Hysteroscopic Sterilization: Counseling

1. Hysteroscopic Sterilization:Counseling “Bayer, Inc. is providing the content of this presentation to you for informational and educational purposes only.

2. Patient Selection • Unhappy with current form of birth control or contraindicated (i.e., smokers over 35, hypertensive on OCs) • OB patients pregnant with last child • Contraindicated for pregnancy or tubal ligation • Patients waiting for husband to have a vasectomy • Patients considering endometrial ablation (Essure should be done first and then ablation after HSG confirms bilateral tubal occlusion)

3. Patient Considerations • Like all methods of birth control, the Essure procedure should not be considered 100% effective • Insert placement may not be successful • NOT REVERSIBLE; knowledge of insert compatibility with IVF is limited • Placement discouraged in women undergoing immunosuppressive therapy — therapy may negatively affect tissue response that leads to tubal occlusion • Systemic corticosteroids • Chemotherapy

4. Patient Counseling • Set appropriate expectations • High placement success – small percentage unable to place • Discomfort is similar to menstrual cramps • Average procedure time 10 minutes or less –in and out of the office in 45 minutes • Return to normal activity within one day • Compliance with Essure Confirmation Test is critical • MUST USE RELIABLE CONTRACEPTION UNTIL TUBAL OCCLUSION IS DOCUMENTED ON HSG (3 MONTHS AFTER PLACEMENT)

5. Talking with the Patient

6. Essure Procedure Contraindications* • Uncertain about her desire to end her fertility • Has previously undergone a tubal ligation • Pregnant or suspected pregnancy • Delivery or termination less than 6 weeks prior • Active or recent upper or lower pelvic infection • Known allergy to contrast media** • See Essurepackaging for complete warnings/contraindications * See complete Instructions for Use in Essure packaging ** Non-iodine containing contrast medias are available

7. Optimizing Visualization • Cycle Timing • Cycle day 4-8 (Early Proliferative Phase) • Endometrial Preparation • DMPA • OCPs, Ring, Patch • Implant • LNG secreting IUD • Letrozole

8. Some Issues That Have Gotten Press • Chronic pain • Bloating/weight gain • “Extreme” Fatigue • Depression • Rash/allergy

9. Nickel Allergy? • June 2011 FDA removed nickel as a contraindication and recommendation that patients get skin testing prior to Essure • Our counseling (University of CO): • Explain to patients that nickel is usually a contact dermatitis reaction. If allergy occurs, can remove coils. • Ask if they have any reaction to buttons on jeans. • 700+ procedures1 allergy • Coils removed with hysteroscopy 8 days after placement • Symptoms resolved in <24 hours

11. Pain? • Cramping; chronic • Can’t predict • Offer removal: hysteroscopicallyvs laparoscopic bilateral salpingectomy • Laparoscopic b/l salpingectomy has benefit of sterilizing the patient • University of Colorado: • 700+ procedures3 cases where Essure implants removed secondary to complaints of pain • All symptoms resolved

12. Prior to placement/during general counseling: • Laparoscopic and Hysteroscopic Sterilization: both have risks • Lpsc: mortality1-2/10,000 from GET anesthesia • Lpsc: also involves foreign body (Filshie Clips, Falope Rings) • Explain that removal of Essure is typically a simple procedure, if it is needed for any reason • Explain how it is done • Hysteroscopically • Laparoscopically • SHOULD NOT NEED HYSTERECTOMY

13. Points to Remember • Safe; no incisions & no GET anesthesia • Effective (99.83%) • High rate of bilateral placement in one visit (96.9%) • Typically done in office; minimal recovery time • Not immediate: need 3 month HSG for confirmation • Uterine lining prep and contraception until HSG confirmation • Screen for metal/nickel allergies