ASIA (Shoenfeld's syndrome) due to hysteroscopic Essure sterilization

Abstract Essure (TM, Bayer; Leverkusen, Germany) may act as a potential cause of autoimmune/inflammatory syndrome by adjuvants (ASIA). Essure is a device hysteroscopically inserted into the fallopian tubes to elicit a local inflammatory response for permanent sterilization. Patients with ASIA present with a constellation of symptoms including fatigue, cognitive impairment, and arthralgias. It is well known that ASIA is triggered by implantation of foreign material such as breast implants and mesh for hernia repair. In the current study, we present a retrospective cohort of 33 patients electing to remove Essure due to pelvic pain and systemic symptoms consistent with an ASIA diagnosis, and detail a case report of an Essure patient. Furthermore, we reviewed the existing literature on adverse events associated with Essure and studies assessing outcomes following explantation. The concept that Essure may trigger ASIA is further supported by both in vivo and in vitro studies demonstrating immunostimulatory effects of the material components of the device. We conclude that the existing evidence is sufficient to recommend screening of Essure recipients for ASIA symptoms, and where indicated, discussion of the risks and potential benefits of surgical removal.