Used by 35,000 French women, Essure’s definitive sterilization method is said to be a source of complications and surgical interventions.
Since the early 2000s, French women have had the choice between two methods of permanent contraception: tubal ligation or tubal sterilization using the Essure device (see box). The latter is the most recent sterilization technique. Passing through the vagina, it avoids anesthesia and an incision. In France, 35,000 women have chosen tubal sterilization since 2002 (15,000 opted in 2010 for tubal ligation).
Women who use it are more likely to develop complications requiring surgery compared to women who opt for tubal ligation, reveals study published this Wednesday in the British Medical Journal.
A tenfold risk of operations
This work is the first to compare the safety and effectiveness of these two permanent contraceptive techniques. To do this, they analyzed health data collected between 2005 and 2013 from 8,000 women who preferred sterilization by Essure and those from 44,000 women who chose tubal ligation.
Researchers at Cornell University (New York, United States) were particularly interested in the 30 days following sterilization. They also assess the number of unwanted pregnancies and the number of operations 3 years after the operations.
The results show that the placement of Essure micro-implants is associated with a tenfold risk of operations. According to the authors, this constitutes “a serious risk for the patients”.
In addition, the risk of unwanted pregnancies was similar between the two methods. The researchers also specify that the risk of getting pregnant with the Essure method is one in 100, a greater risk than that reported in previous work. These showed an efficiency rate of over 99%.
Since 2007, the Haute Autorité de santé has recommended that this method be offered as a first-line treatment for women around 40 years old.
Contraceptive sterilization
In France, definitive contraception has only been legal since the law of July 4, 2001. Until that date, doctors could only practice sterilization for contraceptive purposes in a therapeutic setting. From now on, all adults can request sterilization for therapeutic purposes. The law does not provide for any condition of age, children or marital status. However, it obliges to respect a cooling-off period of 4 months after the first medical consultation. If at the end of this period, the person maintains their request, they must confirm it in writing.
Definitive contraception is surgery. It must therefore be performed in a health establishment (hospital or clinic) by a gynecologist. A hundreds of centers are authorized to perform these procedures.
In women, the most common operation is the ligation of the tubes of the fallopian tubes. It can be done under general or local anesthesia depending on the technique considered, the choice of the doctor and the patient. Effective immediately after the intervention, the failure rate is almost zero. In addition, postoperative complications are rare. In the event of a late period, abdominal pain or dizziness, it is important to consult your doctor.
Since 2007, the recommended first-line method has been the insertion of two Essure micro-implants at the entry of the tubes by hysteroscopy (vaginal route) without anesthesia. Measuring 4 cm, this spring causes the progressive occlusion of the tubes. Infertility is therefore not immediate, which is why for 3 months, patients must use contraception. At the end of this period, the gynecologist checks that the occlusion is achieved.
Despite the recent legal cade, gynecologists are reluctant to perform these procedures. Some speak of mutilation, while others (25%) ask for the spouse’s written opinion before performing tubal ligation or fitting an Essure device.
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