The Essure method of permanent contraception by natural means will no longer be marketed in Europe. Long acclaimed for its non-invasive nature, it had been in the spotlight for many months. Patients denouncing an underestimation of the risk of complications.
The Bayer laboratory announced, Monday, September 18, 2017, its decision to end the marketing of its Essure contraceptive implant in all countries, except the United States. A decision for commercial reasons insisted on clarifying the German group. But it’s hard not to see a link with the controversy that surrounded Essure for a few months and which had seriously damaged its capital of confidence with women.
Put under enhanced surveillance by the National Medicines Safety Agency (ANSM), Essure was suspected of causing severe side effects. These doubts led the European authorities to suspend its use last August for a period of three months.
A non-invasive sterilization method
Practiced in France since 2002 and covered by the Health Insurance, this modern technique of non-surgical sterilization, was an alternative to traditional tubal ligation. Like this one, Essure’s principle is to block the passage of sperm through the fallopian tubes, and thus put a definitive end to fertility.
Concretely, it involved placing a soft and flexible micro-implant, containing no hormone, in each of the two fallopian tubes, where the eggs pass from the ovary to the uterus. Three months after the placement of the micro-implants, a connective tissue formed all around and blocked the tubes. The sperm can then no longer fertilize the egg, which makes pregnancy impossible.
Its asset: being Non invasive. That is to say, it was done by natural means, using a hysteroscope (visualization and intervention device) of 5 mm in diameter, without any general anesthesia, nor incision of the skin. It also did not disrupt the menstrual cycle. A check-up three months later during a pelvic x-ray or hysterosalpingography made it possible to ensure the correct positioning of the implants and therefore thepermanent obstruction of the tubes.
The Essure method could be offered to “all adult women of childbearing age” who no longer had a desire for motherhood. It was particularly suitable for women who were not satisfied with a non-definitive method of contraception: difficulty in tolerating hormonal contraception, heavy periods under an IUD, etc. This method being final, it was not possible to go back
Why was the Essure implant disputed?
If the Essure sterilization had demonstrated its effectiveness, it was also under fire from critics. More and more women had reported side effects, most often abdominal or pelvic pain, bleeding, or migration of the device. More rarely, cases of pregnancy, especially ectopic pregnancies, had been reported. Several French women had also launched in December 2016 a legal action against the maker of the Essure device.
This controversy had led the National Medicines Safety Agency (ANSM) to put this device under reinforced surveillance and to supervise its installation practices. The benefit/risk ratio remained favorable according to the initial conclusions, published in April 2017, of the expert committee responsible for re-evaluating Essure implants. Experts had insisted on the need for a vsx-ray check three months after installation. However, only 80% of women benefited from it. New recommendations were to be issued soon by the ANSM. Faced with the continued decline in demand in Europe, the laboratory obviously preferred to take the lead …