A new transcervical sterilization procedure: results of a pilot implant study in humans

Abstract

Objective: We have developed a novel delivery and occlusion method for the purpose of achieving permanent fallopian tube occlusion. This study was designed to determine how the procedure would be tolerated by patients and what early effects there would be on the fallopian tube. Methods: The Adiana procedure consists of applying radio frequency energy to the fallopian tube to ablate the epithelial lining of the tube and depositing a synthetic matrix. Four patients (seven tubes) were treated with the Adiana procedure 12 weeks before an elective hysterectomy. Hysterosalpingography was performed on each patient immediately before the hysterectomy. Additional evaluation of tubal occlusion was performed by applying dye under pressure (up to 150 mm Hg) to the explanted tube. Tissue was then histologically analyzed. Results: All patients tolerated the procedure very well, reporting zero pain on a VAS scale (defined 0 to 100). Patients experienced no pain associated with wearing the implant for the duration of the study. Hysterosalpingography results indicated complete tubal blockage in all treated tubes (seven out of seven). Retrograde dye application determined that six of the seven tubes were resistant to dye passage (150 mm Hg). One of the tubes allowed dye passage after 1 minute of dye application (100 mm Hg), suggesting at least partial occlusion. All seven tubes exhibited host cellular infiltrate into the pores of the matrix. Immunohistologic stains indicated that a variety of host cells made up the occlusive ingrowth. Conclusions: The results of this study indicate that the Adiana procedure is able to promote cellular ingrowth into a matrix and result in occlusion of the fallopian tube for up to 12 weeks.