- Should I have an Essure Removal?
- Common Symptoms
- What is Essure Removal?
- What are the Surgical Options For Removing Essure Coils?1. Laparoscopic Complete (or Total) Salpingectomy
- Common Questions
- What is a common evaluation before removing Essure coils?
- Can I get pregnant after having my Essure coils removed?
- How likely is it my symptoms will go away after the coils are removed?
- What should I look for in a gynecologic surgeon who removes Essure coils?
- Do I need a hysterectomy?
- I’m not having symptoms from my Essure coils. Should I have them removed anyway?
- Real Stories from Women with Essure®
- Benefits of Essure
- Risks of Essure
- Pregnancy Risks Related to Essure
- Ongoing Clinical Study for Essure
- Bayer’s Decision to Pull Essure From the U.S. Market Garners Mixed Reaction
- A Procedure for Women That Was “Akin to Male Vasectomy”
- Patient Concerns About Safety
- The FDA’s Response to Complaints
- Bayer’s Response to Complaints
- Essure Side Effects
- Essure Birth Control Side Effects
- Essure Side Effects and Complications
- Essure Coils Can Fracture and Migrate
- Nickel Allergies
- Unintended Pregnancies
- Essure Removal Often Prompts Hysterectomies
- Injured by Essure?
Should I have an Essure Removal?
Share This Article By Devin Namaky, MD
TriHealth Women’s Services Advances Gynecologic Surgery
The Essure device is a set of metallic coils used for female sterilization. They are placed hysteroscopically using a camera without incisions. The fallopian tubes then cause scarring around the coils, blocking the tubes. The Essure device is an effective form of contraception, and usually doesn’t cause any side effects. However, some patients have had problems with the device, and some of you are experiencing symptoms which may be attributed to the Essure coils.
The most common symptom patients report from Essure coils is pelvic pain. You may have heavy or irregular periods, cramping or pain with periods, pain with intercourse, and in some cases joint problems or systemic symptoms attributed to your Essure coils. Many of you simply describe “not feeling right.” The anxiety you feel each day can’t be understated.
Although most women who have Essure coils never have symptoms from them, it’s possible some of what you’re experiencing is related to the coils, especially when there is no other clear explanation for your symptoms.
An article published in the Journal of Minimally Invasive Gynecologic Surgery in 2017 surveyed patients who had their Essure coils removed. 75% of the women reported total or near total improvement in their symptoms, while 31% had ongoing symptoms even after surgery. (1)
Essure removal won’t always relieve your symptoms. However, given the limited information we have, as well as the stories of many patients, Essure removal is certainly an option for many that may improve your quality of life. For many of you, it just plain works.
What is Essure Removal?
Essure removal is done surgically. The coils are cut out of your body.
What are the Surgical Options For Removing Essure Coils?1. Laparoscopic Complete (or Total) Salpingectomy
Laparoscopic complete salpingectomy for Essure removal takes approximately 30 to 45 minutes, and is an outpatient surgery. Only three to four small puncture incisions are made, and you go home the same day. Most of the recovery happens in the first 2 to 3 days, and full recovery time is approximately 2 weeks. The key to the effectiveness of this procedure is having total or complete removal. This means your entire fallopian tube, including the portion traveling through the wall of the uterus into the uterine cavity, is removed.
This is a complicated laparoscopic procedure requiring an experienced gynecologic surgeon. The base of the tube is injected with vasopressin and desiccated with energy to limit bleeding.
Laparoscopic techniques are then used to dissect through the myometrium (wall of the uterus) to remove the entire tube and coil together as one piece. This is the safest way to remove the entire Essure coil when it is in the normal position. The incisions on the uterus are sewn shut laparoscopically in one or more layers.
I recommend cutting open and inspecting the Essure coils in the operating room once they are outside the body to ensure the leading ball tip and the distal tab are clearly visible in the removed specimen. This confirms both ends are present.
Some surgeons will perform laparoscopy and try to remove the coils by using traction or pulling on them. This may put you at higher risk of damaging the coil or leaving pieces behind. Sometimes surgeons may even cut across your coil and remove only part of the tube. I do not recommend these approaches, and routinely remove the entire tube and coil.
Hysterectomy with Bilateral Salpingectomy
The only way to guarantee the entire Essure length is removed without risk of breaking the coils is to have hysterectomy with bilateral salpingectomy. This is removal of the uterus, cervix, and both fallopian tubes together. While the vast majority of patients who have a laparoscopic complete salpingectomy are able to have the entire length of the coils removed, it may be appropriate in some circumstances to remove the entire uterus to ensure no part of the coils is left behind.
This is an option up front for some of you, and also an option during the procedure if problems arise when removing the coils. Hysterectomy with bilateral salpingectomy can be performed as an open surgery, laparoscopically, or even vaginally.
In some cases the Essure coils can be removed hysteroscopically without any incisions. This is when a camera is placed through the vagina and cervix to look at the coils within the uterus, and then the Essure coils are removed by simply pulling them out through the cervix.
This procedure is only safely done when there are certain number of coils visible within the uterine cavity and placement was not ideal. This is one reason you should seek an experienced gynecologist who is certified to read Essure placement using ultrasound. If a preoperative ultrasound suggests an abnormal position with many coils present in the uterine cavity, it would be reasonable to attempt hysteroscopy first for removal.
What is a common evaluation before removing Essure coils?
