Essure Efficacy Results
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97% of patients with successful bilateral placement were able to rely on Essure for birth control (n=643/664)
Adverse Events Preventing Reliance
|Adverse Events||Phase II||Pivotal|
|Perforation||7/206 (3.4%)*||5/476 (1.1%)|
|Expulsion||1/206 (0.5%)||14/476 (2.9%)†|
|Unsatisfactory insert location||1/206 (0.5%)||3/476 (0.6%)|
|Initial tubal patency||7/200 (3.5%)‡||16/456 (3.5%)‡|
*Included 1 patient that relied for 31 months before laparotomy and cornual resection due to pain; the other 6 never relied.
†9 out of 14 patients underwent a successful second placement procedure after expulsion.
‡Patients with initial tubal patency at the 3-month Essure Confirmation Test using a modified HSG were instructed to continue with alternative contraception and undergo a repeat Essure Confirmation Test at 6 months. All patients were found to have tubal occlusion at the repeat Essure Confirmation Test 6 to 7 months post-procedure.
No pregnancies were reported in the Phase II and Pivotal clinical studies
However, all subjects in the Phase II and Pivotal trials underwent modified HSG prior to being counseled to discontinue alternative contraception and rely on Essure. No method of contraception is 100% effective and pregnancies have occurred in the commercial setting.
Effectiveness Results Among Women Told to Rely: Cumulative Failure Rates (N=643)C
|1 Year||2 Year||3 Year||4 Year||5 Year|
(95% CI 0 – 0.10%)A
(95% CI 0 – 0.20%)A
(95% CI 0 – 0.30%)A
(95% CI 0 – 0.40%)A
(95% CI 0 – 0.50%)A
A95% confidence intervals are based on a “constant-hazard” exponential failure-time model, whose parameter is determined by the total number of woman-months accumulated during the trial as well as the observed number of pregnancies (0 in Phase II and Pivotal trials). The combined effectiveness data was obtained using Bayesian statistics.
BThe number of women, “N”, were considered to have completed follow-up at 1 year if patient contact occurred at ≥11 months, 2 years if contact occurred at ≥23 months, 3 years if contact occurred at ≥35 months, 4 years if contact occurred ≥47 months, and 5 years if contact occurred at ≥59 months.
CThe number of women, “N”, who were told to rely.
In the 5-year follow-up of the Phase II and Pivotal studies:
- 643 women (194 Phase II and 449 Pivotal) with successful bilateral placement relying on the Essure inserts contributed a total of 35,633 woman-months of follow-up time
- Of these women, 567 completed the full 5 years of follow-up and no pregnancies were reported
- However, no method of contraception is 100% effective and pregnancies have occurred in the commercial setting
The calculated 5-year effectiveness rate for Essure inserts was 99.83%.
- The long-term effectiveness rate calculation for Essure inserts was determined using a Bayesian approach that allowed for the incorporation of data from the Phase II trial into the Pivotal trial calculations
In the commercial setting, unintended pregnancies have been reported in women with Essure inserts. The following table summarizes the reasons for pregnancy from reports received by Bayer and additional reports from the published scientific literature.
Summary of Pregnancies Reported in Commercial Use of Essure*
|United States (US)||Outside the United States (OUS)**||Total|
|n||Percent of US causes||n||Percent of OUS causes||n||Percent|
|Patient noncompliance (eg, failure to use alternate contraception or return for Essure Confirmation Test)||213||32%||16||18%||229||31%|
|Pregnant at time
of placement (luteal)
|Inadequate confirmation test***||28||4%||0||0%||28||4%|
*Table includes pregnancy reports received directly by Bayer, recorded in the FDA MAUDE database and reported in the scientific literature; data reported to FDA in PMA Annual Reports. Pregnancies in Essure patients may be underreported.
**Outside of the United States, during this reporting period, the Essure Confirmation Test may have been an x-ray or transvaginal ultrasound; device location alone, not occlusion, is primarily used to determine whether the patient may rely on Essure.
***Most of these pregnancies are due to misinterpreted Essure Confirmation Tests. Please note that many misinterpretations are due to the fact that occlusion is seen on the hysterosalpingogram (HSG) films even though the insert is not properly located.
