Latest Review Date: October 2024

Category:  Surgery                                                    

POLICY:

Hysteroscopic placement of micro-inserts (i.e. Essure) in the fallopian tubes as a form of permanent sterilization are considered 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 investigational for all indications because its safety and long term effects have not been established.

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. 

KEY POINTS:

A literature search was conducted through October 2, 2024.

Summary of Evidence

The evidence for individuals who received the Essure or Adiana device consists of comparative, observational, and prospective studies.  The primary outcomes included safety, efficacy, and reoperation rates. Although the Essure device reduced the risk of pregnancy, it was associated with a substantially increased risk of re-operation (odds ratio 10.16 (7.47 to 13.81) compared with laparoscopic sterilization. Both the Essure and Adiana devices are no longer being manufactured and/or distributed in the United States.  Based on the available literature, the evidence is insufficient to determine health outcomes and is considered investigational.

KEY WORDS:

Essure™ Permanent Birth Control System, female sterilization, Adiana Permanent Contraception System, silicone matrix tubal implant, hysteroscopy, contraception, microinserts

APPROVED BY GOVERNING BODIES:

Essure

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

Adiana was FDA approved in March 2009, but production was ceased in 2012.

BENEFIT APPLICATIONS:

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.

CODING: 

CPT codes:

HCPCS:

REFERENCES:

1. 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.
2. Connor VF.  Contrast infusion sonography to assess microinsert placement and tubal occlusion after Essure.  Fertil Steril, June 2006; 85(6): 1791-1793.
3. 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.
4. Essure permanent birth control. Safety. Available at: http://www.essure.com/safety#top.
5. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
6. 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.
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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Ryan:  Kistner’s Gynecology and Women’s Health, 7th edition, Chapter 13, Conception Control Part I.
14. 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.
15. 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.
16. 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.
17. U.S. Food and Drug Administration. Regulatory history (of Essure). Available at: www.fda.gov/medical-devices/essure-permanent-birth-control/regulatory-history.
18. U.S. Food and Drug Administration. FDA Activities: Essure.  Available at: www.fda.gov/medical-devices/essure-permanent-birth-control/fda-activities-essure#s2.
19. U.S. Food and Drug Administration. FDA’s review of medical device reports related to essure removal between January 2017 to Jun 2018.  Available at: https://www.fda.gov/medical-devices/essure-permanent-birth-control/fdas-review-medical-device-reports-related-essure-removal-between-january-2017-june-2018.
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.
21. 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.
22. Vancaillie TG, et al.  A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices.  Obstetrics Gynecology, December 2008; 112(6): 1270-1277.
23. 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.
24. www.essure.com/static/consumer/c_what_is_essure_print.html.

POLICY HISTORY:

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

Medical Policy Group, November 2020 (4): Reviewed by consensus.  No change in policy statements.

Medical Policy Group, November 2021 (4): Reviewed by consensus.  No new published peer-reviewed literature available that would alter the coverage statement in this policy. 

Medical Policy Group, October 2022 (4):  Reviewed by consensus.  No new published peer-reviewed literature available that would alter the coverage statement in this policy.  Removed policy statements effective for dates of service prior to September 6, 2019.  Removed “not medically necessary from policy statements. No change in policy intent.

Medical Policy Group, October 2023 (4): Reviewed by consensus.  No new published peer-reviewed literature is available hat would alter the coverage statement in this policy.

Medical Policy Group, October 2024 (4): Reviewed by consensus.  No new published peer-reviewed literature is available that would alter the coverage statement in this policy. Updates to References.

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.