The initial evaluation of pain or bleeding is the same as for patients without Essure coils. Your gynecologist should do a complete evaluation to determine if there may be another cause for your pain, bleeding or other symptoms. A thorough investigation ruling out other causes will make it more likely your pain would be relieved if the coils are removed.
At a minimum, a history, physical examination and pelvic ultrasound should be done for any pelvic pain complaint. The pelvic ultrasound should be read by a surgeon who is certified to confirm Essure placement by ultrasound.
Can I get pregnant after having my Essure coils removed?
Generally speaking, after having Essure coils removed you would still be considered sterile just as you were prior to the procedure. You will not regain fertility.
How likely is it my symptoms will go away after the coils are removed?
Based on the information we have so far, the majority of you will notice improvement as long as other causes are excluded. About 1 in every 3 patients will continue to have symptoms.
What should I look for in a gynecologic surgeon who removes Essure coils?
The gynecologic surgeon you choose should be certified to verify correct Essure placement using ultrasound, and also should have advanced laparoscopic skills. Your gynecologist needs to be familiar with techniques to dissect the wall of the uterus, and have the training to sew the incisions on the uterus laparoscopically.
Don’t be afraid to ask your surgeon about these skills. Remember, you are choosing someone who will operate on your body, and there is no shame in making sure you’re getting the best possible care.
Do I need a hysterectomy?
Most patients do not need a hysterectomy to completely remove Essure coils. However, some patients do choose to have hysterectomy as treatment. This is usually done if you aren’t comfortable with the small risk of the coil breaking, or when other pathologies such as endometriosis, fibroids or adenomyosis are present that may also be contributing to your symptoms.
I’m not having symptoms from my Essure coils. Should I have them removed anyway?
Generally speaking, if you are not having any symptoms from your Essure coils, then you don’t need to have them removed. In most women, Essure coils do not cause any problems.
At TriHealth Women’s Services Advanced Gynecologic Surgery, we understand your daily life is being affected. We want you to feel normal again, as quickly as possible and can walk you through each step of the process to get you the answers you need.
Would you like a consultation to see if Essure removal may be right for you? Please reach out to Dr. Namaky at TriHealth Women’s Services Advanced Gynecologic Surgery.
1. Clark NV et al. Essure Removal for the Treatment of Device-Attributed Symptoms: An Expanded Case Series and Follow-up Survey. J Minim Invasive Gynecol. Sept-Oct 2017;24(6):971-6.
Tags Women’s Health
Last Updated: December 12, 2018
Tens of thousands of women say they suffered painful and serious side-effects from Essure, a medical device meant as a permanent birth control option. The device is the subject of nearly 27,000 complaints to the FDA since its approval in 2002. Women reported excessive pain, severe allergic reactions and, in some cases, perforated organs.
Essure is FDA approved, but the agency recently restricted sales of the device to physicians who provide their patients with a checklist outlining the risks, reports CBS News correspondent Anna Werner. The FDA also gave the device a mandatory black box warning in 2016.
Bayer, the device’s manufacturer, admits there is no way to know who might develop problems. Women who have had problems told us the experience affected every aspect of their lives.
“The whole process was a very, very, very dark time for me,” Amanda Rusmisell said.
Even now, Rusmisell feels the pain from the choice she made 10 years ago. It started after Rusmisell and her husband decided two children were enough. Her doctor recommended Essure, a newer method of permanent birth control.
“‘You can go back to work the next day, it’s not invasive, it will be no problem at all,'” Rusmisell said she was told.
Essure is a medical device designed to prevent pregnancy permanently, without surgery. A doctor inserts two small flexible coils in a woman’s fallopian tubes where they’re supposed to build up scar tissue and block the tubes. Bayer said Essure has been used in over a million women worldwide and advertises it as “surgery free, hormone free and worry free.”
“It was the worst… pain I’ve ever been through,” Rusmisell said.
The pain continued, along with heavy periods so debilitating, she started to miss work. Her doctor told her it was likely just her age. Then when the symptoms persisted said she’d need a hysterectomy. She was 38.
“I didn’t have support of anyone who was dealing with this same things as me. And so it was very hard, and it was very — I felt like my body was failing me,” Rusmisell said.
It wasn’t until she found a Facebook group that she realized she wasn’t alone. Thousands of other women posted about problems they experienced including pain, severe bloating, rashes. Some posted images they say show the devices perforated a fallopian tube or their uterus.
Bayer declined to do an on-camera interview, but Dr. Edio Zampaglione, Bayer’s vice president of U.S. medical affairs, told us in a phone interview: “We take all of this very seriously.” He said the company’s studies show the product has “low and acceptable rates” of adverse events. And he said, “We do not see anything that would indicate that the risks of Essure outweigh the benefits.”
Illinois Dr. Brett Cassidy says at first he agreed, implanting Essure in 114 patients. But his opinion changed, he said, after a patient came back.
“She was having brain fog… migraines, joint pain in her knees arms wrists,” Cassidy said.
“Those seem like strange symptoms to even be linked with a device like this,” Werner said.
“My exact thoughts,” he said.
He eventually determined she needed a hysterectomy, which removed the Essure devices along with the uterus.
“And what happened to her symptoms?” Werner asked.
“Gone. Completely gone,” Cassidy said. “Within a week she was feeling 100 percent better.”
That was three years ago. Since then, Cassidy said he’s done over 100 hysterectomies for women with similar problems. He’s since concluded Essure can cause reactions in some women.
