Chapter 13 – Hysteroscopic Sterilisation

Abstract

Hysteroscopic sterilisation (HS) is a permanent method of contraception and is only suitable for women who no longer desire fertility. The method works by preventing fertilisation of the egg by permanently blocking the passage of sperm through the fallopian tubes. This is achieved by placing occlusive micro-inserts in the proximal section of each fallopian tubal lumen using transcervical hysteroscopy.

A safe, simple and highly effective transcervical sterilisation approach has long been sought. In 1878, Kocks attempted to blindly occlude the proximal segment of each fallopian tube by transcervical insertion of electrodes. In 1927, Mickulicz-Radecki and Freund suggested the use of a hysteroscope for the purpose of female sterilisation. In 1934, Schroeder performed the transcervical hysteroscopic sterilisation using electrocoagulation. Since then, various destructive techniques involving intratubal injection of sclerosing agents such as quinacrine, tissue adhesives or cryosurgery, and mechanical tubal occlusive techniques involving placement of various plugs or devices at the level of the tubal ostium, have been explored.

Chapter 13 Hysteroscopic Sterilisation

Vinod Kumar , Janesh Kumar Gupta and Michael Gannon

13.1 Introduction

With the development of miniaturised hysteroscopes, new transcervical devices were designed to occlude the fallopian tubes. So far, the US Food and Drug Administration (FDA) has only approved two methods of HS: the Essure® micro-insert (previously known as the STOP device), approved in 2002, and the Adiana® permanent birth control method, in 2009.

HS is usually performed in an outpatient setting and involves a hysteroscope being inserted into the cervix vaginoscopically or after inserting a speculum. Tubal occlusion is subsequently achieved by inserting the sterilising device into the proximal segment of each fallopian tube through the hysteroscope. With the Essure device the micro-inserts cause a benign tissue inflammatory and fibrotic response, leading to the permanent occlusion of each tube within approximately three months [2].

The Adiana procedure involved controlled thermal damage of both proximal fallopian tubes using bipolar ablation followed by insertion of a non-absorbable, biocompatible silicone matrix to promote scarring within the tubal lumen. The manufacturing, sale and distribution of Adiana® were discontinued in April 2012, leaving the Essure® Permanent Birth Control System (Bayer) as the only approved commercially available method of HS in the UK for a number of years. However, it too was withdrawn from the UK market in August 2017, primarily for commercial reasons, and from many other countries either before or since then. A factor contributing to its withdrawal was the gradual decline of its popularity due to reports of long-term complications. A study comparing the safety and efficacy of Essure hysteroscopic sterilisation with laparoscopic sterilisation found that although at one year the risk of unintended pregnancies was much the same (odds ratio (OR) 0.84, 95% confidence interval (CI) 0.63–1.12), the risk of undergoing further surgery was significantly higher (OR 10.67, 95% CI 7.47–13.81) [3]. However, women undergoing the hysteroscopic procedures differed from those undergoing the laparoscopic approach, with increased prior incidences of pelvic inflammatory disease (10.3% versus 7.2%, p <0.01), major abdominal surgery (9.4% versus 7.9%, p <0.01) and caesarean section (23.2% versus 15.4%, p <0.01). An unexpected finding was that half of the women (50.6%) who had undergone HS had a general anaesthetic, which is surprising given that it was developed primarily to be an outpatient or office procedure.

The hunt for a safe and efficacious means of performing hysteroscopic sterilisation has continued, as this approach offers advantages over laparoscopic methods, particularly for women for whom a general anaesthetic is best avoided or where abdominal surgery is more hazardous. AltaScience Limited (Dublin, Ireland) is developing an easy-to-use hysteroscopic sterilisation implant called AltaSeal® [4, 5].

This chapter describes the rationale and evidence for the use of hysteroscopic sterilisation in the outpatient setting, along with relevant technical and clinical aspects. It also addresses the essentials of a successful approach to outpatient HS, and discusses the risks, complications and contraindications of the procedure. Reference is made to experience with the Essure system when there is insufficient information available about other devices.

