Description
Essure, manufactured by Conceptus Inc., is a new method of female sterilization that uses the transcervical approach. It was approved by the US Food and Drug Administration in November 2002.
How
It Works
The Essure micro-insert consists of a stainless steel inner coil, a nitinol super-elastic outer coil, and polyethylene (PET) fibers. The coil is placed into the uterine end of the fallopian tubes using hysteroscopy technique. The micro-insert is 4 centimeters in length and 0.8 millimeters in diameter in its wound-down configuration. Essure comes with
a disposable delivery system. When released, the outer coil expands to 1.5 to 2.0 millimeters in diameter to anchor the micro-insert in the varied diameters and shapes of the fallopian tube.
The micro-insert remains anchored in the fallopian tube and results in tubal occlusion by the PET fibers, eliciting a tissue in-growth. The PET fiber mesh and the micro-insert act as scaffolding into which the tissue grows, anchoring the micro-insert within the fallopian tube and occluding the tube. The rest of the tubes remain normal. The larger diameter of the micro insert at the uterine end prevents migration of the micro-insert towards the peritoneal cavity.
Essure comes with a disposable delivery system. The system consists of a single-handed ergonomic handle containing delivery wire, release catheter, delivery catheter and micro-inserts.
Using the hysteroscopy technique, the disposable delivery system is inserted into the fallopian tube through a catheter. The catheter is withdrawn at the opening of the tubes inside the uterus, exposing the microcoil. As the guide wire is withdrawn, the device's coils expand to fit securely inside the fallopian tube. The procedure is repeated on a contra lateral tube. The PET fibers in the device's mesh core cause a moderate foreign body inflammatory reaction and extensive fibrosis, resulting in permanent occlusion of the tube in nearly all patients in 12 weeks.
Using Essure does not require any incision on the abdominal skin, and so there is no scar. The micro-inserts are inserted into the uterine cavity during hystroscopy, and no general anesthesia is required for the procedure. The procedure is completed in 30 minutes, and the client can go home 45 minutes after the procedure. Essure can be inserted in a hospital or outpatient setting. 99 percent of women expressed satisfaction up to 2 years after insertion.
Failure
Rate
In clinical trials, Essure was 99.8% effective after two years of follow-up. Women were back to their regular activities typically in 1- 2 days post procedure. Most adverse events were associated with placement of coils by the providers. 97% of women wearing the device, for up to 2 years during the clinical trials, expressed satisfaction with the method use.
Advantages
and Precautions
Essure requires a trained provider to perform the procedure. Most of the side effects and complications are related to the errors made during the insertion. Failure to correctly place the micro-inserts in the fallopian tubes may result in expulsion. It takes up to 12 weeks for the tissue in-growth to completely occlude the fallopian tubes. Women need to use a backup contraceptive method for 3 months. To confirm the tubal occlusion on both sides, a hystrosalpingogram should by done at the end of 12 weeks.
