Frequently Asked Questions

Click on a topic below.
Edit The Essure Procedure
Edit What is Essure?
The Essure permanent birth control system is designed to provide a non-incisional alternative for women seeking sterilization. Essure does not require general anesthesia and can be performed in a physician's office.
Edit How does Essure work?
Using a hysteroscopic approach, one Essure micro-insert is placed in the proximal section of each fallopian tube lumen. The micro-insert expands upon release, acutely anchoring itself in the fallopian tube.

The micro-insert subsequently elicits a benign tissue response. Over a three-month period, tissue in-growth into the micro-insert anchors it and occludes the fallopian tube, resulting in permanent birth control.
Edit Does Essure contain any drugs or hormones?
No, the Essure micro-insert does not contain any drugs or hormones. During the 3-month alternative contraception period, a woman looking for a hormone free method can opt for barrier methods.
Edit How effective is Essure?
Based on clinical trials of over 600 women, Essure has been demonstrated to be 99.80% effective at four-years of follow-up.
Edit Can a patient immediately rely on Essure for permanent birth control after the procedure?
No. It takes at least three months before the physician can advise the patient whether the Essure micro-insert can be relied on for permanent birth control and this can only be done after the patient undergoes a hysterosalpingogram to evaluate tubal occlusion and micro-insert location. The patient will need to use an alternative form of contraception during this three-month waiting period. Acceptable forms of alternative contraception include oral contraceptives, injectable hormones, barrier methods such as condoms or the diaphragm, or implants, where available. IUDs cannot be used during this time.
Edit Is Essure reversible?
No, the Essure procedure should be considered irreversible. There are no data on the safety or effectiveness of surgery to reverse the Essure procedure. Any attempt at surgical reversal will likely require utero-tubal reimplantation. Pregnancy following such a procedure carries with it the risk of uterine rupture and serious maternal and fetal morbidity and mortality.

Edit Can the micro-inserts be removed?
Micro-insert removal should not be attempted hysteroscopically once the micro-insert has been placed. The only exception is during the actual placement procedure when removal may be attempted if 18 or more coils of the Essure micro-insert are trailing into the uterine cavity. Because of micro-insert anchoring, however, removal may not be possible even immediately after placement. Attempted removal of a micro-insert having less than 18 coils trailing into the uterine cavity may result in fallopian tube perforation or other patient injury.

Edit Could a patient become pregnant with IVF following the Essure procedure?
The effects of the Essure micro-inserts on the success of IVF are unknown. If pregnancy is achieved, the risks of the micro-insert to the patient, to the fetus and to the continuation of a pregnancy are also unknown.

Edit What is the placement rate after the first procedure?
The bilateral placement rate is 94.6% after the first placement attempt.  It was determined in a post approval study (PAS) for newly trained physicians using the Essure system model ESS205.

Edit What type of anesthesia is used for the Essure procedure?

Placement anesthesia method used in Pivotal trial - 544 procedures
(includes first and second procedures)


Anesthesia Used Percent
Local 52.0
IV sedation and/or analgesia 40.8
None 7.0
General 0.2*

* General anesthesia was used in only 1 case, per the woman's request
Edit Does the use of NSAIDs affect the placement rate?
The use of NSAIDs is strongly recommended. Analysis of clinical results demonstrated improved placement rate.
Edit Is it imperative that patients are in the early proliferative phase of their menstrual cycles at the time of the procedure?
Yes, this precaution in our labeling is made for the following reasons:

1) to avoid micro-insert placement in a patient with an undiagnosed (luteal phase) pregnancy; and

2) to enhance visualization of the fallopian tube ostia.

In women with cycles shorter than 28 days, perform the procedure at least 2 days prior to the calculated ovulation date. Micro-insert placement should NOT be performed during menstruation.

Edit When does fibrosis occur?
Based on histology studies, all micro-inserts placed across the UTJ (utero-tubal junction) were fibrosed at 3 months. This fibrosis leads to occlusion of the fallopian tube and anchoring of the micro-insert. This fibrosis is caused by a chronic inflammatory response to the PET fibers contained within the Essure micro-insert.

The PET fibers were chosen for this application due to their success in causing tissue in-growth into devices used in other medical applications, such as prosthetic arterial grafts, percutaneous catheters, aneurysm grafts, and other long-term implants.

Edit What is the average procedure time?
In the pivotal trial, the average procedure time was 35 minutes, from the time the woman entered the room until the procedure was finished (13 minutes of hysteroscopic time; scope in to scope out).
Edit The Essure Clinical Trial Information
Edit How many women have been involved in Essure safety and effectiveness studies?
More than 600.
Edit How many patients have undergone this procedure outside of the clinical trials?
Tens of thousands of patients have undergone the Essure procedure outside the clinical trials. It is difficult to track the exact number of cases performed as commercial use increases worldwide. However, many cases have been done in Europe, Australia, Canada and Singapore since inception of the commercial phase in Australia (Feb 2001).
Edit Were there any pregnancies in the clinical trial?
There were no pregnancies with the current design of Essure in women who were relying on it for contraception. However, one woman in the Phase II study who received a prior device design that was discontinued in 1998 (the Beta design) became pregnant after two years of reliance.

