The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first EssureTMpbc clinical study
| Autor: | John F. Kerin, Charles S. Carignan, Daniel J. Cher |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Adult
medicine.medical_specialty Sterilization Tubal Transcervical sterilization Population Hysteroscopy Paracervical block medicine Humans General anaesthesia Prospective Studies education Fallopian Tubes education.field_of_study business.industry Vasectomy Obstetrics and Gynecology General Medicine Surgery medicine.anatomical_structure Essure Patient Satisfaction Family planning Female business Intrauterine Devices Fallopian tube |
| Zdroj: | The Australian and New Zealand Journal of Obstetrics and Gynaecology. 41:364-370 |
| ISSN: | 1479-828X 0004-8666 |
| DOI: | 10.1111/j.1479-828x.2001.tb01311.x |
| Popis: | 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 micro-insert 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 intra-venous 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™ 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. (authors) |
| Databáze: | OpenAIRE |
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