Endometrial Ablation
Menstruation has been regarded as a curse, as punishment, as tabooed uncleanliness, and as shameful in un-civilised cultures; while in civilised cultures it has been masked by silence, by euphemism, by mystery and by long dresses.
– Fred E. H. Schroeder[1]
For centuries, periods have led to women being shamed, ostracised, believed to be unclean or weak; our “monthly” bleeding masked by silence and often ignorance. Menstrual blood was regarded as anything from unclean to poisonous and outright evil. Pliny wrote that it “that it kills bees by its vapours, makes dogs mad if they taste it, destroys any plant that comes near it,” and Guillaume Mauquest de La Motte wrote, in his 1746 General Treatise of Midwifry, that a menstruating red-haired servant in his house, caused his wine to go sour and pork to spoil.[2]
Even in the 21st century many myths and misunderstandings about women’s periods persist. And, if all the societal myths and misogyny around periods were not burden enough, for many women it seems as if their bodies turn against them, leaving them quite literally, bleeding to death.
Menorrhagia† – heavy periods or abnormal uterine bleeding (AUB) – has been recorded for centuries and historically was particularly associated with perimenopause and menopause.
Often, women’s behaviour and lifestyles were blamed for excessive menstrual bleeding, and all manner of “inappropriate” activities were labelled by puritan and/or misogynist doctors as the cause for heavy periods and menorrhagia, including “prurient incitement of passion-stirring pictures, statues, music, novels, and theatres,” “a long visit to cities [and] a diet of exciting food” and, weirdly, singing. [1, 2] Some even claimed that “all sanguineous flow is abnormal, that there should be no show of blood in a perfectly healthy woman.”[2]
For centuries women’s health has been misunderstood, misdiagnosed, ignored or invisible, and “medical” treatment very much the subject of a misguided, misinformed and patriarchal approach. So, it should come as no surprise that the causes of heavy menstrual bleeding were poorly understood and the lack of adequate treatment led to women dying from persistent severe blood loss and fatal anaemia. For the women who survived persistent heavy menstrual bleeding, the only relief was menopause and the final cessation of their periods.[2]
Early modern attempts to control menorrhagia began with bilateral oophorectomy or removal of the ovaries, inducing surgical menopause.[3] Abandoned because of complications, hysterectomy was then favoured as a “cure” for heavy bleeding, but that was not much better.
While hysterectomies were recorded as early as 20 years BC, up until the beginning of the 19th century abdominal hysterectomy resulted in almost certain death and the first “modern” abdominal hysterectomy was performed in 1843 in the UK.[4] Mortality in these early hysterectomies is described by Wilbush[3] as appalling – the 1843 surgery resulted in death in the immediate post-operative period[4] – but women suffering constant heavy bleeding were prepare to take the risk to end the impacts of uncontrollable menorrhagia on their health and ability to function. It took seventy years – and presumably many deaths and mutilated women – before hysterectomy started to develop and improve as a surgery.
The progress in hysterectomy surgery would not have been possible “but for the cooperation of women. It would have never happened had not gynaecologists been constantly pressured by ailing women, invalided by constant bleeding, who clamoured for relief: it would have not been accomplished had not women taken chances against all odds, demanding gynaecologists do the same and help them.”[3]
In 1988, Joel Wilbush wrote two papers looking at menorrhagia and menopause from an historical perspective, and suggested that the incidence of menorrhagia had declined as the use of hysterectomy became more common. From the 1920s, with the rise of feminism the popularisation of hysterectomy as a method of birth control saw women having hysterectomies at a younger age, well before perimenopause. He wrote that hysterectomy “has not only made excessive menstrual loss in the late childbearing years uncommon, or easily rectifiable, but has helped to dissociate such episodes from the climacteric.”[3]
However, he acknowledges at the end of his second paper that “reports of excessive climacteric menstrual loss are being heard afresh.”[3]
Perhaps the advent of less invasive methods of birth control, and particularly the contraceptive pill, has led to a return to the days of women suffering heavy bleeding as they reach perimenopause. Research suggests that typically one third of menstruating women suffer from heavy periods,[5] but the results of studies vary from 25%[6] to as high as 52%.[7] A Cochrane review found that heavy bleeding is very common and “can affect 20% to 50% of people who menstruate during their reproductive years.”[8]
Heavy Bleeding or Menorrhagia
Heavy menstrual bleeding or menorrhagia is defined both quantitatively and qualitatively; that is, excessive menstrual blood loss of more than 80 ml per cycle, that interferes with a woman’s physical, emotional, social wellbeing and quality of life.[9]
Because it is difficult for women to assess the actual volume of blood lost during their periods* it can be easier to assess in ways other than direct measurement of blood loss. For women with abnormally heavy bleeding they may:
- need to change pads or tampons every one to two hours or fill a menstrual cup every two to three hours;
- experience ‘flooding’ that soaks through bedclothes, pyjamas, clothing or upholstery;
- need to get up in the middle of the night to change their pad or tampon;
- find blood clots the size of a NZ$1 coin on their pad or tampon;
- feel very tired or short of breath.