“The coils are made of nickel and polyester fibers. And when they’re placed in the tube, it creates an inflammation reaction… But this inflammation reaction continues in the body,” Cassidy said.
“So you’re basically saying that these two tiny little coils can make your whole body go haywire,” Werner said.
“Yeah, it’s hard to imagine or believe,” Cassidy said.
Bayer said hysterectomy is not the only option for Essure removal. Their executive said the reason for the complaints is “hard to say.” He told us “a lot of those symptoms can be hormonally-related and common as women go through reproductive life.”
But the explanations aren’t good enough for Rusmisell.
“We still want this product off the market… Everything we’ve done is because we have banged on people’s doors and we don’t go away,” Rusmisell said.
One way those women have had an impact is on Essure sales. The company confirmed to us that sales have dropped. We also spoke with a doctor who is a paid consultant for Bayer, Dr. Peter Rothschild. He told us he has implanted Essure devices in more than 1,100 patients with no reported problems.
The FDA has ordered Bayer to conduct a post-market trial to compare Essure side effects with those of tubal ligation. The final report date is 2023.
After our report, Steven Immergut, Bayer’s head of communications in pharmaceuticals, sent us an email in response. Among his points:
- “Essure has been tested in more than 200,000 women over about the last two decades and the conclusions of this scientific research show that its safety and efficacy are comparable to the only other form of permanent birth control, tubal ligation.”
- “Women should consult with their physician about any medical decisions involving Essure.”
- “Ms. Rusmisell has sued Bayer two times in cases involving Essure and has financial interests that are adverse to the company.”
Real Stories from Women with Essure®
Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.
Important Safety Information
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.
Essure is not right for you if you are uncertain about ending your fertility, suspect you are pregnant, can have only one insert placed, have had your tubes tied, have a known allergy to contrast dye, are unwilling to undergo the Essure Confirmation Test, have unexplained vaginal bleeding, or have suspected or known cancer of the female reproductive organs.
You should delay having the Essure procedure if you are or have been pregnant within the past 6 weeks, have an active gynecological infection, or are in the second half of your menstrual cycle.
Tell your doctor if you are taking immunosuppressants, have, or think that you may have, a history of metal allergies, or an allergy to polyester fibers, nickel, titanium, platinum, silver-tin, or stainless steel or any other components of the Essure system, are currently using an IUD for contraception, or have had or are considering a procedure to reduce bleeding from the uterus such as endometrial ablation.
WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control.
WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test (3 months after the procedure) and your doctor tells you that you can rely on Essure for birth control. For some women, it may take longer than 3 months for Essure to be effective, requiring a repeat confirmation test at 6 months. Talk to your doctor about which method of birth control you should use during this period. If you rely on Essure for birth control before receiving confirmation from your doctor, you are at risk of getting pregnant.
During the Procedure: In the premarketing study, some women experienced mild to moderate pain (9.3%). Your doctor may be unable to place one or both Essure inserts correctly. In rare cases, part of an Essure insert may break off during placement. If breakage occurs, your doctor will remove the piece, if appropriate. There is a risk of perforation of the uterus or fallopian tube by the hysteroscope, Essure system or other instruments used during the procedure. In the original premarket studies, perforation due to the Essure insert occurred in 1.8% of women. A perforation may lead to bleeding or injury to bowel or bladder, which may require surgery. Your doctor may recommend a local anesthesia. Ask your doctor about the risks associated with this type of anesthesia.
Immediately Following the Procedure: In the premarketing study, some women experienced mild to moderate pain (12.9%) and/or cramping (29.6%), vaginal bleeding (6.8%), and pelvic or back discomfort for a few days. Some women experience headaches, nausea and/or vomiting (10.8%), or dizziness and/or fainting. You should arrange to have someone take you home after the procedure. In rare instances, an Essure insert may be expelled from the body.
During the Essure Confirmation Test: As one of the Essure Confirmation Tests (a modified HSG) requires an x-ray, you may be exposed to very low levels of radiation, as with most x-rays, if this test is used. Some women may experience nausea and/or vomiting, dizziness and/or fainting, cramping, pain or discomfort. In rare instances, women may experience spotting and/or infection
Long-term Risks: Pain (acute or persistent) of varying intensity and length of time may occur and continue following Essure placement. This is also more likely to occur in women with a history of pain. There are reports of an Essure insert being located in the lower abdomen and pelvis. If this occurs, you cannot rely on Essure for birth control. Patients with known hypersensitivity to any of the components of the Essure system may experience an allergic reaction to the insert. In addition, some patients may develop an allergy to nickel or other components of the insert following placement. Symptoms reported in women using Essure that may be associated with an allergic reaction include hives, rash, swelling and itching. There is no reliable test to predict who may develop a reaction to the inserts. No birth control method is 100% effective. Ectopic pregnancies (pregnancy outside the uterus) may occur with Essure. This can be life-threatening. If insert removal is indicated, surgery will be necessary.
The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old.
Essure does not protect against HIV or other sexually transmitted diseases.
Talk to your doctor about Essure and whether it is right for you. Review the Patient-Doctor Discussion Checklist in the Patient Information Booklet with your doctor before deciding to have the Essure procedure.
Essure is a permanently implanted birth control device for women (female sterilization). Implantation of Essure does not require a surgical incision. In the procedure, a health care provider would place flexible inserts through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs and prevents conception.
