Adverse reactions of the copper intrauterine device and related consequences: experiences described in discussion boards

The copper intrauterine device is a recommended and effective method for contraception. Recently, agencies have seen an increase in spontaneous reports of adverse reactions, and analysis of messages in discussion boards may lead to new insights. The aim was to explore experiences of adverse reactions related to the copper intrauterine device described by posters in Swedish public discussion boards. Messages containing descriptions of client experiences were collected via Swedish public discussion boards about sexual and reproductive health, identied through searches in Google. Posters with experience of adverse reactions were included (n = 145 unique posters) and their messages were inductively analyzed with qualitative manifest content analysis.


Introduction
Page 3/20 The copper intrauterine device (Cu-IUD) is a long-acting reversible contraception (LARC) that prevents unintended pregnancy through contraceptive mechanisms that lasts for several years and can be removed when desired. The LARC's do not require user compliance and are associated with high contraceptive effectiveness. They also lead to high user satisfaction among clients, in regard to how satis ed they are of having chosen LARC as their contraceptive method [1]. Many leading organizations and experts now recommend LARC as suitable alternatives for those who desire effective contraception [2][3][4][5]. Research show that clients choose the Cu-IUD because of its high e cacy and lack of hormonal mechanism [6]. However, the overall use of LARC is still limited worldwide, with regional differences across different contexts [7][8][9]. Client's expectations of possible adverse reactions are inversely associated with them deciding to use long-acting methods [10], and potential adverse reactions have a considerable impact on which contraceptive method that is ultimately chosen by clients [11]. This calls attention to the importance that clients place in potential adverse reactions of contraception. According to the literature, the most expected adverse reactions of Cu-IUD are localized in the uterus and are not considered medically serious [12,13]. However, elevated levels of copper in the blood have been observed when the Cu-IUD is used [14], raising questions concerning potential systemic effects. The Cu-IUD is often categorized as a medical device, meaning that it is not subjected to similar regulation and adverse reactions are not studied in the same manner as other medical products, such as the hormonal intrauterine system. The Swedish Medical Products Agency recently received an increase of spontaneous reports about adverse reactions of the Cu-IUD, which they relate to increased activity in social media [15]. Posts in online discussion boards contain information that may be relevant to explore patient experiences related to adverse reactions [16] and a growing number of Internet users participate in discussions that take place in virtual discussion boards [17]. Such communication allows laypersons to discuss sensitive subjects in a setting in which they can be anonymous and feel comfortable enough to disclose information about their health [18]. Using material collected from online discussion boards presents an opportunity for researchers to explore unobtrusive data that can complement other methods used for data collection [19]. The aim of this exploratory study was to explore experiences of adverse reactions related to the copper intrauterine device, as described in Swedish public discussion boards.

Data collection
Swedish public discussion boards about sexual and reproductive health were identi ed via Google, the most used search engine on the Web [20]. Two large Swedish virtual communities about reproduction, pregnancy and parenthood were identi ed. In these communities, searches were performed using combinations of search terms related to the study aim. The speci c search terms will not be published in order to protect the identities of the posters included in the sample. Threads in which the rst post was written by a poster that described own experiences related to adverse reactions of Cu-IUD were included.
In total, 51 threads were identi ed and included in the sample. In these threads, a total of 144 unique posters (that had written a total of 369 posts in the included threads) described experiences of adverse Page 4/20 reactions related to Cu-IUD. The mean number of messages per unique poster was 2.5 (range = 1-77), and 14 posters wrote in more than one thread.

