National Institute for Health and Clinical Excellence

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1 National Institute for Health and Clinical Excellence 218_2 Hysteroscopic sterilisation by tubal cannulation and placement of intrafallopian implants Consultation Comments table IPAC date: Thursday 16 th April 1 Consultee 1, Sec. Comments Response 1 We would like to recommend that Ensure that patients understand that additional contraception must be used until imaging confirms tubal occlusion and that there is a small risk of pregnancy in the longer term after any form of tubal occlusion procedure. be modified to state: Ensure that patients understand that additional contraception must be used until imaging confirms proper placement of the micro-inserts, and, if necessary, HSG confirms tubal occlusion. Thank you for your comment. Sections 1.2 and of the guidance will be changed. However, section 1.2 will still state that there is a small risk of pregnancy in the longer term after any form of tubal occlusion procedure. Note that there is a small risk of pregnancy in the longer term after any form of permanent birth control procedure. The modification to the statement regarding imaging would be more accurate because the Essure Confirmation Test protocol involves an initial x-ray at 3 months only if the placement appears suspicious is an HSG required to evaluate occlusion. The modification to the risk of pregnancy statement helps patients understand that there is a small risk of pregnancy for any permanent birth control procedure. 1 of 22

2 2 Consultee 2, 3 Consultee 2, 4 Consultee 3, Sec. Comments Response : The Adiana procedure requires verification of bilateral tubal occlusion through an hysterosalpingography (HSG) procedure. Thank you for your comment. Section of the guidance details the use of imaging and HSG after the procedure. The IP programme issues guidance on procedures rather than individual devices. 2.1 no comments Thank you for your comment. 2.1 The commonest female sterilisation technique is Laparosopic Serilisation using Filshie clips to achieve tubal occlusion under general anaesthetic. Thank you for your comment. Section lists laparoscopic sterilisation as a comparator procedure for female sterilisation. 5 Consultee 1, 2.2 We would like to recommend that A small, flexible titanium microinsert is passed through the hysteroscope using a guidewire and placed into each of the fallopian tubes. be changed to: A small, flexible nickel-titanium & stainless steel microinsert is passed through the hysteroscope using a guidewire and placed into each of the fallopian tubes. Â because the micro-insert is composed of nitinol, a nickel-titanium alloy, stainless steel and PET (polyethylene terethalate fibers). We would also like to recommend that An additional form of contraception is used for 3 months until imaging (such as hysterosalpingogram [HSG] or X-ray) confirms correct placement of the microinserts and HSG can ensure that the fallopian tubes have become occluded. Â be changed to An additional form of contraception is used for 3 months until imaging (such as an X-ray) confirms proper placement of the micro-inserts, and, if necessary, HSG confirms tubal occlusion. in order to be consistent with device labeling. Thank you for your comment. The IP programme issues guidance on procedures rather than individual devices. Sections and of the guidance will be changed to become more generic. Section will be added to state that a number of different devices may be used for this procedure. 2 of 22

3 6 Consultee 3, Sec. Comments Response 2.2 It is entirely possible to perform the procedure, in my experience, without the need for local anaesthetic and/or intravenous sedation. Â I advise the patient to take simple analgesia (eg NSAID or paracetamol based analgesic) 1 hr prior to the procedure. I carry out the procedure regularly in the out-patient setting using the vaginoscopic technique. Â In so doing, this obviates the need for the use of a speculum, volsellum. local anaesthetic or intravenous sedation. Â In adopting the vaginoscopic technique, the average procedure time (from introduction to removal of the hysteroscope from the vagina) is 4-5 mins. Provided the placement of the devices appears satisfactory at the time of insertion, device placement confirmation can be made by TA/TV ultrasound at 3 months. If this is satisfactory the patient can be considered adequately sterilised. Â If there is any doubt on the placement of the devices however an HSG can then be done. Â This is the follow up protocol I have adopted in my experience of the technique. Thank you for your comment. Section of the guidance will be changed to include the term usually. Section will be changed to include ultrasound scanning. 3 of 22

