By Heba Elsherif  |  April 12, 2018

Category: Legal News

Essure birth control woman on bed holding stomachWomen seeking permanent sterilization may choose between laparoscopic sterilization, commonly referred to as having one’s tubes tied, or hysteroscopic sterilization, the method used by the Essure birth control system.

However, when it comes to permanent sterilization and the various options to choose from, none of them is without risk. According to a reportby Fox6Now News, a new study published by JAMA compared the risks involved with both permanent sterilization techniques.

While laparoscopic sterilization is done by reaching a woman’s fallopian tubes and closing them off with clips or bands through a surgical incision made close to her naval, hysteroscopic sterilization involves inserting a woman with a small birth control device known as Essure. Essure is placed non-surgically into a woman’s fallopian tube and acts as a birth control device to prevent pregnancy.

However, according to the new study that was conducted in France which compared the risks between both permanent sterilization techniques, there are increased risks for gynecological complications with hysteroscopic sterilization.

According to the study, hysteroscopic sterilization was associated with a higher risk of gynecological complications. Complications associated with Essure include the device’s failure to work and the need for a second sterilization procedure. However, there were no added medical risks involved with hysteroscopic sterilization, the study confirmed.

According to the scientific advisor with the French National Agency for Medicines and Health Products Safety, “The Novelty of our study lies in the fact that we did not find differences in several medical outcomes between both approaches.”

“Hysteroscopic sterilization was associated with lower procedural complications and increased gynecological complications compared with laparoscopic sterilization”, he added.

Hysteroscopic Permanent Sterilization

According to the study, there have been nearly 1 million hysteroscopic permanent sterilization procedures done in women around the world. After the U.S., France is also second in line in terms of the number of women that decide to undergo a hysteroscopic permanent sterilization procedure, the researchers also noted.

In women within the ages of 35-44, one in three women in the U.S. had undergone a permanent sterilization method between 2011 and 2013, according to the Centers for Disease Control and Prevention (CDC).

The U.S. Food and Drug Administration (FDA) says more than 5,000 women reported issues related to Essure in 2015. Some of the adverse side effects included perforation of their fallopian tubes, stillbirths, unintended pregnancies, debilitating pain, and bleeding.

According to the FDA, because of the adverse side effects complained about by women, they had to approve a new “black box warning,” for the permanent birth control device. The black box warning was “designed to call attention to serious or life-threatening risks,” the FDA states.

Although Bayer, the device’s manufacturer discontinued the production of Essure in all other countries, such as France, the device is still being sold here in the U.S.

In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.

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