The safety and effectiveness of a new hysteroscopic method for permanent birth control:: results of the first Essure™ pbc clinical study

Background: Current methods of female surgical sterilisation require incisional surgery, general anaesthesia and a prolonged recovery time. We studied the safety and effectiveness of Essure (TM) pbc, a minimally invasive, transcervically placed micro-insert that occludes the Fallopian tubes, resulting in permanent female contraception. Device under study: The Essure (TM) pbc implant is a dynamically expanding micro-insert which is placed in the proximal section of the Fallopian tube using a modified minimal access technology for cannulating the tube. Study population: Women aged 21-43 seeking permanent birth control. Methodology: Essure (TM) pbc micro-inserts were inserted into the proximal portion of the Fallopian tubes under hysteroscopic visualisation with intravenous sedation or paracervical block. Results: Bilateral device placement was achieved in 111 of 130 (85%) women who underwent device placement attempts. Women found the device placement procedure to be highly acceptable. Of women wearing the device for up to two years rate, 97% rated it to be very good to excellent. There have been no pregnancies reported in 1894 woman-months of effectiveness. Adverse events preventing women from relying on Essure (TM) pbc were < 5%. Discussion: This first clinical trial showed the Essure (TM) pbc method of permanent contraception to be safe and highly acceptable to women. Experience and improvements to the delivery system should increase overall micro-insert placement rates. Conclusion: The Essure (TM) pbc method of permanent contraception is an exciting alternative to vasectomy or laparoscopic sterilisation that does not require general anaesthesia or incisions.