According to a Scientific Committee, complications related to the use of the definitive contraceptive implant remain rare.
In 2015, more than 38,000 women chose permanent sterilization. The Essure method represents more than half of this type of intervention. But recently, doubt has been cast on this definitive contraceptive implant. After an increase in reports of side effects, the National Medicines Safety Agency (ANSM) reassessed the risks of the medical device. Meeting on April 19, the Temporary Specialized Scientific Committee (CSST) formed for the occasion delivered its conclusions. Its members do not consider it necessary to further restrict the prescription conditions.
A mixed record
Several studies were launched simultaneously with the same goal: to estimate the true frequency of side effects in carriers of an Essure device. Since its launch, just over 1,000 women have suffered side effects out of the 200,000 implanted. This remains low and comparable to reports made in the Netherlands or the United States.
Another question was raised by the ANSM: what is the rate of complications in relation to patients who have benefited from ligation of the disorders? The data seem rather reassuring. “Surgical and medical complications during fitting are respectively 5 times and 2 times less frequent in the Essure group than in the ligation group”, underlines the CSST. The credit undoubtedly goes to the minimally invasive approach: awake during the pose, the woman can alert the medical team to the pain she feels.
As for the effects at a distance from the installation, the results are more mixed. Tubal disorders are three times more common with the Essure implant. But those of the uterus, on the other hand, affect more women who have chosen ligation.
Real but varied symptoms
Since 2003, 1,177 reports concerning Essure have been sent to the ANSM. The “gynecological incidents” are far from being the majority, since they represent 21% of the declarations. On the other hand, “extra-gynecological manifestations” are reported in 4 out of 10 cases. This concerns muscle or joint pain, cases of depression but also allergies. These symptoms appeared after implant placement and improved after removal.
The CSST is therefore in a delicate situation. On the one hand, the figures leave no doubt: the carriers of the contraceptive implant do not suffer more diseases. “There are no increased signs of general damage to health in the presence of Essure,” summarizes the Committee. On the other hand, the symptoms are real and “shouldn’t be ignored”.
This is the whole problem: the pathologies are varied, are found in other situations, and the mechanisms are poorly understood. “At this stage, there is no predictive test for these manifestations”, deplore the experts. However, research on animals is underway in order to better understand this phenomenon.
Inform more clearly
In view of these data, the CSST does not consider it necessary to restrict the conditions of use of the Essure implant. As it stands, the available data “did not call into question the favorable benefit / risk balance” of the device.
It must be said that the rules have already been revised in February 2016. On that date, the Ministry of Health reduced, in a decree, the list of establishments authorized to implement the Essure device. The Bayer laboratory, for its part, has the obligation to provide a notice which details the risks in particular.
Without modifying the authorizations, the experts believe, however, that women’s information must evolve. Doctors are invited to mention the possibilities of failure, more frequent tubal complications, but also possible pelvic pain.
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