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

Abstract

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™ pbc, a minimally invasive, transcervically placed microinsert that occludes the Fallopian tubes, resulting in permanent female contraception. Device under study: The Essure™ 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™ 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™ pbc were < 5%. Discussion: This first clinical trial showed the Essure™ 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™ pbc method of permanent contraception is an exciting alternative to vasectomy or laparoscopic sterilisation that does not require general anaesthesia or incisions.