On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. Health care providers could implant Essure up to one year from the date the device was purchased. As of December 31, 2019, all unused Essure units should have been returned to Bayer. Women who have been using Essure successfully to prevent pregnancy can and should continue to do so. Postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency. We will continue to communicate publicly about new findings.
Essure should no longer be available for implantation. Women seeking contraception are encouraged to discuss all other availablebirth control options and carefully consider the benefits and risks of each with their health care provider before deciding on the method that is right for them.
The information provided below describes the benefits and risks associated with Essure as included in the current labeling.
Benefits of Essure
- Essure is intended to provide women with permanent birth control. Essure is inserted through the vagina and cervix into the fallopian tubes. The procedure does not require a surgical incision.
- Essure inserts do not contain or release hormones.
- Essure insertion is typically performed in a doctor’s office and does not require general anesthesia.
Risks of Essure
Short-term risks to women with Essure as reported in clinical trials include:
- Mild to moderate pain during and immediately following the Essure placement procedure.
- Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort immediately after the procedure.
Longer-term risks to women with Essure as reported in clinical trials include:
- Abdominal, pelvic, or back pain
- Tear or hole (perforation) of the uterus or fallopian tubes
- Unintended pregnancy
- Allergy or hypersensitivity reactions
- Essure inserts unexpectedly moved to the abdominal or pelvic cavity
- If a patient and health care provider decide to remove Essure, another surgery may be required.
Other reactions included in medical device reports submitted to the FDA include:
- Feeling tired (fatigue)
- Weight changes
- Hair loss
- Mood changes, including depression
It is important for women with Essure to know that, based on clinical studies, approximately 8 percent of women who undergo attempts at Essure placement are not able to rely on the device for birth control.
Pregnancy Risks Related to Essure
While scientific evidence shows that Essure is an effective means of permanent contraception when health care providers and patients follow the appropriate instructions for use, no form of birth control is 100 percent effective. Data show that after 5 years from the date a woman has Essure placed successfully, she has less than a 1 percent (1%) chance of getting pregnant.
All pregnancies carry some risk to women and their fetus. The risks to women and their fetus if pregnancy occurs after Essure placement are unknown. While successful pregnancies with healthy deliveries have been reported with Essure devices in place, neonatal or pregnancy complications have also been reported. Also, the FDA has received reports of pregnancy losses in women who became pregnant following Essure placement. If a woman becomes pregnant with Essure, there may be a risk for the pregnancy to occur outside of the uterus (ectopic pregnancy), which may result in serious complications.
Ongoing Clinical Study for Essure
The FDA continues to collect long-term safety information following the discontinuation of sales and distribution of Essure to better evaluate its safety profile when used in the real world. This includes ensuring that Bayer continues to meet its mandated postmarket study obligations for Essure beyond 2019.
- In February 2016, the FDA ordered Bayer, the company that makes Essure, to conduct a postmarket surveillance (“522”) study to gather more data about Essure’s benefits and risks. As of December 31, 2019, enrollment for this study has ended. The FDA will post the interim study results once the enrollment data are analyzed and the next report is reviewed. Follow-up of patients in the study is ongoing. The FDA believes clinical data from this postmarket study will help patients, health care providers, and the agency better understand certain patient complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation. To learn more about this study, please visit the Essure 522 webpage or find information provided by Bayer at ClinicalTrials.gov (NCT number): NCT03127722.
- Bayer has two ongoing post-approval studies. Both ongoing studies are conditions of approval for premarket application supplements in support of labeling modifications. Details on the study protocols, status and interim results are posted on the Post-Approval Study Status web page.
The FDA will continue providing updates on our ongoing postmarket evaluation of Essure to patients and health care providers.
Bayer’s Decision to Pull Essure From the U.S. Market Garners Mixed Reaction
Bayer’s recent announcement that it would stop selling its Essure brand of permanent birth control has been met with disappointment as well as relief.
The company announced in July that it would voluntarily discontinue sales of Essure by the end of 2018 because of declining sales. But some customers’ complaints have called into question how safe the birth control device was in the first place.
Essure is the only form of permanent sterilization for women that doesn’t require surgery. Coils made of a collection of polyester fibers, nickel, titanium, platinum, silver-tin, and stainless steel are inserted vaginally into the fallopian tubes. They cause inflammation in the tubes, and the tubes grow together to block an egg from moving into the ovary.
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A Procedure for Women That Was “Akin to Male Vasectomy”
Some are dismayed that the device will no longer be available after this year.
“I think this is a loss for women,” says Melissa Goist, MD, an ob-gyn at the Ohio State University Wexner Medical Center in Columbus. “Although it was not the best choice for all women desiring sterilization, it was the closest female procedure akin to male vasectomy … and the ability to perform this without general anesthesia was paramount to quick recovery and return to normal activities.”
Others are cheering Essure’s removal from the market.
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Patient Concerns About Safety
The two women interviewed for this story say the device caused them permanent health issues and that the device was not adequately tested for long-term use.
“It was sold to me like a vacation, that Essure could be done in 10 minutes and there would be no downtime. I was sold on it,” says Angela Desa, 38, of Marysville, California. Desa had the Essure device implanted in 2008.
As a single mother of three children who works in supplies for a local hospital, Desa says that the short downtime appealed to her because “any time you take time off, time is money.”
Immediately after the procedure, Desa experienced cramping, night sweats, and hot flashes. Debilitating migraines began about six months later. Desa, who had never had any reason to see a doctor other than for her pregnancies, ultimately had to stop working when her teeth began crumbling around metal fillings she’d had for prior cavities. She also gained 80 pounds and went from going to the gym every day to having heart palpitations whenever she tried to exercise.
