FSRH Guideline Progestogen-only Implant

1 fsrh Guideline Progestogen-only Implant February 2021 | FSRHF aculty of Sexual & Reproductive Healthcare ( fsrh ) provided funding to the Clinical Effectiveness Unit (of the fsrh ) to assist them in the production of this Guideline , Progestogen-only Implant (February 2021).Published by the Faculty of Sexual & Reproductive Healthcare. Registered in England No. 2804213 and Registered Charity No. 1019969 Progestogen-only Implant first published in February Faculty of Sexual & Reproductive Healthcare February is granted to reproduce or transmit this document for non-commercial personal and non-commercial education use only . Commercial use of any kind, including copying, hiring and lending, is reproduction of the whole of this document must reproduce this copyright notice in its reproduction of a part of this document must include a statement that it is reproduced under licence from fsrh and the notice Copyright Faculty of Sexual & Reproductive Healthcare.

2 February in the has accredited the process used by the Faculty of Sexual & Reproductive Healthcare to produce this Guideline . More information on accreditation can be viewed at accreditation. iiiCopyright Faculty of Sexual & Reproductive Healthcare February 2021 Abbreviations usedATEarterial thromboembolismBMDbone mineral densityBMIbody mass indexCEUC linical Effectiveness UnitCHCcombined hormonal contraception/contraceptiveCIconfidence intervalCOCcombined oral contraception/contraceptiveCu-IUDcopper intrauterine deviceDMPA depot medroxyprogesterone acetateECemergency contraceptionENGetonogestrelFSRHF aculty of Sexual & Reproductive HealthcareGDGguideline development groupHCPhealthcare practitionerHMBheavy menstrual bleedingIMPimplantIUSintrauterine systemLARC long-acting reversible contraception/contraceptiveLNGlevonorges trelLNG-IUSlevonorgestrel-releasing intrauterine systemMHRAM edicines

3 And Healthcare products Regulatory AgencyPCOS polycystic ovary syndromePOPprogestogen- only pillRCTrandomised controlled trialRPreference periodRRrelative riskSRHsexual and reproductive healthcareUKMECU nited Kingdom Medical Eligibility CriteriaUPAulipristal acetateUPSI unprotected sexual intercourseVTEvenous thromboembolismWHOW orld Health OrganizationProgestogen- only Implantiv Copyright Faculty of Sexual & Reproductive Healthcare February 2021 Progestogen-only ImplantGrading of recommendations Refer to Appendix 1 for a full explanation of the classification of evidence level and grading of least one meta-analysis, systematic review or randomised controlled trial (RCT) rated as 1++, and directly applicable to the target population;orA systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population and demonstrating overall consistency of body of evidence including studies rated as 2++ directly applicable to the target population and demonstrating overall consistency of results;orExtrapolated evidence from studies rated as 1++ or 1+.

4 CA body of evidence including studies rated as 2+ directly applicable to the target population and demonstrating overall consistency of results;orExtrapolated evidence from studies rated as 2++.DEvidence level 3 or 4;orExtrapolated evidence from studies rated as 2+. Good Practice Point based on the clinical experience of the Guideline development of tables and boxesTable 1 Medical conditions that are UKMEC3 or UKMEC4 for use of the etonogestrel subdermal implantTable 2 Starting the etonogestrel Implant : no recent hormonal contraceptionTable 3 Switching to the etonogestrel Implant from other hormonal contraceptionTable 4 Replacing the etonogestrel implantTable 5 Starting the etonogestrel Implant : after emergency contraceptionTable 6 Switching from the etonogestrel Implant to a hormonal method of contraceptionTable 7 Switching from the etonogestrel Implant to a non-hormonal method of contraceptionBox 1 Clinically important bleeding patterns in women aged 15 44 yearsBox 2 Points to cover in the clinical history from an etonogestrel Implant user who presents with problematic bleeding vCopyright Faculty of Sexual & Reproductive Healthcare February 2021 Progestogen-only ImplantContentsAbbreviations used iiiGrading of recommendations ivList of tables and boxes ivContents vExecutive summary of recommendations viii1 Purpose and scope 12 Identification and assessment of the evidence 13

5 Introduction 14 Summary, including changes to existing guidance 15 What is the Progestogen-only Implant ? 46 How does the etonogestrel Implant work for contraception? 47 How effective is the etonogestrel Implant for contraception? 5 Contraceptive effectiveness during extended use of the etonogestrel Implant 5 What drug interactions are important to consider? 6 What is the effect of weight/body mass index on contraceptive effectiveness? 7 Contraceptive effectiveness of bent or broken implants 8 Pregnancy diagnosed when there is an etonogestrel Implant in situ 88 Assessing suitability of the etonogestrel Implant for an individual 8 Medical eligibility 8 Assessment of factors that could affect contraceptive effectiveness 109 Non-contraceptive benefits associated with use of the etonogestrel Implant 10 Dysmenorrhoea 10 Heavy menstrual bleeding 10 Endometriosis 11 Endometrial protection in polycystic ovary syndrome 1110 Risk of adverse health events associated with use of the etonogestrel Implant 12 Venous and arterial thromboembolism 12 Osteoporosis 13 Breast cancer 13

