Essure® technology – Proven over a decade of clinical and commercial experience
FDA approved in 2002, Essure is safe, proven over time and the most effective, permanent birth control method available. Essure is safe, with no incisions or general anesthesia needed. Essure is quick and easy, with a total hysteroscopic procedure time averaging 10 minutes or less. In fact, the Essure procedure can be performed in the doctor’s office in a few simple steps.
Using a hysteroscopic approach, the Essure insert is placed in the proximal section of each fallopian tube. Safe, physiologic saline is used for uterine distention while a hydrophilic delivery catheter facilitates tubal cannulation.
The insert is then released, expanding and acutely anchoring and conforming itself within the tubal lumen. Essure confirmation coils visually document placement of the inserts.
The mechanism of action is the body’s natural healing response which results in permanent tubal occlusion. Polyester (PET) fibers on the inner core of the insert elicit a benign tissue healing response and acts as a scaffolding into which tissue growth occurs, completely occluding the fallopian tubes in three months’ time. The tissue response has been found to be reliable and localized to the insert.
The unique benefits of this proven, effective and dependable technology are unprecedented:
- The Essure procedure has a highly successful bilateral placement rate. Multiple peer-reviewed, published studies show that successful placement of both inserts occurs in more than 19/20 procedures supporting the 96.9% labeling placement rate
- The hydrophilic delivery catheter facilitates tubal cannulation
- The Insert outer diameter starts small and expands when deployed up to 2 mm in diameter
- The exceptional properties of the outer coil allow the insert to naturally conform to variable tubal anatomy.
- In the clinical trials, 100% of patients with correct placement had occlusion
- The tubal anatomy variations in women are accounted for in the flexible, dynamic nature of the insert
- The trailing coils of the insert are easily visualized at each tubal ostium ensuring confirmation of bilateral placement within the fallopian tubes
- The 3.85 cm (1.5 inch) insert length allows placement variability while achieving successful tubal occlusion
- The Essure confirmation test confirms tubal occlusion and device placement
- The Essure procedure is the ONLY permanent birth control procedure that can verify proper device location as well as tubal occlusion.
- With a 99.74% effectiveness rate at 5 years, Essure is proven
Excellent Patient Tolerance
The Essure procedure is well tolerated under local anesthesia. On a scale of zero to 10, women rated their discomfort of undergoing Essure in the office setting with local anesthesia an average of 2.5/10 – similar to their menstrual cramps.
Minimal or no dilation reduces discomfort, allowing patients to quickly return to everyday activities. 92% of patients in the clinical trial missed one day or less of work following the day of the procedure.
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