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WHO Library Cataloguing-in-Publication DataWHO guidelines on the management of health complications from female genital mutilation.

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Contents

Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

Acronyms and abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

Executive summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .viii

. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Types of FGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Reasons why FGM is performed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Health risks from FGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. FGM and human rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Medicalization of FGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Objectives of the guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. Why these guidelines were developed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.. Purpose of these guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.. Target audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Guideline contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Declaration of interests by external contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Identification of priority research questions and outcomes – scoping exercise. . . . . . . . . . . . . . . . . . .

. Evidence retrieval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Quality assessment, synthesis and grading of the evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Qualitative research and human rights evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Formulation of recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Document preparation and peer review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Guiding principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Recommendations and best practice statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.. Deinfibulation (recommendations – and best practice statements –) . . . . . . . . . . . . . . . . . . . .

.. Mental health (recommendation and best practice statement ) . . . . . . . . . . . . . . . . . . . . . . . . . . .. Female sexual health (recommendation ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.. Information and education (best practice statements –) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Interventions for which no recommendations were issued . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.. What are the treatment alternatives for vulvodynia and clitoral pain in

girls and women with any type of FGM? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.. What is the role of clitoral reconstruction? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Dissemination and implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Dissemination of the guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Implementation of the guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Monitoring and evaluating the impact of the guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Updating the guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


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. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annex : International and regional human rights treaties and consensus documents

providing protection and containing safeguards against female genital mutilation . . . . . . . . .

Annex : Guideline contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annex : Factors considered while rating the quality of the evidence . . . . . . . . . . . . . . . . . . . . . . . . . .

Web Annex: GRADE tables – available online at:

http://www.who.int/reproductivehealth/topics/fgm/management-health-complications-fgm/en/


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Acknowledgments

The Department of Reproductive Health andResearch, at the World Health Organization (WHO),has produced this guideline document, under

the leadership of Dr Lale Say. Dr Doris Chou andDr Karin Stein coordinated the development ofthe guideline. The WHO Steering Group (Dr IanAskew, Dr Lale Say, Dr Doris Chou, Dr MichelleHindin, Mr Rajat Khosla, Dr Christina Pallitto,Dr Karin Stein) gratefully acknowledges thecontributions of all the Guideline DevelopmentGroup (GDG) members: Dr Jasmine Abdulcadir,Ms Joya Banerjee, Dr Owolabi Bjalkander, Dr SusanaFried, Professor Adriana Kaplan Marcusán,Professor Joseph Karanja, Professor Caitlin

Kennedy, Dr Morissanda Kouyaté, Professor ElsLeye, Professor Martin M. Meremikwu, Dr NawalNour, Professor Olayinka Olusola Omigbodun,Professor Gamal Serour, Professor Moustapha Toureand Dr Ingela Wiklund; and our United Nationspartners from the UNFPA-UNICEF Joint Programme,on Female Genital Mutilation/Cutting: AcceleratingChange, Dr Nafissatou J. Diop and Mr CodyDonahue.

Many thanks to the following individuals for peer

reviewing the document: Professor Pascale A.Allotey, Dr Comfort Momoh and Ms Marycelina H.Msuya.

The WHO Steering Group would also like to thankall the anonymous participants who took part inthe guidelines scoping survey.

Special thanks to Dr Helen Smith for conductingthe qualitative systematic reviews and to ProfessorMartin Meremikwu of the Nigerian Branch of the

South African Cochrane Centre for leading thesystematic review team composed of the followingmembers: Dr Olukayode Abayomi, Dr AdegokeAdelufosi, Mr David Agamse, Mr EmemobongAquaisua, Mrs Dachi Arikpo, Dr Iwara Arikpo,

Dr Segun Bello, Mrs Moriam T. Chibuzor, Dr BasseyEdet, Dr Emmananuel Effa, Dr Regina Ejemot-Nwadiaro, Mr Ekpereonne Esu, Dr Ifeanyi Ezebialu,

Dr Austin Ihesie, Dr Elizabeth Inyang, Dr OgonnaNwankwo, Mr Edward Odey, Dr Friday Odey,Dr Udoezuo K. Ogbonna, Dr Miriam Ogugbue,Dr Olumuyiwa Ojo, Ms Obiamaka Okafo, Dr UduakOkomo, Mr Anthony Okoro, Dr Ifeyinwa Okoye,Dr Babasola Okusanya, Ms Chioma Oringanje,Ms Chukwudi Oringanje, Dr Atim Udo andDr Ekong E. Udoh. Many thanks also to Mr GrahamChan who developed the search strategies.

This document was written on behalf of the GDG

by Dr Karin Stein and Dr Doris Chou.We appreciate the contributions of the followingindividuals to the development of the guidelines:Dr Olufemi Oladapo, Ms María Barreix, Ms LianneGonsalves and Ms Marie Hélène Doucet. Wethank Dr Jasmine Abdulcadir, Dr Lucrezia Catania,Dr Patrick Petignat, and Dr Omar Abdulcadirfor their assistance with conceptualization ofillustrations on types of FGM. Many thanks toMr Svetlin Kolev and Ms Janet Petitpierre for

providing technical assistance with the guidelinegraphics. This guideline document was edited byMs Jane Patten, of Green Ink, United Kingdom.

The WHO Steering Group would like to thank theWHO Guidelines Review Committee Secretariatfor the overall support during the guidelinedevelopment process, with grateful thanks toDr Susan L. Norris.

The development of these guidelines was fundedby the UNFPA–UNICEF Joint Programme on Female

Genital Mutilation/Cutting: Accelerating Change,and the Department of Reproductive Health andResearch, UNDP/UNFPA/UNICEF/WHO/World BankSpecial Programme of Research, Development andResearch Training in Human Reproduction (HRP).


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Acronyms and abbreviations

CBT cognitive behavioural therapy

CEDAW Convention on the Elimination of All Forms of Discrimination against Women

CRC Convention on the Rights of the Child

DOI declaration of interest

ERG External Review Group

FGM female genital mutilation

GDG Guideline Development Group

GRADE Grading of Recommendations Assessment, Development and Evaluation

HRP UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and

Research Training in Human Reproduction

IEC information, education and communication

NGO nongovernmental organization

OHCHR Office of the United Nations High Commissioner for Human Rights

PICO population, intervention, comparator, outcome

PTSD post-traumatic stress disorder

UN United Nations

UNAIDS Joint United Nations Programme on AIDS

UNDP United Nations Development Programme

UNECA United Nations Economic Commission for Africa

UNESCO United Nations Educational, Scientific and Cultural Organization

UNFPA United Nations Population Fund

UNHCR United Nations High Commissioner for Refugees

UNICEF United Nations Children’s FundUNIFEM United Nations Development Fund for Women (now UN Women)

UTI urinary tract infection

WHO World Health Organization


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Glossary

Terms associated with female genital mutilation (FGM):

Infibulation (type III FGM)

Narrowing of the vaginal orifice with the creation of a covering seal by cutting and appositioning the labia

minora and/or the labia majora, with or without excision of the clitoris.

Deinfibulation

The practice of cutting open the narrowed vaginal opening in a woman who has been infibulated, which isoften necessary for improving health and well-being as well as to allow intercourse or to facilitate childbirth.