Data analysis
The material was inductively analyzed with qualitative content analysis, inspired by the outline presented by Graneheim and Lundman [21]. All included threads were read repeatedly to gain an overall understanding of the content. Meaning units related to the aim were then identi ed, de ned as words, sentences or paragraphs that contain aspects related to each other through their content and context.
Meaning units were labeled with a code, and collated into categories and sub-categories, i.e., the obvious and observable content identi ed with as little interpretation as possible. Table 1 presents examples of the analytic process. The rst and last authors were responsible for the primary analysis. The rst author, a female registered nurse-midwife, identi ed meaning units and performed an initial categorization for eight of the threads (n = 51 posters). The last author aided in this process, who is a male specialist nurse, registered midwife and researcher with formal training and experience of content analyses. In addition, he separately identi ed meaning units and performed initial categorization for the remaining 43 threads (n = 93 posters). The second author (registered nurse-midwife) scrutinized the analysis to check if the meaning units, categorization, and results represented the raw data. The third author (registered specialist nurse-midwife and professor) aided in the identi cation of categories.

Ethical Considerations
The sample consists of messages in public discussion boards accessible without any password requirements. According to current guidelines for Web-based research, and in line with recommendations from the Codex rules and guidelines for research in Sweden [22], texts that are published on the Web without password requirements may be regarded as public and involve an implied consent for use in research [23][24][25][26]. In order to protect the identity of the included posters, we translated and modi ed the quotes, while still making sure that the meaning of the quotes was retained, and changed the user names of the posters to ctitious pseudonyms. The details regarding identi cation of threads will not be made public, in order to protect the identity of the included posters.

Results
Four categories were derived from the data: physical reactions, psychological reactions, intensity of adverse reactions, and consequences of adverse reactions. Figure 1 presents an overview of the categories and sub-categories. Nine posters described positive dechallenge, meaning that the adverse reactions ceased when the Cu-IUD was removed. Two posters described positive rechallenge, meaning that the adverse reactions recurred when a new Cu-IUD was inserted after a positive dechallenge.

Category 1: Physical adverse reactions
The sub-categories in physical reactions included blood system, cardiovascular system, device-related reactions, ears, eyes, excretory system, gastrointestinal and metabolic system, general reactions, integumentary system, menstrual cycle and uterine bleeding, muscoskeletal and connective tissue, nervous system, reproductive tract infections and in ammations, uterus, vulvovagina, and sexual health ( Fig. 1 and Additional File 1). The most common adverse reactions mentioned by the posters were menorrhagia (n = 68 posters), dysmenorrhea (n = 17 posters), and metrorrhagia (n = 18 posters), please see Additional File 1 for more information.

Category 2: Psychological adverse reactions
The sub-categories in psychological reactions included anxiety, cognitive impairment, general psychological health, negative alterations in cognitions and mood, and self-injurious behaviors ( Fig. 1 and Additional File 1).

Category 3: Intensity of adverse reactions
Negative expressions illustrating intensity (sub-category 1): 34 codes of expressions illustrating intensity were identi ed ( Table 2). The expressions portray a signi cant intensity of the adverse reactions, such as the reaction being "awful", "extreme", "indescribable", and "traumatic". Several described the intensity of increased menstruations as an adverse reaction, including the amount of blood feeling like "a ood", "a river", "a downpour", and "gigantic". Posters also described bleeding "like a pig" and "like crazy". Some took tranexamic acid or naturopathic drugs to counteract the increased menstruation. Posters described that they needed to change their tampons very often and that heavy menstruation had such intensity that it had a considerable impact on their daily life. Additional File 2 presents an expanded overview of the identi ed expressions. Temporal aspects (sub-category 2): adverse reactions were described as constant (described for anemia, dysgeusia, dysmennorhea, metrorrhagia, nausea, unspeci c pain, and vertigo), accelerating over time (described for abdominal distention, alopecia, altered mood, chest pain, depression and depressive mood, excessive worries and fears, fatigue, general anxiety, mental fatigue, nervousness, palpitations, panic reactions, paresthesia, and vertigo), having a fast onset (described for altered mood, depression and depressive mood, and premenstrual syndrome), and recurrent (described for menorrhagia and metrorrhagia). One poster had reactions that prolonged over several years, and another described having sought care several times to get help with the reactions.
Retrospective thoughts (sub-category 3): eleven posters wrote that they would never again consider a Cu-IUD and one poster wrote that she would never had have the Cu-IUD inserted if she had known beforehand about the adverse reactions she experienced.

