What Is Essure?
Essure is a permanent method of birth control for women, which, according to the Mayo Clinic, is composed of two tiny coils, a stainless coil wound with polyethylene terephthalate polyester fibers that sit within a larger nickel-titanium coil. The coils are placed in the woman’s fallopian tubes through a catheter via the vagina.
An incision is not necessary for the procedure, which may be completed in a doctor’s office. Scar tissue forms around the coils, which is meant to block the fallopian tubes and stop sperm from reaching the egg, causing permanent fertilization prevention.
For the first few months following the insertion of Essure, another form of birth control is suggested until occlusion (blockage) has been confirmed. The procedure must also be followed up with an hysterosalpingography X-ray to confirm that the fallopian tubes successfully blocked. According to a September 2015 MedPage Today report, the FDA approved transvaginal ultrasound as an alternative test to confirm proper Essure placement.
The Essure procedure, as noted by the Mayo Clinic, does not protect against sexually transmitted diseases, is not reversible, and does not impact menstruation. Some patients are poor candidates for the Essure. Also, some procedures may not be performed following implantation, such as some pelvic electrosurgical procedures, due to Essure inserts’ metallic components.
The procedure, marketed by Bayer, received pre-market approval (PMA) by the U.S. Food and Drug Administration (FDA) in 2002. Conceptus, Inc., is Essure’s original designer and manufacturer, and it indicated that more than 700,000 women had undergone the permanent Essure procedure. According to Bayer, as of 2015, approximately 750,000 units of Essure were sold. That figure remains unchanged as of 2017. Bayer AG acquired Conceptus, Inc. in 2013.
Essure System is Linked to Serious Adverse Reactions
Thousands of women have reported significant health issues they allege were caused by the Essure system; thousands of women have filed lawsuits against Bayer over Essure.
According to the FDA, more than 10,000 Essure injuries were reported as of April 2017.
Also, over 30 deaths were reported that included four adult deaths, 21 pregnancy losses, one potential stillborn baby, and two infant deaths following birth. The agency also received 1,113 reports of pregnancy from women implanted with Essure and 474 pregnancy losses by women implanted with Essure.
A total of 5,016 medical device reports involving Essure were reported in 2016 and another 6,176 reports in 2015. Many of the reports indicate multiple side effects, including Essure being difficult to remove; fatigue; headache; heavier menstrual bleeding or irregularities; malposition of Essure; miscarriage; pain/abdominal pain, patient-device incompatibility, such as nickel allergy; pregnancy; and weight changes.
NBC News reported in late 2015 that study information released at the time that might confirm what some women have been saying about Essure. The researchers discovered that women who were implanted with the Essure device had to undergo 10 times as many operations to correct problems allegedly tied to Essure when compared to women who underwent traditional surgery to their fallopian tubes to prevent pregnancy.
Dr. Art Sedrakyan of Weill Cornell Medicine in New York and colleagues reviewed data from 2005 through 2013 in New York. The study involved 8,048 women who were implanted with Essure implants who were compared to 44,278 women who underwent standard surgery to block their fallopian tubes. The researchers discovered that women who chose Essure often required surgery, despite that Essure is marketed as a nonsurgical method of permanent birth control, according to NBC News.
The risk of a second procedure was 10 times greater in women implanted with Essure when compared to women who underwent laparoscopy. The study appeared in the online version of the British Medical Journal.
Essure Injury Reports
“It seems every two or three years we have another controversy in women’s health,” said Steve Xu, a health policy researcher and Northwestern University dermatology resident who co-wrote a paper that found “significant weaknesses” in FDA approval of high-risk gynecological devices. “We have pelvic mesh, we have concerns with morcellators” — devices used during hysterectomies that are known to spread undiagnosed cancer. “And then with Essure, it’s like, here we go again,” according to The Washington Post.
In one case in 2015, a woman attempted to go to bed despite suffering from a toothache that was accompanied with a severe headache. “I couldn’t stand still. I was up walking around,” she said. She woke her husband, who called her dentist’s emergency line and drove to a 24-hour pharmacy for pain medication. The following morning, at her emergency appointment with the dentist, she learned that her wisdom tooth was badly infected and required extraction. This was one of five teeth she would ultimately lose, according to The Washington Post. The woman, 35 years old at the time, never suffered from bad teeth.
She and her husband also noted that her hair was falling out in clumps, she was having unusually heavy periods and severe cramps at off times in her cycle, she was gaining weight, and suffering with brain fog and severe fatigue. She missed a period, which was odd because, seven weeks after giving birth to her twins, her obstetrician-gynecologist inserted her with an Essure device. At that time, she and her husband had eight children between them. She said, “God has blessed us abundantly…. We knew we were done.”
The woman’s OB/GYN suggested Essure to avoid risks tied to the incisions and anesthesia used in tubal ligation. The patient was provided with a brochure that indicated that Essure is “the most effective method of permanent birth control available” noting that the device was 99.74 percent effective and describing Essure as two “soft, flexible inserts” that, in a “gentle, non-surgical” procedure, are passed through the vagina and cervix and into the fallopian tubes, according to The Washington Post.
The woman did use an alternative form of birth control for three months after being implanted with Essure, in compliance with her doctor’s orders; however, due to a lapse in insurance coverage, the woman was unable to return for the medical procedure needed to confirm that her tubes had been completely blocked by the Essure device.
