Better monitor the side effects of Essure sterilization implants. This is the goal of the women’s registry “explanted“, that is to say who had these implants removed, put in place”in the coming months“as announced by the Ministry of Health on December 17.
Better follow-up and better support
It was during a meeting held on December 15 at the ministry that the National College of Obstetricians and Gynecologists (CNGOF) “shared, in connection with the National Council of the Order of Physicians“, of its intention to create this register, indicates the Directorate General of Health (DGS) in a press release.
This register will allow “improve their monitoring and scientific knowledge to better adapt the management of these patients“.
“A review of the different explantation methods will soon be published“, also indicated the CNGOF during this meeting.
Read also: Essure implants: removing them to improve women’s health?
Bleeding, pain, fatigue …
These spring-shaped female sterilization devices, implanted in the fallopian tubes, are accused by more than a thousand women of having caused sometimes serious adverse effects after their implantation: bleeding, pain, severe fatigue, allergic reaction or still depression …
To date, according to the EPI-Phare group, more than 22,000 women would have carried out a removal of the implants, or explantation. A sometimes delicate procedure, but which results in an improvement in 70 to 80% of cases, according to figures presented last October by the National Medicines Safety Agency (ANSM).
Understanding the origin of side effects
A explant protocol has already been released at the end of 2018 by the health authorities. They do not recommend removal of the implant for women who do not have symptoms, “taking into account the risks associated with the surgical act of removal “.
The ministry adds that a “research protocol“will be funded”in the coming months” for “better characterize the phenomena at the origin of the undesirable effects presented by certain women carriers of Essure“.
240,000 women with implants in France
Marketed in France in 2002, the Essure implant was placed under enhanced surveillance in 2015 by the ANSM. Their manufacturer, the Bayer laboratory, ceased marketing in 2017. Between 2001 and 2017, around one million units of the Essure medical device were sold worldwide, including 240,000 in France, according to Bayer.
Last April, around thirty patients filed a criminal complaint after adverse effects from this medical device. Since 2017, the laboratory has also been targeted by a civil group action involving several hundred patients.
According to the ANSM, 1,087 women were confronted with a malfunction of the device or the occurrence of adverse effects between 2003 and the beginning of February 2017.