“I felt like I was dying, like I was being poisoned,” she says.
Desa came across the Facebook group Essure Problems in 2012, when it had 130 members. It functioned as a support group. Through her ongoing research, Desa appealed to several doctors in search of help, but never got relief.
Ultimately, Desa was told she could have a hysterectomy to remove the device. “You can’t just pull it out,” she explains. “It’s like a screw going into a piece of wood.” The device gets embedded into scar tissue and can’t be removed without breaking.
At 33, Desa had a hysterectomy through another doctor, not the one who placed the device.
“Three days after the surgery, I felt really great,” she says. “It was like waking up from the five-year flu. Everyone told me my color looked different.” She returned to work two and a half weeks after the surgery. Along with others from the Essure Problems group, which today has more than 40,000 members and 50 subgroups for women around the world, according to its founder, Angie Firmalino (see below), Desa she reached out to legislators to discuss Essure’s ill effects.
Desa is not alone.
Angie Firmalino created the Essure Problems Facebook group in 2011 after she experienced immediate sharp stabbing pains, cramping, fevers, and ongoing vaginal bleeding following her 2009 Essure implantation.
Firmalino, 46, a mail carrier based in Tannersville, New York, had an ultrasound and learned that the device had migrated from her tubes to her uterus.
After searching for the right physician to remove it, Firmalino had surgery and the device was removed vaginally. She was told the procedure went fine, but follow-up X-rays and postoperative notes revealed there were shards of foreign bodies all over her uterus.
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Three years later, Firmalino finally found an ob-gyn who would do a hysterectomy (many had refused). While she was still in surgery, doctors X-rayed her uterus and fallopian tubes once they were removed from her body, and saw they were filled with metal fragments.
Firmalino, who today deals with systemic autoimmune issues including Raynaud syndrome, connective tissue disorder, and small fiber neuropathy, says she believes that polyethylene terephthalate (PET) fibers from the Essure coils have caused her health problems.
Firmalino and others in Essure Problems appealed to the U.S. Food and Drug Administration (FDA), which restricted Essure sales in April 2018, and her group’s efforts pushed Congress to introduce the Medical Device Safety Act.
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The FDA’s Response to Complaints
The FDA took patient complaints seriously, says spokeswoman Deborah Kotz in an email message. “Through the past few years, as the FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns,” she says.
“Before the April sales restriction, we conducted a thorough review of our database and medical literature; we convened an expert panel to discuss new concerns; we ordered Bayer to conduct a new postmarket surveillance study to better evaluate the safety profile of the device when used in the real world; and we required Bayer to add a boxed warning to the labeling and a Patient Decision Checklist to help women considering Essure to be fully informed about potential risks,” says Kotz.
Following Bayer’s July 20 announcement that it would discontinue Essure sales, the FDA’s commissioner, Scott Gottlieb, MD, issued a statement about the news, and included a timeline of FDA actions taken in light of patient complaints about Essure’s safety.
“Consumers rely on the FDA to oversee the regulation of vital medical products. In turn, the agency also relies on consumers for important feedback to help us learn more about the benefits and risks of medical products when they’re used outside of clinical trials in the real world,” the statement read.
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The timeline dates to September 2015, when “the FDA convened a panel of experts to get their input on how we should investigate patient complaints that included abdominal pain, abnormal uterine bleeding and device migration.”
Gottlieb also noted that those who have used Essure without problems can keep using it.
“I also want to reassure women who’ve been using Essure successfully to prevent pregnancy that they can continue to do so. Those with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take,” he said in the FDA statement.
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Bayer’s Response to Complaints
Bayer maintains that the company voluntarily discontinued selling and distributing Essure in the United States “based on a decline in sales in recent years and the conclusion that the Essure business is no longer sustainable,” says Courtney Mallon, a Bayer spokesperson.
“The benefit-risk profile for Essure has not changed,” Mallon says in an email message. “We are working closely with the FDA and have planned a slow wind-down process to ensure patients and providers are appropriately supported. It’s extremely important that this voluntary discontinuation is characterized correctly as it is not a recall or safety situation .
“We’ve been extremely concerned about comments made by third parties promoting Essure removal, which combined with the spread of inaccurate or misleading information, may drive women who have relied on Essure as their birth control option to seek risky and unnecessary surgery to remove the device.”
But for Essure users like Firmalino and Desa, the important thing was that Essure would no longer be available for anyone after 2018.
“We’ve been fighting this fight for a really long time,” says Desa. “To us, it’s a huge accomplishment.”
Since 2002, Essure has been marketed as a permanent birth control method for women that is convenient and can be performed in their own doctor’s office.
The procedure is simple: A 4-centimeter metal coil is inserted through the cervix and placed into each fallopian tube, where scar tissue builds and eventually blocks sperm from reaching an egg. Resembling the spring of a ballpoint pen, the medical device requires no incision or invasive surgery, and offers women an alternative to tubal ligation. (The FDA’s instructions for use of the contraceptive device specify that a hysterrectomy is not the primary removal option.) Women can even go back to work the very next day. So far, the device remains the only FDA-approved, non-incisional form of permanent birth control.
But this July, Bayer Pharmaceuticals announced it would stop selling the device by the end of 2018, citing declining sales. However, the roughly 17,000 lawsuits filed against Bayer by women who have used Essure as well as a damning Netflix documentary that spotlighted the medical device industry may also have been factors.
