The copper IUD

The importance of long-acting reversible contraceptive methods (LARC), including copper intrauterine devices (IUDs), for the prevention of unintended pregnancies is emphasized internationally and in Sweden [45]. The efficacy and safety of the copper IUD have been affirmed (e.g., [46, 47]) and Swedish medical guidelines point it out as suitable for most women who want to use a LARC method [48]. Established side effects include increased menstrual bleeding and pain on insertion [49]. The use of LARC has increased in Sweden, particularly among young women [50, 51]. In 2017, 6 percent of women aged 16–29 and 12 percent aged 30–44 were estimated to have used a copper IUD in the last year [52]. While research affirms user satisfaction with copper IUDs [53, 54], studies have also pointed to negative attitudes toward and experiences of the device, including in Sweden [35, 53, 55, 56]. In Sweden, where concerns about hormonal contraceptive methods have been noted [50, 52], a larger share of women have expressed concerns about using a copper IUD (52.3 percent) than a hormonal IUD (41.2 percent) [56]. A recent survey study [35] found that 34.7 percent of the respondents reported negative attitudes towards the copper IUD, while 45.4 percent of users indicated negative experiences, and open responses called for improved healthcare communication and updated research about the device. Apart from concerns with side effects, negative attitudes or experiences relate to, e.g., efficacy, device expulsion or unwillingness to insert a foreign object in the body [35] (cf. [53]).

Negative views on the copper IUD have often been associated with communication in social networks, particularly online, where negative commentaries on IUDs have been prevalent [11, 53, 57–59], although positive attitudes are also communicated [57, 59]. The importance of social networks for contraceptive choice and use has been observed, and accounts relayed through social contacts, or from individuals with personal experience, have been deemed by some to be more reliable than information from healthcare providers [11, 13, 25]. Studies observing negative attitudes toward the copper IUD and other contraceptive methods, not least as communicated online and through other social networks, have emphasized the importance of countering misinformation [11–13]. Meanwhile, researchers have expressed concern about caregivers approaching women’s experiences of or worries about side effects of contraceptives in terms of misinformation or myths [27, 32].

Claims about systemic side effects of the copper IUD

Online communication about contraceptives has included claims about systemic side effects of the copper IUD, attributed to the release of copper from and chronic inflammation caused by the device. Noted symptoms are both somatic and psychological, and include anxiety, depression, panic attacks, fatigue, heart palpitations, weight gain, hair loss, skin problems, headaches and insomnia. Such reports have circulated internationally. They have been briefly noted in studies [56, 57, 60, 61] and addressed more in-depth in research from Sweden [35, 55, 62]. It may be mentioned that a large-scale safety and efficacy study of IUDs ([63], p 498) observed some cases of “symptoms compatible with hormonal side effects”, such as anxiety, depression, fatigue, weight gain, skin problems, dizziness and headaches, among copper IUD users. Another [49] found more severe side effects of copper IUDs in which the levels of copper were higher.

In Sweden, claims about systemic side effects of the copper IUD are largely centred on a social media group, founded in 2014 and now gathering around 8,700 members [55]. In a survey study about attitudes toward the copper IUD [35], 42 participants (2.1 percent) referred to copper toxicity or unestablished systemic side effects in response to open survey questions. While this is a small number, it is notable as this type of perceived or reported side effects was not mentioned in the survey or the accompanying text, thus suggesting that such notions are not entirely uncommon in Sweden.

Largely due to communication in the noted social media group, a number of suspected side effects of the copper IUD have been reported to the Swedish Medical Products Agency. This led to an investigation which concluded, in 2018, that no scientific evidence supports the claims [64]. Meanwhile, these claims have been referred to as an example of ‘alternative facts’ spreading through social media [65], expressive of broader tendencies to understanding claims contesting established medical knowledge in terms of misinformation [3].

Healthcare principles and health-related claims

Evidence-based medicine (EBM), i.e., medical practice based on “integrating individual clinical expertise with the best available external clinical evidence from systematic research” [66], is a well-established principle according to which healthcare should be conducted, including in Sweden (e.g., [50]). EBM has been debated, for example with reference to tacit or individualized elements that do [67] or should [68] form part of medical practice. As noted by Mykhalovskiy & Weir [69], both medical and social scientists have pointed to risks involved in applying epidemiological knowledge about populations to the assessment of individuals (cf. [70]), through the standardization of clinical judgment and care. It has also been emphasized that EBM should encompass not only scientific research but also clinical experience and patient preference, and that EBM can thus be seen to align with the concept of ‘science and tried experience’ (vetenskap och beprövad erfarenhet) [71], on which healthcare in Sweden should be based [72]. Meanwhile, Miles and Loghlin [73] note that EBM is unable to incorporate patient perspectives when these are in conflict with the available science, arguing that EBM is therefore irreconcilable with person-centered care (cf. [74]).