4 7 Consultee 2, 8 Consultee 6, Sec. Comments Response : A small, flexible titanium microinsert or polymer matrix is passed through the hysteroscope using a delivery catheter and placed into each of the fallopian tubes. With the titanium microinserts, scar tissue formation is induced which occludes the fallopian tubes and prevents conception. With the polymer matrix, a light application of radio frequency energy is applied to create a superficial lesion around the polymer matrix. This initiates an acute wound healing response, causing healthy tissue to grow into the matrix, anchoring it in place and preventing conception : The polymer matrix procedure requires confirmation of tubal occlusion through an hysterosalpingogram (HSG) Specific Comment An additional form of contraception is used for 3 months until imaging (such as hysterosalpingogram [HSG] or X-ray) confirms correct placement of the microinserts and HSG can ensure that the fallopian tubes have become occluded. COMMENT: The use of pelvic ultrasound be added to the imaging tests stated above Thank you for your comment. Section will be changed to include radiofrequency ablation technique. Section of the guidance includes HSG. Thank you for your comment. Section will be changed to include ultrasound scanning. 4 of 22

5 9 Consultee 2, Sec. Comments Response 2.3 The Pivotal Clinical Trial for the Adiana System was published in the December 2008 edition of Obstetrics & Gynecology. Efficacy data is as follows: Case series of 645 women, successful bilateral placement in 95% (611/645) of women. Tubal occlusion was confirmed by HSG in 94% (570/604) of women 19/645 women had tubal patency at 3 months, but a second HSG at 6 months confirmed occlusion. In 645 women 6 pregnancies were reported. Â Three pregnancies resulted from misread HSGs and faulty reliance and the other three from indeterminate causes. In this study 99% (524 of 531) of women were very satisfied or satisfied with the procedure. 99% (525 of 532) of women reported their overall comfort as excellent or very good. 98% (626 of 636) of women returned to normal activities by 48 hours postprocedure of these, 90% (560 of 626) resumed normal activities the day after the procedure. Reference: Thierry G. Vancaillie, MD, FRANZCOG, Ted L. Anderson, MD, PhD, and D. Alan Johns MD A 12-Month Prospective Evaluation of Transcervical Sterilization Using Implantable Polymer Matrices. Obstet Gynecol : Thank you for your comment. This trial was identified in the post-consultation literature search and will be included in the guidance and table 2 of the overview. 5 of 22

6 10 Consultee 2, Sec. Comments Response 2.4 In the case of 645 women in the polymer matrix study 40.2% reported very little or no discomfort during the procedure and 9.2% were very uncomfortable. 80% (504/629) of women reported that the discomfort they experienced during the procedure and at periopertive intervals was the same or less than anticipated. 98% (619/632) described the tolerance of the procedure to be well, very well, or excellent. No uterine or tubal perforations were reported. No injuries related to RF energy or matrix placement occurred. Most procedure-related adverse events were mild in duration and resolved without intervention. No allergic or adverse reactions to the matrices occurred, and there were no known expulsions of the matrices. There were no requests by patients to have the polymer matrices removed. Hyponatremia (sodium 129 meq/l) occurred in one case (0.15%), and was successfully treated with induced diuresis without sequelae. Thank you for your comment. This trial was identified in the post-consultation literature search and will be included in the guidance and table 2 of the overview. 6 of 22

7 11 Consultee 4, Sec. Comments Response I would like to comment on the provisional recommendations NICE have published on the above technique. Having reviewed the literature it does seem to me that the medium and longterm efficacy of hysteroscopic sterilisation by tubal cannulation and placement of intrafallopian implants is as good as laparoscopic sterilisation although I agree that there is a need for more longterm studies and data to be collected. Essure has a good published safety profile and increasingly units of publishing that abdominal x-rays are an adequate method of assessing correct placement and hysterosalpingography may not necessarily be needed except in cases of initial abdominal x-ray uncertainty. I would certainly support the approval of this method of hysteroscopic sterilisation as another important option for women and their doctors to discuss while considering permanent sterilisation. [Conflict of Interests: consultant to Conceptus] Thank you for your comment. 7 of 22

