Essure Side Effects

As of Dec. 31, 2019, all facilities with unused Essure units should have returned the units to Bayer. They are no longer available for implantation. Although Essure is no longer distributed in the United States, the U.S. Food and Drug Administration is committed to collecting long-term safety information on women who have received the device.

As of Dec. 31, 2023, the FDA had received 57,802 reportable events related to the Essure birth control implant since its approval in 2002. These events included 57,099 reports of serious injuries, 588 reports of malfunctions and 115 reports of deaths.

Patients have reported both immediate and delayed short-term side effects, such as pain and vaginal bleeding, at various stages of the product’s implantation. The exact side effects experienced vary from patient to patient.

There were also risks specific to the implantation procedure. For instance, a piece could break off the device during implantation, necessitating the removal of the broken pieces.

Additionally, as with any medical device, allergic reactions to the materials might occur.

“A lot of women had severe allergic reactions to the device — about 20% of the population is allergic to nickel and not aware of it,” Holly Ennis, an Essure lawyer and partner at Ennis & Ennis, told Drugwatch.

In some cases, patients required anesthesia during the implantation. Anesthesia has its own set of side effects, including temporary nausea, headache, muscle twitching and dizziness.

Essure Confirmation Test

The reported side effects of the Essure Confirmation Test were similar to those reported during the implantation procedure.

Doctors would perform the confirmation test on a patient a few months after receiving an Essure implant to ensure the device was working properly. To complete the Essure Confirmation Test, a health care provider performed a transvaginal ultrasound (TVU) or a vaginal X-ray exam.

However, patients who underwent immunosuppressive therapies such as corticosteroid treatment or chemotherapy were discouraged from having a TVU performed.

Because Essure works by scarring the fallopian tubes, there was a high chance for people with compromised immune systems to have a delayed scarring reaction. Because TVU cannot detect scar tissue to confirm the device is working, doctors did not recommend this procedure for patients with immunocompromised systems.

Long-term adverse effects included pain, heavier period flows, perforation, headache and fatigue. Thousands of reports also mentioned movement or device dislocation. Over 1,100 women reported that the device did not meet their expectations due to malfunction or unexpected pregnancy. From 2017-2022, the majority of reports regarding Essure submitted to the FDA mentioned device removal.

Amanda Chavarria had Essure implanted when she was 22. Shortly after the procedure, she began having pelvic pain and irregular menstrual cycles. Then the back pain, fatigue, rashes, swelling and migraines started. She also became depressed and went through an ectopic pregnancy.

“All these medical problems back-to-back, my family labeled me a hypochondriac and an attention seeker,” she told Drugwatch.

Additionally, as a permanent contraceptive device, people who have Essure implanted have a lower chance of getting pregnant than those who do not use any form of birth control.

However, clinical studies indicate that 8% of women who are implanted with the device may still be fertile. The odds of pregnancy decrease over time, as women who have had the device for over five years exhibit less than a 1% chance of getting pregnant.

On December 31, 2019, the manufacturer Bayer officially pulled all Essure devices from the market. The company stopped selling Essure and issued instructions to hospitals and doctors’ offices regarding the return of, and compensation for, previously purchased devices. Bayer advised against implanting any more devices. Today, the device is no longer distributed or implanted in the United States.

While the FDA never officially recalled Essure, it continues to investigate the implant. On February 12, 2024, the administration conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) seeking data on Bayer from the day of its approval back in 2002 through December 31, 2023.

If you have Essure and are experiencing side effects such as debilitating pain, or you don’t feel you can rely on the implant to prevent pregnancy, speak to your health care provider about removing it. Implant removal requires surgery, which has its own risks and benefits unique to each patient.

From 2017-2018, the FDA evaluated medical device reports regarding the removal of Essure. The administration wanted to understand why approximately 17,000 patients were considering the removal procedure which required surgery. The most common reasons for seeking device removal were pain, genital hemorrhage and device dislocation/expulsion.

Additionally, some patients with the implant reported a metal allergy or a suspected metal allergy. Providers often recommended these patients to have their device removed.

Current Essure users who are not experiencing adverse effects do not need to have the device removed. The FDA assures patients, “If you have been using Essure successfully to prevent pregnancy, you can and should continue to do so.”

While Essure is no longer an option, there are other IUD options for those seeking long-term or permanent birth control. Some IUDs, such as Mirena, Kyleena, Liletta and Skyla, are hormonal. Others, such as Paragard, are copper.

Like Essure, a medical practitioner inserts these devices through the vagina. Most IUDs need to be replaced every 5-10 years, depending on the brand. IUDs have many of the same risks as Essure, such as penetration of the uterine lining.

Tubal ligation, which blocks, clips or removes the fallopian tubes, is another form of lasting birth control. Because this is a more invasive procedure, you and your doctor should discuss any potential risks or relevant health factors related to this surgery.

Editor Lindsay Donaldson contributed to this article.