Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
THE ESSURE® OFFICE GUIDE THE ESSURE® OFFICE GUIDE A resource for providing Essure in the office setting To access and customize the most up-to-date forms, please go to EssureMDResources.com. References: 1. Cooper JM, Carignan CS, Cher D, Kerin JF; Selective Tubal Occlusion Procedure 2000 Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102(1):59-67. 2. Arjona JE, Miño M, Cordón J, Povedano B, Pelegrin B, Castelo-Branco C. Satisfaction and tolerance with office hysteroscopic tubal sterilization. Fertil Steril. 2008;90(4):1182-1186. 3. Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010;115(1):26-34. 4. Isley MM, Jensen JT, Nichols MD, Lehman A, Bednarek P, Edelman A. Intrauterine lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized controlled trial. Contraception. 2012;85(3):275-281. 5. Miño M, Arjona JE, Cordón J, Pelegrin B, Povedano B, Chacon E. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting: a prospective study of 857 women. BJOG. 2007;114(6):763-766. 6. The American College of Obstetricians and Gynecologists. Frequently asked questions: FAQ 143, special procedures. https://www.acog.org/~/ media/For%20Patients/faq143.pdf. Accessed December 9, 2013. 7. Guiahi M, Goldman KN, McElhinney MM, Olson CG. Improving hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic sterilization. Contraception. 2010;81(6):520-524. BAYER, the Bayer Cross, and Essure are registered trademarks of Bayer. © 2013 Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981 All rights reserved. 250-87-0003-13a Printed in USA December 2013 Indication Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Important Safety Information Prescription Only Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases. Who should not use Essure • Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or lower pelvic infection, or have a known allergy to contrast media. • Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing the Essure procedure. • Uterine or fallopian tube anomalies may make it difficult to place Essure inserts. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ON PAGE 3. IMPORTANT: Bayer is providing the information in this guide to you for informational and educational purposes only. This document is not intended as training materials, an all-inclusive list, nor to establish a standard of care. You are solely responsible for ensuring that you and your staff have been properly trained in all aspects of providing the Essure procedure to your patients in the office setting. For complete instructions, please refer to the Instructions for Use and Physician Training Manual. If you have any questions, please do not hesitate to contact your Clinical Sales Specialist using the business card provided. To make this process as streamlined as possible, we have created a website where you can access examples of Essure forms and customize them based on your professional judgment: EssureMDResources.com. • Example forms and letters • Reimbursement codes • Account setup and ordering The Essure Office Guide offers information and resources to help you achieve a successful practice implementation, including: You have joined a growing number of practices that have chosen to provide their patients with the Essure in-office procedure for permanent birth control. Welcome to the Essure Office Guide! Dear Doctor and Staff: Introducing the Essure® Office Guide 131806_L01_CVR.indd 1 12/18/13 9:25 PM THE ESSURE® OFFICE GUIDE THE ESSURE® OFFICE GUIDE A resource for providing Essure in the office setting To access and customize the most up-to-date forms, please go to EssureMDResources.com. Indication Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Important Safety Information Prescription Only Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases. References: 1. Cooper JM, Carignan CS, Cher D, Kerin JF; Selective Tubal Occlusion Procedure 2000 Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102(1):59-67. 2. Arjona JE, Miño M, Cordón J, Povedano B, Pelegrin B, Castelo-Branco C. Satisfaction and tolerance with office hysteroscopic tubal sterilization. Fertil Steril. 2008;90(4):1182-1186. 3. Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010;115(1):26-34. 4. Isley MM, Jensen JT, Nichols MD, Lehman A, Bednarek P, Edelman A. Intrauterine lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized controlled trial. Contraception. 2012;85(3):275-281. 5. Miño M, Arjona JE, Cordón J, Pelegrin B, Povedano B, Chacon E. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting: a prospective study of 857 women. BJOG. 2007;114(6):763-766. 6. The American College of Obstetricians and Gynecologists. Frequently asked questions: FAQ 143, special procedures. https://www.acog.org/~/ media/For%20Patients/faq143.pdf. Accessed December 9, 2013. 7. Guiahi M, Goldman KN, McElhinney MM, Olson CG. Improving hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic sterilization. Contraception. 2010;81(6):520-524. Who should not use Essure • Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or lower pelvic infection, or have a known allergy to contrast media. • Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing the Essure procedure. • Uterine or fallopian tube anomalies may make it difficult to place Essure inserts. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ON PAGE 3. BAYER, the Bayer Cross, and Essure are registered trademarks of Bayer. © 2013 Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981 All rights reserved. 250-87-0003-13a Printed in USA December 2013 IMPORTANT: Bayer is providing the information in this guide to you for informational and educational purposes only. This document is not intended as training materials, an all-inclusive list, nor to establish a standard of care. You are solely responsible for ensuring that you and your staff have been properly trained in all aspects of providing the Essure procedure to your patients in the office setting. For complete instructions, please refer to the Instructions for Use and Physician Training Manual. If you have any questions, please do not hesitate to contact your Clinical Sales Specialist using the business card provided. To make this process as streamlined as possible, we have created a website where you can access examples of Essure forms and customize them based on your professional judgment: EssureMDResources.com. • Example forms and letters • Reimbursement codes • Account setup and ordering The Essure Office Guide offers information and resources to help you achieve a successful practice implementation, including: You have joined a growing number of practices that have chosen to provide their patients with the Essure in-office procedure for permanent birth control. Welcome to the Essure Office Guide! Dear Doctor and Staff: Introducing the Essure® Office Guide 131806_L01_CVR.indd 1 12/18/13 9:25 PM Components GETTING STARTED 4 Account setup and ordering 5 Physician coding guide 9 Suggested equipment and supplies checklist 11 Vendor listing 14 Reprocessing hysteroscopic equipment PRE-PROCEDURE 15 Patient selection and scheduling 16 Patient scheduling form (example) 17 Patient pre-procedure letter (example) PROCEDURE 18 Consent form (example) 19 Patient comfort 21 Pre-procedure nursing form (example) 22 Placement steps POST-PROCEDURE 131806_L01_TXT.indd 2 24 Post-procedure nursing form (example) 25 Procedure note (example) 26 Post-procedure instructions (example) 27 Essure Confirmation Test overview 28 Essure Confirmation Test checklist (example) 29 Essure Confirmation Test reminder letter (example) 30 Essure Confirmation Test missed appointment letter (example) 12/18/13 9:47 PM Important Safety Information (continued) Pregnancy Considerations • The Essure® procedure should be considered irreversible. Patients should not rely on Essure inserts for contraception until an Essure Confirmation Test [modified hysterosalpingogram (HSG)] demonstrates bilateral tubal occlusion and satisfactory location of inserts. • Effectiveness rates for the Essure procedure are based on patients who had bilateral placement. If Essure inserts