Research has shown that women experiencing heavy menstrual bleeding have significantly worse health related quality of life in all areas compared with women with normal menstrual bleeding.[10] In one study, “inability to fulfil usual roles at home or in the workplace were central to discussions of periods as a problem”, and that severe pain associated with heavy bleeding exacerbated the impact that their periods had on their quality of life.[5] It is a significant health problem for many women, increasing with age and peaking during perimenopause.[11]
In one study of 15,107 women in Canada, US, Brazil, France and Russia, of whom 6210 women reported heavy menstrual bleeding, 80% reported being worried about bleeding-related accidents; 70% avoided social activities because of their heavy periods; and 40% had experienced embarrassing situations.[12]
In addition to the personal burden experienced by individual women, there are significant costs to both economy and health services.[13]
The impact of heavy bleeding in women’s lives…
“I would sleep with three or four pads and towels underneath me, and I’d still bleed through everything.”‡
“I was at a cocktail party for my husband’s work, and I could feel blood running down my legs and dripping onto the floor; it was literally gushing. I was wearing a floor-length dress so at least it wasn’t too obvious as I rushed off to the toilet.”§
“I had to use tampons and pads at the same time, couldn’t be more than five minutes away from a toilet and in the end – before my hysterectomy – as well as using a menstrual cup I was going through a packet of maternity pads every day during my period. I was severely anaemic. It took five years of doctor visits before I was finally diagnosed with severe fibroids.”§
“My periods were so heavy I had to change my pads every 30 minutes. I would bleed for two weeks or longer, then bleed in between cycles. I also had terrible clotting — the clots were huge, bigger than my fist, and really painful.”*
“At a café we sat outside on seats with cushions on. During lunch, I bled through the cushion and almost fainted. We just fled the scene like criminals and ran through the streets with blood dripping down my legs. Traumatic? Yes. Embarrassing? Definitely.” †
§ Personal communication: personal experiences of New Zealand women as told to the author.
‡ Womens Health: 4 Women on What It’s Like To Have Heavy Periods—And How They Handle It
* Healthy Women: I Thought My Heavy Bleeding Was Normal — Until It Almost Killed Me
† TOTM: Living with menorrhagia: Jo’s story
The causes of heavy menstrual bleeding can be related to physical problems with reproductive system, hormones, illnesses and some medications, including:
- uterine cancer, polyps, fibroids (leiomyoma), adenomyosis or endometriosis;
- ovarian dysfunction or conditions such as PCOS**, leading to hormone imbalance;
- chronic medical conditions, such as diabetes, obesity or disorders of the thyroid or adrenal gland, and genetic disorders, such as poor clotting ability;
- non-hormonal birth control IUDs, hormonal medications and anti-inflammatory medication.
The treatment for or management of heavy bleeding “depends on the underlying cause and the woman’s preference and her fertility wishes.”[8] The first choice is typically medical, including hormonal treatments such as oral contraceptives, hormone releasing IUDs (e.g. Mirena), and other hormonal medications. Other medical options include antifibrinolytic medicines, such as tranexamic acid, which prevent clots from breaking down and causing excessive bleeding.[8, 14]
Surgical options include dilatation and curettage, operative hysteroscopy, endometrial resection, endometrial ablation, uterine artery embolisation, and hysterectomy, the latter of which is commonly used when other options are unsuitable or have failed.[8, 15, 16]
It is endometrial ablation that the rest of this article will focus on.
