Essure was the newest permanent birth control device added to a long list of birth control options.
Essure is meant to be permanent but some women have experienced problems with these permanent birth control devices.
Many of these women have considered removing their Essure devices. Unfortunately removing Essure birth control devices is not as easy as inserting Essure.
This article will provide advice about removing Essure birth control devices for symptoms or side-effects. In a future article, we will discuss Essure device removal for women who want to become pregnant again.
I am a specialist in Essure removal. I write all of these blog articles personally. I thought I would provide my insight and advice about removing Essure.
Essure was marketed as being easy to insert into a woman’s fallopian tubes. The devices could be placed in an office setting. General anesthesia was not required. Claims were made the devices did not cause problems or side-effects and that they were highly effective at preventing pregnancy.
For some women, the Essure claims were true: the devices were easy to insert, there was minimal pain involved, and most of the women did not have problems from the Essure devices.
For other women, the claims of safety were far from accurate: the devices were hard to insert, painful, some women experienced birth control failure (ectopic pregnancies and normal pregnancies), some women had symptoms of pelvic pain, and others had symptoms of joint pain, skin rash, hair loss, etc.
For some women Essure was not an easy form of birth control. Instead it was a living hell. Easy to insert but hell to get out.
There is a ton of misinformation about these devices so I thought I would share my knowledge based on my personal experience.
When did Essure problems start?
Essure was first approved by the FDA and introduced into the US market place in 2002 by a company called Conceptus.
There were not many Essure problems at first but that was only because there were not many doctors who were inserting Essure birth control devices.
The Essure problems and side-effects started gradually. As the numbers of doctors who could insert the devices gradually increased then we started to gradually notice Essure problems increase.
I distinctly remember the Conceptus Essure roll out because it was my first year out of residency training. Conceptus was aggressively trying to get doctors to use it. They had a creative plan where doctors could get the expensive office equipment required for Essure at a very low cost if they used a minimum of two Essure device kits per month.
So ‘free’ or ‘low cost’ equipment in exchange for inserting devices every month.
The initial evidence about the safety of Essure was reassuring. Only the very skeptical doctor would have been aware the initial studies were done on a very small group (about 500) of the very best candidates and done by the very best doctors who were specially trained to insert the devices.
Unfortunately, it is much easier to get devices passed through the FDA than medications.
For devices all you have to do is prove to the FDA that the device accomplishes the stated goal (ie no pregnancy) and no one dies. You don’t have to study anything else.
In comparison, medications are harder to get through the FDA. Not only do you have to prove the medication works but you also have to prove what the best dose is with the lowest side effects and that the medication does not cause damage to other organs, birth defects, or cancer.
Conceptus was very aggressive at marketing the devices. Doctors slowly started to use Essure between 2002 and 2005.
One of the biggest problems was that doctors were doing these procedures in the operating room and health insurance was not paying for these procedures.
Essure when done in the operating room was more expensive than regular tubal ligation. There was some lobbying of the health insurance companies and doctors were encouraged to do the procedures in the office. If the procedures were done in the office then the doctors got paid more. If the procedures were done in the operating room then doctors saw lower reimbursement.The intent was to decreased health care cost, make it easier for women to get Essure, and provide higher reimbursement for the doctors.
Unknown to many of us at the time, the goal was to increase the number of doctors using the devices and show the company was profitable and that even more profits could be made. Eventually a deal was made and Essure was bought from Conceptus by Bayer in 2013. This is when the problems really started to increase.
Essure problems first started when the devices were first used in 2002 but there were not many doctors inserting the devices and not many patients had the devices. Slowly more patients started using the devices and more doctors started inserting the devices. There were Essure problems at first but the complications were so widely scattered across the United States that these problems were difficult to notice.
When Bayer bought Conceptus the bigger healthcare company really started heavily marketing the Essure devices to doctors and patients. This is when the problems really began to escalate because more doctors started using the devices in a larger number of women. Not all of these doctors were well trained. Not all of the patients were the easiest or best patients to have Essure inserted.
More information: Problems reported in patients with Essure birth control devices
My History And Experience With Essure
In 2008, I started working with Dr. Gary Berger at the Chapel Hill Tubal Reversal Center. It was around this time we started to get contacts from women who were suffering Essure side-effects. At first we received about one call a month. Slowly we started to get more contacts.
In the early days, when patients had problems they would return to the doctor that inserted the Essure devices. Their doctors would dismiss them or blow them off. The doctors would essentially tell their patients, “Essure is perfect. It must be in your head.”