Person-centered care (PCC) has become increasingly emphasized, in general (e.g., [73, 75]) and in contraceptive care (e.g., [76, 77]). In Sweden, following legal revisions emphasizing patient autonomy and involvement [78], healthcare–including contraceptive care [56] and other forms of healthcare for women [50]–should be person-centered [79]. While definitions of PCC vary [75, 80], it has been described as tailoring care to “to individual needs, preferences and circumstances by informing, engaging, and empowering patients” [80], or as “providing care that is respectful of, and responsive to, individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions” [81]. Noted aspects have included empathy, trust-building and an egalitarian patient-provider relationship [30], patient emotional well-being being prioritized, patient view-points being valued and respected [82], and focus being placed on the patient as a whole person [75]. As part of PCC, patients should be allowed to describe their ideas regarding their ailments, have their experiences taken seriously and their questions answered, and be given the opportunity to participate in decisions about their care [79]. In the context of contraceptive counselling, Holt et al. [77] emphasize that PCC entails prioritization of patient well-being rather than a more narrow focus on preventing unintended pregnancy at the potential expense of patient autonomy.

Alongside PCC, the maintenance of sexual and reproductive health and rights (SRHR) is an important principle for reproductive healthcare, internationally and in Sweden [50, 83]. The related concepts of reproductive justice and autonomy are also used in research (e.g., [28, 76]). The Swedish national strategy for SRHR emphasizes, for example, the right to acceptable methods of contraception and autonomous decision-making free from stigmatization or coercion. Healthcare should focus on the needs of the individual, all patients should be approached respectfully in ways promoting openness and trust, and all should have access to and be able to express the need for evidence-based information as well as relevant medical and social support, via physical and digital arenas [83]. The importance of caregivers adjusting care to individual patients’ needs, and of not communicating limiting norms, is also noted [50]. In the following, adhering to SRHR will be considered an aspect of PCC.

Regarding contraceptive care, a lack of knowledge on concerns about and experiences of LARC methods has been pointed out, despite the importance of understanding factors influencing contraceptive choices [24, 58], not least for the promotion of PCC and reproductive autonomy [32, 56, 76]. A paucity of research on how caregivers relate to patient concerns or dissatisfaction with contraceptives has also been noted [31, 32, 76], including when reported side effects have no (established) scientific basis [32]. This is despite the relevance of patient-provider interaction for contraceptive choice [34, 44] and use [27], as well as for PCC.

Aim and research questions

This study aims to use the case of reported unestablished side effects of the copper IUD to investigate experiences of and reasoning about healthcare encounters between caregivers and patients contesting established medical knowledge. The following questions guide the study:

• How do women reporting that they have experienced systemic side effects of the copper IUD describe and reason about their encounters with healthcare?
• How do midwives and gynecologists reason about reports of such unestablished side effects and about how they do, would or should respond to them in the clinical encounter?

After an initial analysis of our material, a third question was formulated:

• How do the women’s and the caregivers’ concerns and reasoning relate to the healthcare principles of EMB and PCC?

Principles of evidence-based medicine

Principles of person-centered care

Evidence-based medicine vs. person-centered care?

Reconciliating evidence-based medicine and person-centered care

Mitigating lack of trust in healthcare: Developing EBM and PCC

Health-related communication online, including communication about suspected side effects of contraceptive methods, has in recent years increasingly been associated with the spread of misinformation, linked to distrust in healthcare [3, 5, 100]. In this study, SMG participants spoke about their own decreased levels of trust in healthcare, largely with reference to noted limitations in EBM and PCC. This is in line with a British survey study [101] connecting the erosion of trust in healthcare primarily to perceived limitations in professional expertise and PCC, the latter including not taking patients seriously, concluding that such aspects should be considered in efforts to increase public trust. Accordingly, while studies on attitudes towards IUDs recommend responding to negative accounts through countering misinformation [11, 13] and communicating positive stories of IUD use [11, 102], we suggest that healthcare providers’ efforts to mitigate lack of trust should also include identifying and working towards rectifying any existing tensions related to EBM and PCC.