What is Endometrial Ablation
Essentially, endometrial ablation is a procedure in which the lining of the uterus or endometrium is destroyed using laser, heat or freezing. The aim is to leave very little of the endometrial tissue and in theory the endometrium will heal leaving scarring, which usually reduces or stops menstrual periods.
The term endometrial ablation covers a “spectrum of procedures performed with or without hysteroscopic§ direction”[17] and are categorised as first, second or third generation. Bofill Rodriguez et al., in their 2022 Cochrane review of interventions for heavy menstrual bleeding[8] write that there is evidence that endometrial ablation started in the late 19th century, with two types of procedures described; atmocausis, which used steam directly on the endometrium, and zestocausis, which used metal to provide the heat.
Bofill Rodriguez et al., go on to define modern endometrial ablation as either: resectoscopic endometrial ablation using different forms of energy delivered through a hysteroscope, such as electrocoagulation or desiccation, transcervical endometrial resection, or vaporisation; or non-resectoscopic endometrial ablation designed to destroy the endometrium without fluid distention of the uterine cavity.[18] Modern ablation techniques use different types of energy sources from radiofrequency to electric to heated water.
Endometrial ablation is promoted as safe, effective, minimally invasive procedures, performed through the cervix. However, while it is widely regarded in the literature as a successful technique offering safer and less invasive and less risky relief for women suffering from heavy menstrual bleeding, there is significant evidence that this is frequently not such a wonderful solution for menorrhagia. In fact, some women go on to suffer devastating endometrial ablation failures and crippling pain, sometimes within weeks and sometimes as many as eight to ten years after the procedure.
In research for this article, a large number of medical papers were reviewed. Typically satisfaction with endometrial ablation procedures was high, 80 to 95%; however, follow up was typically relatively short, only a matter of a few months up to five years. For women closer to menopause, success of the procedure appeared to be higher, because symptoms of failure are generally related to the menstrual cycle, and once that ceases failure is a moot point.
In early 2020, MedPage Today published two articles investigating endometrial ablation. The first article interviewed women suffering harm from the procedure. The women said that they were “pitched endometrial ablation as a simple, easy procedure with few risks”. However, the article pointed out that “like any surgery it can carry complications, and there are limited data on rates of ablation “failures”. such as bleeding heavier than before, severe labour-like cyclic pain, and subsequent hysterectomy.” Additionally – and many women are not told this – scarring from the procedure may obscure uterine cancer, delaying diagnosis and potentially worsening the prognosis.
The MedPage Today article mentions a private Facebook support group, NovaSure & Other Endometrial Ablation Procedures Info & Support, that now has more than 13,200 members, all seeking answers about endometrial ablation, and where women “women share stories of crippling pain, haemorrhaging on operating room tables, having bowel surgeries and hysterectomies, and becoming violently ill with sepsis. They also lament economic losses from missed work due to complications, and the damaging impact ablation had on their relationships and their sex lives.”[18]
I joined this group – making clear I was doing so for research for this article; the stories of women from all over the western world, including New Zealand, make painful, terrifying reading.
A petition to pursue a class action started by one of the members of the group has, as of the 18th of December 2022, 2755 signatures. Many of the signatories have left brief descriptions of the harm they have suffered; again painful reading.
While New Zealand has no systematic collection of reports of harm for endometrial ablation (see below) MedPage Today searched the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database for the most frequently used endometrial ablation device – Hologic’s NovaSure – and found hundreds of reports documenting serious harm: severe sepsis, bowel surgeries, hysterectomies, burns, perforations, and other events, including fatalities.[18]
Dr Jill Long, a public health researcher who previously worked for the FDA, says it is well known that harm to the MAUDE database is underreported.[18]
In the second of the MedPage Today articles, they focused on physicians evolving attitudes to the procedure.[19] Several physicians said they no longer do endometrial ablation, or they perform it only selectively. Dr Linda Bradley, medical director of the American Association of Gynecologic Laparoscopists, said “I stopped … over personal concerns about treatment failures.”
