Many women have taken to minimally invasive procedures including endometrial ablation for heavy menstrual bleeding and in-office tubal permanent sterilization procedures for contraception. Two of the most frequently used methods, Novasure endometrial ablation and Essure permanent sterilization, have posed challenges for both physicians and patients who prefer to have these procedures done. Why? Because up until April 2012, you could not have a Novasure if you had a prior Essure sterilization. However last month, the FDA lifted this restriction. In addition, the FDA also removed warnings on the Essure regarding nickel allergy of patients and stated this would not impact the ability and safety to use this device on patients.
What great news! Now patients who have undergone the Essure in-office sterilization procedure can now have the Novasure endometrial ablation technique that 97% of patients would recommend.
You might wonder why this was so controversial. When the Essure is performed for permanent sterilization, a 1 inch flexible surgical steel coil is inserted into each fallopian tube. Over 12 weeks time, the body’s way of healing scars over the coil and ends up blocking the tube making it impossible to pass liquid which is confirmed by a post-procedure test. This occurs 99.83% of the time. The Novasure ablation is performed by inserting a small probe into the uterus, which opens up into a fan-like shape and conforms to the size and shape of the uterus. Using bioelectrical impedance and radiofrequency energy, the lining of the uterus is gently cauterized. The concern was passage of energy through one/both of the coils could cause damage to the surrounding tissue. However, after extensive study the FDA has finally approved the use of the Novasure ablation in women who may have had an Essure sterilization.