1 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F Hysteroscopic Sterilization: Counseling “Bayer, Inc. is providing the content of this presentation to you for informational and educational purposes only.

2 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + 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 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + 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 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + 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 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + Talking with the Patient Instead of…Consider Using… SterilizationPermanent Birth Control Spring/coilEssure insert Non-incisionalNo cutting SurgeryProcedure New procedureFDA approved since 2002 HSGEssure Confirmation Test Scar tissueNatural barrier

6 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + 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 Essure packaging for complete warnings/contraindications *See complete Instructions for Use in Essure packaging **Non-iodine containing contrast medias are available

7 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + Optimizing Visualization Cycle Timing Cycle day 4-8 (Early Proliferative Phase) Endometrial Preparation DMPA OCPs, Ring, Patch Implant LNG secreting IUD Letrozole

8 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + Some Issues That Have Gotten Press Chronic pain Bloating/weight gain “Extreme” Fatigue Depression Rash/allergy 8

9 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + 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 procedures  1 allergy Coils removed with hysteroscopy 8 days after placement Symptoms resolved in <24 hours 9

10 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + 10

11 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + Pain? Cramping; chronic Can’t predict Offer removal: hysteroscopically vs 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 11

12 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + 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 12

13 ©2012 All rights reserved. Conceptus and Essure are registered trademarks. CC MAR12F + 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 13