Dr Diana Bitner said “When endometrial ablation first came out, we all thought it was the best thing since sliced bread. A month later, patients didn’t bleed, they were happy, then six, eight months later, they’re failing.”[19]
The doctors spoken to cite severe pain resulting from endometrial regrowth and blood trapped under scar tissue as one of the main problems. Some believe that “that patients aren’t always selected appropriately…” and say that “the procedure pays well, and some physicians have taken tens of thousands of dollars from Hologic for NovaSure, the market leader.”[19] In the US doctors received about US$1,100 for an outpatient procedure that takes five minutes.[20]
Contraindications for endometrial ablation include endometrial cancer, anatomic conditions such as classical cesarean section or transmural myomectomy, genital or urinary tract infection, IUD implantation, small uterine cavity or unusual uterine anatomy such as a retroverted uterus, active pelvic inflammatory disease, younger age, polyps, fibroids, or painful periods, endometriosis and tubal ligation.[19]
Despite this, these contraindications appeared in only one of the many patient information websites reviewed for this article, and in all but one, most of the potentials harms of the procedure were not mentioned.
McCausland and McCausland discuss the long-term complications of endometrial ablation and write that “The problem is that after this procedure, intrauterine scarring and contracture can occur. The problem is that after this procedure, intrauterine scarring and contracture can occur.” [21] Bleeding from persistent or regenerating endometrium behind the scar may be obstructed and cause central hematometra, cornual hematometra, postablation tubal sterilization syndrome (PATSS),[21, 22] retrograde menstruation, and potential delay in the diagnosis of endometrial cancer.[21]
The Stats in NZ
It is difficult to know how many endometrial ablation procedures have been undertaken in New Zealand. Several former DHBs (now district providers under Te Whatu Ora) have general information on endometrial ablation on their websites.
AWHC lodged requests for information regarding harm/treatment from endometrial ablation from Medsafe, ACC and the HDC under the Official Information Act.
Between 1 July 2016 and 30 June 2021, 61 claims for treatment injury as a result of endometrial ablation had been lodged with ACC; 47 claims were accepted and 14 were declined.[23] A total of $1,266,967.65 was paid out over the same period in relation to endometrial ablation treatment injury claims.
ACC noted in their response to our request that “It is important to note that the number of claims lodged with ACC cannot be taken as an accurate indication of the occurrence of injury during treatment or the quality of care. This is because, among other reasons, not all occurrences of injury during treatment are lodged with ACC.”
Therefore, it is highly likely that more treatment injuries have occurred than claims have been lodged.
In the response from the office of the Health and Disability Commissioner (HDC), we were told that the “complaint database does not have a category for ‘endometrial ablation’, therefore these numbers are based on a search of the database for the word ‘ablation’ and may not have captured all complaints about this procedure.”[24]
“Since 1 January 2012 a search of HDC’s complaints database found 9 complaints about endometrial ablation. Four of these complaints related primarily to ‘inadequate treatment/procedure’ and five related primarily to ‘consent not obtained/adequate’.”
Of the four relating to ‘inadequate treatment/procedure’, two complaints were investigated and in one of those the health services provider was found to be in breach of the Code of Rights, while the other was closed with no further action but with recommendations made to the provider.
For the ‘consent not obtained/adequate’ complaints, three were investigated, of which one provider was found to be in breach of the Code of Rights, and one was closed with no further action with educational comment made to the provider.
One complaint in each category was closed with no further action with educational comment made to the provider, and one in each category are still under assessment by the HDC.
The Ministry of Health responded to the OIA request to Medsafe, saying: “The Ministry does not hold reports relating to endometrial ablation. Therefore, your request is refused under section 18(g)(i) of the Act, as the information requested is not held by the Ministry and there are no grounds for believing it is held by another agency subject to the Act.”[25]
It appears that, despite the fact that a device is used in the performance of an endometrial ablation, there is no regulation of the procedure by Medsafe. The only mention of endometrial ablation on the Medsafe website is regarding the use of Zoladex as an endometrial thinning agent in preparation for endometrial ablation. There appears to be no information online about the regulation or licensing of endometrial ablation in New Zealand, nor any information about endometrial ablation on the Manatū Hauora | Ministry of Heath website. There seems to be absolutely no Government/Ministry accountability or official channels through which New Zealand women can get information on the risk of harm.
