Courtesy Bayer
Essure
Essure micro-inserts for permanent birth control received initial approval from the FDA in November 2002. Despite the fact that Essure can be easily placed, is highly effective, and has seemingly low complication rates, concerns have been raised by the Facebook group “Essure Problems” and Erin Brockovich, the focus of the 2000 biographical film starring Julia Roberts.
After more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, based on unintended pregnancies, miscarriages, stillbirths, severe pain, and bleeding, the FDA announced in 2016 that it would require a boxed warning label for Essure. The FDA also called upon Bayer, which makes and markets Essure, to conduct surveillance to assess “risks of the device in a real-world environment.” The agency stated it will use the results to “determine what, if any, further actions related to Essure are needed to protect public health.”
While Jan. 26, 1988, is a very special date in minimally invasive gynecologic surgery, April 17, 2014, is a day of infamy for the gynecologic laparoscopist. For on this day, the FDA announced a warning regarding electronic power morcellation. Many hospitals and hospital systems throughout the country issued bans on electronic power morcellation, leading to needless open laparotomy procedures and thus, introducing prolonged recovery times and increased risk.
At a time when the recent introduction of barbed suture had made both closure of the vaginal cuff at time of hysterectomy and repair of the hysterotomy at myomectomy easier and faster, the gynecologic laparoscopist was taking a step backward. The FDA based this decision and a subsequent boxed warning – issued in November 2014 – on a small number of studies showing potential upstaging of leiomyosarcoma post electronic power morcellation. Interestingly, many of the morcellation procedures cited did not use power morcellation. Furthermore, a more comprehensive meta-analysis by Elizabeth A. Pritts and colleagues, showed a far lower risk than suggested by the FDA (Gynecol Surg. 2015;12[3]:165-77).
Recently, an article by William Parker and colleagues recommended that the FDA reverse its position (Obstet Gynecol. 2016 Jan;127[1]:18-22). Many believe that ultimately, the solution will be morcellation in a containment bag, which I and my colleagues have been performing in virtually every power morcellation procedure since May 2014. During this current power morcellation controversy, the Master Class in Gynecologic Surgery has continued to update its readers with three different articles related to the subject.
And in conclusion
Without a doubt, the past 50 years of gynecologic surgery has been a time of unparalleled innovation with occasional controversy thrown in. Ob.Gyn. News and more recently, the Master Class in Gynecologic Surgery, has had a major leadership role in bringing this profound ingenuity to the gynecology community by introducing this explosion of surgical creativity to its readers.
And what will the next 50 years bring? I believe we will continue to see tremendous advancements in minimally invasive gynecologic surgery. There will be a definite impact of costs on the marketplace. Thus, many of the minor minimally invasive procedures currently performed in the hospital or surgery center will be brought into office settings. In addition, secondary to reimbursement, the more complex cases will be carried out by fewer gynecologic surgeons who have undergone more intense training in pelvic surgery and who can perform these cases more efficiently and with fewer complications. Our ability to perform surgery and what type of procedures we do will not only be based on randomized, controlled trials, but big data collection as well.
Dr. Miller is clinical associate professor at the University of Illinois at Chicago, and past president of the AAGL and the International Society for Gynecologic Endoscopy (ISGE). He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill.; director of minimally invasive gynecologic surgery and the director of the AAGL/Society of Reproductive Surgery fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. Dr. Miller is a consultant and is on the speakers bureau for Ethicon.