The “Essure” implantable contraceptive device representative action — Turner v Bayer Australia Ltd
Published on August 25, 2025 by Bill Madden and Matilda Lynch
This article was first published in the LexisNexis Australian Health Law Bulletin, Vol 33 Issue 2, 2025. Copyright © 2025 LexisNexis. All rights reserved.
Essure1 was a permanent contraceptive device manufactured overseas, imported to Australia and supplied to women in Australia between 2001 and 20172 as an alternative to laparoscopic tubal sterilisation. It was a spring-like device with inner and outer metal coils and with PET fibres located in between, designed for insertion into a woman’s fallopian tube. Features of the device including the PET fibres and expanded outer coil incited a localised inflammatory foreign body response in the fallopian tube in order to cause fibrosis resulting in tubal occlusion and sterilisation. In Australia, the Essure procedure was performed under anaesthetic in an operating theatre setting by a gynaecologist.
The representative plaintiff Patrice Turner underwent implantation of the Essure device in 2013 but within a few years she began to experience abnormal uterine bleeding and pelvic pain, which worsened over time. On the advice of a gynaecologist, she underwent a hysterectomy in 2018 at age 32 years. Following the hysterectomy her symptoms resolved.
Causes of action
In her claim filed in the Supreme Court of Victoria3 which was heard by Keogh J in 2023 (with judgment on 10 December 2024), the plaintiff relied on three causes of action. She alleged:
- Essure had a defect within the meaning of s 75AC of the Trade Practices Act 1974 (Cth) (TPA) and/or a safety defect within the meaning of s 9 of the Australian Consumer Law (ACL), giving rise to a cause of action under s 138 of the ACL (Defect claim). The defendants raised the statutory “state of scientific knowledge” defence to the Defect claim.
- Essure was not of merchantable quality within the meaning of s 74D of the TPA and/or not of acceptable quality within the meaning of s 54 of the ACL, giving rise to a cause of action under s 271 of the ACL (Merchantable Quality claim).
- The defendants were negligent in that:
- The third defendant, Bayer HealthCare LLC (Bayer HealthCare) and the fourth defendant, Bayer Essure Inc (Bayer Essure) were each negligent in the design, development, manufacture, supply and distribution of Essure in Australia.
- All of the defendants apart from the second defendant Bayer Aktiengesellschaft (Bayer AG), were negligent in failing to provide adequate warnings about the device defects and associated risks to women’s health, and in failing to ensure that information disclosing the defects and risks was made available to women who already had Essure implanted (negligence claims).4
Three limbs of the claim
Early in the quite long judgment (2271 paragraphs), the trial judge identified three limbs of the plaintiff’s claim.
First limb: ongoing chronic inflammation
Firstly, and principally, the plaintiff alleged that, in a not insignificant number of women, Essure caused ongoing chronic inflammation that resulted in chronic pelvic pain (CPP) and abnormal uterine bleeding (AUB). The plaintiff alleged Essure had a fundamentally problematic design and an inherent risk of ongoing chronic inflammation.5
The defendants argued that the foreign body response to Essure devices resolved normally and that there was no evidence that Essure could cause ongoing chronic inflammation resulting in CPP, dysmenorrhea or AUB.
There were six categories of evidence in relation to this first limb, as set out in the table below:
| Clinical studies which reported histologic assessment of fallopian tube tissue from women who had Essure devices surgically removed. The defendants argued the histological studies were not evidence that Essure can cause ongoing chronic inflammation that is pathologic and injurious to health.6 |
| Corrosion studies which the plaintiff argued showed that the Essure device corroded in vivo, resulting in significant accumulation of metal ions and particles in adjacent fallopian tube tissue, likely to be a cause of ongoing chronic inflammation in some women. The defendants argued that Turner had not established that corrosion occurred at a rate or to a degree that was unsafe, or that corrosion was a likely cause of ongoing chronic inflammation.7 |
| Evidence of the biological plausibility of mechanisms that the plaintiff argued explained how Essure could cause ongoing chronic inflammation. The defendants called contrary expert evidence and said that even if the biological explanations were found to be plausible, they were not sufficient to establish that Essure was a cause of CPP and AUB, in the face of contrary evidence including epidemiological studies and the results of extensive testing conducted before and after Essure was placed on the market.8 |
| Epidemiological studies examining the possibility of a relationship between Essure and adverse events including CPP and AUB. However the outcomes, these comparative studies do not show any increase in the rate of CPP and AUB for women who underwent hysteroscopic sterilisation (principally by use of Essure) compared to women who underwent laparoscopic sterilisation. The plaintiff argued that the comparative studies were of inferior design and poor quality, meaning very little weight could be attributed to the available epidemiological evidence. The defendants argued that epidemiological evidence was critical to consideration of the possible causal connection between an exposure such as by implantation of Essure and the adverse outcomes under consideration. The defendants further argued that the comparative studies, which examine the experiences of over 100,000 women, show that Essure is not associated with an increase in the incidence of CPP or AUB.9 |