8 12 Consultee 3, Sec. Comments Response I am a gynaecologist of 20 years standing with a specialist interest in Hysteroscopic Surgery. In my practice, I have also performed numerous Laparoscopic Sterilisation procedures over the years. Being aware from the literature that Essure Hysteroscopic Sterilisation has a superior safety profile as well as being more effective than Laparoscopic Tubal Occlusion, I have worked hard over the last 5 years or so to introduce Essure Hysteroscopic Sterilisation to my unit in Edinburgh. I started the procedure in Edinburgh in December I was funded initially for 75 patients and have completed Essure for 52 patients to date. It is my belief that Essure Hysteroscopic Sterilisation should be offered to all women requesting sterilisation. Its success in my unit has justified the case for ongoing funding. Thank you for your comment. The IP programme issues guidance on procedures rather than individual devices. 8 of 22

9 13 Consultee 3, Sec. Comments Response As noted in the Royal College of Obstetricians and Gynaecologists s guidance on Laparoscopic Tubal Occlusion (LTO), LTO has an estimated lifetime failure rate is 1 in 200. Although Essure s lifetime failure rate has not been calculated, the estimated ten year failure rate is 0.31%, or less than 1 in 300. The manufacturer of Essure has reported that the pregnancies reported in commercial use number 300 out of 259,000 Essure procedures, or less than 1 in 800. Although it can be assumed that there may be underreporting in commercial practice, both the commercial and clinical data demonstrate that essure s long-term effectiveness supports its use as the standard for sterilisation. Thank you for your comment. 9 of 22

10 14 Consultee 3, 15 Consultee 3, Sec. Comments Response The choice of Essure over Laparoscopic Tubal Occlusion is even stronger when comparing the safety of the two procedures. Both procedures carry the risk of failed procedures (failure to gain entry to the abdomen for LTO vs. bilateral placement failure for Essure), the risk of ectopic pregnancy, and the risk of uterine perforation. However, because LTO requires a laparoscopic approach while Essure requires a hysteroscopic approach with minimal or more often no anaesthesia, LTO carries additional risks. For LTO procedures, injuries to the bowel, bladder or blood vessels are serious but infrequent: 2-3 in every 1000 procedures. One study has suggested that 1 woman in every undergoing laparoscopy dies as a result of complications. The use of general anaesthesia in LTO procedures also carries risks which must be considered. In performing Essure Hysteroscopic Sterilisation it is entirely possible in the vast majority of cases to adopt the Vaginoscopic technique whereby there is no need for instrumentation such as introduction of a specululm, use of a volsellum or the need for local anaesthetic or any form of sedation. The average duration for the Vaginoscopic Essure Hysteroscopic Sterilisation procedure in the out-patient setting is 4-5 mins in my current experience. Prior to the procedure I merely advise the patient to take simple analgesia (eg NSAID or paracetamol based analgesia) 1 hour prior to the appointment. Many patients do not require additional analgesia following the procedure. Thank you for your comment. This falls outside the scope of the guidance. Thank you for comment. This falls outside the scope of the guidance. Section of the guidance will be changed to include the term usually. 10 of 22

11 16 Consultee 3, Sec. Comments Response Because the Essure procedure uses a hysteroscoipc approach, risks due to surgical incision, intraabdominal exploration and general anaesthesia can be eliminated. Risks and side effects for the Essure procedure are generally mild, and many do not require further medical intervention for resolution. Risks include pain, cramping, vaginal bleeding and occasionally a vasovagal reaction. Regards the latter I have to date had 1 out of 52 patients who has had a vasovagal response. Thank you for your comment. These outcomes are included in the safety section of the guidance. 11 of 22

12 17 Consultee 3, Sec. Comments Response It is obviously imperative the patient be counseled to continue with their pre-essure contraception following the procedure until they return for the 3 month Confirmation Test to check placement of the devices. If the Essure procedure appears straightforward with 3-8 coils seen trailing into the cavity after positioning and deployment, my practice is for a TA/TV ultrasound scan 3 months later. If device placement at this is satisfactory, the patient is informed she is adequately sterilized although there is still a very small failure rate as aforementioned. She can then discontinue her other method of contraception. I would only suggest a Hysterosalpingogram (HSG) if the Essure procedure is difficult with the risk of suboptimal placement or there is any doubt on the placement at the 3 month Confirmation ultrasound examination. It is because of Essure s safety profile, high effectiveness and patient satisfaction rates that I believe the Essure procedure should be a woman s first choice for sterilisation. Thank you for your comment. Section will be changed to include ultrasound scanning. The IP programme produces guidance on procedures rather than individual devices. 12 of 22