13.2 Pre-Procedure Assessment

13.2.1 Patient Selection and Counselling

The hysteroscopic sterilisation is a suitable option for women who desire irreversible permanent birth control and are certain that their family is complete. All women requesting HS should be meticulously counselled at a suitable interval prior to the procedure. Written informed consent must be obtained after explaining the mechanism of action, efficacy, benefits and risks and also discussing any myths and misconceptions associated with the procedure. An information leaflet should be provided. Both partners ideally should be present during the consultation, if acceptable and appropriate.

A woman requesting HS must be informed about the permanent, non-reversible nature of the method and the comparative pros and cons of alternative forms of contraception. Emphasis should be placed on male sterilisation (vasectomy) and the long-acting reversible contraceptive methods (intrauterine coils, contraceptive implant and injections) to ensure that she is sufficiently informed of all available contraceptive options. She must be willing to continue her current contraceptive method until tubal occlusion or correct device placement is confirmed following the procedure.

Appropriate alternative contraceptive methods, such as the fitting of an intrauterine contraceptive coil/system during the procedure or laparoscopic tubal occlusion at a later date, should be discussed in advance in case the planned HS method cannot be completed successfully due to technical failure.

13.2.2 Medical History and Assessment

A detailed medical, obstetric, gynaecological and contraceptive history should be obtained from a woman to identify conditions that may make her unsuitable for the HS procedure. The relative and absolute contraindications to the procedure include:

Patient uncertain about ending her fertility
Current or suspected pregnancy
Less than six weeks post-partum
Active pelvic inflammatory disease or cervicitis
Suspected or known gynaecological cancer or unexplained vaginal bleeding
Known uterine anatomical anomalies
Prior tubal surgery
Previous endometrial ablation.

The possibility of regret associated with sterilisation should be highlighted and a woman should be assessed for the known predictors of regret, such as age under 30 years, nulliparity, not being in a relationship or in an unhappy relationship, psychological problems and coercion. One question that may help is to ask her to consider how she may feel once she is unable to have children.

The permanent and irreversible nature of sterilisation should be emphasised. A woman should be informed that reversal or tubal reconstruction would not be possible following HS if she changes her mind at a later date. In vitro fertilisation (IVF) would be the only solution and this would not be routinely available within the UK National Health Service.

It is good practice to carry out a bimanual pelvic examination before the procedure to avoid unexpected findings on the day of the procedure.

Women who are considering endometrial ablation for the management of heavy menstrual bleeding are advised to have the ablation procedure performed on a different day following the HS.

A woman should be informed about the advantages and disadvantages of HS compared with traditional laparoscopic sterilisation (LS) under general anaesthesia (GA). The advantages include:

Avoidance of risks of GA
Safe alternative for women with significant medical problems or surgical risks (such as severe cardiac disease, previous abdominal surgery or obesity) [6]
Quicker procedure
No abdominal scars
Shorter hospital stay
Rapid return to normal daily activities.

The disadvantages of HS compared with traditional LS methods include:

Uterine cramping during the procedure
Post-procedural follow-up and contraception are required for three months after the HS
Micro-insert placement may not be successful due to technical non-feasibility, affecting 1–19% of patients (compared with 1–2% of patients who undergo LS).

13.2.3 Efficacy

Long-term data on HS procedures are confined to the Essure device. It is a highly effective method of permanent contraception with very low post-procedural pregnancy rates of approximately 1 in 500 at five years of follow-up [7, 8]. The majority of pregnancies occur in women who do not follow post-procedure instructions and do not attend for follow-up confirmatory imaging [9, 10].

Clinical trials have shown the procedure to be 99.74% effective at five years following successful placement of the micro-insert in both tubal ostia [11]. A retrospective study analysing post-procedure pregnancies (those reported to the device manufacturer only) following an estimated 50 000 Essure sterilisation procedures between 1997 and 2005, quoted a very low failure rate of 1.2/1000 with the majority of pregnancies occurring due to patient or clinician non-compliance [9, 11]. Post-marketing clinical studies of the Essure procedure have consistently shown low failure rates between 0% and 1.7% in variable follow-up periods of 1 to 10 years [12–16]. The authors’ own prospectively collected series of 1085 procedures, carried out in the office setting since 2001, showed a very low failure rate of 0.3%. Median length of follow-up for pregnancy outcome was 5 years [17].