Identifying limitations in and developing PCC

It has been pointed out that diversion from PCC through dismissing patient concerns with potential contraceptive side effects, or resisting IUD removal, can contribute to resistance to IUD use [103]. Morison et al. [33] note that expert-directed decision-making in contraceptive care, in which patient knowledge or concerns are not considered, may lead to covert patient resistance through discontinuation of contraceptive use. Poor PCC in contraceptive care can also damage the patient-provider relationship [34, 104, 105] and increase distrust in healthcare [26, 106]. In other contexts too, such as among patients with contested diseases [107], distrust in medicine and withdrawal from care-seeking have been related to experiences of feeling deprioritized or badly treated by caregivers [6, 39, 40, 108]. Trust-building has meanwhile been conceptualized as an important part of PCC in contraceptive care [77], of relevance not least due to links between lack of trust in healthcare and resistance to contraceptive use [53].

Worth noting here, firstly, is that limitations in PCC [79] have been observed in research on contraceptive care, where caregivers have been noted to downplay, dismiss or neglect to discuss (concerns about) potential side effects of contraceptives including copper IUDs [24, 26–33, 35]. In a study of contraceptive care in Sweden [34], some women reported having felt patronized and bereft of agency, as their worries were dismissed and their experiences invalidated by caregivers. The researchers observed that due to the existing provider/patient power hierarchy, the affirmation of differing views or actions demanded strong self-efficacy on the part of the patient (cf [109]). In other studies, caregivers have been found to frame perceived contraceptive side effects in terms of problems with the patients themselves, as the patients’ own responsibility [27, 106], as excuses for IUD removal [30] or as fabricated [27, 32]. Relatedly, women with contested or medically unexplained disorders, such as chronic fatigue syndrome and fibromyalgia, have reported feeling dismissed and not being taken seriously by caregivers, as their illnesses were deemed imaginary or mental [107, 110]. These findings can all be related to accounts given by our SMG participants.

Some SMG participants reported having faced difficulties in getting their copper IUDs removed on request. While HCPs generally agreed that removal should be granted, some voiced a degree of reluctance. Although such reluctance is at odds with the principle of patient autonomy central to PCC, it is in line with previous research pointing patients who have met resistance when wanting to have their copper IUDs removed [26, 32, 35, 99, 104, 105, 111]. In correspondence with our results, previous research also indicates that some caregivers have leaned toward coercive practices to encourage LARC use [31, 106], including resisting LARC removal (e.g. [35, 99, 105]), through downplaying side effects, encouraging users to stick with the method despite concerns [28, 32], or requiring a valid reason or sufficient efforts toward compliance for removal [31, 99]. In a Swedish study some women reported that caregivers had not let them stop using their current contraceptive [34]. Such practices divert not only from principles of PCC but also of SRHR [26, 28, 32, 77, 105].

Secondly, previous research has indicated that caregivers agreeing with principles of PCC does not self-evidently guarantee that they practice accordingly. For one thing, clinical encounters in Sweden have been less patient-centered when patient concerns were multiple and not purely somatic [79]. Bodegård et al. [79] relate these findings to patients presenting complex or ambiguous medical problems tending to be perceived as “difficult” by doctors, suggesting that when challenged with medical uncertainty, caregivers may be less inclined towards PCC [79, 112, 113]. Moreover, healthcare providers have advocated PCC while simultaneously resisting IUD removal or sliding towards other forms of coercive LARC promotion [27, 30, 31]. Caregivers have thus described embracing PCC when considering requests for LARC removal, while in practice using tenets of PCC such as listening to patients, inquiring about and responding to their concerns, in strategic efforts aiming to delay or prevent removal [30]. Sidelining patient preferences and concerns, caregivers thereby used PCC to in effect undermine it [30]. Relatedly, one HCP participant noted that an open caregiver attitude is likely to increase patient willingness to consider other causes of symptoms than the claimed ones. While mutually finding strategies that fit the patient is a PCC priority (e.g., [56]), this actualizes the question of whether listening to the patient is seen as a way to bring her more into alignment with caregiver views, or as taking the patient’s viewpoint seriously. In sum, it is not entirely clear what PCC entails in meetings with patients whose health concerns do not align with the existing medical evidence.

