Women in the U.S. and Canada have begun to take their Essure complaints to the legal system.

In Canada, over 100 women have joined in a class action lawsuit seeking to hold Bayer accountable for their alleged Essure side effects.

The lawsuit accuses Bayer of failing to adequately warn these women about the risks of complications associated with the Essure procedure.

What is Essure?

Essure is an implantable method of permanent birth control, developed as an alternative to surgical sterilization. In the Essure procedure, two coils are placed inside the fallopian tubes. These coils stimulate the growth of scar tissue over the course of a few months, preventing fertilization.

Bayer, the manufacturer of Essure, describes Essure as the only FDA-approved non-surgical method for permanent birth control. On the Essure website, the company says around 750,000 Essure devices have been sold around the world.

Essure Complaints Number in the Thousands

In online support forums, Facebook groups, and news reports, women are sharing their stories of complications they suffered after undergoing an Essure procedure.

Tess S. from North Carolina says she started suffering Essure side effects within a few months of receiving the implants.

About two months after a follow-up X-ray confirmed the device was in place and functioning correctly, Tess says, she began to experience abdominal pain severe enough to prevent her from sleeping or eating.

Tess’s symptoms worsened over the next six years. She developed several different new allergies, including a metal allergy so sensitive it prevented her from wearing jewelry.

She says she also started having migraine headaches and abdominal bloating. During that time, her doctor’s couldn’t figure out what was wrong.

Finally, Tess says, she saw a news story about other women who had suffered complications after undergoing an Essure procedure.

Taking that report as a tip, Tess and her doctors discovered her Essure implant was starting to erode through her fallopian tubes, she says.

She says tissue growth fused her uterus, fallopian tubes and bowels together.

Removing her Essure implants required a hysterectomy, she says. Tess says that after six years of Essure side effects, she felt better as soon as she woke up from her surgery.

Response from the FDA

The FDA has received over 5,000 Essure complaints since the device was made available for sale in 2002.

Women have reported complications like pain, autoimmune disorders, fatigue, bloating, and device displacement and breakage, all of which they believe are Essure side effects.

After an investigation into the issue, the agency announced it will require a new boxed warning for Essure as well as a new patient checklist intended to put patient on notice about the relevant risks and benefits associated with the Essure procedure.

The FDA is also requiring Bayer to conduct a postmarket surveillance study to gather more information about Essure side effects.

Bayer itself has acknowledged these women’s Essure complaints but has yet to recognize any causal connection between Essure and the complications these women describe.

The manufacturer insists Essure has a positive risk-benefit profile and says it will continue to cooperate with the FDA to monitor aftermarket Essure complaints.

Bayer, the manufacturer of Essure, describes Essure as the only FDA-approved non-surgical method for permanent birth control. On the Essure website, the company says around 750,000 Essure devices have been sold around the world.

Essure Complaints Number in the Thousands

In online support forums, Facebook groups, and news reports, women are sharing their stories of complications they suffered after undergoing an Essure procedure.

Tess S. from North Carolina says she started suffering Essure side effects within a few months of receiving the implants. About two months after a follow-up X-ray confirmed the device was in place and functioning correctly, Tess says, she began to experience abdominal pain severe enough to prevent her from sleeping or eating.

Tess’s symptoms worsened over the next six years. She developed several different new allergies, including a metal allergy so sensitive it prevented her from wearing jewelry. She says she also started having migraine headaches and abdominal bloating. During that time, her doctor’s couldn’t figure out what was wrong.

Finally, Tess says, she saw a news story about other women who had suffered complications after undergoing an Essure procedure. Taking that report as a tip, Tess and her doctors discovered her Essure implant was starting to erode through her fallopian tubes, she says. She says tissue growth fused her uterus, fallopian tubes and bowels together.

Removing her Essure implants required a hysterectomy, she says. Tess says that after six years of Essure side effects, she felt better as soon as she woke up from her surgery.

Response from the FDA

The FDA has received over 5,000 Essure complaints since the device was made available for sale in 2002. Women have reported complications like pain, autoimmune disorders, fatigue, bloating, and device displacement and breakage, all of which they believe are Essure side effects.

After an investigation into the issue, the agency announced it will require a new boxed warning for Essure as well as a new patient checklist intended to put patient on notice about the relevant risks and benefits associated with the Essure procedure.

The FDA is also requiring Bayer to conduct a postmarket surveillance study to gather more information about Essure side effects.

Bayer itself has acknowledged these women’s Essure complaints but has yet to recognize any causal connection between Essure and the complications these women describe. The manufacturer insists Essure has a positive risk-benefit profile and says it will continue to cooperate with the FDA to monitor aftermarket Essure complaints.

New Essure Litigation

Women in the U.S. and Canada have begun to take their Essure complaints to the legal system. In Canada, over 100 women have joined in a class action lawsuit seeking to hold Bayer accountable for their alleged Essure side effects. The lawsuit accuses Bayer of failing to adequately warn these women about the risks of complications associated with the Essure procedure.