A growing number of women have reported experiencing Essure side effects including pain, allergic reactions, and perforation.

Essure is a permanent birth control device released by Bayer Healthcare in 2002. The device was marketed as a non-surgical alternative to tubal ligation. Upon its release, Essure was considered a breakthrough permanent birth control method and expectations were high, securing it a fast track FDA approval.

The Essure system is comprised of two flexible coils. One coil is placed into each fallopian tube through a non-surgical procedure. After implantation, scar tissue develops in the fallopian tubes around the inserted coils. The developed scar tissue blocks ovaries from releasing eggs into the uterus.

Three months after the procedure, women are supposed to be evaluated by their physician to check that the procedure was successful and sufficient scar tissue has developed. Some patients, however, had to suffer through unexpected Essure side effects. 

Despite the high expectations regarding the device, reports suggest that it may not be the miracle birth control method it was advertised as. Nearly 27,000 women have reported Essure side effects following implantation of the permeant birth control system, according to a CBS Chicago article. Reported Essure side effects include bloating, persistent pain, excessive bleeding, rashes, allergic reactions, miscarriage, ectopic pregnancy, and perforation of organs.

“The coils are made of nickel and polyester fibers and when they’re placed in the tube, it creates an inflammation reaction, but this inflammation reaction continues in the body,” said Dr. Brett Cassidy, an obstetrician and gynecologist, to CBS Chicago.

Bayer has reportedly responded to complaints in a statement, saying that the reason for Essure side effects is “hard to say” and that “a lot of those symptoms can be hormonally-related and common as women go through reproductive life.”

Many consumers claim that unwarned Essure side effects occur because the device was approved too quickly, and adequate testing was not completed. Groups of consumers have lobbied for the device’s removal from the market due to the excessive amount of Essure side effects reported.

In response to consumer complaints, the FDA announced in February 2016 a new clinical trial to evaluate Essure side effects as well as changes to the product’s labeling.

“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel during the press conference. Maisel is the deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.

Although the FDA is actively trying to manage and understand Essure side effects, new regulation and research do not benefit women who have sustained injury due to Essure side effects. Some women affected by Essure side effects have filed lawsuits against Bayer, alleging that they were not warned of all the possible risks when they decided to get the birth control device implanted.

If you or a loved one have experienced Essure side effects, you may be eligible for an Essure class action lawsuit. An Essure lawsuit could potentially recover compensation for medical expenses, loss of wages or earning capacity, pain and suffering, and more. Fill out the form on this page for a free case evaluation.