Alongside limitations in PCC in contexts characterized by medical uncertainty [79, 107, 112–114], this, thirdly, brings the assessment of patient credibility to the discussion about PCC. Testimonial injustice is, as noted above, a tenet of epistemic injustice [41] occurring when someone is attributed less credibility due to belonging to a negatively stereotyped group. The person is thus wronged in her capacity as a provider of information, e.g. through acts of silencing or undervaluation [38]. In healthcare, although the epistemic authority of healthcare professionals is typically warranted due to their their scientifically oriented knowledge and training [39], a patient may be subject to this type of injustice if their testimony is ignored, or heard but not acknowledged as potentially relevant for the understanding of the medical situation, or if communication is closed down due to the caregiver being overly dismissive [40]. Pointing to the potential establishment of a climate of distrust in patient care, Buchman et al. [39] argue that to avoid epistemic injustice, caregivers should strive towards a disposition of epistemic humility. Clarifying that this does not mean rejecting clinical expertise or trusting all patients all the time, epistemic humility is described as willingness to engage in dialogue with the patient, including genuine inquiry into her experience, and critical reflection about assumptions made about her trustworthiness. This notion is congenial to wishes regarding healthcare encounters expressed by SMG participants. Their accounts align with all the noted forms of testimonial justice, with the dismissal of the potential medical relevance of their claims being one of their key concerns.

In light of the above, it is worth considering whether a climate of distrust [39] in women’s perceived side effects of contraceptives is present in clinical environments, and on whether caregivers’ efforts towards epistemic humility should involve reflection on how norms and expectations, including ones related to gender [41] (cf. [115]), might affect credibility judgments in the current context [39]. This is while SMG participants referred to breaches in PCC involving dismissal of their credibility (cf. [107, 114]). A clinical environment where it is not unusual for patient concerns with contraceptive side effects to be dismissed is not likely to strengthen trust in healthcare. We therefore join scholars arguing for training in and reflection on PCC in contraceptive care [28, 30, 104], with attention aimed towards epistemic humility [39] and cases characterized by medical uncertainty or complexity [79].

Developing the evidence-base of copper IUD use

SMG participants, and some HCPs, argued that the evidence-base of copper IUD use should be strengthened, through more research and improved routines for reporting suspected side effects. Many related the paucity of research to weak regulatory demands for safety research on medical devices and some expressed concerns with financial conflicts of interests.

Any lack of relevant research is problematic for EBM, and for PCC in which provision of evidence-based information is an important part [50, 68, 77]. The Swedish national strategy for SRHR emphasizes, for example, that “everyone should know about, be able to express the need for, and have access to evidence-based information” [83]. This is in line with the inclusion of patient demands for well presented evidence in Greenhalgh et al.’s [68] delineation of real EBM. Accordingly, efforts of lay health movements in the contraceptive arena have often been focused on access to information about side effects [20, 115–117].

Weak regulatory demands for research on medical devices has been critiqued by healthcare professionals (e.g., [97, 118]), with new legal requirements gradually being put in place in the EU since 2017 [119]. Regarding the reporting of suspected side effects, research from Sweden corroborates participant accounts of underreporting and uncertainty about what and how to report [120], despite the importance of such reporting for post-marketing research and EBM [68, 120], and medical product withdrawals due to safety problems often being based on data from such systems [121]. Notably, some of our HCP participants related making judgments based on established research about what perceived side effects that merit reporting, which may constrain further development of scientific inquiry and EBM.

Concerns about financial conflicts of interests have also been voiced in research. Greenhalgh et al. (2014) argue that the main challenge to EBM is hidden biases due to vested interests of pharmaceutical and medical device industries, and researchers have affirmed that heightened efforts to curb conflicts of interests in medical research would not only benefit EBM but decrease mistrust in healthcare [39] and the spreading of misinformation [6, 122, 123]. Moreover, historical evidence of past examples of negative effects of contraceptives and other reproductive health devices and their methods of distribution, which have initially gone unrecognized [20, 21, 23, 118], may affect perceptions of the trustworthiness of [124], and contribute to an attitude of epistemic humility on the part of, healthcare providers.

Thus, while a few HCPs noted that more research or improved reporting routines would likely not be accepted as sufficient by patients claiming unestablished side effects, we deem it reasonable to assume that stronger regulatory demands for research and clarified procedures for reporting suspected side effects would make healthcare less open to criticism and distrust, particularly when considering the scientific orientation of many of the SMG participant’s arguments [55]. This is while Buchman et al. (2017) note that trust in providers, and the latter’s privileged position in the epistemic hierarchy, are largely based on their science-based knowledge. Relatedly, while writing about the perils of misinformation on contraceptives, Foran [12] argues that providing evidence-based information should be top priority. Worth adding here is that developing research, in areas where science may hitherto be undone [115, 125, 126], is important for discerning what can be defined as evidence or as misinformation.

