mp-110 - mp-110 - Medical Policies
Permanent Forms of Sterilization Using the Hysteroscope
Policy Number: MP-110
Latest Review Date: July 2019
Policy Grade: Effective November 4, 2010: Active policy but no longer scheduled for regular literature reviews and update.
Description of Procedure or Service:
Sterilization generally refers to a surgical procedure that permanently blocks or removes male or female genital tracts so that fertilization will not occur. Permanent forms of elective sterilization include vasectomy and tubal ligation. Tubal ligation can be performed by laparoscopy or by minilaparotomy in the postpartum period with local, regional, or general anesthesia.
The Essure™ System (Conceptus, Inc.) is a form of permanent sterilization that uses micro-inserts placed in the proximal section of both fallopian tubes. The micro-insert expands and elicits tissue in-growth to permanently anchor and occlude the fallopian tube. This results in permanent sterilization. The procedure is done using a hysteroscope, paracervical block and/or IV sedation. To confirm the occlusion, the patient undergoes a hysterosalpingogram (HSG) at three months. If one or both tubes are still patent, a repeat HSG is performed at six months. Patients must use alternate forms of contraception until both tubes are completely occluded.
As of December 31, 2018, the selling and distribution of the Essure device in the United States was discontinued.
The Adiana Permanent Contraception System (Hologic, Inc.) was another medical device used to permanently occlude the fallopian tubes and provide permanent sterilization for women. The device consisted of a delivery catheter, silicone matrix tubal implant, and a Radiofrequency (RF) generator. Using a hysteroscope and local anesthesia, a specially designed catheter is passed through the uterus to reach both fallopian tubes. The catheter gently heats a portion of each tube before implanting a small silicone matrix in each tube. Over the next 3 months, tissue grows into the silicone matrices to occlude the fallopian tubes, which prevents the passage of sperm or eggs. Patients must use an alternate contraceptive method during this 3 month period. After 3 months, the patient undergoes a HSG to confirm that the Matrices are properly occluding the tubes. If the HSG shows both fallopian tubes are occluded, the patient may rely on the Adiana System for permanent sterilization.
In 2012, the manufacture of Adiana stopped production.
Effective for dates of service on and after September 6, 2019 and after:
Hysteroscopic placement of micro-inserts (i.e. Essure) in the fallopian tubes as a form of permanent sterilization are considered not medically necessary and investigational for all indications because its safety and long term effects have not been established.
Hysteroscopic placement of silicon matrices (i.e. Adiana) in the fallopian tubes as a form of permanent sterilization are considered not medically necessary and investigational for all indications because its safety and long term effects have not been established.
Effective for dates of service prior to September 6, 2019:
Hysteroscopic placement of micro-inserts in the fallopian tubes as a form of permanent sterilization may be considered medically necessary for groups which cover elective sterilization.
Hysteroscopic placement of silicon matrices in the fallopian tubes as a form of permanent sterilization may be considered medically necessary for groups which cover elective sterilization.
Placement of the micro-inserts or silicone matrices is considered not medically necessary for an individual:
Who is uncertain about ending fertility
In whom only one micro-insert can be placed (including patients with apparent contralateral proximal tubal occlusion and patients with suspected unicornate uterus)
Who previously had a tubal ligation
With pregnancy or suspected pregnancy
With active or recent upper or lower pelvic infection
With known allergy to contrast media
With known hypersensitivity to nickel confirmed by skin test
Women undergoing immunosuppressive therapy
Delivery or termination of a second trimester pregnancy less than 6 weeks before micro-insert placement*
Gynecological malignancy (suspected or known)*
Has intra-uterine pathology which would prevent access to either tubal ostium or the intramural portion of either fallopian tube (such as large submucous fibroids, uterine adhesions, apparent uni- or bi-lateral proximal tubal occlusion).
Initial short term studies in the early 2000’s of the Essure device showed the procedure was feasible, safe, and effective regarding sterilization. Industry studies reported high placement rates, zero pregnancy rates, and low adverse event rates.
By 2006, Karthigasu et al reported the first failed tubal occlusion by the Essure. Following this report, multiple studies of pain, perforation and dislodgement were published.
In 2015, Mao et al compared the safety and efficacy of hysteroscopic sterilization (i.e. Essure) with laparoscopic sterilization in an observational cohort study. Main outcomes were safety events within 30 days of procedures, unintended pregnancies, and reoperations within 1 year of procedures. A total of 8048 patients had hysteroscopic sterilization and 44,278 patients had laparoscopic sterilization between 2005 and 2013. In this study, at 1 year after surgery, hysteroscopic sterilization was not associated with a higher pregnancy risk (odds ratio 0.84 (95% CI 0.63 to 1.12)), but was associated with a substantially increased risk of re-operation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization. The authors concluded by stating, “Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making.”
