The temporary suspension of the CE marking of contraceptive implants does not call into question the recommendations of the French health agency.
The decision adds a bit of vagueness to the Essure affair. In one communicated published on Friday, the National Medicines Health Agency (ANSM) “asked Bayer Pharma AG to recall products in stock from all health establishments likely to hold them”. This request follows the temporary suspension of CE marking.
An expert committee convened in April by the French health agency had nevertheless concluded “that the data from the literature, surveillance and the results of the epidemiological study, involving more than 100,000 women, did not call into question the benefit / risk balance of this implant, ”recalls the ANSM.
European legislation
The agency would therefore probably not have carried out this suspension itself. But the National standards authority of Ireland (NSAI) would not have sufficient information 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 other countries of the European Union. By this suspension, the NSAI therefore prevents marketing in all countries of the continent. The measure took effect on August 3.
No danger for carriers
The ANSM therefore invites women awaiting implantation to consider an appropriate alternative, in consultation with their gynecologist.
She nevertheless adds that “the decision to temporarily suspend the CE marking for 3 months taken by the notified body is not likely to call into question at this stage the recommendations of the committee of experts relating to the care of women. with an Essure implant ”.
In summary: “Despite some reports of side effects, we do not believe that Essure implants are dangerous; but the body which had validated its certification at European level is not sure; we therefore have no choice but to follow this temporary suspension ”.
A class action in preparation
In France, 240,000 women have had recourse to the device which causes permanent sterilization. Around the world, around a million implants have been sold since 2002. They are particularly recommended for women who are intolerant to hormonal contraceptives.
Since 2003, 1,177 reports concerning Essure have been sent to the ANSM. Gynecological incidents (21% of reports), but also muscle or joint pain, fatigue, allergy and a few cases of depression. Symptoms that go away after removing the device.
These side effects are rare, but not nonexistent, and are more numerous in other countries. They had in particular led the Brazilian health authorities to suspend its use from last February.
A group action is in preparation on the French side against the Bayer laboratory, for September. About 400 people are said to have gathered around the Resist association, to assert personal injury to the courts. On February 20, a woman died following the implantation of the device. In July 2016, she had the implant inserted, but had developed a severe allergy to the nickel contained in the device.
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