13.2.4 Safety

Outpatient Essure HS is a safe procedure with low complication rates. Risks during or immediately after the procedure may include mild to moderate cramping (65–80% of cases) [18–20], vasovagal response (1–4%), bleeding/spotting and nausea/vomiting [13, 19, 21–23]. These complications are self-limiting and mostly resolve soon after the procedure.

The incidence of unsuccessful placement of bilateral Essure micro-inserts using third-generation catheters is 1–19%, following a maximum of two insertion attempts [10, 15, 19, 21, 22]. This may occur due to factors such as the level of operator skill and experience, severe pain, obstructed view of the tubal ostium due to heavy menstrual flow or uterine polyps/fibroids, large uterus, proximal tubal occlusion, tubal tortuosity, or presumed tubal spasm [19, 24–26]. A repeat attempt in a few weeks may be tried in cases of unilateral micro-insert placement where poor visualisation has led to unsatisfactory bilateral device placement.

Post-operatively, minor symptoms such as abdominal cramping (30%), nausea (9%) and light vaginal bleeding (19–57%) may occur and these symptoms may last for up to one week following the procedure [19, 22].

Significant adverse events such as tubal perforation (1–3%), intraperitoneal micro-insert placement (0.01–3%) and device expulsion (0.4–3%) are rare, and may not be detected until follow-up imaging [13, 15, 22–24]. Management of tubal perforations caused by Essure placement may include laparoscopic retrieval of the micro-insert. Other post-operative complications such as chronic pelvic pain, device migration, post-procedure dyspareunia, abnormal vaginal discharge and ectopic pregnancy are rare [9]. Women with pre-existing chronic pain diagnoses may be at increased risk of developing post-procedure pelvic pain [27].

Removal of the Essure devices may resolve chronic post-procedure pelvic pain [23, 28, 29], though pain may persist despite device removal when other causes of pain are present [23]. Surgical removal of the Essure device depends upon the time since insertion and the position of the device within the fallopian tube [30]. Hysteroscopic removal is feasible within three months of placement and at any stage if the device has been expelled into the uterine cavity. Removal by laparoscopy or mini-laparotomy is likely to be necessary once fibrosis is complete. Care must be taken to remove all parts of the device, which is more difficult if fragmentation occurs [30].

13.3 Procedure

13.3.1 Optimal Timing

To reduce the risk of failure to detect a luteal-phase pregnancy before the procedure in women who are not using regular contraception, the date of the last typical menstrual period (LMP) and last unprotected sex should be recorded and a negative pregnancy test should be obtained. Although the procedure can be done on any day of the menstrual cycle, the proliferative phase (days 7–14) is an ideal time to perform the procedure to reduce the possibility of an undiagnosed early pregnancy. Additionally, the endometrium would not be thickened during the proliferative phase, which may facilitate better visualisation of the tubal ostia. The procedure may have to be rescheduled if dates coincide with heavy menstrual bleeding or if there is any risk of undetectable luteal phase pregnancy.

A woman using any regular contraceptive method consistently or who had abstained from sexual intercourse since the LMP can undergo the procedure at any time.

13.3.2 Pre-medication

Most women undergoing an outpatient HS procedure will experience uterine cramping pain during and immediately after the procedure. Therefore, pre-procedural analgesia using non-steroidal anti-inflammatory drugs, such as oral or rectal diclofenac 100 mg and two co-dydramol tablets orally (20 mg dihydrocodeine and 1 g paracetamol), is usually recommended one to two hours before the micro-insert placement procedure to alleviate cramping pain during the procedure [15]. Antibiotics are not given routinely unless there is a specific clinical indication.