Re-infibulation

The procedure to narrow the vaginal opening in a woman after she has been deinfibulated (i.e. afterchildbirth); also known as re-suturing.

Medicalization of FGM

Situations in which the procedure (including re-infibulation) is practised by any category of health-careprovider, whether in a public or a private clinic, at home or elsewhere, at any point in time in a woman’s life.

Terms related to interventions:

Cognitive behavioural therapy (CBT)

A type of psychological therapy based on the idea that feelings are affected by thinking and beliefs. Ifunchecked, these thoughts and beliefs can lead to unhelpful behaviours. CBT typically has a cognitivecomponent (i.e. helping the person develop the ability to identify and challenge unrealistic negativethoughts) and a behavioural component.

Digital health

The use of information and communication technologies in support of health and health-related fields.Health education

The provision of accurate, truthful information so that a person can become knowledgeable about thesubject and make an informed choice.

Information, education and communication (IEC)

A public health approach aiming at changing or reinforcing health-related behaviours in a target audience,concerning a specific problem and within a pre-defined period of time, through communication methodsand principles.


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Executive summary

Female genital mutilation (FGM) comprises allprocedures that involve the partial or total removal

of external genitalia or other injury to the femalegenital organs for non-medical reasons. Theprocedure has no known health benefits. Moreover,the removal of or damage to healthy genital tissueinterferes with the natural functioning of the bodyand may cause several immediate and long-termhealth consequences. Girls and women who haveundergone FGM are therefore at risk of sufferingfrom its complications throughout their lives. Inaddition, FGM violates a series of well-establishedhuman rights principles, including the principles ofequality and non-discrimination on the basis of sex,the right to life when the procedure results in death,and the right to freedom from torture or cruel,inhuman or degrading treatment or punishment, aswell as the rights of the child.

The practice – prevalent in countries in Africa andin a few countries in Asia and the Middle East – isnow present across the globe due to internationalmigration. Health-care providers in all countries maytherefore face the need to provide health care to thispopulation. Unfortunately, health workers are oftenunaware of the many negative health consequencesof FGM and many remain inadequately trained torecognize and treat them properly.

Recognizing the persistence of FGM despiteconcerted efforts to eradicate or abandon thepractice in some affected communities, andacknowledging the million girls and womenliving with or at risk of suffering the associated

negative health consequences, these guidelinesaim to provide up-to-date, evidence-informedrecommendations on the management of healthcomplications from FGM. This document alsointends to provide standards that may serve as thebasis for developing local and national guidelinesand health-care provider training programmes.

Target audience

These guidelines are intended primarily for health-care

professionals involved in the care of girls and womenwho have been subjected to any form of FGM. Thisdocument also provides guidance for policy-makers,health-care managers and others in charge of planning,

developing and implementing national and localhealth-care protocols and policies. The information

contained in this document will also be useful fordesigning job aids and pre- and in-service professionaltraining curricula in the areas of medicine, nursing,midwifery and public health for health-care providerscaring for girls and women living with FGM.

Guideline development methods

This document was developed using standardoperating procedures in accordance with theprocess described in the WHO handbook for guideline

development, second edition. In summary, theprocess involved: (i) identification of critical researchquestions and outcomes; (ii) commissioning ofexperts to conduct systematic reviews; (iii) retrievalof up-to-date evidence; (iv) quality assessmentand synthesis of the evidence; (v) formulationof recommendations; and (vi) planning for thedissemination, implementation, impact evaluationand updating of the guidelines. The scientificevidence that informed the recommendations and

best practice statements was synthesized usingthe Grading of Recommendations Assessment,Development and Evaluation (GRADE) methods. For each priority research question, evidence profileswere prepared from existing or commissionedsystematic reviews. Values and preferences of clientsand health-care providers were assessed usingevidence from qualitative reviews on the contextand conditions of interventions used to managehealth complications of FGM. The recommendationsand best practice statements were developed using

a consensus-based approach by the GuidelineDevelopment Group (GDG), an international group ofexperts in the field of FGM, during a meeting at the

1 WHO handbook for guideline development, 2nd ed.Geneva: World Health Organization; 2014.

2 Further information available at:http://www.gradeworkinggroup.org/

3 The GDG issued recommendations when the availableevidence and ancillary criteria supported theirdevelopment. When the available evidence is of low

quality or weak but the contents of the recommendedstatement were based upon sound judgement andsupported by human rights and equity principles, publicor medical practices, and judged to have little to no risk ofharm to health, best practice statements were issued.


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WHO guidelines on the management of health complications from female genital mutilation ix

World Health Organization (WHO) headquarters inGeneva on – September .

Guidance: recommendations andbest practice statements

The guideline development process led to theadoption of three statements of “guiding principles”,five recommendations and eight best practicestatements, covering the use of deinfibulation,mental health, female sexual health, andinformation and education (see Guidance summary tables). For each recommendation and best practicestatement the quality of the evidence was gradedas “very low”, “low”, “moderate” or “high”, basedon the GRADE methods. When no evidence wasidentified for a recommendation or best practice

statement, or only indirect evidence was available,this was indicated in the summary of the evidence.

Recommendations were considered as “strong”(two recommendations) or “conditional” (threerecommendations), based on the available evidence,as well as considerations of the balance betweenbenefits and harms, women’s and health-careproviders’ preferences, human and other resourceimplications, priority of the problem, equity andhuman rights issues, and acceptability and feasibility

of the proposed intervention. Where there was aneed for guidance, but no relevant research evidencewas available, recommendations and best practicestatements were agreed if they were supported bythe public health or medical practice expertise ofthe members of the GDG. In order to ensure each

recommendation and best practice statement couldbe understood and used as it was intended, the GDGoffered further clarifications as needed, which arenoted below the relevant recommendations and bestpractice statements where they are presented in fullwithin the text of these guidelines.

Input from peer reviewers and a range ofstakeholders, including colleagues working directlywith girls and women living with FGM, was alsosought and helped to further clarify the wording

of the recommendations and best practicestatements. Important knowledge gaps that needto be addressed through primary research wereidentified and included in the document.

The recommendations and best practicestatements on the management of healthcomplications from FGM are summarized in thetable below. They will be reviewed and updatedfollowing identification of new evidence.

Guiding principles

I Girls and women living with female genital mutilation (FGM) have experienced a harmful practiceand should be provided quality health care.

II All stakeholders – at the community, national, regional and international level – should initiate orcontinue actions directed towards primary prevention of FGM.

III Medicalization of FGM (i.e. performance of FGM by health-care providers) is never acceptablebecause this violates medical ethics since (i) FGM is a harmful practice; (ii) medicalization perpetuatesFGM; and (iii) the risks of the procedure outweigh any perceived benefit.

Guidance summary


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Summary of the recommendations (R) and best practice statements (BP)

DEINFIBULATION

R- Deinfibulation is recommended for preventing and treating obstetric complications in womenliving with type III FGM (strong recommendation; very low-quality evidence).

R- Either antepartum or intrapartum deinfibulation is recommended to facilitate childbirth inwomen living with type III FGM (conditional recommendation; very low-quality evidence).

R- Deinfibulation is recommended for preventing and treating urologic complications – specificallyrecurrent urinary tract infections and urinary retention – in girls and women living with type III FGM(strong recommendation; no direct evidence).

