have other choice than to follow this temporary suspension “.