Essure, approved by the Food and Drug Administration (FDA) in 2002 is the first transcervical permanent birth control device available to women (1). The FDA approved this device as a Class III device through the Pre-market Approval Process and in 2016 ordered Bayer to conduct a post-market surveillance study in order to gather and report additional data on the benefits and risks of Essure. (2) Prior to the FDA approval of this device, tubal sterilization via partial or complete salpingectomy, ligation or obstruction with rings or clips, a relatively invasive procedure, was the only option available to women for permanent birth control solution. (3). Tubal sterilization is known to be associated with longer recovery times and increased postsurgical pain. (4) Essure microinserts have a stainless steel inner coil, a nickel-titanium outer coil, and a layer of polyethylene terephthalate (PET) fibers that are hysteroscopically placed into each fallopian tube in a minimally invasive ten-minute outpatient procedure. (3)(4) Over the next 12 weeks, the PET fibers in the microinsert induce fibrosis around each device forming a natural barrier to occlude both fallopian tubes preventing conception. Months after insertion, the tubes are assessed for successful closure using a hysterosalpingogram. (1)(5)
While the Essure system offered women a minimally invasive method of permanent birth control which could be placed in the office or outpatient surgical center, some women experienced side effects varying from widespread inflammatory response to uterine perforation. (1)(7) Approximately 1.1% to 4.2% of women reported effects such as chronic pelvic pain, metallic taste in the mouth, hair loss, stomach cramps, vaginal bleeding or spotting, anaphylactic reactions, and extreme bloating (3)(6)(7). On further investigation microinserts were found to be improperly placed, shown to cause rupture of the fallopian tube, and migration through the uterus and peripheral organs. In September 2015, members of the FDA Obstetrics and Gynecology Device Panel suggested that Essure microinserts be removed if they are not positioned correctly, are causing a woman pain, or result in hypersensitivity reactions. (8)(9)(10)
Given this recommendation and patients’ desire for device removal, three recognized methods of Essure removal are hysteroscopic removal, laparoscopic extraction and open laparotomy. (3)(4)(11)(23) The open and laparoscopic method ranges from bilateral salpingectomy to a complete hysterectomy dependent on complications and device perforations.
Many women with Essure Permanent Birth Control microimplants have been requesting their removal due to adverse side effects post-implantation (not exclusive to severe chronic pelvic pain, fallopian tube perforations, vaginal bleeding, and type four hypersensitivity reactions). At The Miami Institute of Urogynecology and Minimally Invasive Surgery, Dr. Peter Khamvongsa has vast experience on their removal and is part of the Essure Problems site as well as Facebook support groups to provide assistance with this issue. He offers a mimimally invasive robotic approach for Essure implant removal, and one of his approaches was presented at the American Association of Gynecologic Laparoscopist meeting in Vancouver in 2019. Please contact our office if you desire a consultation.