BP- Girls and women who are candidates for deinfibulation should receive adequate preoperativebriefing (Best practice statement).

BP- Girls and women undergoing deinfibulation should be offered local anaesthesia (Best practice statement).

MENTAL HEALTH

R- Cognitive behavioural therapy (CBT) should be considered for girls and women living with FGMwho are experiencing symptoms consistent with anxiety disorders, depression or post-traumatic stressdisorder (PTSD) (conditional recommendation; no direct evidence).

BP- Psychological support should be available for girls and women who will receive or havereceived any surgical intervention to correct health complications of FGM (Best practice statement).

FEMALE SEXUAL HEALTH

R- Sexual counselling is recommended for preventing or treating female sexual dysfunction amongwomen living with FGM (conditional recommendation; no direct evidence).

INFORMATION AND EDUCATION

BP- Information, education and communication (IEC) interventions regarding FGM and women’shealth should be provided to girls and women living with any type of FGM (Best practice statement).

BP- Health education information on deinfibulation should be provided to girls and women livingwith type III FGM (Best practice statement).

BP- Health-care providers have the responsibility to convey accurate and clear information, using

language and methods that can be readily understood by clients (Best practice statement).BP- Information regarding different types of FGM and the associated respective immediate andlong-term health risks should be provided to health-care providers who care for girls and womenliving with FGM (Best practice statement).

BP- Information about FGM delivered to health workers should clearly convey the message thatmedicalization is unacceptable (Best practice statement).

4 WHO defines information, education and communication (IEC) interventions as “a public health approach aiming atchanging or reinforcing health-related behaviours in a target audience, concerning a specific problem and within apre-defined period of time, through communication methods and principles”. Source: Information, education andcommunication – lessons from the past; perspectives for the future. Geneva: World Health Organization; 2001.

5 Health education is the provision of accurate, truthful information so that a person can become knowledgeable aboutthe subject and make an informed choice. Source: Training modules for the syndromic management of sexuallytransmitted infections: educating and counselling the patient. Geneva: World Health Organization; 2007.


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. Background

Female genital mutilation (FGM) comprisesall procedures that involve the partial or total

removal of external genitalia or other injuryto the female genital organs for non-medicalreasons (). Although it is internationallyrecognized as a violation of human rights andlegislation to prohibit the procedure has beenput in place in many countries, to date thepractice is still being reported in countriesin Africa and in a few countries in Asia and theMiddle East (, ). Some forms of FGM have alsobeen reported in other countries, includingamong certain ethnic groups in Central andSouth America (). The rise in internationalmigration has also increased the number ofgirls and women living in the various diasporapopulations, including in Europe and NorthAmerica, who have undergone or may undergothe practice (, ).

It is estimated that over million girls andwomen worldwide are living with the effectsof FGM (), and despite efforts to eradicate thepractice, every year some million girls andwomen are at risk of FGM and are thereforeexposed to the potential negative healthconsequences of this harmful practice ().

The World Health Organization (WHO), as partof its core mandate to provide assistance toMember States in achieving the goal of thehighest attainable standard of health for all,issued in an interagency statement oneliminating FGM. The statement describes,among other things, the negative implications ofthe practice for the health and, very importantly,for the human rights of girls and women, anddeclared vigorous support for its abandonment(). The aspiration to alleviate the associatedadverse health conditions and to restore violatedhuman rights constitutes the cornerstone ofthese guidelines.

. Types of FGM

WHO classifies FGM into four types (), as shownin Box .. The first image shows unaltered femalegenitalia for comparison.

. Reasons why FGM isperformed

FGM is practised for a variety of socioculturalreasons, varying from one region and ethnic groupto another. The primary reason is that it is part ofthe history and cultural tradition of the community.In many cultures, it constitutes a rite of passage toadulthood and is also performed in order to confera sense of ethnic and gender identity within thecommunity. In many contexts, social acceptanceis a primary reason for continuing the practice.Other reasons include safeguarding virginity before

marriage, promoting marriageability (i.e. increasinga girl’s chances of finding a husband), ensuringfidelity after marriage, preventing rape, providinga source of income for circumcisers, as well asaesthetic reasons (cleanliness and beauty) (). Some communities believe that FGM is a religiousrequirement, although it is not mentioned in majorreligious texts such as the Koran or the Bible. Infact, FGM predates Islam and is not practised inmany Muslim countries, while it is performed in

some Christian communities ().Whatever the reason provided, FGM reflectsdeep-rooted inequality between the sexes. Thisaspect, and the fact that FGM is an embeddedsociocultural practice, has made its completeelimination extremely challenging. As such,efforts to prevent and thus eventually eradicateFGM worldwide must continue, in additionto acknowledging and assisting the existingpopulation of girls and women already living with

its consequences whose health needs are currentlynot fully met.

. Health risks from FGM

FGM has no known health benefits, and those girlsand women who have undergone the procedureare at great risk of suffering from its complicationsthroughout their lives. The procedure is painfuland traumatic (), and is often performed underunsterile conditions by a traditional practitioner

who has little knowledge of female anatomyor how to manage possible adverse events(). Moreover, the removal of or damage tohealthy genital tissue interferes with the natural


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Box .: Types of FGM*

Unaltered genitalia

Type I Partial or total removal of the clitoris (clitoridectomy) and/or the prepuce

bartholin glands

clitoris

urethra

vaginal introitus

perineum

anus

labia minora

labia majora

prepuce

bartholin glands

clitoris

urethra

vaginal introitus

perineum

anus

prepuce

FGM Type I

Ia: removal of the prepuce/clitoral hood(circumcision)

labia minora

labia majora

bartholin glands

clitoris

urethra

vaginal introitus

perineum

anus

FGM Type I

Ib: removal of the clitoris with

the prepuce (clitoridectomy)

prepuce

labia minora

labia majora

(box continues on next page)

* Abdulcadir J, Catania L, Hindin MJ, Say L, Petignat P, Abdulcadir O. Female Genital Mutilation: A visual reference and

learning tool for healthcare professionals. 2016 (under review).


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Box .: Types of FGM

Type II Partial or total removal of the clitoris and the labia minora, with or without excision of the labiamajora (excision)

bartholin glands

clitoris

urethra

vaginal introitus

perineum

anus

FGM Type II

IIa: removal of the labia minora only

prepuce

labia minora

labia majora

bartholin glands

clitoris

urethra

vaginal introitus

perineum

anus

FGM Type II

IIb: partial or total removal of the

clitoris and the labia minora

prepuce may be affected

labia minora

labia majora

bartholin glands

clitoris

urethra

vaginal introitus

perineum

anus

FGM Type II

IIc: partial or total removal of

the clitoris, the labia minora and

the labia majora

prepuce

labia minora

labia majora

(box continues on next page)


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Box .: Types of FGM

Type III Narrowing of the vaginal orifice with the creation of a covering seal by cutting and appositioningthe labia minora and/or the labia majora, with or without excision of the clitoris (infibulation)

Re-infibulation The procedure to narrow the vaginal opening in a woman after she has beendeinfibulated (i.e. after childbirth); also known as re-suturing

Type IV All other harmful procedures to the female genitalia for non-medical purposes, for example:pricking, pulling, piercing, incising, scraping and cauterization

bartholin glands

clitoris may be affected

urethra

vaginal introitus

perineum

anus

infibulation may be a resultof the healing and notnecessarily of the stitching

FGM Type III


labia minora

labia majora

IIIa: removal and appositioning the labia minora

with or without excision of the clitoris IIIb: removal and appositioning the labia majora

with or without excision of the clitoris

bartholin glands

clitoris may be affected

urethra

vaginal introitus

perineum

anus

infibulation may be a resultof the healing and notnecessarily of the stitching


labia minora may be affected

labia majora

FGM Type III

bartholin glands

clitoris

urethra

vaginal introitus

perineum

anus

FGM Type IV

Unclassified.

prepucepiercing

labia minora

labia majora


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functioning of the body and may cause severalimmediate and long-term genitourinary healthconsequences (–) (see Box .). The evidenceindicates that there might be a greater risk ofimmediate harms with type III FGM, relative totypes I and II, and that these events tend to be

considerably under-reported ().