A Facebook group, “Essure Problems,” a sisterhood of women sharing their experiences of debilitating pain and a diverse range of physical and emotional side effects, has grown to 38,000 members since Angie Firmalino of Tannsersville, New York, first created it in 2011.
Firmalino suffers from an autoimmune disorder as a result of her Essure implant and wanted to warn her friends.
The group operates as an online support system for the self-styled “E-sisters” to educate one another on the risks, and also act as a resource for legal action. It shows women how to file an “adverse event report” to the FDA if they are experiencing negative side effects, as well as how to use social media to speak publicly about their experiences, contact their state representatives, and educate themselves regarding proper removal of the removal of the device. “We’re still working on advocacy and supporting women,” says Amanda Rusmiesell, the group’s legislative liaison. “We’re still very focused on holding Bayer accountable.”
According to a Bayer spokesman, any individual can submit an adverse event report to the FDA or Bayer, so the existence of a report is not scientific evidence that a device caused the alleged injury or the negative side effects reportedly experienced. Additionally, there may be duplicate reports that were submitted previously by a plaintiff or plaintiff’s lawyer in conjuction with legal proceedings.
Rusmisell’s doctor did not initially believe Essure was to blame for her symptoms. “They’ve done to you what they’ve done to women for thousands of years,” she says. “ ‘You’re hysterical, you’re overacting … your body’s failing you.’”
Rusmisell was finally forced to undergo a hysterectomy after experiencing severe pain during the insertion procedure and for weeks afterward. After seeing a news story about other women reporting similar side effects, she discovered the Facebook group and immediately got involved. Rusmisell recalls saying to her husband, “I’m not the only one.”
“Something always compelled me to be in this movement,” she says. “You see all these women joining, and it’s the same story just different versions, over and over. It’s like waves.”
Rusmisell and her E-sisters have several major goals. They are seeking compensation for all the women who have been harmed by the device, and they are working to change federal and state laws regarding medical device approvals and regulation.
But most of all, they want Essure gone for good.
Attorney Marcus Susen decided to take up Essure cases after learning that many women had been struggling for years to find legal representation. He is the lead counsel of the Essure Plaintiffs Steering Committee that represents the common interests of all plaintiffs. He now represents about 2,000 women in a mass tort lawsuit against Bayer.
While individual plaintiffs can file a lawsuit based on a unique set of damages, a mass tort allows numerous plaintiffs to join forces to seek damages from a company when they have experienced similar injuries from the same product. “We want to get these women some compensation for what they’ve been through,” Susen says. “It’s solely against Bayer and Bayer entities.”
The April release of The Bleeding Edge, a Netflix documentary on the $400 billion medical device industry, helped raised the profile of Essure sufferers, and E-sisters have also traveled to Capitol Hill, lobbying Congress to back a bill that would offer stronger legal protections for women harmed by the device. That proposal, the Medical Device Safety Act, would essentially restore patients’ rights to pursue litigation. Due to FDA preemption, which bars lawsuits against certain medical devices, Bayer claims this makes the company immune to injury lawsuits. The proposal would change the law to make it “retroactively effective and appl to pending civil actions.” But with the 115th Congress winding down its business before the midterms, the measure would likely have to be reintroduced in the next session.
Amanda Dykeman of Orion, Illinois, one of the administrators for the Facebook group, says it didn’t take long for her to realize she was not alone in her own suffering and contacted her state representatives to persuade them to help change the laws. She is a plaintiff in litigation against Bayer regarding the Essure contraceptive.
She told the Prospect that women are struggling to find physicians willing to remove the device because procedural protocol for removal is often unclear. Extracting the device without getting a full hysterectomy can be dangerous. Small fragments of the device could break off or migrate elsewhere in the body.
Oftentimes, women have difficulties convincing their doctors that they are having a serious problem, a disparity not uncommon in medicine in which women’s pain is dismissed or not taken seriously. “Hopefully, this is a game changer and lives are saved,” says Dykeman. “I think it’s pretty sad that trying to discredit thousands and thousands of women. … They’re just making themselves look unethical.”
In 2016, the FDA issued a black box warning—the agency’s strongest—about the device. In addition to the 26,733 complaints it received through the years, eight adult deaths have been reported. In September 2017, Bayer halted all international sales of Essure, but the medical device will remain available in the United States until the end of 2018.
Correction: This article has been corrected to indicate that Essure is an alternative to tubal ligation and that FDA’s approved instructions for use of the contraceptive device specify that a hysterectomy is not the primary removal option. It also has been updated to detail who can submit an adverse event report to the FDC or Bayer and what the submission of an adverse event report means. Ms. Dykeman has also been identified as a plaintiff in against Bayer in litigation regarding the contraceptive device.
Nine years ago, Angie Firmalino was implanted with a permanent contraceptive device called Essure. The procedure, she says, was “extremely painful,” and the discomfort she felt even months later — fevers, achy joints, constant bleeding — was nearly debilitating.
Firmalino eventually took her concerns to a doctor, who did an ultrasound and discovered that the implant, originally inserted in her fallopian tubes, had become dislodged and migrated to her uterus.
Angie Firmalino during a 2017 hospital visit she says was related to complications from her Essure implant.Courtesy Angie Firmalino
She was shocked. After the appointment, “I sat in my car and cried,” Firmalino, 45, of Tannersville, New York, said in a telephone interview on Tuesday.
