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• W2940670029 abstract "Over the past several years, the commercial status of the Essure Coil, a permanent hysteroscopic sterilization device, has switched from assured to pressured. In July 2018, the device's manufacturer, Bayer Healthcare, announced that it would halt sales in the United States (the last country in which the device has been offered) by year's end. This decision was prompted by years of declining sales revenue and came after thousands of women filed complaints of adverse events, including device expulsion, uterine and tubal perforation, intractable pelvic pain, and bleeding necessitating hysterectomy, device-related death, unintended pregnancy and miscarriage, and a variety of other chronic symptoms (1Dhruva S.S. Ross J.S. Gariepy A.M. Revisiting Essure—toward safe and effective sterilization.N Engl J Med. 2015; 373: e17Google Scholar). Originally approved by U.S. Food and Drug Administration (FDA) in 2002 for female sterilization, Essure could be inserted in office settings, with minimal recovery times. The device underwent the FDA premarket approval process, its most demanding review which requires manufacturers to conduct two post-approval studies to continue 5-year follow-up evaluation with participants from the premarket clinical trials. The device was marketed as an alternative to traditional tubal ligation surgery, which requires additional time off from work, a need for pain control, and risks of general anesthesia. Hysteroscopic sterilization offered women many benefits that traditional sterilization could not, especially those at increased surgical risk from conditions such as significant pelvic adhesions. In addition, it has also been used as an alternative to salpingectomy for hydrosalpinges before in vitro fertilization, though its efficacy has recently been questioned compared with traditional approaches (2Xu B. Zhang O. Zhao J. Wang Y. Xu D. Li Y. Pregnancy outcome of in vitro fertilization after Essure and laparoscopic management of hydrosalpinx: a systematic review and meta-analysis.Fertil Steril. 2017; 108: 84-95Google Scholar). In 2011, despite nearly a decade of safety and efficacy data, women began to share their accounts of adverse events after placement of Essure on social media through the 37,000-member Facebook group “Essure Problems.” In 2012, there were just 100 complaints of side effects; by 2014, there were 2,259 unverified reports of problems, spurred on by patient social media advocacy (3Zhang S. How a Facebook group got the FDA to reconsider a type of birth control.https://www.wired.com/2015/09/facebook-group-got-fda-reconsider-type-birth-control/Date: September 15, 2015Google Scholar). The Facebook group eventually grew into Advocating Safety in Healthcare E-Sisters (ASHES), which attracted the interest of Erin Brockovich and private meetings with the FDA commissioner and congressional staff to advocate for the device's market removal. Bayer Healthcare came under criticism (rightly so) as a result of not providing timely 5-year follow-up data; the patient and physician labeling was not updated to include 2002 data until 2012 (4U.S. Food and Drug AdministrationEssure Permanent Birth Control: Regulatory History. April 9, 2018.https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/ucm452270.htmDate: April 9, 2018Google Scholar). The FDA then updated the product's labeling in 2013 to include a warning about risks of chronic pelvic pain and device migration from the fallopian tubes to the uterus. In 2015, the FDA held a public advisory committee meeting to discuss Essure, thereby giving patients more power to affect its regulatory processes. After that meeting, the FDA mandated a black box warning about risks and other possible adverse events, and mandated new labeling, including a decision checklist that patients had to complete before insertion. Furthermore, the FDA also required that Bayer perform an additional postmarket study to further evaluate the device's long-term safety profile. Essure sales declined by 70% after these new constraints. In 2018, the FDA further determined that some women were still not receiving information about Essure's known risks as including severe menstrual cramping, pain after insertion for 1 year, and coil perforation; as a result, the FDA restricted its sale and distribution to physicians that disclosed such information. Facing more than 16,000 lawsuits based on claims that it did not warn patients of Essure's potential severe complications (and the pending release of The Bleeding Edge, a Netflix documentary about Essure and other medical devices' risks), Bayer announced that that it would no longer sell the device in the United States after 2018. The Essure controversy is a perfect storm, a vivid case study of what can happen when social media, patient advocacy, FDA adverse reporting policies, and malpractice litigation can skew the regulatory landscape for certain pharmaceuticals and medical devices. More and more, patients are going online to find and communicate with other individuals who have the same or similar medical conditions (5Ventola C.L. Social media and health care professionals: benefits, risks, and best practices.P T. 2014; 39: 491-520Google Scholar) using sites like Facebook.com or PatientsLikeMe.com. These connections provide support and occasionally lead to organized traditional research, patient-led research, and/or fundraising efforts. Medical communities will increasingly have to consider and negotiate issues of patient and public involvement, whether they are oriented toward treatment, research, or both areas of service. The concept of “patient advocacy” is still murky, as is health care providers' orientations to such activities. That term could mean anything from supporting any decision a patient may make to assertions of what would be good for patients. Greater patient connectivity has brought stronger demands for accountability. Social media provides an ever-available public forum for patients to air their grievances and organize to change the status quo. This increased engagement is overall a positive development, magnifying the voices of those likely to be most vulnerable and thus most likely to be marginalized. Sometimes, however, social media and greater patient connectivity can have more negative consequences. Messages on online forums and social media are inherently incomplete, often unfinished, and one-sided. Patients may post questions about procedures, requests for advice, or solicit opinions about particular products, but it is unclear whether they return to the forum to update individuals on how questions were resolved or how situations played out. Facebook groups form around products such as Essure that patients find problematic, but seldom around those for which patients have positive experiences. In other cases, discussions move from organic to organized social movements, with a few members working to recruit patients into particular online groups to claim strength of numbers. Such groups also often become targets for personal injury lawyers eager to connect with potential clients. In some cases, an onslaught of adverse reports after a documented surge in patient advocacy should be read as a prompt for additional research, not as justification for retiring a product that is still a viable alternative for some patients when it is used by an experienced practitioner and accompanied by appropriate warnings and informed consent procedures. An additional postmarket clinical trial for Essure was already in progress, pursuant to the FDA's 2016 mandates. Now the results of this research cannot be used to refine recommendations as to which patients would be potential candidates for this device. Overall, social media and greater patient connectivity, together with a directional change toward patient-centered care, have helped to positively change the way we, as medical professionals, engage with patients. Patient connectivity, like medical care, demands an approach that recognizes the unique attributes of each individual—and each individual procedure and product. Medical professionals have the expertise to explain to their patients why something another patient recommended on social media is not appropriate for all, and why protocols, procedures, and products that are ideal for some patients are harmful to others. We must embrace social media—indeed, technological innovation ensures that we have little choice in that matter—but we must use anecdotal evidence to strengthen, not undermine, evidence-based conclusions. In short, we can't throw out the baby with the bathwater. Moreover, we must be mindful that patient medical decision making and experiences with products and services, social media, regulatory schemes, and malpractice litigation are not behaviors that exist in silos. Rather, they work as interconnected gears in a complex system in which many professionals collaborate to improve health and technological innovation. When one gear spins too fast and another wobbles from side to side, this system can function in an absurd way or ultimately break down. Thus, when the tide of anecdotal opinion threatens to erode crucial support for a procedure or product that is viable for some patients, we as a professional society can serve a key role in educating patients about recommended treatments. Sadly, the imminent demise of Essure will leave many women who desire permanent sterilization with no other option but laparoscopic sterilization." @default.
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• W2940670029 title "Social media and Essure hysteroscopic sterilization: a perfect storm" @default.
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