Nonsurgical sterilization using the ESSURE device in the fallopian tubes: Results in rabbits

A potential method of nonsurgical tubal sterilization was tested in rabbits to gain Food and Drug Administration (FDA) approval for testing in women. The study design consisted of 37 rabbits, with 74 reproductive tracts that received either no intervention (22 tracts), catheterization only (23 tracts), or attempt at placement of a metal device in the fallopian tube (29 tracts) using a combination of hysteroscopic and fluoroscopic catheterization. Animals were bred and then euthanized, and contraceptive effect documented. No embryos were found in the 14 uteri associated with fallopian tubes containing the ESSURE device (0 conceptions; 100% contraception). In comparison, embryos were found in 36 of the 45 uteri in which a device was not placed (80% conceptions; 20% contraception). Difficulty placing or expulsion of the device occurred in 11 (39%) of the rabbit reproductive tracts, which are more difficult to catheterize than those of women. ESSURE prevented conception 100% of the time in the rabbit when the metal device remained in the fallopian tube. Based on this data, the FDA approved clinical trials using this device, and recently approved placement in women. It is therefore the first alternative to tubal ligation for women seeking permanent birth control in the United States.