Regarding the obstetric risks associated with FGM,a WHO study group that conducted an analysison FGM in concluded that women livingwith FGM are significantly more likely than thosewho have not had FGM to have adverse obstetricoutcomes, and that this risk seems to be greaterwith more extensive forms of the procedure (). These adverse outcomes may also affect the healthof the newborn () (see Box .).

For many girls and women, undergoing FGM canbe a traumatic experience that may leave a lastingpsychological mark and cause a number of mentalhealth problems (, ) (see Box .).

Given that some types of FGM involve the removalof sexually sensitive structures, including theclitoral glans and part of the labia minora, somewomen report reduction of sexual response anddiminished sexual satisfaction. In addition, scarring

of the vulvar area may result in pain, includingduring sexual intercourse (, ) (see Box .).

In addition to these health risks, a numberof procedures and day-to-day activities maybe hindered due to anatomical distortions,including gynaecological examinations, cytologytesting, post-abortion evacuation of the uterus,intrauterine device (IUD) placement and tamponusage, especially in the case of type III FGM.

Providing exact data regarding the direct healthimpacts of FGM has been a challenging task dueto the small sample sizes and methodologicallimitations of the available studies. Despite theselimitations, over the past decade or so, evidenceof the direct health impacts of FGM has accrued,enabling recent systematic reviews and meta-analyses to provide summaries of these healthimpacts. Box . contains a summary of all healthrisks related to FGM.

Although there is evidence showing that theseadverse health outcomes are associated withFGM, and that many communities have startedto acknowledge this association, in reality health-

care providers are still often unaware of themany negative health consequences and remaininadequately trained to recognize and treatthem properly.

. FGM and human rights

Recognizing the persistence of FGM despiteconcerted efforts to eradicate or abandon thepractice in some affected communities, andrecognizing the increased need for clear guidanceon the treatment and care of women who haveundergone FGM, WHO has developed theseguidelines to include a focus on human rights andgender inequality ().

In December , the Member States of theUnited Nations (UN) agreed in UN GeneralAssembly resolution / to intensify efforts toeliminate FGM, as a practice that is “an irreparable,irreversible abuse that impacts negatively on thehuman rights of women and girls” ().

For the past several decades, a diverse group ofscholars, advocates, legislators and health-carepractitioners have offered differing views and ideasabout how to best respond to this UN resolution.One consistent and powerful theme in these

conversations is a call for common recognition ofFGM as a denial of girls’ and women’s ability to fullyexercise their human rights and to be free fromdiscrimination, violence and inequality.

FGM violates a series of well-established humanrights principles, norms and standards, includingthe principles of equality and non-discriminationon the basis of sex, the right to life when theprocedure results in death, and the right tofreedom from torture or cruel, inhuman or

degrading treatment or punishment, as well as therights of the child (see Box .). As it interferes withhealthy genital tissue in the absence of medicalnecessity and can lead to severe consequencesfor a woman’s physical and mental health, FGM isalso a violation of a person’s right to the highestattainable standard of health ().

A variety of human rights treaties and agreementshave also pronounced FGM to be a manifestationof violence against girls and women, and a

practice that sustains unequal gender norms andstereotypes that contravene human rights. Humanrights treaty monitoring bodies have consistentlymade clear that harmful practices like FGM


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Box .: Health risks of FGM

Risk Remarks

IMMEDIATE RISKS ,

HaemorrhagePain

Shock Haemorrhagic, neurogenic or septic

Genital tissue swelling Due to inflammatory response or local infection

Infections Acute local infections; abscess formation; septicaemia; genitaland reproductive tract infections; urinary tract infections

The direct association between FGM and HIV remainsunclear, although the disruption of genital tissues mayincrease the risk of HIV transmission.

Urination problems Acute urine retention; pain passing urine; injury tothe urethra

Wound healing problems

Death Due to severe bleeding or septicaemia

OBSTETRIC RISKS ,

Caesarean section

Postpartum haemorrhage Postpartum blood loss of ml or more

EpisiotomyProlonged labour

Obstetric tears/lacerations

Instrumental delivery

Difficult labour/dystocia

Extended maternal hospital stay

Stillbirth and early neonatal death

Infant resuscitation at delivery

SEXUAL FUNCTIONING RISKS ,

Dyspareunia (pain during sexualintercourse)

There is a higher risk of dyspareunia with type III FGMrelative to types I and II ().

Decreased sexual satisfaction

Reduced sexual desire and arousal

Decreased lubrication during sexualintercourse

Reduced frequency of orgasm or

anorgasmia


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constitute a form of discrimination based on sex,

gender, age and other grounds (). Several regionalhuman rights agreements also take up the issue,especially the Protocol on the Rights of Women

in Africa (“the Maputo Protocol”), which mandateslegal prohibition of harmful practices such as FGM(). For a comprehensive list of international and

regional human rights treaties and consensusdocuments providing protection and containingsafeguards against FGM, please see Annex .

The UN Convention on the Elimination of All Forms

of Discrimination against Women (CEDAW) and theUN Convention on the Rights of the Child (CRC)further called for an end to the practice, as have

a variety of other UN human rights treaty bodies(). They have clarified that states’ “obligations torespect, fulfil and protect” the rights of girls and

women require that they take action to ensurethat girls and women can live free from harmfulpractices, such as FGM.

The obligation to respect requires states to refrainfrom interfering directly or indirectly with the

enjoyment of rights. In the case of FGM, it mayrequire states to ensure that the health system is

not used to perform this practice, as is the case

with medicalization of FGM. The obligation tofulfil requires states to take appropriate legislative,administrative, budgetary, judicial and otheractions to prevent and eliminate FGM. Finally, theobligation to protect requires states to ensurethat third parties do not violate the rights of girlsand women and that protective measures are inplace, such as health, legal and social services. This means that states must set in place systemsand structures to support “women and children

who are victims of harmful practices” by ensuringaccess to “immediate support services, includingmedical, psychological and legal services”, as wellas emergency medical services ().

