In a statement issued by the Food and Drug Administration (FDA) in September 2015, the federal agency noted a significant increase in the number of adverse reactions reported by women who had the Essure permanent birth control implant.

This increase happened as the FDA announced it was planning to meet to discuss problems that had been reported with the device that had not been included on the Essure product label.

The permanent birth control device was FDA approved since 2002. Over 5,100 adverse events were reported before September 2015, with 115 reports filed in 2011. This number increased significantly as there were 2,260 adverse event reports that were filed in the year prior to the meeting.

According to the FDA, four deaths of women implanted with Essure had also been reported.  One death was linked to an infection after the device was implanted, a second was due to uterine injury, a third was due to an embolism that occurred while the device was being removed, and the fourth death was a suicide.

Additionally, five fetal deaths occurring from unplanned pregnancies despite placement of the device were also reported. The FDA said the reports could include information that was not accurate or was unverified, and the reports did not necessarily indicate that the Essure permanent birth control was defective.

Essure is a device made by Bayer Healthcare AG and it consists of small coils and fibers that are implanted into the fallopian tubes of a woman who wishes to have permanent birth control.  After implantation, which is typically done in a doctor’s visit, the woman’s body tissue is supposed to grow around the implant, causing a permanent obstruction to fertilization.

The most commonly reported Essure complications include pain in the abdominal area, problems with menstruation and headaches, according to the FDA.  However, women have also reported much more severe Essure complications including uterine perforation, fallopian tube perforation, migration of the device to other parts of the pelvis or abdomen, irregular bleeding, hypersensitivity reactions and ectopic pregnancy.

According to the FDA website, following the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 2015, there was a docket that allowed the public to submit comments to the FDA regarding the Essure birth control implant.  The agency said it received over 2,800 comments and is reviewing each comment individually.

The FDA stated that information about Essure is currently under review, and they anticipate that the agency will be sharing the results of their review with the public at the end of February 2016.

Essure Lawsuit Information

In February of last year, a law firm based in Florida filed a citizen petition for the Essure implantable birth control to be removed from the market, claiming that the clinical trial information used to gain FDA approval in 2002 had been manipulated.

If you experienced any Essure complications including pain, uterine perforation, fallopian tube perforation, migration of the device to other parts of the pelvis or abdomen, irregular bleeding, hypersensitivity reactions, ectopic pregnancy  or other severe side effects from the implantation of the Essure device, you may have a legal claim.

An Essure attorney can review your case at no charge to you and can assist you in understanding your legal options in pursuing an Essure individual or class action lawsuit.