As more time passed and more women got Essure, more women began to complain of Essure side effects. Soon doctors were forced to admit that Essure did cause side-effects, there was little they could do, and in most cases they could only offer women hysterectomies to remove the devices.
Not only were the doctors dismissive, but the health care insurance companies, initially, refused to pay for treatment of Essure complications. Soon health insurance companies acknowledged patients were having problems from Essure. Health insurance soon started paying for Essure removal and hysterectomy but not Essure reversal.
For many women having a hysterectomy was an unacceptable treatment for side-effects from something that was so easy to insert it could be done in a doctor’s office. Many of them started to contact our office for advice and treatment.
Soon the one contact a month we previously received grew into several contacts a day.
In my early days I did one Essure removal a month….and at the peak of removal in 2016 to 2018 I was doing up to six Essure removal surgeries per week!
More information: Risks of Essure permanent birth control devices
When did Essure stop being used?
On December 31st 2018, Bayer stopped manufacturing and distributing Essure devices. On December 31st 2019, all Essure devices not used were required to be returned to Bayer and were no longer available for implantation.
Almost 20 years after the Essure birth control devices were introduced they were removed from the US marketplace.
The FDA ordered a Essure postmarking followup study for women who already had Essure inserted.
The longterm followup study has not been finalized but the initial results show the occurrence of chronic lower abdominal or pelvic pain and abnormal uterine bleeding was higher among the women who got Essure devices compared to women who got traditional tubal ligation.
More information: Essure devices cause higher chance of pain and bleeding
Essure stopped being manufactured in 2018. Essure was completely taken off the shelves in 2019. Essure stopped being used in December of 2019.
What are the problems associated with Essure?
I always like to reassure women that up to 80% of women with Essure do not report problems.
Approximately 20% of women (or 1 out of 5) report Essure side-effects.
The problems we see are very much in line with the FDA Essure post marketing study: pain, bleeding, and hypersensitivity/autoimmune type reactions.
Pain and Essure
Pain after Essure is the number one complaint we receive from patients who come to us for Essure removal.
In many cases this pain starts soon after the devices are inserted. Sometimes the pain is worse with menstruation. Sometimes the pain is associated with sexual activity and sometimes it is just random ‘twinges’ or sometimes described as ‘electric shocks’.
When we remove Essure devices in women who report pain after Essure we usually find the devices in their normal location without any visible abnormalities. Occasionally, we find endometriosis around the Essure devices. Of note, we will occasionally see Essure devices partially perforating the uterine or fallopian tube muscle. An interesting observation about these patients is that many of the women with Essure perforating the muscle seem to report no pain at all.
Bleeding and Essure
The second most common complaint we hear from patients is that they have heavier or longer periods. We are not sure why this is happening.
In some patients, we find a decent amount of the device is inside the uterine cavity and acting like an IUD. This is not the intended normal location for the device. This may be why some women have heavier bleeding with Essure.
Autoimmune/hypersensitivity reactions with Essure
Less frequently we have patients who report skin rashes, joint pain, atypical food allergies, hair loss, teeth and finger nail issues. We also see a fair number of patients reporting hormonal abnormalities like abnormal thyroid levels.
Thyroid disease associated with Essure is hard to prove because women more commonly have thyroid disease and thyroid disease is typically diagnosed in women in their thirties.
The following are common questions women with Essure often ask us.
Do I need to have my Essure devices removed?
If you are not having symptoms then we do not recommend removal of the devices. You may be in the majority of women who do not report any problems as a result of Essure.
Will your devices cause problems in the future. We don’t know for sure but we don’t think they will cause problems in the future. The most common time to have a problem is within the first several years of insertion.
Will the Essure devices effect my health in the future?
The honest answer is we do not know…but we believe the Essure devices are safe for the long term. The first patient to get Essure was in the early 2000’s….so as of the writing of this article there are some women out there who have had Essure for 20 years. So far we have not seen any increase in problems in these patients who had devices inserted in the very early days of Essure.
Does Essure cause cancer?
To the best of our knowledge, the Essure devices do not cause cancer.
Can the Essure devices move or migrate?
Yes…and no. The Essure devices can move but it is not in the way you think.
There is a big misconception among women when you talk about Essure ‘migration’.
I think some people think the Essure devices act like caterpillars and that they will just crawl around your pelvis. This is not accurate.
Usually the devices are not placed in the correction location at the time of insertion. This is why they end up in abnormal places.
