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Hysteroscopic Sterilization:Counseling

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

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+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)

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+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

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+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)

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+Talking with the Patient

Instead of… Consider Using… Sterilization Permanent Birth ControlSpring/coil Essure insertNon-incisional No cuttingSurgery ProcedureNew procedure FDA approved since 2002HSG Essure Confirmation TestScar tissue Natural barrier

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+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

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+Optimizing Visualization

Cycle Timing Cycle day 4-8 (Early Proliferative Phase)

Endometrial Preparation DMPA OCPs, Ring, Patch Implant LNG secreting IUD Letrozole

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

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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+ procedures1 allergy Coils removed with hysteroscopy 8 days after placement Symptoms resolved in <24 hours

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10+

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11+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+ procedures3 cases where Essure implants removed secondary to complaints of pain

All symptoms resolved

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12+Prior to placement/during general counseling: Laparoscopic and Hysteroscopic Sterilization: both have

risks Lpsc: mortality1-2/10,000 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

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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