| Clinical evidence, in that the evidence of gynaecologists who had treated women for CPP, dysmenorrhea and AUB did not support a causal connection between Essure and these conditions. The histological assessment in the plaintiff’s case did not report the presence of chronic inflammation in her fallopian tubes. Nor did her medical records indicate that her treating doctors had a clinical suspicion of pathologic chronic inflammation. The plaintiff’s treating surgeon, who was not called to give evidence, diagnosed adenomyosis10 as the cause of her gynaecological symptoms.11 |
| Other evidence of the prevalence and range of causes of CPP and AUB in women. (There is a broad range of potential causes of both disorders. Diagnosis is complex and causation is often multifactorial. It is not uncommon that no causal pathology is identified.)12 |
Second limb: migration
Secondly, the plaintiff alleged that following implantation, there were risks that an Essure device would migrate into the peritoneal cavity; be expulsed from the fallopian tube; break or fragment; corrode; fatigue; perforate the fallopian tube, uterus or other organs such as the bowel; and/or leach nickel or other metals into the body of the recipient (“failure defects”). The plaintiff alleged that eventuation of one or more of these risks could result in new pain or increased pain including dysmenorrhea, new or increased menorrhagia and/or damage to internal organs.13
The defendants accepted that there were risks of migration, expulsion, perforation and metal leaching that may be associated with adverse health outcomes. They argued that these risks were associated with many biomedical devices and surgical procedures, that the degree of risk was low, that the magnitude of an adverse health outcome if a risk eventuated was likely to be small, and that the risks were the subject of adequate warnings. The defendants argued that the only evidence of the devices breaking or fragmenting was in the process of surgical implantation or removal, and that the plaintiff had not proven a risk that Essure devices could corrode or fatigue resulting in them breaking or fragmenting in vivo.14
Third limb: lack of disclosure
Thirdly, the plaintiff alleged that the defendants distributed patient information brochures and published webpages about Essure which did not adequately disclose the risks of adverse events and outcomes Essure could cause.15
The defendants accepted that they did not provide a warning that Essure could cause ongoing chronic inflammation resulting in CPP, dysmenorrhea or AUB because they said that risk did not exist. They argued that the warnings and information they provided about Essure included the content of training programs for gynaecologists who performed the Essure procedure, physician training manuals provided to gynaecologists, and Instructions For Use supplied with Essure devices. They argued that this material adequately disclosed risks that were associated with Essure, and that the plaintiff had not demonstrated any relevant deficiency in the information provided about the device.16
Summary of findings
The trial judge largely accepted the defendants’ submissions, concluding in respect of each limb as follows:
… I have concluded that the biostatistical evidence weighs heavily against causation, and represents a very significant barrier to Turner proving general causation. The evidence supporting general causation in the histological and corrosion studies, and the expert evidence of biologically plausible causal mechanisms is far from compelling. The clinical evidence does not support general causation. In relation to the first limb of Turner’s case, I am not satisfied that she has established that Essure can cause ongoing chronic inflammation in some women resulting in CPP, dysmenorrhea and/or AUB.17…
… There was a risk that an Essure device could migrate, be expulsed from the fallopian tube, perforate organs, corrode, and leach nickel or other metals into the body. I conclude that in most cases, the degree and magnitude of these risks were small and that they were often associated with placement or removal of the device. I do not accept that there was a risk that Essure could break, fragment or fatigue once implanted in the body.18
… I have concluded that the defendants provided adequate warnings of the established Essure risks in the [physician training manual documents) and (instructions for use documents]. It was reasonable to expect that treating gynaecologists would provide information and warnings about the established risks to their patients based upon their own specialist skill, expertise and experience and the information provided by the defendants. The [patient information brochures] and webpages relied on by Turner did not represent the entirety of the information and warnings about the Essure risks provided by the defendants and available to women considering undergoing the Essure procedure.19
Causation issues
The length and complexity of the judgment precludes a detailed summary in a short article such as this. However on the central issue of causation, the trial judge said:
Causation is not established if the evidence does no more than prove the possibility of the requisite relationship between the intervention, in this case Essure, and the claimed injuries. It is necessary for the finder of fact to feel actual persuasion that the evidence is sufficient to “justify an inference of probable connection”.20
