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The influential mind and the power of emotion over Essure hysteroscopic sterilization

2019; Elsevier BV; Volume: 112; Issue: 6 Linguagem: Inglês

10.1016/j.fertnstert.2019.09.007

1556-5653

Steven R. Lindheim, Jody Lyneé Madeira, John C. Petrozza,

Reproductive Health and Contraception

A podcast in the National Public Radio series “Hidden Brain” entitled “Facts aren't enough: the psychology of false beliefs” discusses “confirmation bias”—an inductive reasoning error in which someone understands and recalls information in a way that confirms prior beliefs despite evidence to the contrary. In other words, wanting something to be true makes it seem so. With confirmation bias, we not only distance ourselves from the data, we also discredit it by seeking out other (less reputable) sources that agree with us, including social media or trusted others. As a result, it becomes difficult to change people’s strongly held but false beliefs, such that inundating someone with facts is unlikely to change their minds in many cases and might even reinforce their incorrect beliefs. One example where the horse of confirmation bias likely ran away with the cart of reason is the fate of the Essure device, which was originally approved by the U.S. Food and Drug Administration (FDA) in 2002 for female sterilization. Initial short-term follow-up studies revealed that the device was highly effective, easily placed in-office, with minimal recovery times and very low complication rates. Given the initial high patient satisfaction, Essure sterilization became increasingly popular as a means of permanent birth control. In 2011, however, despite nearly a decade of safety and efficacy data, women began to share their accounts of adverse events after Essure placement on social media through a new Facebook group, “Essure Problems,” which eventually grew to 37,000 members. Media reported increased medical risks following Essure sterilization, unlike the studies that failed to support this, experienced by only certain groups: women with a previous diagnosis of chronic pain and those with abnormal uterine bleeding. Both were more likely to develop chronic pain or had a higher likelihood of abnormal uterine bleeding after both Essure sterilization and laparoscopic sterilization (1Casey J. Aguirre F. Yunker A. Outcomes of laparoscopic removal of the Essure sterilization device for pelvic pain: a case series.Contraception. 2016; 94: 190-192Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar, 2Bouillon K. Bertrand M. Bader G. Lucot J. Dray-Spira R. Zureik M. Association of hysteroscopic vs, laparoscopic sterilization with procedural, gynecological, and medical outcomes.Obstet Gynecol Surv. 2018; 73: 285-286Crossref Scopus (3) Google Scholar). Nonetheless, spurred on by patient social media advocacy, 100 complaints of side-effects in 2012 grew to 2,259 unverified reports of problems by 2014, and “Essure Problems” eventually grew into the patient advocacy group Advocating Safety in Healthcare E-Sisters (ASHES), which held meetings with the FDA commissioner and congressional staff to advocate for the device’s market removal. Through this, the groundwork was laid for an Essure confirmation bias. This was very similar to antivaccination bias, as well as historic opposition to medical developments such as variolation for smallpox in the early 1700s, handwashing between obstetrical cases in 1847, and the idea that bacteria caused gastric ulcers in the 1950s. These innovations all met with opposition despite scientific evidence to the contrary, but ultimately gained traction—not because of their scientific bases, but because scientists involved gained sufficient publicity to persuade the general public. Essure’s negative publicity caused it to fall on the wrong side of the science. The study by Siemons et al., to our knowledge, is the first to report on the impact of social media on the long-term satisfaction of Essure sterilization (3Siemons S.E. Vleugels M.P.H. Veersema S. Braat D.M. Nieboer T.E. Long-term follow-up after successful Essure sterilization: evaluation of patient satisfaction, symptoms and the influence of negative publicity.Fertil Steril. 2019; 112: 1144-1149Abstract Full Text Full Text PDF Scopus (6) Google Scholar). According to Siemons et al., Essure inserts had previously enjoyed a high degree of patient satisfaction: After a median follow-up of 29 months, 97.7% of women were satisfied and 88.1% would recommend Essure sterilization. In a 2010 study, Levie et al. (4Levie M. Weiss G. Kaiser B. Daif J. Chudnoff S. Analysis of pain and satisfaction with office-based hysteroscopic sterilization.Fertil Steril. 2010; 94: 1189-1194Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar) reported follow-up data from 84% (n = 176) of the participants enrolled in their office-based Essure placement study, reporting that 164 (93%) would do the procedure again if they had to, and 173 (98%) would recommend the procedure to a friend. Only 10.3% reported symptoms for which they had visited a physician. Earlier studies had also reported that complications were rare. In 2016, Kamencic et al. (5Kamencic H. Thiel L. Karreman E. Thiel J. Does Essure cause significant de novo pain? A retrospective review of indications for second surgeries after Essure placement.J Minim Invasive Gynecol. 2016; 23: 1158-1162Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar) reported on an 11-year follow-up in 1,430 patients after Essure sterilization, where 2.7% (n = 38) reported either a new onset or worsening of preexisting pain after placement of the Essure inserts. Only 4.3% (n = 62) underwent a second surgery, and surgical findings were consistent with a painful gynecologic condition in only 15 cases. Disconcertingly, Siemons et al. now report that after a follow-up of 144 months that included 317 respondents, although almost three-fourths of respondents (n = 234) were still satisfied with Essure sterilization, 49.5% (n = 157) reported having symptoms, 36.6% (n = 116) underwent pelvic surgery after Essure placement, 16.1% (n = 51) had undergone Essure removal surgery, and 10.6% (n = 28) were considering undergoing Essure removal surgery. These authors and others have suggested that the pain attributed to Essure placement may actually be overestimated because a preexisting condition that was previously tolerated may be deemed more serious if it is temporally related to the placement of a permanent