She learned that some 16,000 Facebook members—as of July 2017, that number has doubled—experienced bleeding, fatigue, hair loss, and tooth decay, which they attributed to allergic or autoimmune reactions to materials, especially nickel, in Essure. Some women reported that the Essure migrated from their fallopian tubes and embedded in the uterus or punctured other organs. Some women chose to have the coils removed surgically and reported complications from the operations, and often had to undergo hysterectomies. Some women posted photographs of their so-called “E-Babies,” The Washington Post reported.
The women in the Facebook group graphically described pain and blood loss, fatigue and weight gain; they also posted pictures of their thinning hair and bloated bellies that could be mistaken for pregnancy. They shared joint pain, sudden muscle weakness, and skin rashes.
The woman noted that she is allergic to nickel but was never asked about that allergy. She also noted that she related to a number of adverse reactions discussed by other women. The woman became pregnant while implanted with Essure and said that she was in constant, sometimes paralyzing, pain. There was little to be done to calm the pain without potentially harming the baby. She continued to suffer from an inability to sleep and hair loss. She also underwent root canals and enamel caps in an attempt to save the teeth she still had. Because of her dental issues, she said, “I stopped wanting to go out…. People think of you a certain way when you’re missing teeth,” according to The Washington Post.
She also continued to suffer from depression and pain as she was awaiting for her scheduled Caesarean section. Following the birth, she planned for her OB/GYN to remove the Essure coils and her fallopian tubes. After the birth of a small, but healthy, boy, her doctor informed her that a “tiny fragment” of the Essure coil remained in her body. Working from home, caring for toddler twins and a newborn, and recovering from surgery, she had to undergo a hysterectomy. Her new surgeon found the fragment, as well as a larger piece of coil that migrated outside of the woman’s uterus, near her colon, according to The Washington Post.
Although she has said the severe pain has stopped, her hair began to grow back, and her teeth are no longer rotting, her memory has been adversely impacted, she has ongoing arthritis in her knee and ankle, and the ache in her lower back remains. “I worry it’s kind of like a thing that never ends,” she said. “I really feel betrayed…. I was only 36 and I’m having to have a hysterectomy?” She believes the FDA should be held accountable. “Whoever said, ‘Yes, we can put this on the market,’ sometimes I wish they would have to endure what we’ve gone through.”
In another situation a woman, 45, said that her physician recommended Essure and soon after her 2009 procedure, which describes as causing her excruciating pain, she began experiencing constant bleeding and pain. She developed joint problems that she blames on an autoimmune response. She also had to undergo surgery to remove the coils; however, the surgery left fragments behind and resulted in her having to undergo a hysterectomy. She still suffers from chronic pain, muscle weakness, and blood circulation problems, which she believes are an autoimmune reaction, The Washington Post reported.
Federal Regulator Panels on Essure
Federal regulators indicated that a panel of health experts convened to review Bayer’s Essure to help determine if the device and procedure are safe. The move followed mounting complaints over potential side effects, NBC News reported. The FDA’s Obstetrics and Gynecology Devices Panel met on September 24, 2015 and included a public advisory meeting to discuss Essure and collect feedback from presenters, panel members, and the public “to inform recommendations and next steps about Essure.”
The meeting was intended to discuss if changes should be made to the Essure label and if more research is required to assess Essure device and procedure risks. The panel also reviewed adverse event reports and injuries related to Essure perforation and migration, device removal, chronic pain, allergic reactions, and unintended pregnancies.
Meanwhile, the FDA previously updated Essure’s short- and long-term risks on its website and the drug’s adverse events reported through that May, NPR reported.
According to panel findings, citing the FDA, an “unusually large proportion” of the estimated 5,093 medical device reports filed with the FDA as of June 1, 2015 were submitted voluntarily by patients and not the device maker, wrote MedPage Today.
During the public portion of September 2015’s panel discussion, more than 30 patients spoke, discussing symptoms such as autoimmune disorders, bleeding irregularities, cataplexy, extreme fatigue, migraines, narcolepsy, painful sex, becoming pregnant after being implanted with the Essure system has been implanted, perforation of the uterus, psoriasis, and severe abdominal pain.
Prior to the September 2015 panel, controversy and adverse events were mounting. The Mayo Clinic website indicates that risks tied to Essure include infection, pelvic pain, perforation of the uterus or fallopian tubes, and tubal blockage occurring on one side.
FDA Calls for Clinical Study, Adds Boxed Warning to Essure
On February 29, 2016 the FDA announced actions it would take to address risks tied to Essure, including that it ordered Bayer to conduct a clinical study evaluating real-world side effects and complications associated with Essure.
The FDA also indicated that it plans to require a boxed warning, the strongest type of FDA warning, on the device’s label, as well as a “Patient Decision Checklist” to inform patients about the benefits and risks of using Essure.
The agency also noted that some women may face serious complications with Essure such as abnormal bleeding, allergy or hypersensitivity reactions, perforation of the uterus or fallopian tubes due to device migration, and persistent pain. The black box warning on Essure will list adverse events that have been reported, including insertion and removal procedures.
Meanwhile, Brazil has pulled Essure from its market following the ongoing legal issues in the United States.
Questions about Essure
If you or someone you know wants to learn more about filing an Essure lawsuit, contact the personal injury attorneys at Parker Waichman today. Our firm offers free, no-obligation case evaluations.
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