Essure Problems 

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CE Mark for Essure Suspended on Aug 3 2017

Essure is an implantable medical sterilization device sold by Bayer Pharma AG.

ANSM was informed today that this device was now subject to a temporary suspension of its CE marking by the Irish notified body NSAI 1 , as part of its renewal procedure. T
his suspension takes effect on August 3, 2017 for a period of 90 days, that is, until November 2, 2017.

In view of this information, the Essure device can no longer be placed on the market in France and in Europe during the period of temporary suspension of the CE marking. The ANSM asked Bayer Pharma AG to recall the products in stock from all the health establishments likely to hold them. Accordingly, it is required as a precautionary measure to no longer implant the Essure medical device right away.

In this context, the ANSM invites women currently awaiting implantation by this method of definitive sterilization to approach their gynecologist to consider, in concertation, the most appropriate alternative, on the basis of complete information The available means of contraception and their possible adverse effects.

Regarding women with Essure implants, the ANSM recalls the opinion of the committee of experts which it met on 19 April 2017. The latter concluded that the data from the literature, surveillance and The results of the epidemiological study, involving more than 100,000 women, did not question the benefit / risk balance of this implant.

The Committee of Experts also recalls that women with symptoms should consult their doctor in order not to misunderstand an underlying condition. In the absence of such diagnosis, the benefit of withdrawal may be considered between the woman concerned and the doctor. For women who do not have symptoms, which represent the vast majority of women with the Essure implant, there is no argument to date to advise withdrawal.

ANSM considers that the decision to temporarily suspend the CE marking by the notified body for 3 months is not such as to call into question at this stage the recommendations of the Committee of Experts on the care of women Bearing a Essure implant.

The ANSM continues its work in close collaboration with the representatives of associations, health professionals and the various institutional actors concerned.

On march 3, 2017, bayer received a cluster of essure complaint reports originating from the ansm, health authority of (b)(4), device vigilance database via legal proceedings. Following receipt, bayer consulted ansm in order to obtain the relevant casereference number information. On march 24, 2017, ansm provided the available corresponding case reference numbers to bayer. Upon receipt of this information bayer evaluated and processed the cluster of essure reports within the global safety database by april 12, 2017.


https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.cfm?MDRFOI__ID=6533560