implant. Thus, they conclude, the negative publicity, particularly through social media, changed patients’ opinion of Essure. Essure is no longer available to patients. Nonetheless, the story of how this device went from a popular sterilization option with high patient satisfaction to a dangerous product which set social media abuzz is a valuable lesson that should be learned to avoid future occurrences. This cautionary tale indicates the realities of medical practice in the digital age, where patients can seek information from many not-so-reputable sources and have difficulty identifying the gold threads among the dross (Proverbs 25:4). Medical professionals, too, are subject to confirmation bias and may err too early in the direction of disfavoring controversial devices because of fear of litigation. Social media seems more accessible, responsive, and persuasive than peer-reviewed scientific articles, prompting us to find new and more efficient ways of communicating standards of care and scientific conclusions without recourse to media. It is vital that we as scientists and practitioners engage directly with our public—who are, after all, our patients—through media that foster real participation on both parties’ behalf. In so doing, we can respond to evolving discourses instead of being caught unaware, and thus more comprehensively protect our patients’ interests. In doing so, medical professionals and organizations can also take advantage of social media analytics to determine the popular pulse on medical topics and try to find balance when misinformation threatens to tilt public opinion in an inaccurate direction. Relevant information can be communicated in easy-to-understand formats, using the example of Bill Nye, “The Science Guy,” who has made difficult scientific concepts easy to understand for children. We could invite influential bloggers and social media gurus to the table to help us in these efforts, or discuss scientific results with journalists committed to exploring the truth about scientific misquotes or misperceptions. These efforts are especially crucial because patients are going online with increasing frequency to find and communicate with other individuals who have the same or similar medical conditions on sites such as Facebook.com and PatientsLikeMe.com. These connections provide support and occasionally lead to organized traditional research, patient-led research, and fundraising efforts. Thus, medical communities have to consider and negotiate these issues of patient and public involvement, whether they are oriented toward treatment, research, or other areas of service. In our role as patient advocates, the concept is still murky as we as health care providers orient to such activities. “Patient advocacy” can mean anything from supporting any decision a patient may make to asserting what a practitioner thinks is in the patient’s best interests. Greater patient connectivity has strengthened demands for accountability, and social media provides a continuously open public forum for patients to exchange information, air grievances, and organize to change the status quo. Overall, this increased engagement is a positive development, connecting and magnifying the voices of those likely to be most vulnerable and therefore marginalized. At extremes, however, social media and greater patient connectivity can have more negative consequences. Messages on online forums and social media are inherently incomplete; threads are often unfinished and one sided. Patients may post questions about procedures, requests for advice, or solicit opinions about particular products, but it is unclear if they return to the forum to update individuals on the outcomes of their decisions. Facebook groups form around products such as Essure that patients believe to be problematic, but seldom around those for which patients have positive experiences. At times, membership in these groups can be increased not through organic interest but through targeted outreach, as individuals recruit patients into particular online groups to claim strength of numbers and strengthen advocacy. Although some recruiters genuinely want to increase public awareness, such groups often become targets for personal injury lawyers eager to connect with potential clients. Thus, it is especially crucial to review all circumstances when an onslaught of adverse reports follows a documented surge in patient advocacy; in some cases, it should be read as a prompt for additional research (indeed, an additional postmarket clinical trial of Essure was already in progress, pursuant to the FDA’s 2016 mandates) and not as a death knell. Essure was still a viable alternative for some patients when inserted by an experienced practitioner and accompanied by appropriate warnings and informed consent procedures. Sadly, after Essure was retired, the results of the postmarket research cannot be used to refine recommendations as to which patients would be potential candidates for the device. Further studies regarding long-term patient satisfaction, symptoms, and Essure removal and symptom relief would likely provide more information, as well as helping health care providers to determine which future devices are most appropriate for certain patients who wish permanent sterilization. Siemons et al. have provided us with valuable long-term follow-up data. These studies are crucial for informing women who still have the Essure device about possible long- term risks, as well as for helping health care providers to determine which future devices are most appropriate for certain patients who wish permanent sterilization. Moreover, this research amply demonstrates the need to find—and communicate—balance when misinformation threatens to warp public opinion. Sadly, in extreme situations as with Essure, social media and greater patient connectivity can have very negative consequences, introducing patients to “fake news.” It is an ongoing challenge to determine how to best convey unbiased and impartial information to reduce confirmation bias in a world increasingly connected through and influenced by social media. Long-term follow-up after successful Essure sterilization: evaluation of patient satisfaction, symptoms, and the influence of negative publicityFertility and SterilityVol. 112Issue 6PreviewTo evaluate long-term patient satisfaction and symptoms after successful Essure sterilization and the influence of negative publicity on patients' opinion. Full-Text PDF