cannot be placed bilaterally, then the patient should not rely on Essure inserts for contraception. • Effects, including risks, of Essure inserts on in vitro fertilization (IVF) have not been evaluated. • Pregnancies (including ectopic pregnancies) have been reported among women with Essure inserts in place. Some of these pregnancies were due to patient non-compliance or incorrect clinician interpretation of the Essure Confirmation Test (modified HSG). Procedural Considerations • Perform the Essure procedure during early proliferative phase of the menstrual cycle. Terminate procedure if distension fluid deficit exceeds 1500cc or hysteroscopic time exceeds 20 minutes as it may signal uterine or tubal perforation. Never attempt to advance Essure insert(s) against excessive resistance. If tubal or uterine perforation occurs or is suspected, discontinue procedure and work-up patient for possible complications related to perforation, including hypervolemia. Do not attempt hysteroscopic Essure insert removal once placed unless 18 or more trailing coils are seen inside the uterine cavity due to risk of fractured insert, fallopian tube perforation or other injury. • DO NOT perform the Essure procedure concomitantly with endometrial ablation. Avoid electrosurgery on uterine cornua and proximal fallopian tubes without visualizing inserts. Nickel Allergy Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. In addition, some patients may develop an allergy to nickel if this device is implanted. Typical allergy symptoms reported for this device include rash, pruritus, and hives. MRI Information The Essure insert was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05. Clinical Trial Experience • Safety and effectiveness of Essure is not established in patients under 21 or over 45 years old, nor in patients who delivered or terminated a pregnancy less than 8-12 weeks before procedure. Women undergoing sterilization at a younger age are at greater risk of regretting their decision. • The most common (≥10%) adverse events resulting from the placement procedure were cramping, pain, and nausea/vomiting. The most common adverse events (≥3%) in the first year of reliance were back pain, abdominal pain, and dyspareunia. This product does not protect against HIV infection or other sexually transmitted diseases. 3 131806_L01_TXT.indd 3 12/18/13 9:47 PM Account Setup and Ordering PHONE: 855-406-2861 EMAIL: [email protected] FAX: 888-281-8199 FOR OUR NEW CUSTOMERS • Shipping/billing address (including facility name) • Name of certified/trained Essure® provider and date of certification or scheduled training • Facility license, in-house pharmacy license, or provider license* • Letter of Affiliation form† • Copy of resale certificate or Department of Revenue letter proving tax exemption (if applicable) FOR OUR EXISTING CUSTOMERS • Facility license, in-house pharmacy license, or provider license* • Letter of Affiliation form† • Copy of resale certificate or Department of Revenue letter proving tax exemption (if applicable) • Shipping is FREE • Orders received prior to 3:30 PM ET will ship the SAME DAY, unless otherwise requested • Standard delivery is 2 business days; expedited delivery may be available upon request A FACILITY LICENSE, IN-HOUSE PHARMACY LICENSE, OR PROVIDER LICENSE IS REQUIRED FOR SHIPPING *Once the license is on file, it is not necessary to provide another copy until the license has expired. †For all states except Florida, a Letter of Affiliation form is needed if there is not an address on the license or if the address on the license does not match the shipping location. Please note that some offices are slow to return this document. Due to the E-Pedigree law in the state of Florida, Florida customers must submit their HCCE permit or the Declaration of Intent Letter before orders can be released. GETTING STARTED 131806_L01_TXT.indd 4 4 12/18/13 9:47 PM Physician Coding Guide Accurate diagnosis, procedure, and product coding are essential to help ensure prompt claims processing and reimbursement. Using the correct and specific codes is critical. Most payers, public and private, utilize coding systems developed by the Centers for Medicare & Medicaid Services (CMS). Healthcare providers are responsible for selecting the appropriate codes used in filing a claim. Codes should be based on the patient’s diagnosis and the items and services furnished by the provider. GLOBAL FEE There are multiple necessary services done by a healthcare provider when performing a procedure. These services are said to be billed/paid “globally”—sometimes referred to as the global/surgical package. The global/surgical package also includes a global period: a set number of days during the post-operative period. The global period is usually 90 days for major procedures and 0-10 days for minor procedures. Therefore, all follow-up care, including the treatment of complications, is included in the global period and cannot be billed separately. Because the Instructions for Use states that a hysterosalpingogram is a required part of the Essure® procedure, it is considered typical and usual, and will not be paid separately if it is performed within the 90-day global period of the Essure procedure. IMPORTANT: The information in this guide is for informational purposes and does not guarantee payment or coverage. Offices should research coding, coverage, and payment for individual patients prior to initiating treatment since policies and guidelines vary by payer and health plan. Offices are responsible for submitting accurate, complete, and appropriate claims to payers and for compliance with any obligations required by law, contract, or otherwise. GETTING STARTED 131806_L01_TXT.indd 5 5 12/18/13 9:47 PM Physician Coding Guide (cont'd) ESSURE PROCEDURE CODING Current Procedural Terminology (CPT®) Fourth Edition* codes CPT-4 is a listing of descriptive terms and codes for reporting services and procedures performed by healthcare providers. The following code may be used to report procedures associated with Essure: Product/Service CPT Code Code Description Essure procedure 58565 Hysteroscopy, surgical; with bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants Healthcare Common Procedure Coding System (HCPCS) codes Level II HCPCS codes are published and updated annually by CMS. These alphanumeric codes are used to report drugs, supplies, and services. Please note that Medicare does not allow for separate reporting and billing of the permanent implantable contraception. Private payers and Medicaid will make their own determination on whether or not to use the HCPCS code. Please confirm with your payer that A4264 is allowed for billing and will be paid. The HCPCS code used by facilities and some Medicaid plans to report Essure is: Product/Service HCPCS Code Code Description Essure A4264 Permanent implantable contraceptive intratubal occlusion device(s) and delivery system ICD-9 diagnosis codes The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes are used to classify diagnoses and conditions, and support medical necessity for specific procedures and services. They are used to indicate the reason for performing a given procedure and may be used by payers to determine coverage. The following ICD-9-CM codes may be applicable to women who receive Essure: ICD-9-CM Code Code Description V25.2 Encounter for contraceptive management; sterilization *CPT codes, descriptions, and other data only are copyright 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association (AMA). (continued on next page) GETTING STARTED 131806_L01_TXT.indd 6 6 12/18/13 9:47 PM Physician Coding Guide (cont'd) ESSURE® CONFIRMATION TEST CODING Current Procedural Terminology (CPT®) Fourth Edition* codes Product/Service CPT Code Code Description Modified HSG 58340 Catheterization and introduction of saline or contrast material for saline infusion sonohysterography (SIS) or hysterosalpingography (HSG) Modified HSG, interpretation and supervision 74740 HSG, radiologic supervision and interpretation Modified HSG, interpretation 74740-26 Professional component only Modified HSG, supervision 