Following an increase in reported adverse events related to the Essure implant, a panel of experts had to re-evaluate the benefit / risk balance of this definitive method of contraception. According to their findings, there is no reason to restrict the use of this device, although it is desirable to improve information for women who resort to sterilization
Summary
Definitive contraception: first recommended sterilization implant
No changes to the Essure regulations
Better inform patients about risks associated with definitive methods of contraception
The committee of independent experts responsible for evaluating the risks associated with the sterilization implant Essure considers that it is "not necessary" to modify the regulation on this device of the laboratory Bayer, according to its findings published Thursday on the site Of the Medicines Agency (ANSM). The available data do not call into question the benefit / risk balance of the Essure implant and "new regulatory conditions are not necessary", concluded the committee "unanimously".
Definitive contraception: first recommended sterilization implant
The final contraception or medical sterilization concerns more than one woman in 10 after 40 years. This permanent contraception is possible in France by two methods: the Essure device and the tubal ligation. Since 2006, the Essure method has been recommended as a first-line treatment and has taken a dominant position in relation to tubal ligation since 2009. About 200,000 women have used this definitive contraception in France, which was put on the market in 2002 .
The principle of Essure® is based on the placement of a 4 cm implant in the fallopian tubes which causes fibrosis and their obstruction, making it impossible to encounter the egg and spermatozoa. This operation is carried out by natural means, without anesthesia or incision and therefore leaves no scar. Specifically, the doctor will initially introduce the hysteroscope by crossing the cervix. He then introduces a physiological fluid to enlarge the uterine cavity and to locate the fallopian tubes (ostium). Finally, he introduces the Essure ® catheter into the working channel of the hysteroscope and places an implant inside each horn. Sterilization is effective after three months.
In France, but also in other countries (the United States, the Netherlands and Canada), a growing number of reports and complaints have appeared. Many women complain of very disabling side effects: abdominal pain, severe weight loss, muscle disorders or even severe depression. On the Change.org website, a letter to the Minister of Health requesting the withdrawal of the device has collected 75,000 signatures. It was in this context that an independent specialized Scientific Committee (STC) appointed by the National Agency for Drug Safety (ANSM) was seized to reassess the benefit / risk balance of this device.
No changes to the Essure regulations
The advantages of the Essure technique in relation to tubal ligation are that it is a minimally invasive technique (posing via the natural pathways), that it does not require systematic general anesthesia and that it is carried out in an outpatient setting Possible resumption of activity at the end of the act in the absence of anesthesia. On reading the data available on this implant and after hearing various associations and learned societies, the conclusions of the CSST are:
The use of anesthesia during the placement of Essure is high (50% to 73%, versus 100% for tubal ligation). While the alertness of the woman during the installation allows to alert on pain that may correspond to problems of pose.
The surgical and medical complications during laying are respectively 5 times and 2 times less frequent in the group Essure than in the group ligature.
The control at 3 months of the placement of Essure is carried out in 80% of the cases.
By comparing the complications between Essure and tubal ligation, the CSST judges that:
For gynecological incidents (21% of adverse reactions reported to the ANSM), the CSST reports that the incidence of tubal affections is increased in the Essure group (0.7% vs 1.2% at 3 years) The uterus are less frequent (1.3% vs 1.5% at one year, 4.2% at 5.3% at 3 years). A further sterilization after the initial act was carried out in the following year for 4.1% of the women because of a poor placement or an impossibility of placement of the device
Regarding extra-gynecological manifestations, the CSST considers that their number is very low compared to the women who benefited from the implant (457 of the 1087 incidents reported for 200,000 women with Essure) and that, compared with a group having Benefited from tubal ligation, "the results do not provide any argument in favor of an excess of morbidity and mortality in women carrying the Essure implant," "pathologies likely to explain non-gynecological symptoms Presented are rare and there are no increased signs of general health damage in the presence of Essure. "
With regard to removal of the implant, the CSST considers that this is a difficult act that must be performed by an experienced gynecologist to avoid the risk of fractures and the persistence of implant debris in the implant. The peritoneal cavity. The CSST recalls that reports of extragynecological manifestations must be reported systematically to the ANSM. In the absence of an underlying condition, the benefit of withdrawal should be discussed between the patient and her physician. For women without symptoms, the CSST considers that there is no reason to advise the withdrawal.
Better inform patients about risks associated with definitive methods of contraception
Considering that the data did not call into question the benefit / risk balance of this device, the Committee considers that:
New regulatory requirements are not necessary
The continuation of the enhanced surveillance enjoyed by this scheme is desirable
Control at 3 months after laying is essential and must be actively proposed
Better risk information for women contemplating permanent contraception is needed, whether the Essure implant or tubal ligation. Either according to the CSST, possibilities of failure or a difficulty of placement leading to a reoperation in 4% of cases with Essure, tubercular complications more frequent (less than 1% of cases) with Essure but uterine complications less frequent (1.3% of cases) than with tubal ligation. The possible occurrence of pelvic pain, painful or abundant menstruation after laying with Essure or ligature, symptoms that may be related to the discontinuation of hormonal contraception and to age.
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