92 deaths, including pregnancy loss and infant death linked to Essure birth control device, prompting legal action
Key Takeaways
Essure is a permanently implanted birth control device. Two hundred patients in the UK who had the Essure device implanted are taking group legal action against Bayer, the manufacturer.
Patients say the device led to pain, heavy bleeding, and other complications—with some needing hysterectomies.
Two hundred patients fitted with the implanted birth control device Essure are taking group legal action against Bayer, the manufacturer, reports the BBC. Bayer is set to pay a billion-dollar settlement.[][]
Lawyers began legal action against Bayer in 2020 by lodging claims of the UK-based patients against the company. Other patients in the UK wishing to join the group will have until 2024 to do so. Device sales were discontinued in the UK in 2017.[]
Patients in the UK have reported “constant pain and complications afterwards, including heavy bleeding, with some ending up having hysterectomies,” according to the BBC. One patient told the news outlet that her symptoms were thought to have stemmed from her Crohn's disease. Only after conducting a CT scan did her doctor realize the patient’s symptoms were likely caused by the device, which was then removed as part of a hysterectomy.[]
The problem exists in the US as well. In 2022 alone, 1,606 reports related to Essure were received by the Food and Drug Administration (FDA). In the five years prior, reports tallied more than 50,000, according to the FDA, which also notes that the “nature and severity of the reports in 2022 remain consistent with prior years.”[]
From 2002 to 2022, the most reported patient problems included—in order of frequency:
Pain, including abdominal pain
Menstrual irregularities
Foreign body and device fragment
Device perforation
Headache
Fatigue
Weight loss and gain
Depression and anxiety
Hypersensitivity
Rash
Device problems reported—in order of frequency—included patient-device incompatibility/biocompatibility (for example, a possible nickel allergy), migration of the device or device component, device breakage or fragmentation, dislodged or dislocated device, device operating differently than expected, malposition of the device, device difficult to remove, and device difficult to insert.
Through December 31, 2023, there have been 92 reports of death, including incidences of pregnancy loss, death of an infant after live birth, and ectopic pregnancies. The FDA has also received nearly 5,000 reports of pregnancies in patients with Essure. []
Over the years, patients started rallying together after experiencing Essure-related health problems. A 2018 NBC News article detailed the experience of one patient, Angie Firmalino, who was implanted with Essure. Firmalino told the news outlet that after the implantation, she experienced nearly debilitating discomfort—“fevers, achy joints, [and] constant bleeding”—for months.[]
When Firmalino eventually had an ultrasound completed, MDs discovered that the implant—originally inserted in her fallopian tubes—had migrated to her uterus. She later had the device removed, which NBC News says, “left behind metal fragments that ravaged her reproductive system.” Afterward, Firmalino started a Facebook group called Essure Problems,which, at the time, was used by more than 36,000 women.
Bayer stopped selling and distributing the Essure device in the US in December 2018, according to the FDA. Starting in September 2019, Bayer informed its customers that, “As of December 31, 2019, all unused Essure units should have been returned to Bayer and are no longer available for implantation.”[]
A Bayer representative told the BBC, "While all birth-control products and procedures have risks, the totality of scientific evidence on Essure demonstrates that the benefit-risk profile is positive.” The claimants in the UK will still need to prove the merits of their claims.[]
What is Essure, exactly?
Huong Nghiem-Eilbeck, MD, MPH, OB/GYN and staff physician at Pandia Health explains, “Essure was a smart device that allowed for outpatient or minimally invasive procedure for a tubal ligation. This means a patient could get a tubal ligation under local anesthesia.”
The device, she says, used a non-allergenic nickel coil that was easily placed hysteroscopically. To do so, a camera was inserted vaginally into the uterus so that an MD could insert a tiny device into each fallopian tube.
“Over time (usually three months), the nickel would cause a reaction that would scar and seal over the device causing complete blockages. Patients would perform a uterine dye test 3 months later to confirm blockage,” Dr. Nghiem-Eilbeck says. “It was an alternative to postpartum or elective surgical sterilizations that would require one to three small open incisions on the abdomen.”
Dr. Nghiem-Eilbeck says that the device implantation should not have caused pain or bleeding, especially if inserted correctly. “Some patients did claim these symptoms afterwards.” And because the device was inserted at the cornua, or the two cavities of the uterus, it wasn’t reversible. “The small coils are nearly impossible to remove without doing a hysterectomy,” she adds.
According to David Kimble, MD, a female pelvic medicine and reconstructive surgery specialist in Pasadena, CA, the device’s concept was “brilliant and the technique of placement ingenious. However, the reality is that unexpected and unforeseen complications have left women with adverse sequelae.”
Dr. Kimble went on to say that Essure can cause “significant tubal damage, migration, collateral damage to adjacent organs, and chronic pain—just to mention a few,” noting case reports that document unexpected implantation of the coil outside the tube, inside the uterine wall, and within adjacent organs.
Keeping and removing Essure
If a patient currently has an Essure device implanted, the FDA says that women who have successfully used Essure to prevent pregnancy can and should continue to do so. Meanwhile, the agency says Bayer must continue meeting its mandated postmarket study obligations.
“We believe clinical data from this postmarket study will help patients, health care providers, and the agency better understand certain complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation,” the FDA notes.[]
A 2021 review published in the European Journal of Contraception & Reproductive Health Care looked at 17 studies regarding Essure removal.[] The most frequently described surgical techniques for removing Essure included laparoscopic salpingectomy (LS), laparoscopic cornuectomy (LC), and laparoscopic or vaginal hysterectomy (LH, VH) with en-bloc salpingectomy. The authors found that there “were more fractures of the device with the LS procedure (6.25%) followed by the LC technique (2.77%), while there was no fracture with hysterectomy.” That said, complications due to hysterectomy— compared with the LC and LS procedures—were more severe and frequent.
A 2020 article in the Journal of Gynecology Obstetrics and Human Reproduction found that the “major improvement rate is not significantly different between laparoscopic salpingectomy and vaginal hysterectomy,” with, essentially, an “equivalent rate for the resolution of extra-gynecological symptoms.”[]