Category 4: Consequences of adverse reactions
Deciding to keep the Cu-IUD despite adverse reactions (sub-category 1): some decided to accept adverse reactions related to changes in menstrual bleeding. Reasons why these decided to accept the reactions and keep their Cu-IUD were that they regarded that the bene ts associated with the contraception outweighed the adverse reactions, preferred using a contraceptive method without hormonal components, and considered the Cu-IUD as the more environmentally friendly alternative in comparison with hormonal contraception. Posters expressed that it was negative that there are so few methods for effective contraception that do not involve hormonal treatment, other than the Cu-IUD. "I've had a copper IUD before, and had spotting before menstruation. But I still feel that the advantages clearly overweigh the disadvantages. It's nice that it's without hormones, both for the environment and myself. But I'm so tired of the fact that there isn't any contraception that is just great." (Poster 15) Removing the Cu-IUD due to adverse reactions (sub-category 2): 31 posters articulated that they did not accept the adverse reactions and decided to remove the Cu-IUD. Adverse reactions that led to removal included menorrhagia, metrorrhagia, depression and depressive mood, dysmenorrhea, ovulation pain, fatigue, arthralgia, inability to lose weight, altered mood, headaches, unspeci ed uterine infection, anemia, vaginal discharge, ocular hyperemia, ocular pruritus, pruritus, nausea, paresthesia, eczema, and somnolence.
"I bled most days of the year when I had the copper IUD. Finally, I couldn't bear it anymore and decided to take it out." (Poster 10) Consequences on sexual health and relationships (sub-category 3): posters described that the experienced adverse reactions had negative effects on their sexual health, because of menorrhagia, vulvovaginal pain, vaginal discharge, and the partner feeling the cords of the Cu-IUD. These consequences were described to have negative effects on their quality of life. When psychological reactions were experienced, it had negative consequences on the poster's relationships with their partners. Some described that they feared that their relationships would end because of the adverse reactions. Some described that their partner was negatively affected by the alterations in mood and psychological health they experienced.
"I've had terrible premenstrual syndrome during these years that keeps getting worse. I cry, scream and have anxiety. I drive my partner crazy." (Poster 25) Fears and worries because of adverse reactions and a traumatic insertion (sub-category 4): some described fears and worries related to the adverse reactions, particularly when they did not recognize the manifestations or could explain them. Posters who had experienced a painful and traumatic insertion expressed considerable fears of seeking care at a gynecologist or midwife. This consequence resulted in deciding not to remove the Cu-IUD, despite wanting to. Some required repeated visits to the midwife before they felt prepared and ready to remove the device.
"I tried to have it removed for several months but could not go through with it because of the pain I experienced when it was inserted. It was the most painful situation I have ever experienced" (Poster 32)