References
[1] Schroeder FEH, 1976: Feminine Hygiene, Fashion and the Emancipation of American Women, American Studies, Vol. 17, No. 2, an issue about change in America (Fall, 1976), pp. 101-110.
[2] Joel Wilbush: Menorrhagia and menopause: a historical review, Maturitas, Volume 10, Issue 1, May 1988, Pages 5-26.
[3] Joel Wilbush: Menopause and menorrhagia: A historical exploration, Maturitas, Volume 10, Issue 2, July 1988, Pages 83-108.
[4] Sutton CJG, 2018. The History of Hysterectomy, in Alkatout I & Mettler L (eds) Hysterectomy. Springer, Cham.
[5] Santer M, et al. 2007: What aspects of periods are most bothersome for women reporting heavy menstrual bleeding? Community survey and qualitative study, BMC Womens Health, 2007 Jun 2;7:8.
[6] Fraser IS, et al., 2015: Prevalence of heavy menstrual bleeding and experiences of affected women in European patient survey, International Journal of Gynaecology and Obstetrics, 2015;128:196–200.
[7] Bitzer J, et al., 2013: Women’s attitudes towards heavy menstrual bleeding, and their impact on quality of life, Open Access Journal of Contraception, 2013;4:21–28.
[8] Bofill Rodriguez M, et al. 2022: Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis. Cochrane Database of Systematic Reviews 2022, Issue 5. Art. No.: CD013180.
[9] Davies J and Kadir RA, 2017: Heavy menstrual bleeding: An update on management, Thrombosis Research, 2017 Mar;151 Suppl 1:S70-S77.
[10] Karlsson TS, et al., 2014: Heavy menstrual bleeding significantly affects quality of life, Acta Obstetricia et Gynecologica Scandinavica, 2014 Jan;93(1):52-7.
[11] Duckitt K, 2010: Managing perimenopausal menorrhagia, Maturitas 2010 Jul;66(3):251-6.
[12] da Silva Filho AL, et al., 2021: The difficult journey to treatment for women suffering from heavy menstrual bleeding: a multi-national survey, The European Journal of Contraception & Reproductive Health Care, 26:5,390-398.
[13] Whitaker L & Critchley H, 2016: Abnormal uterine bleeding, Best Practice & Research: Clinical Obstetrics & Gynaecology. 2016 Jul; 34: 54–65.
[14] Maybin J & Critchley H, 2015: Medical management of heavy menstrual bleeding, Womens Health (Lond), 2016 Jan;12(1):27-34.
[15] Walker MH, Coffey W, Borger J. 2022: Menorrhagia. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022.
[16] CDC, 2022: Heavy Menstrual Bleeding, online in Bleeding Disorders in Women, Centers for Disease Control and Prevention.
[17] Munroe M, 2017: Endometrial ablation, Best Practice & Research: Clinical Obstetrics & Gynaecology, 2018 Jan;46:120-139.
[18] Fiore K, et al., 2020: Women Burned by Quick Fix for Heavy Periods, MedPage Today 29 January, 2020.
[19] Fiore K & Firth S, 2020: Doctors Back Away From ‘Quick Fix’ for Heavy Periods, MedPage Today, 26 February 2020.
[20] Makary M with Ghomi A, 2020: The Dangerous Side of Device Overuse, MedPage Today, 4 March 2020.
[21] McCausland AM & McCausland VM, 2007: Long-term complications of endometrial ablation: cause, diagnosis, treatment, and prevention, Journal of Minimally Invasive Gynecology, 2007 Jul-Aug;14(4):399-406.
[22] Barymon D & DuBose C, 2017: Endometrial Ablation: A Tale of Two Women, Journal of Diagnostic Medical Sonography, 33:3; 217–222.
[23] Sara Freitag, Personal Communication, 5 July 2022, ACC response to Official Information Act request, reference: GOV-018696.
[24] Jayde Mead, Personal Communication, 7 July 2022, HDC response to Official Information Act request, reference: E22HDC01180/ARED.
[25] Jan Torres, Personal Communication, 29 June 2022, MoH response to Official Information Act request to Medsafe, reference: H202207527.