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Essure is a method of permanent sterilization offered by the pharmaceutical company Bayer. Since its approval in 2002, thousands of women have come forward complaining of the side effects of the device. Despite that, it wasn’t until the media found out about a Facebook page called “Essure Problems” that the device gained national attention.
The group’s creator, Angie Firmalino, started the group in 2011, the same year that she had her Essure coils removed. After having the device implanted, Firmalino began experiencing heavy bleeding, back pain, fatigue, and a sharp, stabbing pain in her left side. It wasn’t until years later that her physicians discovered that her Essure coils had migrated. One was inside her uterus and the other was embedded in her uterine wall.
Many women interviewed said that they felt that their doctors were not being responsive to their complaints. The Facebook group gave them a place to talk to others experiencing the same complaints. The group has grown to include 28,000 women who update and make posts daily.
Essure was designed as an alternative to tubal ligation surgery, also known as “getting your tubes tied.” It comprises of two metal coils that when inserted through the vagina and cervix into the fallopian tubes, eventually prevent pregnancy. It is able to do so due to the scar tissue that grows around the device.
Besides pain, cramping, heavy bleeding and the possibility of migration, another potential hazard is unintentional pregnancy. Women are counseled to take an alternative form of birth control for three months following implantation and are required to attend a follow-up appointment at three months. The purpose of the appointment is to ensure that the device is properly placed and the scar tissue has grown sufficiently to prevent pregnancy.
In 2012, the Facebook group began tracking pregnancies. Any time a member posted an incident in the group, the admins of the group jotted it down in a database. Since beginning to keep track, there have been 650 reported pregnancies. Of those, 273 were reported to have miscarried.
In September of 2015, the members of the Essure Problems Facebook group finally got what they had been wanting: a chance to stand before an FDA panel to recount their stories. 22 patients in total were allowed to speak to their experiences. Another 21 speakers who were physicians, CEOs, and representatives from Planned Parenthood were also given time to speak. Most urged both Bayer and the FDA to conduct more studies.
While the device has yet to be banned, the FDA has required that the device carries it’s strictest “black box” warnings. In addition, Bayer must develop a new post-market study that will assess all risk of complications.
The push to have the device banned still remains.
If you have suffered an adverse health event due to the implantation of an Essure device, you might be entitled to compensation. Contact the law offices of John Foy & Associates. The “Strong Arm” attorneys will work to get you the compensation you deserve. Contact us today.