Discussion
The aim was to explore experiences of adverse reactions related to the Cu-IUD. Public discussion boards were used to analyze from posters with experience of the Cu-IUD, revealing various physical and psychological adverse reactions. The reactions were described in powerful words illustrating an intense experience and burdensome consequences, including impacts on sexual health and relationships as well as fears and worries.
The ndings illustrate that patients place great importance in potential adverse reactions of Cu-IUD and base their decisions to continue or discontinue contraception partly on this aspect. While the desire to have contraception without hormonal effects is an acknowledged reason why clients decide to use a Cu-IUD, changed menstrual bleedings and pain are expected reasons for discontinuation [27]. In addition to the expected menorrhagia and dysmenorrhea [12,13], we also observed more unexpected physical and psychological reactions, including symptoms that could implicate serious conditions such as anemia, fatigue, depression and suicidal ideation. Posters in this study also described alterations in their cognition and mood, such as mental fatigue and increased irritability. Studies have observed a potential association between levels of free copper in blood and cognitive impairment [28]. Although inconclusive results have been reported [29], one study also suggests a relationship between elevated copper levels and depression [30]. The identi ed adverse reactions illustrate the importance of follow-up consultations with the aim to identify those who develop adverse reactions. However, research indicates variability with regard to how much attention that is given during contractive counseling to inform about possible adverse reactions, and further, that only a proportion who are prescribed contraception are offered a follow-up visit [31].
The adverse reactions resulted in burdensome consequences for included posters, including negative consequences on sexual health and relationship with partner. These ndings are in line with previous research, illustrating the association between medical conditions and sexual health [32]. Another serious consequence was the articulated fear of gynecological care developed among posters with a traumatic experience of the insertion of the device. Pelvic examinations are an essential part of gynecologic care needed for many purposes, including establishing diagnoses, screening for cervical cancer, and for the insertion or removal of intrauterine devices. Consequently, fear of pelvic examinations could lead to serious consequences for women. Therefore, clinicians need to take active measures as to effectively prevent development of these fears [33]. Research acknowledges that a proportion of clients experience high pain during insertion of intrauterine devices [34,35] and that they nd the pain more intense than expected [36]. Oral analgesia, local anesthesia and cervical priming have the potential to alleviate pain during insertion, but no rm conclusions have yet been drawn concerning implementation of routine clinical use [37]. We did not observe any descriptions whether or not the posters were given any pain relief before the insertion. Nevertheless, the ndings illustrate the potential impact that painful insertion may have and portray the importance of an individualized approach in which clients who are at risk of high pain are identi ed and supported. Research indicates that few midwives and gynecologists use analgesia in clinical practice [38], calling attention to the need for further improvement in clinical management and more studies that investigates how to prevent insertion-related pain for patients who are at risk.
Qualitative methodologies have the potential to offer insights into patient perspectives explored in an inductive approach within the eld of drug utilization [39]. Using the Web to collect patient-generated data could lead to further insights regarding adverse reactions [40], which was the rationale behind the chosen methodology. This was a convenience sample consisting of persons who decide to write about their experiences on web-based discussion boards. Thus, the transferability of the ndings is limited and we acknowledge the probability that those who write about adverse reactions could constitute a subgroup with especially challenging reactions and consequences. The fact that anyone can write in public discussion boards implicate that it would be possible to fabricate stories about adverse reactions. On the other hand, web-based communication involves an opportunity for patients to tell their stories in an anonymous setting and previous research indicates that people disclose more about themselves than they do during face-to-face interactions [41]. We did not observe anything during the analysis that would suggest fabrication. Moreover, while all posters did describe their adverse reactions as being caused by the Cu-IUD, we cannot make any certain claims about causality and adverse reactions among the general population. Thus, there is a need for more descriptive and exploratory studies in this eld, particularly concerning the impact and consequences that adverse reactions may have for clients.

Conclusion
Posters who write in public discussion boards about adverse reactions of the copper intrauterine device describe both expected and more unexpected reactions. Some of these are serious events that need to be identi ed and treated in clinical praxis. When adverse reactions of the copper intrauterine device are experienced they can have burdensome consequences, including sexual health and relationships. Those who experience a traumatic insertion are at risk of developing fear of pelvic examinations, resulting in reluctance to seek care at a gynecologist or midwife. It is important that health professionals identify, prevent and treat pain during insertion. Health professionals need to ensure that clients who have a copper intrauterine device are followed-up accordingly, so that potential adverse reactions and its potential consequences are adequately assessed and supported.

Abbreviations
Cu-IUD Copper intrauterine device LARC Long-acting reversible contraception

Declarations
Ethics approval and consent to participate Not applicable.

Consent for publication
Not applicable.

Availability of data and materials
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests
The authors declare that they have no competing interests.

Funding
No funding supported this work.
Authors' contributions MF designed the study, collected the data, analyzed the data, wrote an early Swedish draft of the manuscript, and critically reviewed the manuscript. MSM designed the study, aided in the analysis of the data and critically reviewed the manuscript. SG aided in the identi cation of categories and critically reviewed the manuscript. TC conceived and designed the study, collected the data, analyzed the data and drafted the English version of the nal manuscript. All authors approved the nal version of the manuscript.   Intensity of adverse reactions described by posters.