Also in 2015, la Chapelle et al assessed in a systematic review whether hysteroscopic sterilization is feasible and effective in preventing pregnancy. They also aimed to identify risk factors for failure of hysteroscopic sterilization. A total of 45 cohort studies were analyzed. No randomized controlled trials (RCTs) were identified. Six articles concerned Ovabloc, 37 Essure, and two Adiana sterilization. Successful bilateral placement was reported on the first attempt for Ovabloc (78%-84%), Essure (81%-98%), and Adiana (94%). Successful bilateral placement could not be pooled because of substantial heterogeneity. The 36 months' cumulative pregnancy rate of Adiana was 16 of 1,000. Reliable pregnancy rates after sterilization with Ovabloc or Essure method could not be calculated. For all three hysteroscopic techniques, the incidence of complications and their severity has not been studied adequately and remains unclear. We also found too little evidence to identify risk factors for placement failure. The authors concluded by stating, “Sterilization by hysteroscopy seems feasible, but the effectiveness and risk factors for failure of sterilization remain unclear owing to the poor-quality evidence. Both currently applied hysteroscopic sterilization techniques and the coming new techniques must be evaluated properly for feasibility and effectiveness. Appropriate RCTs and observational studies with sufficient power and complete and long-term (>10 years) follow-up data on unintended pregnancies and complications are needed.”
A total of 2230 post Essure pregnancies has been reported to the FDA between 2002 to 2018. The most frequently reported patient problem from the Essure device was pain, menorrhagia, headache and fatigue. The most frequently reported device complication was patient-device incompatibility, migration of the device/component, dislodged or dislocated device, and device breakage/fragmentation/fracture. Hemorrhage and perforation have also been reported.
The FDA approval for the Adiana permanent contraception system was based on the pivotal clinical study by Vancaillie, et al (2008). The study was done to evaluate placement efficacy and reliability of an intratubal occlusion device for permanent contraception and to assess tolerability and overall satisfaction. The procedure was attempted in 645 women. Overall, bilateral placement was successfully achieved in 611 of 645 women (95%). At three months, the HSG procedure confirmed bilateral occlusion in 570 of 645 (88.4%). The one year pregnancy prevention rate was 98.9%. The three year cumulative pregnancy rate was 1.6%. The side effects on the day of the procedure include cramping (26%), vaginal spotting (12%), post-procedural bleeding (10%), pelvic pain (9%), back pain (8%) and nausea (5%).
Essure™ Permanent Birth Control System, female sterilization, Adiana Permanent Contraception System, silicone matrix tubal implant, hysteroscopy, contraception, microinserts
Approved by Governing Bodies:
Essure was FDA approved November 2002 using the PMA process. The FDA required the manufacturer to conduct 2 post approval studies.
In February 2016, the FDA ordered Bayer to conduct a postmarket surveillance study focusing on the benefits and possible health risks of the device.
In October 2016, the FDA ordered a black box warning to the Essure packaging to “better communicate” the significant side effects or complications associated with this device.
In April 2018, the FDA restricted the sale and distribution of the Essure device to providers who used the “Patient-Doctor Discussion Checklist- Acceptance of Risk and Informed Decision Acknowledgement”.
In July 2018, Bayer released a statement that they would discontinue the selling and distribution of the Essure device in the United States effective December 31, 2018.
Multiple labeling updates have occurred on the Essure device. In 2013 the label was updated to include risks of chronic pain and device migration. In 2016 it was updated to include the boxed warning and patient decision checklist. In 2018, the label was updated again to include the restriction of sale and distribution of Essure to providers that review the “Patient Doctor Discussion Checklist- Acceptance of Risk and Informed Decision Acknowledgement” prior to receiving the device.
Currently there is a warning that states:
“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.”
The FDA states they “will continue to evaluate medical device reports related to Essure removal and will keep the public informed of significant new information” as it becomes available.
Adiana was FDA approved in March 2009, but production was ceased in 2012.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply. Refer to member’s benefit plan.
Hysteroscopy, surgical; with bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants
Permanent implantable contraceptive intratubal occlusion devices(s) and delivery system
Chern B and Siow A. Initial Asian experience in hysteroscopic sterilisation using the Essure permanent birth control device, BJOG, September 2005; 112(9): 1322-1327.
Connor VF. Contrast infusion sonography to assess microinsert placement and tubal occlusion after Essure. Fertil Steril, June 2006; 85(6): 1791-1793.
Duffy S, Marsh F, Rogerson L, et al. Female sterilization: A cohort controlled comparative study of ESSURE versus laparoscopic sterilization, BJOG, November 2005; 112(11): 1522-8.
Essure permanent birth control. Safety. Available at: www.essure.com/safety#top.