The right to health means that states mustgenerate conditions in which everyone can beas healthy as possible. Despite some progress,governments face persistent challenges in meetingtheir international obligations within their nationallaws and policies related to FGM. These range from

failing to fully implement and enforce existinglaws, failing to foresee and address unintendedconsequences of laws and policies, and takingmisguided actions that may increase the practice,

Box .: Health risks of FGM

Risk Remarks

PSYCHOLOGICAL RISKS

Post-traumatic stress disorder (PTSD)Anxiety disorders

Depression

LONGTERMRISKS ,

Genital tissue damage With consequent chronic vulvar and clitoral pain

Vaginal discharge Due to chronic genital tract infections

Vaginal itching

Menstrual problems Dysmenorrhea, irregular menses and difficulty in passingmenstrual blood

Reproductive tract infections Can cause chronic pelvic pain

Chronic genital infections Including increased risk of bacterial vaginosis

Urinary tract infections Often recurrent

Painful urination Due to obstruction and recurrent urinary tract infections


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such as the medicalization of FGM (see section .),which is often instituted as a harm-reductionmeasure (). Health interventions targeted atwomen suffering from FGM-related complicationscan contribute, from within the health system, tothe safeguarding and restoration of a number of

health-related human rights. In order to achievethis, appropriate evidence-based clinical guidanceaccompanied by adequate training of health-care providers is a key requirement. While thepromotion and protection of human rights isultimately the responsibility of governments, itis clear that health-care providers have a criticalrole to play in ensuring that efforts to eradicateFGM and provide care for women living withFGM are accomplished with the utmost attentionand consideration of girls’ and women’s human

rights ().

. Medicalization of FGM

The medicalization of FGM refers to situations inwhich the procedure (including re-infibulation) ispractised by any category of health-care provider,whether in a public or a private clinic, at home orelsewhere, at any point in time in a woman’s life. This definition was first adopted by WHO in (), and reaffirmed in by UN agencies

in the interagency statement, Eliminating femalegenital mutilation (). The interagency statementstrongly emphasizes that regardless of whetherFGM is carried out by traditional or medicalpersonnel, it represents a harmful and unethicalpractice, with no benefits whatsoever, whichshould not be performed under any circumstances.

Communities may be increasingly turning tohealth-care providers to perform the procedurefor a combination of reasons. An important

contributing factor is the fact that FGM has beenaddressed for years as a health issue, using what isknown as the “health risk approach”. This approachhas involved locally respected health expertsexpressing concern about the health risks of FGM,in the form of a didactic and factual delivery ofmessages (). In several high-prevalence countries,this approach unfortunately did not result inindividuals, families or communities abandoningthe practice, but began to shift it from traditional

circumcisers to modern health-care practitionersin the hope that this would reduce the risk ofvarious complications (, ). This brought to lightthe problem that although providing information

about the associated health risks of FGM is animportant part of its elimination, it is not sufficientto eradicate a practice strongly based on culturalbeliefs and deeply embedded in societal traditions.

As an additional side-effect of the “healthrisk approach” to FGM, some professionalorganizations and governments have increasinglysupported less radical forms of cutting (e.g. thepricking of the clitoris), performed under hygienicand medically controlled conditions; such harm-reduction strategies are an attempt to reducethe risk of severe complications arising fromthe procedure when carried out in precariousconditions.

These circumstances – paired with the fact thata number of health-care providers still considercertain forms of FGM not to be harmful and a largeproportion of them are unable or unwilling tostate a clear position when confronted with crucialissues like requests for performing FGM or re-infibulation () – have contributed to increasing thepopularity of medicalized FGM across Africa andin the Middle East. In addition, the involvement ofhealth-care providers in performing FGM is likelyto confer a sense of legitimacy on the practiceand could give the impression that the procedure

is good for women’s health, or at least that it isharmless ().

Efforts to stop this unintended consequence wereinitiated by WHO in at the first internationalconference on FGM, held in Khartoum, Sudan,where WHO established that it is unacceptableto suggest that performing less invasive formsof FGM within medical facilities will reducehealth complications. Since then, this positionhas been endorsed by numerous other medical

professional associations, international agencies,nongovernmental organizations (NGOs) andgovernments. The condemnation of medicalizationof FGM was further highlighted and reiterated inthe interagency statement on the eliminationof FGM (). It has been recognized that stopping themedicalization of FGM is an essential componentof the holistic, human-rights-based approachtowards the elimination of the practice: whencommunities see that health-care providers have

taken a stand in favour of the abandonment of theprocedure and have refrained from performingit, this will foster local debate and questioning ofthe practice.


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Box .: Human rights violated by the practice of FGM

HUMAN RIGHT RATIONALE

Right to the highest

attainable standard of

health

Because FGM can result in severe physical and mental harm andbecause it constitutes an invasive procedure on otherwise healthy

tissue without any medical necessity, it is seen as a violation of theright to health. The International Covenant on Economic, Socialand Cultural Rights recognizes the right of all human beings to the“highest attainable standard of physical and mental health”().

Right to life and physical

integrity, including

freedom from violence

Right to freedom

from torture or cruel,

inhuman or degradingtreatment

FGM can cause severe physical and mental damage, sometimesresulting in death. As such, it interferes with a woman’s right tolife and physical integrity and freedom from violence. The right tophysical integrity includes the right to freedom from torture, inherentdignity of the person, the right to liberty and security of the person,and the right to privacy. This category of rights is protected by

various human rights instruments including: the Universal Declarationof Human Rights, Articles and ; the International Covenant onEconomic, Social and Cultural Rights, Preamble; the InternationalCovenant on Civil and Political Rights (ICCPR), Preamble and Article ;and the Convention on the Rights of the Child (CRC), Article (–).

Right to equality and

non-discrimination on

the basis of sex

FGM perpetuates the fundamental discriminatory belief of thesubordinate role of girls and women, which fits within the definition ofdiscrimination against women. This refers to “any distinction, exclusionor restriction made on the basis of sex which has the effect or purposeof impairing or nullifying the recognition, enjoyment or exercise by

women, irrespective of their marital status, on a basis of equality ofmen and women, of human rights and fundamental freedoms in thepolitical, economic, social, cultural, civil or any other field” ().

Rights of the Child Because FGM is predominantly performed on girls under the ageof , the issue becomes fundamentally the protection of therights of children. The Convention on the Rights of the Child (CRC)acknowledges the role of parents and families in making decisionsfor children, but places the ultimate responsibility for protecting therights of a child in the hands of the government (Article ). The CRCalso established the “best interests of the child” standard in addressing

the rights of children (Article ). FGM is recognized as a violation of thatbest interest standard and a violation of children’s rights. In addition,the CRC mandates governments to abolish “traditional practicesprejudicial to the health of children” (Article ) ().

On this basis, WHO has issued within these

guidelines a guiding principle statement against

the medicalization of FGM, aiming to stop this

practice (see section .). One fundamental

measure needed to tackle this situation is thecreation of protocols, manuals and guidelines to

guide health-care providers in dealing with issues

related to FGM, including what to do when faced

with requests from parents or family members to

perform FGM on girls, or requests from women

to perform re-infibulation after delivery. Technical

knowledge about how to recognize and manage

complications of FGM, including suitable obstetriccare and how to counsel women on FGM-related

issues, must be provided in order to emphasize

the health-care provider’s role as a caregiver


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rather than a perpetrator (). Therefore, adequate

training becomes not only a preventive measure,

but also an urgently needed tool for coping

with the reality that millions of women have

already undergone FGM and must live with its

consequences.