74740-TC Technical component only ICD-9 diagnosis codes These codes must be used together and in this order: ICD-9-CM Code Code Description V67.09 Follow-up examination following other surgery V26.51 Tubal ligation status The following code may be used to identify the Essure Confirmation Test as a preventive service: ICD-9-CM Code Code Description V25.8 Other specified contraceptive management *CPT codes, descriptions, and other data only are copyright 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the AMA. IMPORTANT: The information in this guide is for informational purposes and does not guarantee payment or coverage. Offices should research coding, coverage, and payment for individual patients prior to initiating treatment since policies and guidelines vary by payer and health plan. Offices are responsible for submitting accurate, complete, and appropriate claims to payers and for compliance with any obligations required by law, contract, or otherwise. GETTING STARTED 131806_L01_TXT.indd 7 7 12/18/13 9:47 PM Physician Coding Guide (cont'd) MODIFIERS Preventive services CPT Modifier 33 is applicable for the identification of preventive services without cost sharing and may be added to the following codes as shown below. Product/Service CPT Code Code Description Essure procedure 58565-33 Hysteroscopy, surgical; with bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants Modified HSG 58340-33 Catheterization and introduction of saline or contrast material for SIS or HSG Note: Not all commercial payers will require the use of Modifier 33. Some will automatically process Essure and the Essure Confirmation Test without patient cost sharing. Incomplete procedure In some cases, the Essure procedure is initiated but cannot be completed. In these cases, it may be appropriate to bill within Modifier 52 or 53 as described below. Product/Service CPT Code Code Description Essure procedure, reduced services 58565-52 This modifier is used to report a service or procedure that is partially reduced or eliminated at the physician’s election. An example of the correct use of Modifier 52 would be a failure of placement on one side, resulting in unilateral placement of Essure. Essure procedure, discontinued 58565-53 This modifier is used to report a procedure that is discontinued by the physician because of extenuating circumstances. Modifier 53 can only be used after anesthesia has been administered. An example of the correct use of Modifier 53 would be an Essure procedure being discontinued because the ostium of the fallopian tube is not visible. LOCAL CODING Some state Medicaid programs may require the use of state-specific coding. Providers should research Medicaid coding guidelines on a state-specific basis. To access state Medicaid reimbursement information, please go to EssureMDResources.com. 131806_L01_TXT.indd 8 GETTING STARTED 8 12/18/13 9:47 PM Suggested Equipment and Supplies Checklist ESSURE® PROCEDURE SETUP Review the following checklist to help make sure you have what you need to begin the Essure procedure. EQUIPMENT AND SUPPLIES CHECKLIST General £ Urine pregnancy test £ Under-buttocks pouch drape £ Leg drapes £ Drape sheet (optional) £ Essure kit —Do not open until ostia have been visualized —Have a back-up kit available Essure procedure tray/Mayo stand £ 2 sterile field drapes (one to cover tray until needed) £ Sterile single-hinged (open-sided) speculum £ Sterile gloves £ Sterile tenaculum £ Sterile ring forceps £ Sterile 4" ⫻ 4" £ Sterile cervical dilators (small sizes) Paracervical block supply items (optional) £ Sterile speculum—warmed if possible £ Sterile tenaculum £ Supplies to clean off cervix (ie, antibacterial swabs or antibacterial solution in a specimen cup with 4" ⫻ 4") £ 18G needle for drawing up local anesthetic agent—1 or 1.5 inch £ 22G 1.5-inch needle £ 6-inch-long needle extender £ Sterile control syringe £ Local anesthetic, per physician GETTING STARTED 131806_L01_TXT.indd 9 9 12/18/13 9:47 PM Suggested Equipment and Supplies Checklist (cont'd) Hysteroscopy equipment £ Sterile 12- or 30-degree hysteroscope with a ≥5 French operating channel £ Sterile sealing cap for instrument port £ Camera (white balance; use sterile drape if camera is not sterile) £ Sterile light cord £ Sterile inflow tubing £ Sterile outflow tubing £ Warm, normal saline bag (preferably 3 liters) £ Pressure bag or cuff for saline infusion Have available £ Hysteroscopic grasper IMPORTANT: Bayer is providing the information in this guide to you for informational and educational purposes only. This document is not intended as training materials, an all-inclusive list, nor to establish a standard of care. You are solely responsible for ensuring that you and your staff have been properly trained in all aspects of providing the Essure procedure to your patients in the office setting. For complete instructions, please refer to the Instructions for Use and Physician Training Manual. GETTING STARTED 131806_L01_TXT.indd 10 10 12/18/13 9:47 PM Vendor Listing Although the majority of supplies for the Essure® procedure may already be available in your practice, there are several items you may need to order. Please contact the vendor for the most up-to-date pricing, order numbers, and availability. MEDICAL OFFICE RESOURCES (MOR) HYSTEROSCOPIC STERILIZATION PACKS Pre-assembled, sterile trays designed specifically for Essure office procedures. Tel: 419-367-8249 Website: http://www.medofficeresources.com/essu001.htm Product #ESSU001 Product #ESSU006 Prep tray components: 1 tray, 2 compartments 1 gloves, exam LG 12 oz Betadine solution 20 gauze, 4 x 4 12 ply 4 swab 8" 1 wrap 30 x 30 Prep tray components: 1 tray, 2 compartments 1 gloves, exam LG 12 oz Betadine solution 15 gauze, 4 x 4 12 ply 4 swab 8" 1 wrap 30 x 30 Pack components: 1 back table cover 2 10-cc control syringes L/L 1 needle, spinal 22G x 3.5 1 pad, prep alcohol 1 large-bore cystoscopy tubing set 1 tubing suction 1 gown, XLG 1 drape, camera 1 needle, 18G x 1.5 short 1 drape, under-buttocks 40 x 44 w/pouch 1 Lidocaine® 1% HCl 20 mL 1 17" x 11" x 2.5" platform tray 3 towels OR blue 17" x 26" 1 label, 3 3/8" x 2 1/3" 1 label, custom kit 1 bag, header 19 x 24 Pack components: 1 back table cover 2 10 cc control syringes L/L 1 needle, spinal 22G x 3.5 1 pad, prep alcohol 1 large-bore cystoscopy tubing set 1 tubing suction 1 drape, camera 1 drape, under-buttocks 40 x 44 w/pouch 3 towels OR blue 17" x 26" 1 label, 3 3/8" x 2 1/3" 1 label, custom kit 1 bag, header 19 x 24 1 17" x 11" x 2.5" platform tray GETTING STARTED 131806_L01_TXT.indd 11 11 12/18/13 9:47 PM Vendor Listing (cont'd) OBP MEDICAL OFFICEPACK HYSTEROSCOPY KIT Pre-assembled sterile kits for use in office hysteroscopy. Tel: 1-888-300-2946 Website: www.obpmedical.com Product #C040101 OfficePACK Hysteroscopy Kit includes: 1 disposable Mayo tray 1 Mayo tray drape 2 plastic cotton tips 15 gauze 100 x 100 mm 1 surgical lubricant, 3 g 1 povidone iodine solution w/ plastic cotton tips 1 alcohol prep pad 2 control syringes, 10 mL 1 hypodermic needle 18G 1 spinal needle 22G 1 sanitary paper 1 OR towel 1 cysto irrigation set in-flow w/ Luer lock 1 OutflowBAG drainage collection bag w/ tubing & Luer lock 2 pair gloves 1 OfficeSPEC disposable side-opening speculum w/ light 1 endoscopic seal GYN 1-size-fits-all w/ Luer lock 1 item tray 1 under-buttocks drape w/ graded collection bag LARGE-BORE INFLOW/OUTFLOW TUBING Baxter Healthcare Corporation Tel: 1-800-933-0303 Saline 3000cc bags; cat #2B7126 Cysto/Bladder Irrigation set; cat #2C4040 Hospira Inc. Address: Lake Forest, IL 60045 TUR Y-Set; cat #6543-01 McKesson Irrigation set/cysto; cat #208806 (continued on next page) GETTING STARTED 131806_L01_TXT.indd 12 12 12/18/13 9:47 PM Vendor Listing (cont'd) SUCTION TUBING Cardinal Health Tel: 1-800-964-5227 Suction tubing for outflow; cat #N56A 3/16" CONMED Tel: 1-315-797-8375 Website: www.conmed.com Suction tubing, 10 feet, 3/16''; ref #0036770 Kendall Tyco/Healthcare Tel: 1-800-962-9888 Argyle non-conductive connecting tubing, 3/16" x 6'; cat #284513 UNDER-BUTTOCKS DRAPES 3M Tel: 1-800-228-3957 Fluid pouch 3M Steri-Drape; cat #1016 Mölnlycke