6 Gynaecological cancers 14 Ectopic pregnancy 14vi Copyright Faculty of Sexual & Reproductive Healthcare February 2021 Progestogen-only Implant11 Side effects associated with use of the etonogestrel Implant 14 Unpredictable bleeding patterns 15 Headache 21 Acne 21 Depression 22 Weight change 23 Other side effects 2312 When can the etonogestrel Implant be inserted? 23 Starting the etonogestrel Implant at the beginning of a natural menstrual cycle 24 Starting the etonogestrel Implant after day 5 of a natural menstrual cycle 25 Starting the etonogestrel Implant after childbirth 25 Starting the etonogestrel Implant after abortion 25 Switching to the etonogestrel Implant from another contraceptive method 25 Replacing the etonogestrel Implant 28 Starting the etonogestrel Implant after oral emergency contraception 2813 Checklist prior to etonogestrel Implant insertion 2914 Nexplanon insertion 29 What is the safest insertion site?

7 30 Insertion site in existing users 31 Nexplanon insertion procedure 31 Advice after etonogestrel Implant insertion 3115 Etonogestrel Implant removal 31 When can the etonogestrel Implant be removed? 31 Switching from the etonogestrel Implant to another method of contraception 32 Standard etonogestrel Implant removal procedure 33 Advice after etonogestrel Implant removal 3316 Local anaesthesia for Implant insertion and removal procedures 34 Lidocaine 1% 34 Ethyl chloride spray 3417 Implant insertion and removal in anticoagulated individuals, those with inherited bleeding disorders and people with low platelet count 35 viiCopyright Faculty of Sexual & Reproductive Healthcare February 2021 Progestogen-only Implant18 Complications of Implant insertion and removal Implant migration Local reaction Nerve damage Intramuscular insertion 3819 Impalpable and deeply sited etonogestrel implants Initial management of impalpable implants Etonogestrel implants that have been identified deeply sited in the arm Etonogestrel implants that are not identified in the arm 3920 Broken implants 39 Removal of broken etonogestrel implants 4021 Cost-effectiveness of the etonogestrel Implant 4022 Other Progestogen-only implants 41 Recommendations for future

8 Research 41 Considerations for implementation of this Guideline 41 Useful links 41 References 42 Appendices 52 Appendix 1: fsrh clinical Guideline development process 52 Appendix 2: Suggested Nexplanon insertion procedure 57 Appendix 3: Suggested standard Nexplanon removal procedure (palpable implants with pop-up sign only ) 59 Questions for continuing professional development 61 Auditable ouctomes 62 Comments and feedback on published Guideline 62 Information boxTitleProgestogen- only Implant February 2021 Author/PublisherFaculty of Sexual & Reproductive HealthcarePublication dateFebruary 2021 Superseded document Progestogen-only Implant February 2014 Review dateFebruary 2026 Available Copyright Faculty of Sexual & Reproductive Healthcare February 2021 Progestogen-only ImplantExecutive summary of recommendationsWhat is the Progestogen-only Implant ?

9 Key information The etonogestrel Implant (ENG-IMP) is currently the only Progestogen-only contraceptive subdermal Implant available in the UK. The ENG-IMP is a highly effective long-acting reversible method of contraception, licensed for 3 years of use for effective is the etonogestrel Implant for contraception?Key informationCThe first year contraceptive failure rate for the ENG-IMP has been estimated at Cases of apparent true contraceptive failure have, however, been effectiveness during extended use of the etonogestrel implantKey informationCThe limited available evidence indicates that the risk of pregnancy during the fourth year of use of an ENG-IMP is likely to be very recommendations Healthcare practitioners (HCPs) can advise individuals who present after unprotected intercourse during the fourth year of use of an ENG-IMP that pregnancy risk is likely to be very low and emergency contraception is unlikely to be required.

10 Routine use of the ENG-IMP for longer than 3 years is not currently recommended. This is because available evidence is too limited to enable users to be given accurate information about effectiveness during extended drug interactions are important to consider?Enzyme-inducing drugsClinical recommendations Individuals using enzyme-inducing drugs should be informed that the contraceptive effectiveness of the ENG-IMP could be reduced during use of the enzyme-inducer and for 28 days after stopping the enzyme-inducer. Individuals using enzyme-inducing drugs should be offered a reliable contraceptive method that is unaffected by acetate (UPA)Key informationDThe ability of ulipristal acetate oral emergency contraception (UPA-EC) to delay ovulation could be reduced if an ENG-IMP is inserted within 5 days of taking the ability of UPA-EC to delay ovulation could theoretically be reduced if a woman has an ENG-IMP in situ (even if it has been in situ for longer than 3 years).