13 18 Consultee 5, 19 Consultee 5, Sec. Comments Response I am the Vice President of Europe for Conceptus, Inc., manufacturer of the Essure System for permanent birth control. Conceptus would like to provide additional information regarding Essure to assist you with finalizing the NICE draft guidance. We are submitting a marked PDF of the draft guidance with small changes that aid in the accuracy of the guidance [see comments from Consultee 1]. More than 275,000 women worldwide have undergone the Essure procedure since Essure was certified with its CE mark in The strength of evidence for the Essure Procedure shows that the procedure offers substantial benefits over the current surgical regimen, tubal ligation. Conceptus clinical trials demonstrated that Essure s effectiveness is unparalleled; preliminary analysis of nine years of long-term clinical trial data and over 45,068 women-months of Essure reliance confirms that there have been zero reported pregnancies among women relying upon Essure.(1) This preliminary data was presented by Dr. Linda Bradley at the AAGL 2008 Global Congress. The following table shows Essure s adjusted failure rate as compared to CREST, the Collaborative Review of Sterilization. Years 9 & 10 are estimates. [See table at the end of this consultation comments table.] Thank you for your comment. Please see responses to consultee 1. The IP programme issues guidance on procedures rather than individual devices. Thank you for your comment. The IP programme issues guidance on procedures rather than individual devices. 13 of 22

14 20 Consultee 5, 21 Consultee 5, 22 Consultee 5, Sec. Comments Response The low rate of pregnancies reported in commercial use supports the results obtained in the clinical trials.(2) From Essure s commercial release in 2001 through December 2008, 300 pregnancies were reported out of an estimated 259,000 procedures performed.(2) Reported pregnancies tend to be related to noncompliance with the Essure instructions for use or a misread Essure confirmation test. (3) Essure also exhibits an exceptional safety profile. One researcher summarized that compared to laparoscopic sterilisation, the hysteroscopic approach obviates admission, general anaesthesia, surgical incisions and a complication rate of 5 per 1,000 procedures. (4) Adverse events observed during the Essure Procedure are generally mild, and many do not require further medical intervention for resolution. Patients are extremely satisfied with Essure. In one recent study, all study subjects were highly satisfied after hysteroscopic sterilisation: 91% of subjects rated the method at 10 (high satisfaction degree on a 0 to 10 visual analog scale) and none of the subjects rated it under 8.(5) More than 97% of the patients said that they would recommend the procedure to others. (5) 86.5% of study subjects considered the procedure painless or scarcely painful.(5) The most valuable aspects of the Essure procedure were stated to be absence of surgery room (52.7%), method's quickness and comfort (19.9%), and permanent sterilisation (18.2%). (5) Thank you for your comment. Thank you for your comment. This falls outside the scope of the guidance. Thank you for your comment. 14 of 22

15 23 Consultee 5, 24 Consultee 6, Sec. Comments Response In summary, both the published literature and Essure s record in commercial use demonstrate the substantial benefits of effectiveness, safety, and patient satisfaction offered by Essure. As concluded by one of the researchers, the Essure procedure should be one of the first-line options for female permanent sterilisation. (5) Thank you for your telephone message agreeing to receive my belated comments regarding the provisional NICE guidance for IP218. I would like to outline my views supporting the more widespread use of outpatient hysteroscopic hysteroscopic sterilisation using the Essure TM technique and also to comment on radiological follow up supporting the use of pelvic ultrasound. Thank you for your comment. The IP programme issues guidance on procedures rather than individual devices. Thank you for your comment. The IP programme issues guidance on procedures rather than individual devices. Section will be changed to include ultrasound scanning. I am a Consultant Obstetrician and Gynaecologist at the Birmingham Women s Hospital and I have a major interest in outpatient hysteroscopic techniques. I have been performing outpatient hysteroscopic sterilisation using the Essure TM permanent birth control system since 2002 and have published our initial experience in the British Journal of Obstetrics and Gynaecology (1). To date I have performed over 350 Essure sterilisation procedures and we are prospectively collecting all our data on a secure database (available on request), from which we hope to publish further work. 15 of 22