Karthigasu KA, Garry R, Hart R. Case report of failed tubal occlusion using Essure pbc hysteropscopic sterilization procedure. Aust NZJ Obstet Gynaecol. 2006 Aug; 46(4):365-7.
Kerin JF, Carignan CS, and Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: Results of the first Essure™ pbc clinical study, The Australian and New Zealand Journal of Obstetrics and Gynecology, 2001; 41: 364-70.
Kerin JF, et al. Essure hysteroscopic sterilization: Results based on utilizing a new coil catheter delivery system, Journal of the American Association of Gynecologic Laparoscopy 2004; 11(3): 388-393.
Kerin JF and Levy BS. Ultrasound: An effective method for localization of the echogenic Essure sterilization micro-insert: Correlation with radiologic evaluations, J Minim Invasive Gynecol, January 2005; 12(1): 50-4.
la Chapelle CF, Veersema S, Brolmann HA, Jansen FW. Effectiveness and feasibility of hysteroscopic sterilization techniques: a systematic review and meta-analysis. Fertil Steril. 2015 Jun;103(6):1516-25.
Mao J, Pfeifer S, Schlegel P, Sedrakyan A. Safety and efficacy of hysteroscopic sterilization complared with laparoscopic sterilization: an observational cohort study. BMJ. 2015 Oct 13;351:h5162.
Rosen D. Learning curve for hysteroscopic sterilization: Lessons from the first 80 cases, Australian and New Zealand Journal of Obstetrics and Gynecology 2004; 44: 62-64.
Ryan: Kistner’s Gynecology and Women’s Health, 7th edition, Chapter 13, Conception Control Part I.
Sinclair EJ and Cher Daniel J. Essure effectiveness report. An interim analysis of the phase II and pivotal clinical trial 4 and 5 year, Conceptus.
Thiel JA, Suchet IB and Lortie K. Confirmation of Essure microinsert tubal coil placement with conventional and volume-contrast imaging three-dimensional ultrasound, Fertility and Sterility, August 2005; 84(2): 504-8.
Ubeda A, Labastida R, Dexeus S. Essure®: A new device for hysteroscopic tubal sterilization in an outpatient setting, Fertility and Sterility, July 2004, Vol. 82, No. 1.
U.S. Food and Drug Administration. Regulatory history (of Essure). Available at: www.fda.gov/medical-devices/essure-permanent-birth-control/regulatory-history.
U.S. Food and Drug Administration. FDA Activities: Essure. Available at: www.fda.gov/medical-devices/essure-permanent-birth-control/fda-activities-essure#s2.
U.S. Food and Drug Administration. FDA’s review of medical device reports related to essure removal between January 2017 to Jun 20 Available at: www.fda.gov/medical-devices/essure-permanent-birth-control/fdas-review-medical-device-reports-related-essure-removal-between-january-2017-june-20
U.S. Food and Drug Administration. Essure™. Permanent birth control system. //www.fda.gov/ohrms/dockets/ac/02/briefing/3881b1_03.pdf. Accessed March 19, 2008.
U.S. Food and Drug Administration. Adiana Permanent Contraception System. March 2009, //www.accessdata.fda.gov/scripts/cdrh/cfdocs/efTopic/pma/pma.cfm?num=P070022.
Vancaillie TG, et al. A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices. Obstetrics Gynecology, December 2008; 112(6): 1270-1277.
Weston G and Bowditch J. Office ultrasound should be the first-line investigation for confirmation of correct ESSURE placement, Aust N Z J Obstet Gynaecol, Aug 2005; 45(4): 312-5.
Medical Policy Group, May 2003 (3)
Medical Policy Administration Committee, May 2003
Available for comment May 7-June 20, 2003
Medical Policy Group, April 2004
Medical Policy Group, April 2005 (3)
Medical Policy Group, January 2006 (3)
Medical Policy Administration Committee, February 2006
Available for comment February 15-April 2, 2006
Medical Policy Group, October 2006 (3)
Medical Policy Administration Committee, November 2006
Medical Policy Group, April 2008 (1)
Medical Policy Administration Committee, May 2008
Available for comment May 3-June 16, 2008
Medical Policy Group, May 2009
Medical Policy Administration Committee, July 2009
Available for comment July 1-August 14, 2009
Medical Policy Group, November 2010 (1): Policy retired
Medical Policy Group, July 2019 (4): Updates to Description, Policy, Key Points, Approved by Governing Bodies, Key Words, Coding and References. Deleted Previous Coding section and deleted code S2255 (deleted 12/2015). Updated policy section to state that Essure and Adiana are considered investigational. Added key words hysteroscopy, contraception, microinserts.
Medical Policy Administrative Committee: August 2019
Available for Comment: July 23, 2019 through September 6, 2019
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.