Firmalino later had the device removed, but that procedure left behind metal fragments that ravaged her reproductive system. She was alarmed that other women, unaware of the potential dangers, were still receiving the Essure implant. She started a Facebook group called Essure Problems to warn her friends and family about the device, and the group is now a forum for more than 36,000 women, some of whom say doctors, regulators and Essure’s maker have not taken their concerns seriously.
But finally, Firmalino and many of her fellow advocates were encouraged this week when the Food and Drug Administration said it would restrict the sale and distribution of Essure.
“We have been banging on the door with information and data, begging and pleading with them to do something,” Firmalino said of the FDA.
Bayer’s birth control implant Essure.Bayer / via AP file
Essure consists of two sets of small metal coils that are inserted through the vagina and cervix into the fallopian tubes. The coils are meant to cause inflammation, building up scar tissue that blocks the tubes and stops eggs from being carried from the ovaries to the uterus.
The FDA said Monday that over 15 years — Nov. 4, 2002, when Essure was approved, through December 2017 — it received 26,773 reports of problems, including pain, heavier periods and irregular bleeding, headaches and fatigue. Patients also reported that the device had become dislodged or had broken. And the agency has received reports of eight adult deaths related to Essure.
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In its announcement on Monday, the FDA said Bayer, the manufacturer of Essure, can sell the device only to health care providers and facilities that guarantee women have been fully informed about its potential side effects.
Doctors must review with patients a checklist of the side effects, and both are required to sign it. (Two years ago, the FDA ordered Bayer to place a “black box” warning on the product package, but doctor-patient discussions were not mandatory at the time.)
FDA Commissioner Scott Gottlieb, who met with a group of Essure critics earlier this year, said in a statement that his agency is taking action because “despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information.”
Scott Gottlieb appears at his confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions, on Capitol Hill in Washington on April 5, 2017.J. Scott Applewhite / AP file
“That is simply unacceptable,” Gottlieb added. “Every single woman receiving this device should fully understand the associated risks.”
Amanda Edwards Rusmisell, 45, of Charlotte, North Carolina, who says the pain from her Essure implant was so intense she would often cry in her sleep, hailed the FDA decision.
“We were ecstatic,” said Edwards Rusmisell, a recruiter and an administrator of the Essure Problems group. “We finally felt like somebody was listening.”
The FDA did not ban Essure, although many patients have said they would like the device taken off the medical market altogether. That would be a rare move as the agency has only ever banned two medical devices: prosthetic hair fibers and powdered gloves.
Holly Ennis, a lawyer who said she represents close to 1,000 women who have filed lawsuits against Bayer over Essure, sees the FDA action as “a huge step in the right direction.”
“The requirements are so tight that they will effectively sound the death knell for the device,” Ennis said. “Doctors will realize it is just not worth the burden and the risk.”
In a statement, Bayer said the “benefit/risk profile of Essure has not changed and remains positive.”
“Bayer has educated and continues to educate health care providers about the importance of appropriately counseling each patient on the benefits and risks of Essure,” the German multinational said. “The FDA requested we update the label to emphasize this point.”
More than 750,000 Essure devices have been sold worldwide since it was introduced in 2002, according to Bayer. The product, long presented as a less invasive alternative to surgical sterilization, is no longer sold outside the U.S. for “commercial reasons,” company spokeswoman Courtney Mallon said in an email. She said that decision was not related to product safety.
“Essure critics regularly attempt to paint that picture, which leads to broad dissemination of misleading and inaccurate information on social media that is directly influencing women’s choices,” Mallon said.
In the last two years, since a stronger warning was added to the box, there has been a roughly 70 percent decline in the sales of Essure in the United States, the FDA said.
Lisa Saenz, 49, a social worker who lives in New York City, received an Essure implant in 2008. She later experienced so many problems — hair loss, fatigue, stabbing pains in her side, blood clotting — that at one point, she said to herself, “I feel like I’m dying.” The coils had perforated her uterus, and she needed an operation to remove them.
In the future, she hopes Essure will no longer be sold at all.
“We don’t want this offered as an option to any woman,” Saenz said. “Hopefully we see the end of this awful product soon.”
CLARIFICATION (July 20, 2018, 5:40 p.m. ET): An earlier version of this article implied that the FDA had considered banning Essure but decided not to do so. Although many patients have requested that the device be banned, the agency has consistently said that the benefits of Essure outweigh its risks.
Essure Side Effects
Essure Birth Control Side Effects
(Updated March 28, 2018)
Essure, the permanent form of birth control, has been linked to serious complications. The device, which consists of two metal coils inserted in each fallopian tube, may break and migrate within the body, causing chronic pain and other side effects.
In 2016, the FDA issued a black box warning for Essure—the highest warning it can issue—for its health risks.
Women have complained of side effects like chronic pain, menstrual irregularities, and device migration on support websites like Essure Problems as well as in formal complaints to the FDA.
Thousands of lawsuits filed against Bayer, Essure’s manufacturer, allege that the company was aware of Essure’s high risk for complications but failed to properly warn the public.
If you or a loved one suffered side effects after being implanted with the Essure device, you may be eligible for a lawsuit. Contact our attorneys today for a free case review.
Free Legal Review
Essure Side Effects and Complications
Though Bayer advertised Essure as a less invasive alternative to tubal ligation, the device’s side effects likely outweigh any benefits.
