Frequently Asked Questions

Using a transcervical hysteroscopic approach, an Essure micro-insert is placed in the proximal section of each fallopian tube. The micro-insert expands to conform to the natural contours of the fallopian tube lumen and immediately anchors. Over the next 3 months the micro-insert elicits a benign occlusive tissue in-growth response which permanently occludes the fallopian tube, resulting in permanent birth control. The Essure micro-insert does not contain drugs or hormones

Essure has over ten years of clinical experience, with zero pregnancies among users in the clinical trial. The Essure micro-insert 1 year failure rate is 0% which translates to an age- adjusted 1 year effectiveness rate of 99.95%. Additionally, the five year effectiveness rate for the Essure micro-inserts is 99.74%. For complete effectiveness and failure rate data, refer to the Essure Instructions For Use.

There were zero pregnancies in the clinical trials. In the commercial setting, reported pregnancies have been within the labeled effectiveness rate of 99.74% at 5 years. See table 1 for the a comparison of “Typical Use” failure rates versus “Perfect Use” failure rate for commonly used birth control methods.

*Adiana is a registered trademark of Hologic, Inc
** Limited data due to recent FDA approval and limited commercial use

The Essure micro-inserts provide permanent contraception, and the procedure should be considered irreversible.There is limited data on the safety and effectiveness of micro-insert removal, which would likely require surgery. Pregnancy and associated risks following micro-insert removal are unknown and the risks may include both maternal and fetal morbidity and mortality. Please email clinical_consult@conceptus.com or call 1-877-377-8732 for additional information.

It takes at least three months for the desired tissue response to occlude the fallopian tube. At this point, the Essure confirmation test is performed to confirm both proper placement of the Essure micro-insert and bilateral tubal occlusion giving you and your patients piece of mind. Prior to a successful confirmation test, your patients must use an alternative form of contraception.

Bench and clinical studies have been conducted which demonstrate that balloon thermal (THERMACHOICE* Uterine Balloon System) and hydro-thermal (HTA** System) endometrial ablation of the uterus can be safely and effectively performed with the Essure micro-inserts in place. Global auto-ablative systems that employ RF energy should not be used in women with the Essure micro-inserts in place. The Essure procedure should not be performed concomitantly with endometrial ablation. Ablation causes intrauterine synechiae which can compromise the 3-month Essure confirmation test (HSG).

(OUS LABELING ONLY) Bench and clinical studies demonstrated that endometrial ablation of the uterus can be performed safely and effectively with the GYNECARE THERMACHOICE* Uterine Balloon System, the Hologic NovaSure** Endometrial Ablation System and the Boston Scientific Hydro ThermAblator*** immediately following Essure micro-insert placement. No specific studies have been conducted to evaluate Essure micro-insert expulsion or contraception rates following combined Essure and endometrial ablation procedures. There are no data evaluating the use of other GEA technologies with the Essure system. For complete information please refer to the Essure Instructions for Use.

Bench studies suggest that endometrial ablation using monopolar radio frequency (RF) energy devices can 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.

There is limited data on effects of the Essure micro-inserts on the success of IVF. If pregnancy is achieved, the risks to the patient, fetus, and to the continuation of a pregnancy are unknown. For additional information, please contact the physician consult line at 1-877-ESSURE2 (1-877-377-8732) prompt 3 or email medical_liason@conceptus.com.

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

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.

The use of NSAIDs is strongly recommended. Analysis of clinical results demonstrated improved placement rate.

Progesterones 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.

Hundreds of thousands of women have undergone the Essure procedure.

There were no pregnancies during the clinical trials in patients wearing the current Essure device design. Four patients were pregnant at the time of the Essure procedure (luteal phase pregnancies) in the pivotal trial.

No method of contraception is 100% effective. Based on clinical trials of over 600 women, Essure has been demonstrated to be 99.74% effective at five-years of follow-up. The effectiveness rate is stated as 99.74% instead of 100% as age adjustments were made for comparison to the CREST study as a reference population.

The bilateral placement rate is 94.6% after the first placement attempt. This was determined in a post approval study (PAS) for newly trained physicians using the Essure system model ESS205 with a new catheter design.

The reliance rate is the percentage of patients that will be told to rely on Essure for contraception, and is typically calculated in two ways. The Intent to Treat Reliance Rate includes all patients in the clinical trials in whom a hysteroscope was used, including patients in which Essure was not attempted, unsuccessful placement attempts and those who were lost to follow-up. The Bilateral Placement Reliance Rate is calculated from the patients that had a successful confirmation test after bilateral Essure micro-insert placement. The Essure Intent to Treat Reliance Rate was 87% as calculated from the Essure Pivotal trial data. The Essure Bilateral Placement Reliance Rate is 97%.

The reliance rate (97%) is the percentage of patients that will be told to rely on Essure for contraception after bilateral placement success. The effectiveness rate (99.74% at 5 years) is the percentage of patients who will not become pregnant once told to rely on Essure.

Local anesthesia is used for the Essure procedure. No general anesthesia is required.

The Essure procedure should be performed in the early proliferative phase of a women’s cycle for two reasons; first, to avoid placing a micro-insert in a patient with an undiagnosed (luteal phase) pregnancy; and second, to maximize visualization of the fallopian tube ostia

Miicro-insert placement is not recommended during menstruation.

In the pivotal trial , the average hysteroscope time was 13 minutes; scope in to scope out.and the average total procedure time was 35 minutes from the time the woman entered the room until the procedure was finished.

To be trained in Essure, you must either already possess operative hysteroscopy skills or be willing to train in hysteroscopy. 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 training on the Essure procedure. Click here to begin your online training program

You should minimize the time between didactic training and preceptorship to optimize your learning experience. Prior to the didactic training, you need to identify 2-3 women in you practice who are interested in Essure as a permanent birth control option.

The Essure Confirmation Test is a low pressure HSG which verifies both proper micro-insert location and tubal occlusion. This test lets both you and you patient know she can rely on the Essure micro-inserts for contraception.

In the clinical trials, 3,5% of women required a repeat Essure Confirmation Test, all of whom were occluded by the six-month visit.

Our labeling specifically recommends an Essure Confirmation Test at the three-month visit before the patient can be instructed to discontinue alternate contraception.

There is limited clinical trial data regarding the placement of Essure using fluoroscopy.

In the Phase II study, a woman's tolerance to Essure was 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 Essure as "good" to "excellent". Women 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.”

In the pivotal trial, 92% of employed patients returned to work in 24 hours or less after the day of the procedure.

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%

Essure is contraindicated in patients with a confirmed hypersensitivity to nickel (a positive skin test administered by an allergist or dermatologist). If there is a suspicion of Nickel hypersensitivity, a skin test should be performed.

There is no warning or contraindication for the use of and IUD for alternative contraception during the three-month waiting period.

If a patient has taken corticosteroids more than a few months prior to Essure placement, there should be no impact on the in-growth response to the micro-insert. Chronic or very recent immunosuppressant treatment may impair tissue in-growth; therefore patients should be advised that it may take longer than three months to be able to rely on the Essure micro-inserts for contraception. Please see warning statement in IFU.

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 three months before resuming the use of corticosteroids. The use of corticosteroids, theoretically, can reduce the inflammatory response required for the Essure mechanism of action.

There is no contraindication for Essure placement in women with a history of hydrosalpinx. If the proximal fallopian tube is dilated due to the hydrosalpinx, micro-insert placement success may not be possible.

The Essure micro-inserts have been tested under 3T MRI conditions and have been determined to be MR-conditional (patients may be safely scanned after Essure placement). Full information can be found in the Instructions for Use.