The paucity of research can be seen as a claim to hermeneutic injustice [41], the form of epistemic injustice which arises when a group of people faces trouble when trying to understand their experience due to inadequate conceptual resources, resulting in their marginalization. While the lack of interpretative resources results in collective inadequacy of understanding of the phenomenon, the disadvantaged group is prevented from understanding their own experience [41]. This is one possible interpretation of the situation of the women claiming unestablished side effects of the copper IUD.

Straddling EBM and PCC: Considering patient experiences

Among HCP participants, further research was pointed out as a potential resolution to the sometimes explicitly noted tension between PCC and EBM, i.e., between listening to the patient and taking her claims seriously. The reporting of suspected side effects was also noted as a means to resolving this tension. As one SMG participant put it, the reporting of possible side effects can be a way of strengthening PCC by taking the patient seriously, while also enabling the development of EBM through the evaluation of any build-up of similar reports.

Moreover, the tension between principles of EBM and PCC noted in the participant accounts can be related to observations of a general conflict between EBM and PCC, i.e. between following standardized guidelines based on scientific population-level study and tending to individual patient needs [68–70, 73]. While Downey et al. [74] refer to discussions of EBM highlighting tensions between scientific data and patient experiences, Miles and Loghlin [73] observe, as noted above, that an inability of EBM to incorporate patient perspectives when these conflict with the available science indicates an incommensurability between EBM and PCC. Attempts to overcome this tension have been conceptualized in terms of evidence-informed individual care [73], patient-based evidence [127] or real EBM emphasizing the clinician-patient relationship and the care of the individual [68].

Researchers have also argued that dominant paradigms in contraceptive care may rely on a narrow definition of scientific evidence, and that in order to be appropriate and patient-centered it should also engage with evidence grounded in patients’ experiential knowledge [33, 74]. Invoking reproductive justice, Fulcher et al. [128] state that contraceptive counselling should acknowledge the importance of experiential information, and include discussion of accounts patients may have received from different sources [128]. It has been noted that while many patients, across racialized and class groups [27], prioritize embodied experience in contraceptive decision-making [25], although it is often combined with available biomedical knowledge [55], the reliance on epistemically privileged biomedical knowledge enables the overlooking of patient experiences, including the understanding of perceived side effects in terms of fabrications or misconceptions [27, 32, 106]. This, Berndt and Bell argue [27], can entail a major interactional barrier to contraceptive use.

This sense of conflict between forms of evidence or knowledge can be juxtaposed with studies pointing to lay perceptions of caregivers as a source of positively charged information about the copper IUD, whereas negative accounts, and information about side effects, are primarily shared via social contacts [11, 35, 44]. While negative accounts may be regarded as more memorable than positive ones, and attract more attention [5, 11, 12], this sense of discrepancy [35] is noteworthy not least due to conflicting messages being conducive to lack of trust in healthcare [11] and the spread of misinformation [5].

While a few SMG and HCP participants noted that the social media group in question could be viewed as a resource for healthcare, signaling a need for and potentially contributing to medical research, Richards et al. [129, p 7] argue that online patient communities can be seen as “a rich and as yet largely untapped learning resource for health professionals”. Patient-driven efforts have contributed to medical knowledge, for example through evidence-based activism [130] and pointing to gaps in scientific knowledge [125], including in cases where contested illnesses have progressively become considered as real medical issues [131]. This poses questions about conditions under which patient perspectives can and should be considered or integrated into clinical communication or research, and about how trust in caregiver expertise should be balanced against trust in the experiences of patients [39].

Limitations

The SMG participants were highly educated overall, and likely more engaged and well-resourced than many other members of the social media group. In turn, the HCPs were probably more interested in the topic of potential systemic side effects than many other caregivers. These issues are, however, common to many qualitative studies, and do not detract from the relevance of the themes generated in our analysis.

While the accuracy of our interpretations were not checked by participants [132], the trustworthiness of our results were ensured through probing questions during the group interviews and through the authors’ collaborative analysis encompassing meticulous discussion of the analytic themes and their grounding in the empirical data, including reflexive dialogue about balancing between participant claims and the authors’ own assumptions about these.

While the generalizability of elements of our analysis to other cases of clinical communication involving lay contestation of established medical knowledge may be limited, we believe that our arguments can be used in reflection on and assessment of other such cases, not least in so far as, as noted above, our findings echo, and add new nuances to, previous findings concerning contraceptive care.