In the course of developing these guidelines (see

Methods, section .), the Guideline Development

Group (GDG) noted that an increasingly relevant

issue related to FGM is female genital cosmetic

surgery (FGCS). Although parallels may exist

between FGM and FGCS procedures (which

include labial reduction or vaginal tightening

because of social, cultural and community norms

that promote a particular aesthetic of female

beauty and appropriate female bodies), criticaldifferences are evident. FGM as described by

the WHO classification () and referred to within

this document is the result of a procedure that is

performed on individuals without full informed

consent, and who may face profound direct or

indirect coercion to take part in these procedures,

which are done in the absence of any potential

medical benefit. The underlying reasons for

performing FGM in the context discussed

within these guidelines perpetuate deep-rooted

inequality between the sexes and constitute

human rights violations, as described above

and noted in the UN report to the General

Assembly on the Girl Child: FGM is “perpetrated

without a primary intention of violence but is de

facto violent in nature” ().

Thus, although outside of the immediate

scope of these guidelines, the GDG thereby

differentiated FGM from FGCS. In the eventthat FGCS is requested by an individual who is

fully autonomous and able to give consent, the

individual should be given complete preoperative

counselling, including a discussion of normal

variation and physiological changes over the

lifespan, as well as the possibility of unintended

consequences of cosmetic surgery to the genital

area. The lack of evidence regarding outcomes

and the lack of data on the impact of subsequent

changes during pregnancy or menopause should

also be discussed and considered part of the

informed consent process ().

. Objectives of the guidelines

.. Why these guidelines were developed

Following the publication of the interagencystatement on elimination of FGM co-signed byWHO and nine UN partner agencies (), the UN

General Assembly resolution / of December, Intensifying global efforts for the eliminationof female genital mutilations, called on MemberStates to:

. . . protect and support women and girlswho have been subjected to female genitalmutilations and those at risk, including bydeveloping social and psychological supportservices and care, and to take measures toimprove their health, including sexual and

reproductive health, in order to assist womenand girls who are subjected to the practice;

and to:

. . . develop, support and implementcomprehensive and integrated strategies forthe prevention of female genital mutilations,including the training of social workers,medical personnel, community and religiousleaders and relevant professionals, and

to ensure that they provide competent,supportive services and care to womenand girls who are at risk of or who haveundergone female genital mutilations, andencourage them to report to the appropriateauthorities cases in which they believewomen or girls are at risk ().

Since the release of the interagency statement andthe resolution, significant efforts have been madeto counteract FGM, through (i) research to generate

further evidence to inform both policy and healthinterventions; (ii) working with communities onprevention strategies; (iii) advocacy; and (iv) passingof laws. The last involves enabling legislationagainst FGM and focuses primarily on punitivemeasures against practitioners and communitymembers who perform FGM, as well as parentswho support or condone it. Laws against FGMexist in more than half of the countries whereFGM is a traditional practice, as well as in many

of the countries with communities of immigrantsfrom countries where FGM is practised. Whilelegal prohibitions create an important enablingenvironment for abandonment efforts, and


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criminal prosecutions can send a strong messageagainst the practice, if these are not combinedwith education and community mobilization,they risk placing health-care practitioners in theposition of enforcers of punitive policies, potentiallydamaging their relationships with their clients and

limiting their capacity to engage in rights-basedand gender-equality-promoting health practices(). A framework that includes preventive measuresto promote abandonment, as well as punitivemeasures for those who engage in the practice,has been shown to have a positive effect whencoupled with community-based work ().

In spite of the positive signs resulting from theseefforts, prevalence of the practice in many areasremains high and millions of women live today

with the negative health consequences of FGM(). In this regard, the development of pertinent,evidence-based clinical guidelines for healthworkers is of key importance. First and foremost,guidelines help guide clinical decision-making andensure the delivery of standardized, quality healthservices to girls and women currently sufferingcomplications of FGM.

Secondly, guidelines serve as an important basisfor both pre- and in-service medical training

programmes, which are urgently needed notonly in countries with a high prevalence of FGM,but also in high-income countries that are hometo growing diaspora communities of peoplewho have migrated from regions where FGM iswidespread. As a result, health-care providersacross the globe, many of whom have receivedlittle or no formal education on the issue of FGM,may find themselves ill-prepared to make sensitiveenquiries about FGM and to treat and care for girlsand women with FGM-related complications ().

Further, the development of guidelines offers aunique opportunity to systematically review theavailable evidence in specific areas of interest, andin this way to identify and target critical researchgaps that are crucial to expanding our knowledgein any given scientific field.

Lastly, the technical knowledge conveyed withinthese guidelines on how to recognize and managecomplications of FGM makes it clear that the

procedure is inherently harmful to the health ofgirls and women and, what is more, that it is aviolation of several human rights, including thehuman right to the highest attainable standard

of health. This is especially relevant with regardto the efforts to stop medicalization, placingthe emphasis on the role of health workersas caregivers who must not also becomeperpetuators of a harmful practice.

.. Purpose of these guidelines

The main purpose of these guidelines is to provideevidence-informed recommendations on themanagement of health complications associatedwith or caused by FGM.

The guidance provided covers selected topicsrelated to FGM that were considered criticallyimportant by an international, multidisciplinarygroup of health-care providers, patient advocatesand other stakeholders. These guidelines, therefore,

do not include all reported FGM-related healthconditions, but this should on no account be takento indicate that those conditions are not also real orimportant.

Additionally, these guidelines, and in particular theknowledge gaps it identifies, may be used as ablueprint for the design of research protocols thatcould further enrich the scarce evidence currentlyavailable on the management of health conditionsthat may arise from FGM.

.. Target audience

These guidelines are intended primarily for health-care professionals involved in the care of girls andwomen who have been subjected to any form ofFGM. These health-care professionals may include,among others, obstetricians and gynaecologists,surgeons, general medical practitioners, midwives,nurses and other country-specific health cadres.Health-care professionals involved in theprovision of mental health care and educationalinterventions, such as psychiatrists, psychologistsand social workers, are also part of the targetaudience. This document also provides guidancefor policy-makers, health managers and others incharge of planning, funding and implementingpre- and in-service professional training, and forthose responsible for developing training curriculain the areas of medicine, nursing, midwifery andpublic health.


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. Methods

This document was developed according tothe standards and requirements specified in the

WHO handbook for guideline development, secondedition (). In summary, the process included:(i) identification of critical research questionsand outcomes; (ii) commission of systematicreviews to experts; (iii) retrieval of evidence;(iv) quality assessment and synthesis of theevidence; (v) presentation of the evidence usinga structured approach; and (vi) formulation ofrecommendations.

. Guideline contributors The guideline development process was guidedby three main groups (a detailed descriptionof their roles is available in Annex ). The WHOSteering Group, comprising a core group ofWHO staff members and consultants from theAdolescents and at-Risk Populations team withinthe Department of Reproductive Health andResearch, led the guideline development process. The Guideline Development Group (GDG),

formed of external (non-WHO) internationalstakeholders, including health-care providers,researchers, health programme managers, humanrights lawyers and women’s health advocates,advised on the content of the guidelines andformulated the evidence-based recommendations.Finally, an External Review Group (ERG) ofrelevant international stakeholders reviewed thefinal guideline document to identify any factualerrors and commented on the clarity of thelanguage, contextual issues and implications forimplementation.