Healthcare Website: www.molnlycke.com/us/ Under-buttocks drape with pouch, latex free; ref #229 Allegiance Address: McGaw Park, IL 60085 Under-buttocks drape with fluid control; pouch II; cat #8482 Medline Tel: 1-800-MEDLINE (633-5463) Proxima under-buttocks drape with pouch and drainage port; re-order #DYNJP6002 Gyrus ACMI Tel: 1-888-524-7266 DISTEN-U-FLO fluid management system (set includes under-buttocks drape and outflow tubing); ref #GY5-TUB McKesson Under-buttocks drape; #314027 CAMERA DRAPES McKesson Camera drape; arthroscopy covers; part #577706 GETTING STARTED 131806_L01_TXT.indd 13 13 12/18/13 9:47 PM Reprocessing Hysteroscopic Equipment It is important to establish a protocol for reprocessing your hysteroscopy equipment. Refer to the manufacturer’s Instructions for Use for recommended guidelines for your particular hysteroscope and/or accessory. The following contacts are provided for your convenience: Richard Wolf Medical Instruments Tel: 1-800-323-9653 Website: www.richardwolfusa.com Karl Storz Endoscopy Tel: 1-800-421-0837 Website: www.karlstorz.com Olympus Tel: 1-800-848-9024 Website: www.olympusamerica.com/msg_section/msg_ask.asp Gyrus ACMI, an Olympus Company Tel: 1-888-524-7266 Website: www.olympusamerica.com/msg_section/msg_ask.asp GETTING STARTED 131806_L01_TXT.indd 14 14 12/18/13 9:47 PM Patient Selection and Scheduling PATIENT SELECTION Indications for use The Essure® system is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Contraindications for use The Essure Permanent Birth Control System should not be used in those patients: • Unsure about desire to end fertility • In whom only one insert can be placed (including proximal tubal occlusion [PTO] and unicornuate uterus) • Who have previously undergone a tubal ligation Or any patient with any of the following conditions: • Pregnancy or suspected pregnancy • Delivery or termination of a pregnancy (<6 weeks before placement) • Active or recent upper or lower pelvic infection • Known allergy to contrast media PATIENT SCHEDULING Insert placement should be performed during the early proliferative phase of the menstrual cycle to: • Decrease potential for insert placement in a patient with an undiagnosed (luteal phase) pregnancy • Enhance visualization of the fallopian tube ostia In women with menstrual cycles shorter than 28 days, the day of ovulation must be carefully calculated to reduce the potential of a luteal phase pregnancy. Insert placement should NOT be performed during menstruation. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ON PAGE 3. IMPORTANT: Bayer is providing the information in this guide to you for informational and educational purposes only. This document is not intended as training materials, an all-inclusive list, nor to establish a standard of care. You are solely responsible for ensuring that you and your staff have been properly trained in all aspects of providing the Essure procedure to your patients in the office setting. For complete instructions, please refer to the Instructions for Use and Physician Training Manual. PRE-PROCEDURE 131806_L01_TXT.indd 15 15 12/18/13 9:47 PM Patient Scheduling Form (Example) To access and customize this form, please go to EssureMDResources.com. This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment. ESSURE® PROCEDURE SCHEDULING (EXAMPLE) Patient name: Allergies: NSAID allergy: Contrast media (dye) allergy: Current form of birth control (to be continued until insert location and tubal occlusion verification by the Essure Confirmation Test): Last menstrual period: The Essure procedure should be performed during the early proliferative phase for most women. If less than a 28-day cycle is occurring, consideration should be given for timing of the procedure. Date scheduled: Insurance: E L P M A X E Insurance reimbursement amount for procedure: Insurance reimbursement amount for the Essure Confirmation Test: Total patient financial responsibility (includes co-pay, deductible, non-covered services): rvices Did you remember to: Give the Patient Information Booklet, patient pre-procedure letter, ter, and any prescriptions to the patient? pa ܆Yes ܆No Prescriptions (please list): Prescriptions provided to (please checkk one): one ܆Patient ܆Pharmacy Pharma If pharmacy, please provide pharmacy armacy name: Order a urine pregnancy test to be completed within 24 hours before the procedure? ܆Yes ܆No Inform the patient of the e need for alternative contraception contraceptio until insert location and tubal occlusion verification by the Essure Confirmation tion Test? ܆Yes ܆No o Provide the location (office, surgery center, or hospital)? ܆Yes ܆No e patient with the procedure locati Inform the patient atient of the potential need for transportation to/from procedure? ܆Yes ܆No Inform the patient responsibility? ܆Yes ܆No ent of her financial finan Indication Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Important Safety Information Prescription Only Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases. Who should not use Essure x Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or lower pelvic infection, or have a known allergy to contrast media. x Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing the Essure procedure. x Uterine or fallopian tube anomalies may make it difficult to place Essure inserts. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE. PRE-PROCEDURE 131806_L01_TXT.indd 16 16 12/18/13 9:47 PM Patient Pre-Procedure Letter (Example) To access and customize this form, please go to EssureMDResources.com. 7KLVIRUPLVDQH[DPSOH<RXVKRXOGUHYLHZDQGPRGLI\WKLVIRUPDV\RXGHHPDSSURSULDWHEDVHGRQ\RXUSURIHVVLRQDOMXGJPHQW 3$7,(1735(352&('85(/(77(5(;$03/( 'DWH 3DWLHQW1DPH $GGUHVV 'HDU <RXDUHVFKHGXOHGIRUWKH(VVXUHSHUPDQHQWELUWKFRQWUROSURFHGXUHRQ 7LPHRISURFHGXUH 3OHDVHDUULYHDWWKHRIILFHPLQXWHVSULRUWR\RXUSURFHGXUH <RXPD\EHUHTXLUHGWRWDNHPHGLFDWLRQEHIRUHDQGDIWHUWKHSURFHGXUH E L P M A X E 0HGLFDWLRQ'RVLQJLQVWUXFWLRQV 3UHVFULSWLRQKDVEHHQ܆SURYLGHG܆FDOOHGLQWRSKDUPDF\ QV 0HGLFDWLRQ'RVLQJLQVWUXFWLRQV 3UHVFULSWLRQKDVEHHQ܆SURYLGHG܆FDOOHGLQWRSKDUPDF\ QVWUXFWLRQV 0HGLFDWLRQ'RVLQJLQVWUXFWLRQV PDF\ 3UHVFULSWLRQKDVEHHQ܆SURYLGHG܆FDOOHGLQWRSKDUPDF\ 3KDUPDF\SKRQHQX 3KDUPDF\QDPH3KDUPDF\SKRQHQXPEHU HD /LTXLGVRQO\ 1RWKL 3ULRUWRWKHSURFHGXUH(܆DWOLJKWPHDO܆/LTXLGVRQO\܆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x <RXFDQUHO\RQ(VVXUHIRUELUWKFRQWURORQO\DIWHU\RXUGRFWRUKDVUHYLHZHG\RXU(VVXUH&RQILUPDWLRQ7HVWUHVXOWV<RXUGRFWRUZLOO FRQILUPWKDWWKHLQVHUWVDUHSURSHUO\SODFHGDQGERWKRI\RXUIDOORSLDQWXEHVDUHEORFNHG,I\RXUHO\RQ(VVXUHIRUELUWKFRQWUROEHIRUH KDYLQJ\RXU(VVXUH&RQILUPDWLRQ7HVW\RXDUHDWULVNRIJHWWLQJSUHJQDQW x 7DONWR\RXUGRFWRUDERXWZKLFKPHWKRGRIELUWKFRQWURO\RXVKRXOGXVHIRUWKHPRQWKVDIWHUWKHSURFHGXUH6RPHZRPHQFDQUHPDLQ RQWKHLUFXUUHQWELUWKFRQWURO2WKHUZRPHQVXFKDVWKRVHXVLQJDQLQWUDXWHULQHGHYLFHRUFRQWUDFHSWLYH,8'RU,8&ZLOOQHHGWR VZLWFKWRDQRWKHUPHWKRG x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indd 17 17 12/18/13 9:47 PM Consent Form (Example) To access and customize this form, please go to EssureMDResources.com. 7KLVIRUPLVDQH[DPSOH<RXVKRXOGUHYLHZDQGPRGLI\WKLVIRUPDV\RXGHHPDSSURSULDWHEDVHGRQ\RXUSURIHVVLRQDOMXGJPHQW (6685(352&('85(&216(17)250(;$03/( x ,XQGHUVWDQGWKDWWKH(VVXUHSURFHGXUHLQYROYHVSODFLQJDQLQVHUWLQWRHDFKIDOORSLDQWXEHZKLFKRYHUWLPHFDXVHVWKHWXEHVWRFORVH WKHUHE\SUHYHQWLQJSUHJQDQF\ x ,XQGHUVWDQGWKDW,VKRXOGQRWKDYHWKH(VVXUHSURFHGXUHLI,KDYHGHOLYHUHGRUWHUPLQDWHGDSUHJQDQF\OHVVWKDQZHHNVDJRRUKDYH DUHFHQWSHOYLFLQIHFWLRQ x ,XQGHUVWDQGWKDWWKH(VVXUHSURFHGXUHLVFRQVLGHUHGWREHSHUPDQHQWDQGLUUHYHUVLEOH x ,XQGHUVWDQGWKDWVRPHZRPHQPD\QRWKDYHVXFFHVVIXOSODFHPHQWRIERWK(VVXUHLQVHUWVDQGVKRXOGWKLVRFFXU,ZLOOQHHGDQRWKHU IRUPRIELUWKFRQWURO x ,XQGHUVWDQGWKDWQRELUWKFRQWUROPHWKRGLVHIIHFWLYHDQGWKDWWKH(VVXUHSHUPDQHQWELUWKFRQWUROSURFHGXUHLVHIIHFWLYH LQSUHYHQWLQJSUHJQDQF\LQZRPHQZKRKDGVXFFHVVIXOSODFHPHQWLQHDFKIDOORSLDQWXEHDVFRQILUPHGE\WKH(VVXUH&RQILUPDWLRQ 7HVW x ,XQGHUVWDQGWKDW,FDQUHO\RQ(VVXUHDVELUWKFRQWURORQO\DIWHUWKH(VVXUH&RQILUPDWLRQ7HVWKDVEHHQSHUIRUPHGPRQWKVIROORZLQJ WKHSURFHGXUH'XULQJWKLVWHVWDFRQWUDVWPHGLDG\HDQG[UD\ZLOOEHXVHGWRVKRZWKDWP\IDOORSLDQWXEHVDUHEORFNHGDQGWKDWWKH DUH LQVHUWVDUHLQWKHFRUUHFWORFDWLRQ E L x ,XQGHUVWDQGWKDWXQWLOWKH(VVXUH&RQILUPDWLRQ7HVWKDVFRQILUPHGP\IDOORSLDQWXEHVDUHEORFNHGDQGWKHLQVHUWVDUHLQWKHFRUUHFW QGWKHLQVHUWVD SODFHDQRWKHUIRUPRIELUWKFRQWUROPXVWEHXVHG x ,XQGHUVWDQGWKDWVKRXOG,EHFRPHSUHJQDQW,VKRXOGLPPHGLDWHO\VHHNPHGLFDOFDUHIRUHYDOXDWLRQRIWKHSUHJQDQF\ UHYDOXDWLRQRIWKHSUHJQDQF\ x ,XQGHUVWDQGWKDW(VVXUHGRHVQRWSURWHFWDJDLQVWVH[XDOO\WUDQVPLWWHGLQIHFWLRQVDQGWKDWEDUULHUPHWKRGVVXFKDVFRQGRPVVKRXOGEH QVDQGWKDWEDUULHUPHWKRGVVXFKDVF P M XVHGIRUSURWHFWLRQDJDLQVWVH[XDOO\WUDQVPLWWHGLQIHFWLRQV x ,XQGHUVWDQGWKDWWKHULVNVDVVRFLDWHGZLWKWKHSODFHPHQWRIWKH(VVXUHLQVHUWVLQFOXGHEXWDUHQRWOLPLWHGWRSDLQEOHHGLQJLQIHFWLRQ VXUHLQVHUWVLQFOXGHEXWDUHQRWOLPLWH SHUIRUDWLRQH[SXOVLRQSRVVLEOHDOOHUJLFUHDFWLRQ x ,XQGHUVWDQGWKDWSDWLHQWVWKDWDUHDOOHUJLFWRQLFNHOPD\KDYHDQDOOHUJLFUHDFWLRQWRWKLVGHYLFHHVSHFLDOO\WKRVHZLWKDKLVWRU\RI KDYHDQDOOHUJLFUHDFWLRQWRWK QDOOHUJ\WRQLFNHOLIWKLVGHYL PHWDODOOHUJLHV,QDGGLWLRQVRPHSDWLHQWVPD\GHYHORSDQDOOHUJ\WRQLFNHOLIWKLVGHYLFHLVLPSODQWHG x ,KDYHUHFHLYHGDQGUHYLHZHGWKH3DWLHQW,QIRUPDWLRQ%RRNOHWDQGXQGHUVWDQGWKHULVNVDVVRFLDWHGZLWKWKH(VVXUHSURFHGXUH RUPDWLRQ%RRNOHWDQG QGHUVWDQGW A X E x ,DPQRWDOOHUJLFWRFRQWUDVWPHGLDG\H DG\ x ,KDYHEHHQFRXQVHOHGRQDOWHUQDWLYHVWR(VVXUHLQFOXGLQJVXUJLFDOIHPDOHVWHULOL]DWLRQPDOHVWHULOL]DWLRQRWKHUIRUPVRIELUWKFRQWURO DOWHUQDWLYHVWR(VVXUHLQFOXGLQJVX x ,KDYHKDGWKHRSSRUWXQLW\WRDVNTXHVWLRQVUHJDUGLQJWKH(VVXUHSHUPDQHQWELUWKFRQWUROSURFHGXUHDQGZLOOSURFHHGZLWKWKH SRUWXQLW\WRDVNTXHVWLRQVUHJDUG SODFHPHQWRIWKH(VVXUHLQVHUWV WKH(VVXUHLQVHUWV 6LJQDWXUH 'DWH7LPH :LWQHVV ,QGLFDWLRQ (VVXUHLVDSHUPDQHQWELUWKFRQWUROSURFHGXUHWKDWZRUNVZLWK\RXUERG\WRFUHDWHDQDWXUDOEDUULHUDJDLQVWSUHJQDQF\ 'DWH ,PSRUWDQW6DIHW\,QIRUPDWLRQ :$51,1*<RXPXVWFRQWLQXHWRXVHDQRWKHUIRUPRIELUWKFRQWUROXQWLO\RXKDYH\RXU(VVXUH&RQILUPDWLRQ7HVWDQG\RXU GRFWRUWHOOV\RXWKDW\RXFDQUHO\RQ(VVXUHIRUELUWKFRQWURO x <RXFDQUHO\RQ(VVXUHIRUELUWKFRQWURORQO\DIWHU\RXUGRFWRUKDVUHYLHZHG\RXU(VVXUH&RQILUPDWLRQ7HVWUHVXOWV<RXUGRFWRUZLOO FRQILUPWKDWWKHLQVHUWVDUHSURSHUO\SODFHGDQGERWKRI\RXUIDOORSLDQWXEHVDUHEORFNHG,I\RXUHO\RQ(VVXUHIRUELUWKFRQWUROEHIRUH KDYLQJ\RXU(VVXUH&RQILUPDWLRQ7HVW\RXDUHDWULVNRIJHWWLQJSUHJQDQW x 7DONWR\RXUGRFWRUDERXWZKLFKPHWKRGRIELUWKFRQWURO\RXVKRXOGXVHIRUWKHPRQWKVDIWHUWKHSURFHGXUH6RPHZRPHQFDQUHPDLQ RQWKHLUFXUUHQWELUWKFRQWURO2WKHUZRPHQVXFKDVWKRVHXVLQJDQLQWUDXWHULQHGHYLFHRUFRQWUDFHSWLYH,8'RU,8&ZLOOQHHGWR VZLWFKWRDQRWKHUPHWKRG x ,WFDQWDNHORQJHUWKDQWKUHHPRQWKVIRUWKH(VVXUHSURFHGXUHWREHHIIHFWLYH,QUDUHFDVHVLWKDVWDNHQXSWRPRQWKV0DNHVXUHWR FRQWLQXHXVLQJDQDOWHUQDWHIRUPRIELUWKFRQWUROXSXQWLO\RXUGRFWRUKDVUHYLHZHG\RXU(VVXUH&RQILUPDWLRQ7HVWUHVXOWVDQG FRQILUPHGWKDW\RXFDQUHO\RQ(VVXUHIRUELUWKFRQWURO :$51,1*%HVXUH\RXDUHGRQHKDYLQJFKLOGUHQEHIRUH\RXXQGHUJRWKH(VVXUHSURFHGXUH(VVXUHLVDSHUPDQHQWPHWKRGRI ELUWKFRQWURO7KH\RXQJHUDZRPDQLVZKHQVKHFKRRVHVWRHQGKHUIHUWLOLW\WKHPRUHOLNHO\VKHLVWRUHJUHWKHUFKRLFHODWHU 3/($6(6(($'',7,21$/,03257$176$)(7<,1)250$7,21$%287(6685(211(;73$*( PROCEDURE 131806_L01_TXT.indd 18 18 12/18/13 9:47 PM Patient Comfort Patient comfort is an important part of a successful Essure® placement. Recommended anesthesia options for the Essure procedure include: £ NSAIDs 1-2 hours pre-procedure £ Anxiolytic 30 minutes pre-procedure £ Paracervical block with or without IV sedation An NSAID given prior to the procedure has been shown to increase the likelihood of bilateral placement success in clinical trials. IN THE ESSURE PIVOTAL TRIAL NSAIDs were administered prior to the procedure1 £ In 84% of 544 procedures, patients received pre-operative NSAIDs1 PREDOMINANT ANESTHESIA USED1 n Percent Local anesthesia 283 52.0% IV sedation and/or analgesia 222 40.8% None* 38 7.0% 1 0.2% 544 100% General anesthesia Total *Other than pre-operative oral nonsteroidal anti-inflammatory drug (NSAID). RECOVERY ROOM MEDICATION1 75% of patients required no pain medication in the recovery room Ensure that office staff members are properly trained and that emergency equipment is on hand in accordance with the level of anesthesia selected and pursuant to any state requirements. PROCEDURE 131806_L01_TXT.indd 19 19 12/18/13 9:47 PM Patient Comfort (cont'd) SUMMARY OF LITERATURE FOR PAIN MANAGEMENT DURING HYSTEROSCOPIC STERILIZATION PROCEDURES Publication Arjona J. Satisfaction and tolerance with office hysteroscopic tubal sterilization. Fertility and Sterility. 2008.2 Chudnoff S. Paracervical block efficacy in office hysteroscopic sterilization. Obstetrics and Gynecology. 2010.3 Isley MM. Intrauterine lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized controlled trial. Contraception. 2012.4 Miño M. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting: a prospective study of 857 women. BJOG. 2007.5 Trial design Prospective analysis of case series N=1630 Double-blind, randomized, placebocontrolled trial N=80 NSAID Local anesthesia Sedation Anxiolytic Ibuprofen 600 mg Benzodiazepine 10 mg 1 hour pre-procedure 1 hour pre-procedure Ketorolac 60 mg IM immediately before procedure Randomized, double-blind, placebocontrolled trial Ibuprofen 800 mg PO N=58 30-45 min pre-procedure Paracervical block with 1% lidocaine at 12:00, 4:00, and 8:00 Paracervical block with buffered 1% lidocaine, at the tenaculum site, at 4:00, and 8:00 Lorazepam 2 mg PO 30-45 minutes pre-procedure 5 mL 4% intrauterine lidocaine† Prospective, single-center cohort N=857 Ibuprofen 600 mg 1 hour pre-procedure 50.5% of patients received paracervical block with mepivacaine cloridrate 3% Diazepam 10 mg 1 hour pre-procedure †Did not significantly reduce pain. Note: This selection of literature is not intended to be a comprehensive list, nor provide a conclusive approach to pain management, but rather, a range of examples. PROCEDURE 131806_L01_TXT.indd 20 20 12/18/13 9:47 PM Pre-Procedure Nursing Form (Example) To access and customize this form, please go to EssureMDResources.com. This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment. ESSURE® PRE-PROCEDURE NURSING FORM (EXAMPLE) Date of procedure: Patient name: Last menstrual period: Current birth control: Birth control to be used between Essure procedure and Essure Confirmation Test: Birth control prescription given? ܆Yes ܆No Results of urine pregnancy test (within 24 hours): BP: E L P M A X E Pulse: Temp: Medications taken today: NSAID given? Other? Time: Time: Time: When did patient last eat or drink? What did she eat or drink? Consent signed and witnessed? nessed? ܆Yes ܆No Physician reviewed viewed and answered patient questions? ܆Yes ܆No Indication Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Important Safety Information Prescription Only Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases. Who should not use Essure x Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or lower pelvic infection, or have a known allergy to contrast media. x Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing the Essure procedure. x Uterine or fallopian tube anomalies may make it difficult to place Essure inserts. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE. PROCEDURE 131806_L01_TXT.indd 21 21 12/18/13 9:47 PM Placement Steps INTRODUCE Place introducer through working channel. Hysteroscopically visualize and assess both fallopian tube ostia. Carefully insert Essure catheter. Advance the catheter until the black positioning marker is at the tubal ostium. If excessive force is encountered, terminate procedure to avoid uterine perforation or placement into a false passage. PLACE Stabilize the Essure handle to the hysteroscope to prevent inadvertent forward movement. Roll thumbwheel back so black positioning marker moves towards you until reaching a hard stop. Gold band Stop and check placement of insert. The entire gold band must be just outside the ostium with the green release catheter in view. If the gold band is not in view, reposition catheter prior to deployment. Press button to release thumbwheel. Insert will not yet expand. Roll thumbwheel back to a hard stop that expands and detaches insert. DOCUMENT Document placement and visible coils. (continued on next page) Ideally, 3 to 8 coils should be trailing into the uterus. Inserts showing 0-17 trailing coils should be left in place. 