Causation in the plaintiff’s negligence case required determination in accordance with s 51 of the Wrongs Act 1958 (Vic).21 The decisions in Seltsam Pty Ltd v McGuiness, Amaca Pty Ltd v Ellis, Merck Sharp & Dohme (Australia) Pty Ltd v Peterson and Amaca Pty Ltd v Booth22 served to emphasise the importance of epidemiological evidence in cases where there is scientific uncertainty about whether a tortious exposure can and did cause injury.23
The trial judge (referring frequently to the epidemiology issue) was not persuaded by the plaintiff’s causation arguments. He addressed in some detail the defendants’ argument (arising from the evidence of Professor Lam) that adenomyosis was the most likely diagnosis and cause of the plaintiff’s symptoms:
Adenomyosis involves infiltration of endometrial tissue, composed of glands and stroma, into the myometrium. The displaced glands incite “spiral vessel angiogenesis and smooth muscle hyperplasia and hypertrophy, leading to thickening of the junctional zone, and cause diffuse uterine enlargement when severe”. Endometrial tissue may invade the myometrium either diffusely or in focalised areas.24
Adenomyosis generally only affects women in their reproductive years and tends to affect older women, more commonly those in their forties. Prevalence is uncertain, “with diagnosis rates varying from 10–80 per cent depending on the subjects examined and the stringency with which it is sought”. The causes and mechanisms of adenomyosis are unclear.25
The symptoms of adenomyosis are variable. They commonly include heavy and/or prolonged menstrual bleeding, dysmenorrhea, dyspareunia and pelvic pain. Women are asymptomatic in about one-third of cases. A clinical history of a progression of symptoms over time is consistent with adenomyosis. However, symptoms may be stable.26
Abdominal tenderness on palpation, and an examination finding indicating a bulky uterus, are consistent with a diagnosis of adenomyosis.27
The trial judge summarised the evidence of Professor Lam as follows:
Lam concluded, for the following reasons, that adenomyosis was the most likely diagnosis and cause of Turner’s symptoms. First, the pain symptoms reported by Turner were consistent with adenomyosis. Second, the reported signs on ultrasound examination, being the bulky uterus that became more enlarged over time and the eccentric thickening of the myometrium reported by Dalton, were consistent with adenomyosis. Third, there is a high level of under-diagnosis of adenomyosis following histological examination of uterine tissue. Lam said that the lack of reference to adenomyosis by the examining pathologist did not weigh heavily against the diagnosis of the disorder. Fourth, Lam said that on his examination of a number of still images from the ultrasound performed in 2017, there were clear signs consistent with adenomyosis that were not reported by the radiologist. Fifth, Lam said that on his examination of images taken at the time of hysterectomy surgery, there were signs consistent with adenomyosis that were not reported by Dalton or the examining pathologist. Sixth, “Turner’s uterine weight was 158g, which is heavy, consistent with the ultrasound, laparoscopic and pathologic findings of a bulky, enlarged uterus, as seen in adenomyosis”.28
The plaintiff consulted a gynaecologist, Dr Dalton, in mid-2018. As evident from his clinical notes, Dr Dalton diagnosed adenomyosis on the basis of the history of the gynaecological symptoms, a physical examination and the results of a transvaginal ultrasound. Dr Dalton confirmed the diagnosis of adenomyosis immediately post-hysterectomy surgery on 25 June 2018. The trial judge noted:
Dalton was in a position to give relevant evidence in relation to the cause of Turner’s gynaecological symptoms. Given that causation was a central issue in her case, Turner would be expected to call her treating surgeon to give evidence. There was no explanation for her not doing so.29
This gave rise to a Jones v Dunkel submission30 by the defendants, in respect of which the trial judge said:
There are competing inferences as to the cause of Turner’s gynaecological symptoms. The failure to call Dalton also means that I can more confidently draw an inference that adenomyosis was the cause of Turner’s symptoms.31
Ultimately the trial judge summarised his conclusion in respect of causation as follows:
I am satisfied … that adenomyosis is the most likely cause of Turner’s gynaecological symptoms. If I am wrong in that conclusion, there would be three possible causes of Turner’s symptoms. The first is adenomyosis, which White agreed remained a plausible diagnosis. The second is that Turner is among the group of women of reproductive age who suffer symptoms of CPP and AUB, where there is no pathology found following hysterectomy and the cause of the symptoms cannot be determined. The third is Essure. There is no evidence on which I could be satisfied that Essure is the most likely of those three possibilities. In those circumstances I would conclude that, having regard to those competing possibilities, the evidence does not support an inference that Essure was a cause of Turner’s gynaecological symptoms.32
In relation to causation in the failure to warn case, the court was not persuaded that the plaintiff would have acted differently and not undergone the Essure procedure had she been told there was any risk of CPP, AUB and hysterectomy.33
Damages assessments
Although the plaintiff’s claim failed, damages were assessed in respect of the claims under the Competition and Consumer Act 2010 (Cth)34 and the Wrongs Act 1958 (Vic).35 Had she succeeded, the plaintiff would have been required to make an election between the general damages/non-economic loss available under the two. Special damages were agreed between the parties.