16 25 Consultee 6, Sec. Comments Response We, along with many others (2), have demonstrated that outpatient hysteroscopic sterilisation using the Essure TM system is safe, convenient, feasible and effective. It does not require the use of a vaginal speculum, cervical dilatation or local anaesthesia in the majority of women. It has major advantages over traditional laparoscopic sterilisation, in that it avoids the need for admission to hospital, risks from general anaesthesia, need for abdominal incisions and damage to internal organs (bowel, bladder, vasculature etc. estimated 3 in 1000 procedures) associated with the use of closed entry laparoscopy. In my experience, the only complication arising from Essure TM sterilisation is mild, self-limiting vasovagal responses in up to 5% of women (1). To my knowledge (personal and from the published literature), no serious, life-threatening complications have been associated with the technique. This contrasts markedly with traditional laparoscopic sterilisation i.e. the risks of intra-abdominal visceral injury are likely to increase over time in view of the increasing rates of caesarian sections (leading to abdominal adhesions) and obesity which are known to be independent risk factors for bowel and vascular injury at laparoscopy. In addition to potential serious morbidity with laparoscopy, it should be noted that women die every year from complications arising from laparoscopic sterilisation. Thank you for your comment. This falls outside the scope of the guideline. 16 of 22

17 26 Consultee 6, 27 Consultee 6, Sec. Comments Response Laparoscopic sterilisation has an estimated lifetime failure rate of up to is 1 in 200 (3). The failure rate associated with the EssureTM technique compares favourably, with an estimated ten year failure rate of less than 1 in 300. The manufacturer of Essure has reported that the pregnancies reported in commercial use number 300 out of 259,000 Essure procedures, or less than 1 in 800, although this figure reflects reported cases only (source Conceptus). The feasibility and effectiveness rates are consistent across the increasing number of published studies pertaining to EssureTM sterilisation in both the short and medium term (2). Longer-term effectiveness data will inevitably become available over time, but there is no plausible reason to assume that failure rates should dramatically increase in the longer term over what the short and medium term data tell us now. In view of the safety, convenience, short recovery time, avoidance of abdominal entry and incisions and effectiveness, I believe that the evidence supporting the first-line use of outpatient hysteroscopic sterilisation using the Essure TM permanent birth control system is compelling and that the technique should be available to all women requesting permanent birth control. Moreover, with the increasing body of published data supporting the technique, I believe that the outpatient hysteroscopic Essure TM sterilisation should replace laparoscopic approaches as the first line method of female sterilisation. 17 of 22 Thank you for your comment. Thank you for your comment. The IP programme issues guidance on procedures rather than individual devices.

18 28 Consultee 6, 29 Consultee 6, Sec. Comments Response Abdominal X-ray (AXR) is considered the first line confirmation test following the EssureTM procedure in the UK (4-9)(approved by Conceptus notified body for CE marking purposes). An AXR confirms satisfactory placement of the EssureTM microinserts. Where device placement is considered unsatisfactory, additional contraception should be continued and an HSG performed (10). We published the largest series to date from the UK on outpatient hysteroscopic sterilisation using the EssureTM permanent birth control system (1). We chose to use HSG initially to confirm tubal occlusion. We surveyed patient satisfaction with the overall procedure (including radiological follow up with HSG) and found whilst the overall procedure was associated with high levels of satisfaction, some women found the HSG somewhat invasive. Whilst our follow up rates were good (95%), we, along with other published series, had patients who did not attend for follow up. We were concerned that this noncompliance in a minority may, in part, be attributable to the need for an HSG. On completion of our first 200 outpatient procedures, we were going to amend our protocols to using less invasive AXR as the first line confirmation test for uncomplicated procedures (as recommended by the manufacturer s), but following discussions with international colleagues it became clear that many experienced users were utilising pelvic transvaginal ultrasound (TVS) rather than AXR or HSG to confirm satisfactory tubal placement of the EssureTM microinserts. Thank you for your comment. Section describes confirmation tests for the procedure. Thank you for your comment. Section will be changed to include ultrasound scanning. 18 of 22

