In 2002 the FDA approved Essure, a small metal coil that could be placed through the cervix into the fallopian tubes providing permanent contraception for women. Essure offered an alternative to laparoscopic tubal ligation which requires general anesthesia and 2 small abdominal incisions. Hope was this new devise would be easier, safer, cheaper while being equally effective as a laparoscopic tubal ligation.
Has this new devise been a better option?
Over a million Essure devices have been placed, most in the US. Since 2004, over 5,000 complaints/allegations about Essure have been made, most for pelvic/abdominal pain, bleeding irregularities, allergy/hypersensitivity or migration of the device. In September a FDA advisory panel including the manufacturer, gynecologists/women’s health care experts and patients met to evaluate theses complaints. Although no formal findings or recommendations were made the panel suggests:
- Additional patient counseling/labelling about risk,benefits and that this is a permanent implant
- Additional training for gynecologist
- Training and plan for removal (with funding) if necessary. Until recently hysterectomy was required to remove devise but a few gynecologist are removing it surgically without removal of the uterus.
- establishment of a registry see how well the devise works, true incidence of complications
- consideration of reserving Essure devise for patients who should not have a laparoscopy or general anesthesia
Essure would seem to be less expensive option (no general anesthesia required) but a recent study 44,278 laparoscopic tubals vs 8,048 Essures shows:
- Laparoscopic tubal ligation costs $5,068 vs Essure $7,832
- Re operation rate by a year after procedure is 10 xs higher for Essure (2.4%) vs laparoscopic tubals (0.2%) Most reoperations are for migration or incompatibility with Essure
- Rate of unintended pregnancy was the same
Although I have successfully placed many Essure devises, at this time I am going to reserve the Essure devise for those patients in which laparoscopic tubal ligation or general anesthesia are risky or contraindicated.