1 See Turner v Bayer Australia Ltd [2024] VSC 760l; BC202418278.
2 On 31 May 2017, Bayer informed the TGA that it intended to discontinue the sale of Essure in Australia, Canada, Belgium, Czech Republic, Denmark, Finland, Italy, the Netherlands, Norway, Portugal, Slovenia, Sweden, United Kingdon, Chile, Columbia, Costa Rica, Mexico and New Zealand: above, at [385]. The device was withdrawn from the Australian market shortly after 30 August 2017: above, at [386]. In its communications with relevant regulatory bodies, Bayer maintained that the decision to discontinue sales of Essure internationally was commercial in nature and not based on safety or effectiveness concerns. In cross-examination, the Essure medical lead from 2013 to 2017 and the Essure global safety lead from 2018 to 2020 (Dr Carney) agreed that the decline in Essure sales coincided with increased regulatory intervention and that the public’s underlying safety concerns had directly impacted sales: above, at [390].
3 There were six defendants to the proceedings, four being “Bayer” companies, the fifth defendant Gytech Pty Ltd and the sixth a New Zealand company Australian Medical & Scientific Ltd: above n 1, at [43]–[53]. The trial judge concluded that in the circumstances of this case, the provisions of the Trade Practices Act 1974 (Cth) (TPA) and Australian Consumer Law (ACL) relied on by Turner apply to Bayer AG, Bayer HealthCare and Bayer Essure, without the need to consider whether each of those corporations were “carrying on business” in Australia for the purposes of s 5(1) of the TPA and Competition and Consumer Act 2010 (Cth) (CCA): above n 1, at [2136]. Had it been necessary, the trial judge would also have concluded that the foreign Bayer defendants were “carrying on business” in Australia: above n 1, at [2137].
4 Above n 1, at [6].
5 Above n 1, at [8].
6 Above n 1, at [9].
7 Above n 1, at [10].
8 Above n 1, at [11].
9 Above n 1, at [12]–[13].
10 Adenomyosis involves infiltration of endometrial tissue, composed of glands and stroma, into the myometrium. (See discussion below, under the causation heading).
11 Above n 1, at [14].
12 Above n 1, at [15].
13 Above n 1, at [17].
14 Above n 1, at [17]–[18].
15 Above n 1, at [19].
16 Above.
17 Above n 1, at [16].
18 Above n 1, at [20].
19 Above n 1, at [21].
20 Above n 1, at [1452].
21 Above.
22 Seltsam Pty Ltd v McGuiness (2000) 49 NSWLR 262; [2000] NSWCA 29; BC200000735; Amaca Pty Ltd v Ellis (2010) 240 CLR 111; [2010] HCA 5; BC201000970; Merck Sharp & Dohme (Australia) Pty Ltd v Peterson (2011) 284 ALR 1; 196 FCR 145; [2011] FCAFC 128; BC201107861; Amaca Pty Ltd v Booth (2011) 246 CLR 36; [2011] HCA 53; BC201109716.
23 Above n 1, at [1468].
24 Above n 1, at [1646].
25 Above n 1, at [1647].
26 Above n 1, at [1648].
27 Above n 1, at [1649].
28 Above n 1, at [1653].
29 Above n 1, at [1751].
30 Jones v Dunkel (1959) 101 CLR 298; ALR 367; [1959] HCA 8; BC5900240. The content of the rule in Jones v Dunkel is uncontroversial. Two consequences may flow from the unexplained failure of a party to call a witness who that party may be expected to call. First, the court may infer that the evidence of the absent witness would not assist the case of the party. Second, the court may draw an inference unfavourable to the party with greater confidence. In the latter case the inference must already be available on the evidence. Also, the uncalled witness must be one who appears to be in a position to cast light on the facts relied on as the ground for the inference. However, the rule in Jones v Dunkel does not permit an adverse inference that the uncalled evidence would have been positively damaging to the party. The absence of the witness cannot be used to make up any deficiency of evidence: above n 1, at [1752].
31 Above n 1, at [1757].
32 Above n 1, at [1790].
33 Above n 1, at [1816].
34 25% of a most extreme case for non-economic loss.
35 $200,000 for pain, suffering and loss of enjoyment of life.