19 30 Consultee 6, Sec. Comments Response TVS offers potential advantages over AXR in that it has the ability to locate the devices within the enveloping tissue, additional information is gained about surrounding soft-tissue structures and the position of the device within the utero-tubal junction can be displayed on ultrasound while it can be merely be inferred from plain X-ray films. Moreover, TVS is relatively non-invasive (compared to HSG), cheap and avoids the use of potentially harmful ionising radiation. Published data (from the US, Australia and Europe) (11-15) supports the use of TVS to confirm satisfactory tubal placement of the EssureTM microinserts. In view of this, since January 2008, our unit has introduced TVS as the first line imaging technique to confirm satisfactory bilateral tubal placement at 3 months post-procedure, with recourse to HSG for equivocal results or where procedures have been considered not to be straightforward (our protocol and follow up algorithm is available on request includes conservative definitions of what constitutes a straightforward procedure and when to use TVS and HSG). I know that a similar approach, with follow up based upon TVS, is adopted across the Netherlands (Personal communication S Veersema). Thank you for your comment. Section will be changed to include ultrasound scanning. 19 of 22

20 31 Consultee 6, Sec. Comments Response Thus the requirement of radiological follow up, posthysteroscopic sterilisation using the EssureTM system, is to confirm satisfactory placement of the microinserts and this can be achieved by TVS as well as AXR, with the advantages of TVS described above. HSG can be used to confirm tubal occlusion, but given its more invasive nature (as well as associated costs and morbidity), it should be reserved for equivocal AXR or TVS results following standard EssureTM procedures or as a first line where the EssureTM procedure is considered difficult or suboptimal. It is my belief that in time we will be able to dispense altogether with radiological follow up following standard EssureTM procedures (as we did with laparoscopic sterilisations using the Filshie clip). However, for the time being, whilst the procedure is becoming more widely established, we should continue with radiological follow up based upon TVS, AXR or HSG. Thank you for your comment. Section will be changed to include ultrasound scanning. All studies referenced below have been considered. References 1. Sinha D, Kalathy V, Gupta JK, Clark TJ. The feasibility, success and patient satisfaction associated with outpatient hysteroscopic sterilisation. BJOG 2007;114: NICE overview IP 218 (November 2008) 3. National Evidence Based Guideline. Male and Female Sterilisation 2004 (Available at ) 4. Cooper JM, Carignan CS, Cher D, Kerin JF, Microinsert nonincisional 5. hysteroscopic sterilization, Obstet Gynecol, 2003;102: of 22

21 31 cont. Consultee 6, (cont) Sec. Comments Response (cont) 6. Kerin JF, Cooper JM, Price T, et al., Hysteroscopic sterilization using a micro-insert device: results of a multicentre phase II study, Hum Reprod, 2003;18: Ubeda A, Labastida R, Dexeus S, Essure: a new device for hysteroscopic tubal sterilization in an outpatient setting, Fertil Steril, 2004;82(1): Heredia F, Cos R, Moros S,Torrabadella L, Radiological control of Essure placements, Surg, 2004;1: Gynecol 9. Conceptus SAS, Physician Training Manual: X- ray Protocol, 2003; Conceptus USA, US Physician Training Manual: HSG Protocol, TR ; Teoh M, Meagher S, Kovacs G, Ultrasound detection of the Essure permanent birth control device: a case series, Aus NZ J Obstet, 2003:43: Kerin JF, Levy BS, Ultrasound: an effective method for localization of the echogenic Essure sterilization microinsert: correlation with radiologic evaluations, J Minim Invasive Gynecol, 2005;12: "Comments received in the course of consultations carried out by NICE are published in the interests of openness and transparency, and to promote understanding of how recommendations are developed. The comments are published as a record of the submissions that NICE has received, and are not endorsed by NICE, its officers or advisory committees." 21 of 22

22 Essure Long-Term Effectiveness Rate from Clinical Trials (posterior mean, age adjusted) (est) Essure 99.97% 99.93% 99.90% 99.87% 99.84% 99.80% 99.77% 99.74% 99.71% [Table submitted as part of the consultation response from Consultee 4,. This graph will be removed prior to publication]. 22 of 22