****Number of pregnancies reported from worldwide commercial launch in 2001 through end of 2010. The number of Essure kits sold during this time was 497,306. Note that an accurate pregnancy rate is difficult to obtain, as the number of devices actually implanted is not known.
#A causal association cannot be established between perforation and pregnancy. However, perforations have been identified in pregnant women who were relying on Essure for contraception.
The majority of unintended pregnancies are preventable. Most unintended pregnancies are related to patient noncompliance and physician misinterpretation of the Essure Confirmation Test. In order to ensure maximum contraceptive effectiveness by Essure, the physician should ensure that the patient is counseled. It is also important to evaluate insert location and, in some cases, occlusion carefully before telling the patient that she may rely on Essure for contraception.
Prospective, multicenter, single-arm, non-randomized, international study of women seeking permanent birth control (N=518).
- 88% of patients rated tolerance of the placement procedure as good, very good, or excellent1
- Women were typically discharged from the medical facility 44 minutes after the 36-minute (on average) procedure1
- 60% of women returned to normal activity within 1 day or less
- 75% of patients resumed normal activity by day 21
Reference: 1. Cooper JM, Carignan CS, Cher D, Kerin JF; Selective Tubal Occlusion Procedure 2000 Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102(1):59-67.
In the most recent clinical study, ESSTVU, 547 trial participants were instructed to rely on Essure for contraception. The Essure TVU/HSG Confirmation Test Algorithm was used to determine the confirmation test used. In this study, three pregnancies were reported in the 1 year follow up. All three pregnancies occurred in women who had TVUs to confirm Essure placement.
Insert Placement Rate and Reliance Rate (ESSTVU Trial)
|Placement Status||ESSTVU Study|
|Placement Rate: Assessed at the time of placement|
|Insert Placement AttemptedB||594/597||99%|
|Successful bilateral placement after first attempt||574/597||96%|
|Successful bilateral placement after first or second attempt||582***/597||97%|
|Reliance Rate: Assessed at the Essure
Confirmation Test (at least 3 months after placement)
|Reliance in women who had procedure initiated||547D/597||92%|
|Reliance in women with successful bilateral placement after first or second attempt||547D/582C||94%|
AIntent to treat (ITT) population in the ESSTVU trial includes all participants who had the Essure procedure initiated (i.e., all study subjects who entered the procedure room/operating room with the intent to undergo the procedure).
BAll subjects where the Essure system was passed through the working channel of the hysteroscope.
CExcludes 15/597 subjects with no insert placement attempt 3/597(0.5%) and non bilateral placement after 1 or 2 procedures 12/597 (2.0%).
DExcludes 50/597 subjects who were unable to rely for the following reasons: No insert placement attempt 3/597 (0.5%), non bilateral placement after 1 or 2 procedure 12/597 (2.0%), incomplete or no confirmation testing (28 /597; 4.7%); unsatisfactory device location/occlusion identified at confirmation testing (perforation, expulsion, distal placement, proximal placement) (7/ 597; 1.2%).
ESSTVU Trial with TVU/HSG Confirmation Test Algorithm Effectiveness Results Among Women Told to Rely: Cumulative Failure Rates
BThe number of women, “N”, who attended follow-up at 1 year.
Three pregnancies were reported in the 1 year follow up in the ESSTVU trial based on 518 woman–years of follow up. In all 3 pregnancies, TVU was utilized as the confirmation test, and the insert locations were deemed “optimal” in the initial assessment. In 2 of the 3 pregnancies, perforation not detected by initial TVU assessment was determined to be the cause. In the third pregnancy, insert location was unsatisfactory, and not detected by initial TVU. One additional pregnancy was reported 16 months after the subject was told to rely. As it occurred after the 1-year follow up, this pregnancy was not included in the 1-year effectiveness rate calculation. No pregnancies were reported in the Phase II and Pivotal clinical trials; however, all subjects in the Phase II and Pivotal trials underwent modified HSG prior to being counselled to discontinue alternative contraception and rely on Essure.