Sometimes the devices are partially placed in the tube.
Problems happen if the Essure devices are not inserted deep enough.
If they are not put in deep enough. The tubal and uterine muscle then start to contract and spasm and may cause the Essure devices to dislodge. The Essure devices could be pushed by the tubal muscle into the uterine cavity. The devices may stay inside the uterus or be expelled with menstruation.
Problems happen if the Essure devices are inserted too deep.
If they are put in too deep. The devices can also be pushed out of the end of the fallopian tube and into the pelvis.
Usually if the devices move or migrate this is something that happens within the first 1 to 3 months of insertion. Once they are documented in place at the time of the 3 month Essure confirmation test the devices will not move after that time.
Does Essure scar tissue get worse with time?
We believe the most scar tissue ingrowth through the devices forms in the first 12 months. Scar tissue does not progressively get worse after the first 12 months.
Could I be having problems from the Essure?
Only a patient can answer this question. Our experience has been if the Essure devices are causing problems this usually happens within the first several months after the Essure devices are inserted. The problems usually don’t start years later.
Can Essure removal help my symptoms?
Most of our patients report improvement after Essure removal. If the symptoms started soon after insertion then removal of the devices will most likely help.
If the symptoms started years after Essure insertion then Essure may not be the cause of your problems.
Do you need a hysterectomy to remove my Essure devices?
Most doctors will offer you a hysterectomy to remove the Essure devices. They will offer hysterectomy because 1) hysterectomy is a procedure they are trained to offer and 2) most health insurance companies will pay for this procedure.
In our experience, you do not need a hysterectomy to remove Essure. If you have other gynecologic issues like fibroids or endometriosis then a hysterectomy will be a reasonable approach to treat all of those conditions at once and prevent any future problems.
We have had good success with removing the devices and reimplanting the fallopian tubes or removing the Essure devices and leaving the tubes closed so pregnancy does not occur.
If I remove my Essure birth control devices will I get pregnant?
If you simply remove the Essure birth control devices you will not become pregnant.
The Essure devices really damages the smallest part of the tube that travels through the uterine muscle. Once the devices are inserted the damage is done. Just like when you remove a piercing…when you simply remove or pull the devices out that damaged area of the tube will heal closed after the removal.
We see many patients who have the Essure removed by their local Ob/Gyns because 1) their health insurance will pay for the procedure and 2) these patients think they will be able to become pregnant. Many of them will contact us for a reversal of Essure after they realize simple removal will not allow pregnancy.
How can I become pregnant after Essure?
If you want to become pregnant after Essure you have two options: 1) in-vitro fertilization (IVF) or 2) Essure reversal.
We surgically reverse Essure by removing the devices and reinserting the healthy tube back into the uterus. This is called a tubouterine implantation procedure. The chance of pregnancy is 40% to 50%.
More information: Chances of pregnancy after Essure reversal
Essure reversal surgery can provide a good chance at natural pregnancy.
Removing Essure birth control devices
We specialize in removing Essure with a low risk of device fragmentation.
Is there a class action lawsuit against Essure?
There is currently not a class action lawsuit against Bayer for the Essure birth control device. There was a settlement against Bayer for the Essure birth control devices but not a class action lawsuit.
Is there an Essure lawsuit?
Kind of…there was a settlement in 2020 for women hurt by the Essure birth control devices.
In 2020, Bayer entered into a $1.6 billion settlement to resolve most Essure claims. The settlement was expected to resolve around 90% of the 39,000 cases that had been filed at the time. The approximate share per plaintiff from the Bayer settlement was $45,600.
Can you file an Essure lawsuit?
If you think you were harmed by Essure you can file a lawsuit but you would need to speak with an attorney.
In general, they have to consider if your cases is within the statute of limitations.
The time of your statute of limitations varies depending on what state you live in and the type of claim you are making. If you do not file a claim within the timeline of the statute of limitations, then you may not be entitled to legal action or damage awards.
For more information: Essure Lawsuit Update September 2023
Would you like a free consultation about removing Essure?
For some women the Essure devices are no different than a wooden splinter. Removing the devices could help you with your problems.
If you started experiencing symptoms soon after Essure devices were inserted then removal may help treat your symptoms.
If you would like a free consultation about removing your Essure birth control devices then we encourage you to send us your records for a free review.
More information: Sending records for a free review
We specialize in Essure removal and Essure reversal. Using our proven surgical techniques we can remove the devices safely, with a low chance of fracture, and a high chance of curing your abnormal symptoms.