18 or more visible coils requires insert removal. Withdraw Essure catheter. Repeat steps with second catheter for contralateral ostium. IMPORTANT: Bayer is providing this information to you for informational and educational purposes only. This document is not intended to be a training document. You and your staff must be properly trained in all aspects of providing the Essure procedure. For complete placement procedure, please refer to Instructions for Use and Physician Training Manual. 131806_L01_TXT.indd 22 PROCEDURE 22 12/18/13 9:47 PM Placement Steps (cont'd) TIPS AND TECHNIQUES • Insert placement should be performed during the early proliferative phase of the menstrual cycle to decrease the potential of an undiagnosed (luteal phase) pregnancy and enhance visualization of the fallopian tubes. DO NOT perform during menstruation • Administer an NSAID 1-2 hours prior to procedure. Data suggests this will increase the likelihood of placement success • A bivalve, open-sided speculum is recommended so that it can be readily removed once the hysteroscope is in place • Do not dilate cervix unless necessary. If necessary, dilate only enough for hysteroscope insertion • Use warm saline for uterine distension medium—preferably a 3-liter bag • If having difficulty advancing insert into tube, advance the hysteroscope closer to provide column strength, then apply gentle, constant forward movement of the Essure® catheter • Operative notes should include the number of visible coils, and the need for a 3-month Essure Confirmation Test • Counsel patient on the need for alternative contraception until insert location and tubal occlusion are verified by the Essure Confirmation Test Delivery system after deployment of insert If no trailing coils are visible after deployment, examine delivery system upon removal from the hysteroscope to verify device deployment (see picture). Do not place more than one device in each fallopian tube unless an Essure Confirmation Test has been performed. Delivery system with insert PROCEDURE 131806_L01_TXT.indd 23 23 12/18/13 9:47 PM Post-Procedure Nursing Form (Example) To access and customize this form, please go to EssureMDResources.com. This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment. ESSURE® POST-PROCEDURE NURSING FORM (EXAMPLE) Date of Procedure: BP: Patient Name: Pulse: Temp: Procedure documentation: Number of coils visible in uterine cavity: Left: Right: Scope time: Start: Total: Stop: Lot #: (Use sticker from Essure kit) Nursing responsibility after procedure: ܆Provide patient with Essure ID card E L ܆Give post-procedure instructions to patient ܆Clean room and equipment per protocol P M A X E ܆Place this sheet in patient’s chart Patient instructions: x May resume normal activities on: x May resume intercourse on: x Call when: he office, make an appointm appointment for your 3-month Essure Confirmation Test x Before leaving the n: x Return on: irth control until your physician verifies that the inserts are in the correct location and your fallopian tubes x Continue birth are blocked x Take as prescribed by your physician Indication Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Important Safety Information Prescription Only Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases. Who should not use Essure x Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or lower pelvic infection, or have a known allergy to contrast media. x Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing the Essure procedure. x Uterine or fallopian tube anomalies may make it difficult to place Essure inserts. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE. POST-PROCEDURE 131806_L01_TXT.indd 24 24 12/18/13 9:47 PM Procedure Note (Example) To access and customize this form, please go to EssureMDResources.com. This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment. ESSURE® PROCEDURE NOTE (EXAMPLE) Patient name: Date: Risks, alternatives, and benefits of the procedure were discussed with the patient. All questions were answered, and informed consent was signed. The patient received the following medication prior to the procedure: A paracervical block was performed using a gauge spinal needle and cc of . The Essure procedure was performed per protocol. Trailing coils: Left: Right: E L P M A X E Other findings during the hysteroscopy are noted here: The Essure patient card was given. for pain relief, and will call if she has unusual ven. She will use symptoms such as pain/cramping, or fever. She will use alternative contraception ramping, heavy bleeding, vaginal discharge, d (except IUD or IUS) until occlusion are verified by the Essure Confirmation Test, done at til insert location and tubal occlus 3 months post-procedure. rocedure. Essure Lot # <Physician name>, MD Indication Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Important Safety Information Prescription Only Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases. Who should not use Essure x Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or lower pelvic infection, or have a known allergy to contrast media. x Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing the Essure procedure. x Uterine or fallopian tube anomalies may make it difficult to place Essure inserts. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE. POST-PROCEDURE 131806_L01_TXT.indd 25 25 12/18/13 9:47 PM Post-Procedure Instructions (Example) To access and customize this form, please go to EssureMDResources.com. This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment. ESSURE® POST-PROCEDURE INSTRUCTIONS (EXAMPLE) Going Home x Obtain a completed ID card before you leave. Keep your ID card with you at all times and present it to other doctors involved in your present or future care. x Schedule your Essure Confirmation Test (see below) for 3 months from now. When You are Home x If you are experiencing cramping, follow your doctor’s instructions regarding pain medication. — Medication instructions: x E L P M A X E You may feel faint or nauseous. Follow your doctor’s recommendations regarding activity during the first 24 hours ffollowing your procedure. Spotting or light bleeding is normal. If bleeding becomes heavy, you suspect you may be e pregnant, or you become conc concerned, please contact your doctor. x You must use alternative contraception until your physician verifies that hat the inserts are in the correct loca location and your . fallopian tubes are blocked. You may resume intercourse on x Please call your doctor if your period is more than 5 days late or you u suspect you may be pregnant. 3-month Essure Confirmation Test x You will need to schedule the Essure Confirmation n Test for 3 months post-procedure. The test is performed to make sure that both of your Essure inserts are in the correct location and that hat your fallopian n tubes are blocked sso you can rely on Essure as permanent birth control. x Return on for the Essure ssure Confirmation Test. Tes You must use alternative e contraception until your 3-month Essure Confirmation Test confirms that your Essure inserts are in the correct location and that your fallopian tubes are blocked. Only at that point can you rely on Essure for birth control. he Essure device for birth control before befo completing the Essure Confirmation Test, you may get pregnant or have an If you rely on the nancy (pregnancy outside of yourr u ectopic pregnancy uterus, but inside the body). Ectopic pregnancies can be life-threatening; so if you think you might be pregnant, please call yo your physician. Indication nent birt Essure is a permanent birth control procedure that works with your body to create a natural barrier against pregnancy. Important Safety Information WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test and your doctor tells you that you can rely on Essure for birth control. x You can rely on Essure for birth control only after your doctor has reviewed your Essure Confirmation Test results. Your doctor will confirm that the inserts are properly placed and both of your fallopian tubes are blocked. If you rely on Essure for birth control before having your Essure Confirmation Test, you are at risk of getting pregnant. x Talk to your doctor about which method of birth control you should use for the 3 months after the procedure. Some women can remain on their current birth control. Other women, such as those using an intrauterine device or contraceptive (IUD or IUC), will need to switch to another method. x It can take longer than three months for the Essure procedure to be effective. In rare cases, it has taken up to 6 months. Make sure to continue using an alternate form of birth control up until your doctor has reviewed your Essure Confirmation Test results and confirmed that you can rely on Essure for birth control. WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control. The younger a woman is when she chooses to end her fertility, the more likely she is to regret her choice later. