Cooper JM, Carignan CS, Cher D, Kerin JF, Selective Tubal Occlusion Procedure 2000 Investigators Group
To assess the safety, effectiveness, and reliability of a tubal occlusion microinsert for permanent contraception, as well as to document patient recovery from the placement procedure and overall patient satisfaction.
A cohort of 518 previously fertile women seeking sterilization participated in this prospective, phase III, international, multicenter trial. Microinsert placement was attempted in 507 women. Microinserts were placed bilaterally into the proximal fallopian tube lumens under hysteroscopic visualization in outpatient procedures.
Bilateral placement of the microinsert was achieved in 464 (92%) of 507 women. The most common reasons for failure to achieve satisfactory placement were tubal obstruction and stenosis or difficult access to the proximal tubal lumen. More than half of the women rated the average pain during the procedure as either mild or none, and 88% rated tolerance of device placement procedure as good to excellent. Average time to discharge was 80 minutes. Sixty percent of women returned to normal function within 1 day or less, and 92% missed 1 day or less of work. Three months afterplacement, correct microinsert placement and tubal occlusion were confirmed in 96% and 92% of cases, respectively. Comfort was rated as good to excellent by 99% of women at all follow-up visits. Ultimately, 449 of 518 women (87%) could rely on the microinsert for permanent contraception. After 9620 woman-months of exposure to intercourse, no pregnancies have been recorded.
This study demonstrates that hysteroscopic interval tubal sterilization with microinserts is well tolerated and results in rapid recovery, high patient satisfaction, and effective permanent contraception.
Women's Health Research, Phoenix, Arizona 85015, USA. firstname.lastname@example.org