. Declaration of interests byexternal contributors

All GDG members and other external contributorswere required to complete a standard WHODeclaration of Interest (DOI) form before engagingin the guideline development process and takingpart in any of the guideline meetings. Before

finalizing experts’ invitations to participate inthe development of the guidelines, the WHOSteering Group reviewed all the DOI forms usingthe criteria for assessing the severity of a conflict

of interest in the WHO handbook for guidelinedevelopment (). None of the meeting participants

declared a conflict of interest that was consideredsignificant enough to pose any risk to the guidelinedevelopment process or to reduce its credibility. Asummary of the DOI statements and how conflictsof interest were managed is included in Annex .

. Identification of priorityresearch questions and outcomes– scoping exercise

After an initial scoping review of the availableliterature, the WHO Steering Group identifiedand drafted a list of potential priority questionsand outcomes related to health complicationsfrom FGM using the population, intervention,comparator, outcome (PICO) format. Thispreliminary list was then presented to the GDGduring the first guideline development meetingheld in Geneva, Switzerland, in February .Based on the outputs of this meeting, an onlinescoping survey containing the updated list of

potential research questions was prepared inorder to obtain input. Survey participants wereasked to rate the importance of the questionson a scale from to and to provide input onthe selection and rating of the outcomes. In thiscontext, questions that scored between and were ranked as “critical”, while those with a scorebetween and were considered as “important,but not critical”. The questions that scored lowerthan were not considered to be important forthe purposes of these guidelines. A web annexcontaining the scoping survey and the completelist of questions is available upon request.

The survey was sent out electronically tointernational experts in the field of FGM nominatedby members of the GDG. In an effort to includeas many respondents as possible, a public linkto the survey, was included on the Departmentof Reproductive Health and Research website.Provided that all potential questions were ranked

either as “critical” or “important, but not critical” bysurvey respondents, and given that the number ofsystematic reviews that could be commissionedwas limited due to resources, the WHO Steering


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Group agreed to include the most highly ratedquestions in the scope of the guidelines.

Given that the initial search for articles performedby the systematic review team revealed a paucityof robust studies pertaining to almost all relevantresearch topics, the WHO Steering Group, inconjunction with the systematic review leadinvestigator and the guideline methodologist (seeAnnex ), revised the list of questions in an effortto broaden their scope. Thus, complying with thepriority topics selected by survey participants,a number of questions that shared the sameintervention were identified and merged intoa broader research question that included thecommon intervention and an expanded list ofoutcomes. Both the original and prioritized lists of

research questions are available upon request.

. Evidence retrieval

A systematic and comprehensive retrieval ofevidence was conducted to identify publishedstudies concerning the FGM-related healthcomplications prioritized during the scopingexercise. None of the priority questions could beanswered using an existing, recent systematicreview (published less than two years prior) of

currently available publications. Therefore, toinform the development of the recommendations, new reviews were commissioned from anexternal team of systematic reviewers fromthe Nigerian Branch of the South AfricanCochrane Centre.

A standard protocol was prepared for eachsystematic review, containing the PICO questionand the criteria for identification of studies,including search strategies, methods for assessing

risk of bias and the plan for data analysis. The WHOSteering Group and the guideline methodologistreviewed and endorsed the protocols beforethe team of reviewers carried out each review. To identify relevant studies, systematic searchesof several electronic databases were conducted,including MEDLINE, CENTRAL via CSRO, CINHALPlus (EBSCOhost), Web of Science, SCOPUS,PILOT, African Index Medicus, LILACS, PsycINFO(EBSCOhost), POPLINE, WHOLIS via LILACS, ERIC

(EBSCO host), NYAM Library, ClinicalTrials.gov,African Journals Online (AOL) and Pan AfricanClinical Trials Registry. The search strategiesemployed to identify the studies and the specific

criteria for inclusion and exclusion of studieswere reported using the PRISMA Guidelines andflow diagram, and are described in the individualsystematic reviews. There were no restrictions onlanguage or publication dates.

. Quality assessment, synthesisand grading of the evidence

The external team of systematic reviewersperformed a quality assessment of the body ofevidence using the Grading of RecommendationsAssessment, Development and Evaluation (GRADE)methodology. Following this approach, thequality of evidence for each outcome was ratedas “high”, “moderate”, “low” or “very low”, basedon the following set of pre-established criteria:

(i) limitations in the study design and execution;(ii) inconsistency of the results; (iii) indirectness;(iv) imprecision; and (v) publication bias ().

In the final step of the assessment process, GRADEprofiler software was used to construct GRADEevidence profiles (or “summary of findings” tables)for each priority research question for whichevidence was available; these tables include theassessments and judgements relating to theelements described above and the illustrative

comparative risks for each outcome and areavailable in the Web Annex: GRADE tables.

. Qualitative research andhuman rights evidence

To obtain evidence on the values and preferencesof girls and women living with FGM andhealth workers who provide health care to thispopulation, four additional systematic reviews ofqualitative research were carried out by an external

consultant in collaboration with the WHO SteeringGroup. These reviews focused on the contexts andconditions surrounding:

medical/surgical interventions

psychological interventions

counselling interventions and

health information interventions.

6 Further information available at:http://www.gradeworkinggroup.org/

7 Available at: http://www.who.int/reproductivehealth/topics/fgm/management-health-complications-fgm/en/


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Each of these four qualitative systematic reviewsaimed to: (i) understand stakeholder experiencesand perceptions of the interventions; (ii) identifyand summarize contextual barriers and facilitatorsto implementation of the interventions; and(iii) explore how the context and conditions of

implementation relate to the outcomes reported inthe effectiveness reviews.

Given that the provision of health services towomen living with FGM should be accomplishedwith the utmost care and consideration of girls’and women’s human rights, two literature reviewswere commissioned from an external group ofhuman rights experts to better understand thepublic health and human rights/gender equalitylinkages that pertain to FGM. These two reviews

sought to identify evidence on: (i) interventionsto address and/or promote gender equality andhuman rights in the context of FGM programmesand policies; and (ii) how specific manifestations ofgender inequality and neglect/violations of humanrights affect and are affected by FGM.

The evidence obtained from the above-mentionedreviews helped inform the GDG about the valuesand preferences and human rights and equityissues, which constituted important considerations

in deciding on the direction and strength of theissued recommendations.

. Formulation ofrecommendations

Prior to the second guideline developmentmeeting, which took place in September ,the guideline methodologist in conjunction withmembers of the WHO Steering Group formulatedan initial draft statement for each priority question,

which served as a blueprint for each of the finalizedrecommendations and some of the best practicestatements. During the September meeting,all draft statements, evidence summaries andcorresponding GRADE tables (where evidence wasavailable) were presented to the GDG members.Before issuing a final recommendation or bestpractice statement, participants discussed thepresented evidence and systematically reviewedeach proposed draft statement considering a set ofestablished criteria (see Box .).

Box .. Factors considered while

formulating each recommendation and

best practice statement

Quality of the available evidence

Balance between benefits and harms

Values and preferences of girls and womenliving with FGM, and of health-care providers

Resource implications

Priority of the addressed health problem

Equity and human rights issues

Acceptability of the proposed intervention

Feasibility of the proposed intervention

Using each draft statement as a startingpoint, participants could decide torecommend, recommend against, or notmake a final recommendation or best practicestatement. Additionally, before issuing a finalrecommendation, the strength of each issuedstatement was agreed upon. The GDG’s use ofthe different categories for the strength of a

recommendation is explained in Annex .