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE. POST-PROCEDURE 131806_L01_TXT.indd 26 26 12/18/13 9:47 PM Essure® Confirmation Test Overview ESSURE CONFIRMATION TEST Patients must have the Essure Confirmation Test to verify that the Essure inserts are in the correct location and that the fallopian tubes are blocked. Besides being an integral part of the Essure procedure, the Essure Confirmation Test provides confirmation that the procedure was successful and can be relied upon for permanent birth control. KEY POINTS • To avoid confusion with an infertility HSG and help ensure a positive patient experience, gynecologists should contact the radiologist and provide a copy of the Essure Confirmation Test Process and Checklist prior to referring patients. Both can be downloaded at EssureMDResources.com • Consider administering an over-the-counter pain reliever 1 hour prior to the procedure6 • Consider establishing a protocol in your office for scheduling confirmation test appointments, calling with appointment reminders, and tracking confirmation test compliance. This has been shown to increase patient compliance and rates of confirmed Essure location and tubal occlusion7 ESSURE CONFIRMATION TEST RESOURCES For Physicians Process for performing the Essure Confirmation Test: Electronic version available at EssureMDResources.com. Can be forwarded to the radiologist. Essure Confirmation Test Checklist: Can be found on the next page and is also available electronically at EssureMDResources.com. The checklist can be provided to the radiologist to ensure that the procedure is performed correctly and that the radiology report contains all required information. Example Essure Confirmation Test letters: Remind your patients to schedule their Essure Confirmation Test. See example letters at EssureMDResources.com. For Patients Essure Confirmation Test patient brochure: Provides an overview of Essure Confirmation Test for your patients. IMPORTANT: Bayer is providing the information in this guide to you for informational and educational purposes only. This document is not intended as training materials, an all-inclusive list, nor to establish a standard of care. You are solely responsible for ensuring that you and your staff have been properly trained in all aspects of providing the Essure procedure to your patients in the office setting. For complete instructions, please refer to the Instructions for Use and Physician Training Manual. POST-PROCEDURE 131806_L01_TXT.indd 27 27 12/18/13 9:47 PM Essure Confirmation Test Checklist (Example) To access and customize this form, please go to EssureMDResources.com. This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment. ESSURE® CONFIRMATION TEST OVERVIEW (EXAMPLE) The Essure Confirmation Test is a modified hysterosalpingogram (HSG) performed 3 months after the Essure placement procedure. This test is used to confirm and document satisfactory location of both inserts and bilateral tubal occlusion. The Essure Confirmation Test differs from an infertility HSG by using a lower contrast volume and a slow, gentle, constant filling of the uterine cavity. This is NOT a pressure study. In order to produce and report satisfactory images to allow for adequate evaluation of location and occlusion, adhere to the following guidelines: 1. Do not dilate cervix unless necessary; if dilation occurs, maintain a good cervical seal. 2. Obtain good cornual filling; uterine cavity silhouette should be clearly visualized. Instill contrast slowly and gently until the uterine cornua are distended. An increase in intrauterine pressure beyond that should be avoided due to patient discomfort and the possibility of resultant vasovagal reaction. 3. Place fluoroscopy beam as close to anterior/posterior (A/P) projection as possible. If patient has a midpositional uterus, downward traction with tenaculum may be required to achieve adequate images. Remove speculum prior to fluoroscopy scopy for best visualization of uterine anatomy. 4. Take a minimum of 6 radiographs to assess insert location and tubal occlusion. 5. Report must include reference to satisfactory location and occlusion. L P M A X E The Radiology Report must include: ude: 1. Number and location of inserts serts 2. Tubal occlusion assessment sessment for each side 3. Description n of unusual findings LOCATION ܆Satisfactory Location Distal end of the inner coil is within the fallopian tube, with <50% of the inner coil trailing into the uterine cavity, OR the proximal marker of the inner inn coil is 30 mm into the tube from where contrast ere co rast fills the uterine cornua ܆ LEFT ܆ RIGHT ܆ Proximal al location location: 50% 50% of the inner coil is tr trailing into the uterine cavity ܆ ܆ Expulsion: n: One or both inserts are a not present in the radiographic image ܆ ܆ Distal location: tion: Insert is in the fa fallopian tube, but the proximal end of the inner coil is more than 30 0 mm from the contrast filling the uterine cornua ܆ ܆ Perforation or perito peritoneal location of the insert: Insert has punctured the uterine cavity and may be in the peritoneal cavity ܆ ܆ ܆ ܆ ܆ ܆ ory Location Unsatisfactory OCCLUSION ܆Satisfactory Occlusion Tube is occluded at the cornua OR contrast is visible within the tube but not past any portion of distal end of the outer coil of the insert ܆ Unsatisfactory Occlusion Contrast is visible past the insert OR in the peritoneal cavity Assessing patient ability to rely on Essure: x Patient can rely on Essure for permanent birth control (satisfactory bilateral insert location and bilateral tubal occlusion) x Patient cannot rely on Essure (unsatisfactory bilateral insert location with or without tubal patency) x Patient should return for a repeat Essure Confirmation Test in 3 months (satisfactory bilateral insert location with tubal patency) PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE. POST-PROCEDURE 131806_L01_TXT.indd 28 28 12/18/13 9:47 PM Essure® Confirmation Test Reminder Letter (Example) To access and customize this form, please go to EssureMDResources.com. This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment. ESSURE® CONFIRMATION TEST REMINDER LETTER (EXAMPLE) Date: Patient Name: Address: Dear As a follow-up to your recent Essure procedure, I am writing to remind you to schedule an Essure Confirmation Test appointment with our office as soon as possible. This simple test verifies that the Essure inserts are in the correct location and that your fallopian tubes are blocked so you can rely on Essure as your permanent birth control. Besides being an integral part of the Essure procedure, the Essure Confirmation Test provides you with confirmation that the procedure was successful and can be relied upon for permanent birth control. You can visit the Essure.com website to learn more about the Essure Confirmation Test. As a reminder, until the Essure Confirmation Test verifies that the inserts are in the correct location your fallopian on and that yo tubes are blocked, you must use alternative contraception and cannot rely on Essure. E L Please call our office today to schedule your Essure Confirmation Test appointment. We will be happy to answer any questio questions you may have. Sincerely, Physician Name: P M A X E Indication Essure is a permanent birth control procedure that works with your body to create a natur natural barrier against pregnancy. Important Safety Information WARNING: You must