Marketed as the only permanent birth control with a nonsurgical procedure, Essure is billed as a modern alternative to having one’s “tubes tied.”

Bayer maintains that the product has a long history of safety and effectiveness, but these claims have been questioned by women who allege that pain after Essure placement seriously damaged their health.

What is Essure?

Approved by the FDA in 2002 for women ages 21 to 45, Essure is a very soft, flexible metal spring made from a nickel-titanium alloy. The Essure procedure is often done in a medical office with minimal anesthesia and recovery time.

Over the next several months, scar tissue grows around the implants, thereby blocking the fallopian tubes and preventing eggs from becoming fertilized or making their way to the uterus.

Women must return three months after the procedure for a follow-up X-ray using dye to confirm that the tubes are fully blocked, at which point the method is considered 99.83 percent effective.

However, since Essure permanent birth control entered  the market, the FDA has received over 5,000 complaints, with pain being the top symptom.

Pain After Essure Placement Likely More Serious

Many of these complaints claim complications associated with Essure include:

• Additional surgery, including hysterectomy
• Autoimmune response such as fatigue, rash, hair loss, weight gain
• Chronic pain
• Bleeding
• Miscarriages
• Ectopic pregnancies
• Unintended pregnancy
• Perforation
• Expulsion
• Migration of the device
• Death

Call to Pull Essure from Market

Thousands of American women have come forward on social media with stories of injuries and malfunctions related to the device. There is even a dedicated Facebook group called Essure Problems with over 28,000 members that details many of these accounts of Essure complications.

In fact, many of these women, known as “E-Sisters,” who say they have been harmed by the Essure birth control device are urging the FDA to take it off the market and warn the public about its potentially serious side effects.

Even lawmakers are calling for the federal agency to withdraw its original approval amid reports of complications and pain after Essure placement experienced by women across the country.

FDA Takes Action

Despite the thousands of complaints concerning pain after Essure placement, the FDA has declined to withdraw the device. The agency says that Essure is safe and effective for many women, even though some experienced “very serious and sometimes debilitating problems.”

But in November 2016, the agency ordered a new “black box warning” label for Essure—the strongest warning available to call attention to serious or life-threatening risks, saying the permanent birth control could cause injury.

The FDA also took the unorthodox step of guiding Bayer in the development of a new checklist of risks for doctors to review with patients before implanting the device. The three-page checklist is broken into five sections, each followed by a spot for the patient’s initials, and is to be signed by both doctor and patient.

The checklist is not mandatory, and critics say it does not mention many common side effects linked to Essure.

Filing an Essure Lawsuit

Several women and their loved ones have pursued Essure lawsuits, claiming the device seriously injured them.

If you or a loved one suffered pain after Essure placement that led to a serious or life-threatening side effect, you may be entitled to compensatory damages.