By the end of 2017, the FDA received more than 25,000 adverse event reports for Essure and 40 reports of death.
Common complications reported by women include:
- Patient-device incompatibility (such as metal allergy)
- Pregnancy losses
- Migration of device or device component
- Malposition of device
- Device not operating as expected
- Device breakage
- Device difficult to insert or remove
Some women have also complained of unexplainable persistent pain after receiving Essure. In some cases, the pain is so debilitating that it interrupts their daily activities.
Essure lawsuits complain of the following side effects:
- Back pain
- Abdominal pain
- Severe cramps
- Pelvic pain
- Kidney pain
- Joint pain
- Weight fluctuations
- Menstrual changes (heavier periods, irregularities, etc.)
- Painful intercourse
Some of these side effects may indicate an autoimmune disorder like lupus. Though the risk is low, a Bayer representative did confirm that there is a chance some Essure patients will develop one of these life-altering diseases.
Essure Coils Can Fracture and Migrate
One of the primary causes of Essure-related pain and complications is the device fracturing and migrating in the body. The coils can break into multiple pieces and migrate within and outside of the fallopian tubes.
Fragments from the metal coils can perforate or embed within the fallopian tubes, uterus, and other organs. Women are not only susceptible to additional injuries when the device moves in this way, but they may also face more complex Essure removal surgeries in the future.
More than half of Essure is made from nickel-titanium alloy. However, nickel allergies are common—the FDA estimates that 20% of women are allergic to nickel.
Often, women won’t know whether or not they have a nickel allergy until they are implanted with the Essure device. Because of this, it’s important to be aware of common nickel allergy symptoms, including:
The FDA initially required that patients were tested for a possible nickel allergy before receiving Essure. Unfortunately, they have since removed that requirement.
Bayer says Essure is 99% effective in preventing pregnancy. But research shows that its failure rate is much higher: 9.6%.
Essure defends against pregnancy by triggering an inflammatory response in the fallopian tubes. This reaction causes scar tissue to build up, which provides a barrier against egg fertilization.
This process, however, takes about three months. Until then, women need to use alternative forms of birth control to prevent pregnancy.
Outside of this three-month period, Bayer says the device is 99% effective in preventing pregnancy. But, research shows that the Essure failure rate is much higher: 9.6%.
Cecilia Bogle told Refinery29 that during her three-month follow-up appointment, she learned that one of the Essure coils had migrated, leaving one of her fallopian tubes open. Ten days later, she discovered she was pregnant.
The FDA has received 1,826 reports of pregnancies in Essure patients. Nearly half of these resulted in pregnancy loss.
Essure’s pregnancy risk is greater than older forms of birth control, like tubal ligation. A 2014 U.C. Davis study found that women who used Essure were more than 10 times likely over a 10-year period to get pregnant than women who underwent tubal ligation.
Essure Removal Often Prompts Hysterectomies
Because the Essure device can fracture and migrate, removing the device often requires invasive surgery. Some women have complained that they had to undergo multiple procedures in order to remove the device. In some cases, the metal coils remain indefinitely.
Follow-up surgery is more likely after Essure implantation than tubal ligation. A study published in the British Medical Journal found that one year after receiving Essure, 2.4% of patients required follow-up surgery, compared to only 0.2% of women who underwent tubal ligation surgery.
Hysterectomies (procedures that remove the uterus) are sometimes the only way to remove Essure. This is often the last course of action for Essure patients, as it results in early onset of menopause. Sadly, even young women are often desperate enough to undergo the invasive surgery in hopes of relieving their pain.
Injured by Essure?
Our attorneys are filing lawsuits against Bayer on behalf of Essure victims. If you or a loved one were implanted with the Essure device and suffered complications, you may be entitled to compensation.
Contact us today for a free, no-obligation case review. Our attorneys have the experience and resources to tackle complex litigation such as this. To date, our firm has recovered more than $4 billion for our clients.
Dr. Scott Gottlieb, the F.D.A. commissioner, said Friday that sales of the device in the United States had declined by about 70 percent since the agency ordered Bayer to conduct a post-market study on women using the device and to place the boxed warning and patient decision checklist on the labeling.
Dr. Gottlieb also said the F.D.A. would continue to evaluate reports filed about injuries related to Essure, as well as reports of surgeries required to remove it.
Bayer blamed “inaccurate and misleading publicity” as a key factor in sales loss. The company also said that American women were becoming less interested in permanent contraception, and instead were relying more on other birth control options, like long-acting reversible contraceptives.
“The benefit-risk profile of Essure has not changed,” the company said, “and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research.”
Public health advocates have long been troubled by what they see as a lack of solid data on Essure’s safety and effectiveness.
“Thousands of women have reported serious complications from Essure, and there has been no unbiased long-term research to refute or confirm those reports,” said Diana Zuckerman, president of the National Center for Health Research, who has been a paid expert witness in one of the cases involving Essure plaintiffs against Bayer. “Both the F.D.A. and the company are responsible for a situation where women could not make informed decisions.”
The company said it would continue to enroll patients in a postmarket surveillance study and will work with the F.D.A. to ensure appropriate follow up.
Steven Immergut, a Bayer spokesman, said that as of mid-April, there were about 16,800 plaintiffs who have filed claims regarding Essure. Many of the lawsuits have been consolidated or merged from states across the country. “We believe we have meritorious defenses and intend to continue to vigorously defend Essure,” he said.