Edit If there were no pregnancies reported in the Essure clinical trials, then can Essure be considered 100% effective?
No. No method of contraception is 100% effective. Based on clinical trials of over 600 women, Essure has been demonstrated to be 99.80% effective at four-years of follow-up. The effectiveness rate is stated as 99.80% instead of 100%, since the statistical calculation of the effectiveness rate was based on a sample size in the trials of over 600 women.
Edit Were there any luteal phase pregnancies in the clinical trial? If so, what were their outcomes?
There were 4 luteal phase pregnancies in the pivotal trial; 3 were terminated and 1 spontaneously aborted. Of the 3 terminations, 2 were by D&C and 1 by mifepristone.
Edit Training for the Essure Procedure
Edit What skills are needed to attend Essure Training?
In order to be trained in Essure you must be a skilled operative hysteroscopist. You will find the procedure easier to learn if you are already proficient in operative hysteroscopy and management of the awake patient. If your skills are minimal or out of date, you should attend a hysteroscopy course before learning Essure.
Edit What preparation is needed for didactic training and the subsequent preceptorship?
You should minimize the time between didactic training and preceptorship to optimize your learning experience. Prior to the didactic training, you are required to select 5 women who are interested in Essure as a permanent birth control option.

Edit The Essure Confirmation Test
Edit What percentage of patients needed to have a repeat Essure Confirmation Test at 6 months, and what percentage were occluded by that visit?
4% of women required a repeat Essure Confirmation Test, all of whom attained occlusion by the 6-month visit.
Edit Can ultrasound replace the 3-month Essure Confirmation Test?
Our labeling specifically recommends an Essure Confirmation Test at the 3-month visit before the patient can be instructed to discontinue alternate contraception.
Edit Can a radiologist perform the procedure with fluoroscopy?
There is no clinical trial data regarding the placement of Essure with fluoroscopy.
Edit The Essure Procedure and Patient Care
Edit How did patients rate their comfort and overall satisfaction with the implanted micro-inserts?
In the Phase II study, a woman's tolerance to wearing Essure was ascertained at the 3, 6, 12, 18, 24, 36 and 48-month follow-up, and has been rated as "good" to "excellent" in 99% of women at all visits.

Women in the pivotal trial consistently rated their comfort in wearing the micro-inserts as very high. One-week post-device placement >95% of women rated their comfort as "good"to "excellent". At all subsequent study visits >97% of women rated their comfort with wearing Essure as "good" to "excellent".

In the Pivotal trial, women consistently rated their overall satisfaction with the micro-inserts as very high. One-week post-device placement >95% of women rated their satisfaction as "somewhat satisfied" to "very satisfied". At all study visits through two years of follow-up, at least 98% of women rated their overall satisfaction as "somewhat" to "very satisfied" (this included women who were not able to rely on Essure). At their four-year follow-up, 92% of women rated their overall satisfaction as "somewhat" to "very satisfied".

Edit How soon can patients get back to work?
In the pivotal trial, 92% of employed patients returned to work in 24 hours or less after the day of the procedure.
Edit What types of adverse events were experienced in the clinical trials?
Micro-insert expulsion 2.9%
Perforation 1.8%
Unsatisfactory micro-insert placement 0.6%
Non-specific pelvic pain 0.2%
Persistent changes in menstrual function
            Bleeding between menses 0.5%
            Heavier than usual flow 2.3%
            Less than usual menstrual flow 1.8%
Abdominal (pain, cramps, gas and bloating) 5.1%
Musculo-skeletal (back pain, arm/leg pain) 9.8%
Nervous/Psychiatric (headache/PMS) 3.3%

Edit Can a patient with a nickel allergy undergo this procedure?
Essure is contraindicated if a patient has a confirmed allergy to nickel (a positive skin test administered by an allergist or dermatologist). Alternative permanent birth control should be considered.

If a patient expresses concern about nickel allergy due to a previous skin reaction (contact dermatitis or skin turning green) to jewelry, orthodontic or endodontic appliance, etc., we recommend confirming by skin test.

Edit Can an IUD be used for alternative contraception during the 3-month waiting period?
No. The IUD could become entangled with the micro-inserts, resulting in both difficulty of IUD removal and potential disruption of the micro-inserts.
Edit Can an endometrial ablation be performed after the procedure?
Bench studies suggest that endometrial ablation using radio frequency (RF) energy will cause significant damage to surrounding tissue if an active RF instrument comes into direct contact with the Essure micro-inserts. Consequently, if using RF energy to perform endometrial ablation, direct contact with the Essure micro-inserts should be avoided. Global auto-ablative systems that employ RF energy should not be used in women with the Essure micro-inserts in place.

