Over 750,000 women and their doctors have chosen Bayer’s Essure for their birth control needs.

However, new labeling changes advise women to carefully consider whether the risks associated with the permanent birth control device outweigh the benefits.

What is the Essure Permanent Birth Control Device?

Essure is a permanent birth control device that works by creating scar tissue in a woman’s fallopian tubes to stop eggs from descending into the uterus and sperm from entering the fallopian tubes.

The Essure permanent birth control device is a coil made from stainless steel, nickel titanium and polyethylene fibers.

The coil is inserted through the vagina into the fallopian tubes, where it expands and anchors into the walls of the tubes. During the months following insertion, scar tissue builds up to seal the fallopian tubes.

Bayer markets Essure as the only FDA-approved permanent birth control device available to women without a surgical procedure. Essure is promoted as being over 99% effective at permanently preventing pregnancy with a quick recovery after insertion.

What are the Risks of Essure?

Since the FDA approved Essure in 2002, the FDA has received more than 9000 reports about Essure problems for women. These reports include:

• Severe, Debilitating Pain/abdominal pain
• Heavy Menstruation and Irregular Periods
• Persistent, Regular Headaches
• Chronic Fatigue
• Device Migration and Breakage
• Additional Surgeries, Including Hysterectomy
• Unexplained Bleeding
• Weight Fluctuation
• Unintended or Ectopic Pregnancies
• Autoimmune Reactions: Rashes, Hair Loss
• Fetal Death
• Chronic Back or Pelvic Pain

Often times removal of Essure can alleviate the symptoms. However, in certain cases, a normal Essure removal is not possible because the fallopian tubes and uterus are too damaged. In these cases, surgeons often opt to perform a complete hysterectomy.

FDA Responds to Essure Complaints

In response to thousands of complaints made to the FDA from women about Essure, in September 2015 the FDA convened a meeting of its Gynecology Panel.

The panel made recommendations that certain women should not use Essure. These women include those with allergy or hypersensitivity to nickel, chronic pelvic pain, autoimmune disorders or women that have had prior uterine surgery.

The panel was concerned that Bayer failed to collect data that might have helped predict the risks to women of using Essure.

As a result of this meeting, in February 2016 the FDA ordered Bayer to conduct a new Essure safety study designed to provide important information about the risks of the device in a real-world environment.

Additionally, the FDA mandated labeling changes for Essure that include a boxed warning and patient decision checklist to help ensure that women receive and understand the benefits and risks of the permanent birth control device.

Filing an Essure Lawsuit

Women who receive an Essure permanent birth control device for pregnancy prevention may be at risk for side effects like device fracture, migration and perforation of internal organs.

If you or a loved one has taken Essure and experienced severe side effects, contact a specialized Essure attorney to help assert your legal rights.