continue to use another control until you have your Essure Confirmation Test and your er form of birth cont doctor tells you that you can rely on Essure for birth control. x You can rely on Essure for birth control only after your doctor has re reviewed your Essure Confirmation Test results. Your doctor will re properly placed and both of your fal confirm that the inserts are fallopian tubes are blocked. If you rely on Essure for birth control before e Confirmation Test, you are at ri having your Essure risk of getting pregnant. x Talk to yourr doctor about which method of birth control con you should use for the 3 months after the procedure. Some women can remain rent birth control. Other women, su on their current such as those using an intrauterine device or contraceptive (IUD or IUC), will need to switch to another other method. x It can take longer er than three mont months for the Essure procedure to be effective. In rare cases, it has taken up to 6 months. Make sure to n alternate fo continue using an form of birth control up until your doctor has reviewed your Essure Confirmation Test results and confirmed that you rely on Essure for birth control. u can re WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control. The younger a woman is when she chooses to end her fertility, the more likely she is to regret her choice later. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE. POST-PROCEDURE 131806_L01_TXT.indd 29 29 12/18/13 9:47 PM Essure Confirmation Test Missed Appointment Letter (Example) To access and customize this form, please go to EssureMDResources.com. This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment. ESSURE® CONFIRMATION TEST MISSED APPOINTMENT LETTER (EXAMPLE) Date: Patient Name: Address: Dear I am writing to let you know that you missed your appointment for the Essure Confirmation Test following your Essure procedure. This simple test verifies that the Essure inserts are in the correct location and that your fallopian tubes are blocked so you can rely on Essure as your permanent birth control. Besides being an integral part of the Essure procedure, the Essure Confirmation Test provides you with confirmation that the procedure was successful and can be relied upon for permanent birth control. You can visit the Essure.com website to learn more about the Essure Confirmation Test. As a reminder, until the Essure Confirmation Test verifies that the inserts are in the correct location and that your fallopian y tubes are blocked, you must use alternative contraception and cannot rely on Essure. Please call our office today to reschedule your Essure Confirmation Test appointment. We will be happy to questions you o answer any q may have. Sincerely, Physician Name: Indication Essure is a permanent birth control procedure that works with your body to create a natural natu barrier against pregnancy. Important Safety Information WARNING: You must continue to use another controll until you ther form of birth co yo have your Essure Confirmation Test and your doctor tells you that you can rely y on Essure for birth control. x You can rely on Essure for birth control only after your doctor has as rreviewed your Essure Confirmation Test results. Your doctor will ts are properly placed and both of your fa confirm that the inserts fallopian tubes are blocked. If you rely on Essure for birth control before having your Essure ure Confirmation Test, you are at risk of getting pregnant. x Talk to your our doctor about which method of birth b rth control c you should use for the 3 months after the procedure. Some women can remain on their current birth control. Other women, ssuch as those using an intrauterine device or contraceptive (IUD or IUC), will need to switch to another metho method. x It can take longer onger than three mon months for the Essure procedure to be effective. In rare cases, it has taken up to 6 months. Make sure to continue using ng an alternate form of birth control up until your doctor has reviewed your Essure Confirmation Test results and confirmed that you can rely on Essure for birth control. WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control. The younger a woman is when she chooses to end her fertility, the more likely she is to regret her choice later. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE. POST-PROCEDURE 131806_L01_TXT.indd 30 30 12/18/13 9:47 PM Notes 31 131806_L01_TXT.indd 31 12/18/13 9:47 PM GETTING STARTED GETTING STARTED 131806_L01_TXT.indd TAB1P1 12/18/13 9:47 PM 131806_L01_TXT.indd TAB2P1 PRE-PROCEDURE PRE-PROCEDURE 12/18/13 9:47 PM PROCEDURE PROCEDURE 131806_L01_TXT.indd TAB3P1 12/18/13 9:47 PM POST-PROCEDURE POST-PROCEDURE 131806_L01_TXT.indd TAB4P1 12/18/13 9:47 PM THE ESSURE® OFFICE GUIDE THE ESSURE® OFFICE GUIDE A resource for providing Essure in the office setting To access and customize the most up-to-date forms, please go to EssureMDResources.com. References: 1. Cooper JM, Carignan CS, Cher D, Kerin JF; Selective Tubal Occlusion Procedure 2000 Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102(1):59-67. 2. Arjona JE, Miño M, Cordón J, Povedano B, Pelegrin B, Castelo-Branco C. Satisfaction and tolerance with office hysteroscopic tubal sterilization. Fertil Steril. 2008;90(4):1182-1186. 3. Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010;115(1):26-34. 4. Isley MM, Jensen JT, Nichols MD, Lehman A, Bednarek P, Edelman A. Intrauterine lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized controlled trial. Contraception. 2012;85(3):275-281. 5. Miño M, Arjona JE, Cordón J, Pelegrin B, Povedano B, Chacon E. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting: a prospective study of 857 women. BJOG. 2007;114(6):763-766. 6. The American College of Obstetricians and Gynecologists. Frequently asked questions: FAQ 143, special procedures. https://www.acog.org/~/ media/For%20Patients/faq143.pdf. Accessed December 9, 2013. 7. Guiahi M, Goldman KN, McElhinney MM, Olson CG. Improving hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic sterilization. Contraception. 2010;81(6):520-524. BAYER, the Bayer Cross, and Essure are registered trademarks of Bayer. © 2013 Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981 All rights reserved. 250-87-0003-13a Printed in USA December 2013 Indication Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Important Safety Information Prescription Only Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases. Who should not use Essure • Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or lower pelvic infection, or have a known allergy to contrast media. • Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing the Essure procedure. • Uterine or fallopian tube anomalies may make it difficult to place Essure inserts. PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ON PAGE 3. IMPORTANT: Bayer is providing the information in this guide to you for informational and educational purposes only. This document is not intended as training materials, an all-inclusive list, nor to establish a standard of care. You are solely responsible for ensuring that you and your staff have been properly trained in all aspects of providing the Essure procedure to your patients in the office setting. For complete instructions, please refer to the Instructions for Use and Physician Training Manual. If you have any questions, please do not hesitate to contact your Clinical Sales Specialist using the business card provided. To make this process as streamlined as possible, we have created a website where you can access examples of Essure forms and customize them based on your professional judgment: EssureMDResources.com. • Example forms and letters • Reimbursement codes • Account setup and ordering The Essure Office Guide offers information and resources to help you achieve a successful practice implementation, including: You have joined a growing number of practices that have chosen to provide their patients with the Essure in-office procedure for permanent birth control. Welcome to the Essure Office Guide! Dear Doctor and Staff: Introducing the Essure® Office Guide 131806_L01_CVR.indd 1 12/18/13 9:25 PM