There are no data regarding cryo-ablation techniques or the use of laser for endometrial ablation of the uterus with Essure micro-inserts in place.



Edit Can an intrauterine procedure be performed using microwave technology after the Essure procedure?
There are no data regarding the use of endometrial ablation devices that operate at microwave frequencies with the Essure micro-inserts in place. The use of microwave energy near metallic implants has been shown to pose significant risk of serious injury to patients. Use of microwave endometrial ablation devices near the Essure micro-inserts, therefore, should be avoided.
Edit Can other electrosurgical procedures be performed after the Essure procedure?
The Essure micro-insert will conduct energy if directly or closely contacted by an active electrosurgical device. If this occurs, there is a risk of patient injury. Therefore, electrosurgery should be avoided in procedures undertaken on the uterine cornua and proximal fallopian tubes without either hysteroscopic visualization of the micro-inserts, or visualization of the proximal portion of the fallopian tube via open surgical procedures or laparoscopy. During LAVH and other procedures in which electrosurgical instruments could contact the serosa of the fallopian tube, instruments should not be placed more proximal than the ampullary portion of the tube.

Edit What are the concerns about performing other intrauterine procedures (i.e., D&C) after the Essure procedure?
Diagnostic procedures under direct visualization are optimal with the Essure micro-inserts in place. Blind insertion of instruments into the uterus with the micro-inserts in place should be undertaken with caution to avoid disruption of the micro-inserts. Any intrauterine procedure performed following the Essure procedure could interrupt the ability of the Essure micro-inserts to prevent pregnancy. In addition, the presence of the Essure micro-inserts could involve risks associated with such procedures that, at this time, have not been identified. Following such procedures, micro-insert retention and location should be verified by hysteroscopy, x-ray, or ultrasound.
Edit What are the effects of using cryogen with the micro-insert?
There is no information about the safety of cryo surgery with Essure.
Edit Would thickness of the endometrium during a progesterone treatment affect placement of the micro-inserts?
Progesterones actually lead to a thinning of the endometrium. Many women on progestins become amenorrheic due to the very thin endometrium. A thin endometrium can also be "shaggy" due to the poor estrogenic support of the endometrium, which may make visualization more difficult if the procedure is prolonged.

Edit How long should a patient wait to have the procedure if she has taken corticosteroids in the past?
If a patient has taken corticosteroids in the past, more than a few months prior to Essure placement, there should be no impact on the inflammatory response to the PET fibers. However, if a patient is in need of chronic steroid treatment or other immunosuppressant treatment, it is strongly discouraged, and our labeling contains a warning statement to this effect, because the immunosuppressive therapy is expected to negatively affect the tissue response to Essure that leads to tubal occlusion.

Edit How long should a patient wait after the procedure before returning to using corticosteroids?
To date, there is no clinical data on patients using systemic corticosteroids following Essure placement. Once Essure micro-inserts have been placed it is important that the tissue in-growth phase be allowed to be completed before resuming corticosteroid or immunosuppressant therapy. The patient should wait at least 3 months before resuming the use of corticosteroids. The use of corticosteroids, theoretically, can reduce the inflammatory response required for the Essure mechanism of action.

Edit Can a patient with a history of hydrosalpinx (not acute) have a micro-insert placed?
There is no contraindication for Essure placement in women with a history of hydrosalpinx, however, it is contraindicated for women with active or recent upper or lower tract pelvic infections. Also, be aware that uterine or fallopian tube anomalies may make it difficult to place the micro-insert, and a hydrosalpinx could result in a dilated proximal tube, making placement or micro-insert retention difficult.
Edit Are there plans to reduce the 3-month alternative contraception period?
We are considering the possibility of conducting additional clinical trials to evaluate whether or not the 3-month waiting period can be shortened or eliminated. Plans and timelines for such studies have not yet been determined, and we currently have no data to support a different waiting period.
Edit Can CO2 gas be used for hysteroscopic procedures to place the micro-insert?
There is no clinical trial data on the use of CO2. The Essure system has been optimized with a hydrophilic coating on the outer catheter to work in a saline environment. Without fluid, this hydrophilic coating is not activated and will not aid in insertion.

Edit Is it safe to perform Magnetic Resonance Imaging (MRI) on a patient with Essure micro-inserts?

Testing to ensure safety and compatibility with Magnetic Resonance Imaging (MRI) has been conducted using a 1.5 tesla magnet.  The Essure micro-inserts were found to be MR safe at this field strength.  Test results at 1.5 tesla indicate zero magnetic force and radio frequency (RF) heating of 0.60 C in a phantom when a whole body specific absorption rate (SAR) of 1.3 W/kg was applied.  The presence of the micro-inserts produces an MR artifact, which will obscure imaging of local tissue.  The artifact is expected to be larger at higher field strength.


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