Best practice statements were issued when theavailable direct evidence was of low quality orabsent, and the contents of the recommendedstatement were based on sound practical judgement, in addition to being supported byhuman rights and equity principles, public healthor medical practice, and when they were judged tocarry little to no risk of harm to health.

The final adoption of each best practicestatement and recommendation – and itsstrength – was decided by consensus, which wasdefined as the agreement of all the participants.Unanimous agreement was reached for all butone recommendation. This recommendationwas put to vote and stood by simple majority. This situation was recorded as such in the textaccompanying the recommendation. WHO staff atthe meeting, external technical experts involvedin the collection and grading of the evidence, and

observers were not eligible to vote.


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. Document preparation andpeer review

Following the GDG meeting, members of theWHO Steering Group prepared a draft of thefull guideline document containing all the

recommendations and best practice statementsformulated by the GDG as well as the key pointsof the deliberations and decisions of the meetingparticipants. The draft guidelines were then sentelectronically to all GDG members for furthercomments before being sent to the External

Review Group (ERG) for peer review (for a full listof the ERG members, please see Annex ). TheWHO Steering Group carefully evaluated all theinput from the ERG members, which was limitedto correction of factual errors and language clarity,and provided responses to each of their comments

and then sent these responses back to eachexternal reviewer. No major disagreements aroseduring this process and no modifications weremade to the direction, strength or content of therecommendations.


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. Guidance

During the guideline development meetingin September , the participants adopted

three guiding principle statements, fiverecommendations and eight best practicestatements covering health interventions forpreventing and treating health risks of FGM.

. Guiding principles

Decades of prevention work undertaken by localcommunities, governments, and national andinternational organizations have contributed toa reduction in the prevalence of FGM in some

areas (). However, the overall rate of decline inprevalence of FGM has been slow. Therefore, allrecommendations and best practice statementsissued in these guidelines are framed by thefollowing three guiding principles that reflect thestance of WHO and a wider group of UN agencies and the Guideline Development Group (GDG)with regard to FGM and the need to end thisharmful practice.

I Girls and women living with FGM haveexperienced a harmful practice and should beprovided quality health care.

II All stakeholders – at the community,national, regional and international level –should initiate or continue actions directedtowards primary prevention of FGM.

III Medicalization of FGM (i.e. performanceof FGM by health-care providers) is never

acceptable because this violates medicalethics since (i) FGM is a harmful practice;(ii) medicalization perpetuates FGM; and(iii) the risks of the procedure outweigh anyperceived benefit.

8 OHCHR, UNAIDS, UNDP, UNECA, UNESCO, UNFPA,UNHCR, UNICEF, UN Women (formerly UNIFEM). See list ofacronyms for full agency names.

. Recommendations and bestpractice statements

The recommendations contained in theseguidelines were issued after consideration of theexisting evidence (when available) and its quality,in addition to a series of factors as mentioned insection : Methods (see Box .).

In general, the quality of evidence was lowacross most recommendations and best practicestatements, and for a number of topic areas noevidence was available. Despite the low quality or

non-existence of the evidence, some interventionswere endorsed and labelled as “best practicestatements” if they were supported by the GDG’ssound practical judgement. These statementswere also required to carry little to no risk of harmto health, and be supported by internationallyrecognized human rights standards and principles.

The justification for each of these decisions wasrecorded, along with key issues that need to beconsidered for implementation. The corresponding

research gaps identified in each topic area werealso included. Where clinical recommendationswere based on indirect evidence (i.e. evidence thatwas not directly from the population of womenliving with FGM), this was labelled accordingly.

.. Deinfibulation (recommendations –and best practice statements –)

Deinfibulation is a minor surgical procedure carriedout to re-open the vaginal introitus in womenliving with type III FGM. In order to achieve this, a

trained health professional performs an incisionof the midline scar tissue that covers the vaginalintroitus until the external urethral meatus, andeventually the clitoris, are visible. The cut edgesare then sutured, which allows the introitus toremain open. This procedure is performed toimprove health and well-being, as well as to allowintercourse and/or to facilitate childbirth.


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Recommendation : Deinfibulation is recommended for preventing and

treating obstetric complications in women living with type III FGM

Strength of recommendation: Strong (very low-quality evidence)

SUMMARY OF EVIDENCE SEE WEB ANNEX: GRADE TABLES

The evidence was extracted from a systematic review investigating the effects of deinfibulationfor preventing and treating obstetric complications in women with type III FGM (). The reviewincluded four case–control studies: two conducted in the United Kingdom (, ) and two in SaudiArabia (, ).

Two studies compared women with type III FGM. One group had deinfibulation during labour andthe other laboured and delivered without deinfibulation (, ). The studies found better obstetricoutcomes among women who underwent deinfibulation during labour, compared with womenwho remained infibulated. Caesarean section and postpartum haemorrhage rates were statistically

significantly lower in women with deinfibulation (very low-quality evidence). Two studies compared women with type III FGM who underwent deinfibulation during labour towomen who had never undergone FGM (therefore, non-infibulated) (, ). Both groups had similarrates of episiotomy and duration of second stage of labour. Rouzi et al. () further showed, whencomparing women with deinfibulation to women who had not undergone FGM, that their meanamount of blood loss, length of maternal hospital stay (in days), and rates of caesarean section, vaginallacerations, and newborns’ Apgar scores at and minutes were not statistically different (very low-quality evidence).

Additional evidence from a WHO collaborative prospective study carried out in six African countriesshows a potentially causal, dose-response risk between increasingly extensive types of FGM

and adverse obstetric and neonatal outcomes, with greater risk for adverse reproductive healthoutcomes with FGM types II and III (). The evidence further suggests that FGM does not impact fetaldevelopment (no association between FGM and birth weight), but has an impact on delivery, withhigher rates of fresh stillbirths among women living with FGM ().

RATIONALE

Considering the potential dose–response relationship described between the types of FGM andthe risk of obstetric complications, and based on the clinical benefits described within the evidencereviews, which in addition show that when using women who were never infibulated as controls,

performing deinfibulation during vaginal delivery is a management option that does not increase thelikelihood of superimposed obstetric complications, the GDG recommended reversing type III FGMthrough deinfibulation for preventing and treating obstetric complications.

In addition the GDG noted:

Based on the causal relationship between type III FGM (infibulation) and a number of healthcomplications identified by the WHO collaborative prospective study carried out in six Africancountries (), deinfibulation can be considered as a surgical procedure that can re-open the narrowedintroitus, restoring the anatomy of the pelvic outlet (to the extent possible). This may contribute toa reduction of overall health-care costs by encouraging a trial of labour (rather than using history

of FGM alone as the indication for caesarean section), or avoiding severe perineal injury due tospontaneous lacerations or episiotomy performed at the time of delivery. Both caesarean section andrepair of third- and fourth-degree lacerations require significantly higher levels of surgical skill and


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may themselves have longer-term adverse outcomes resulting in higher health-care costs (e.g. careand management of urinary incontinence due to pelvic floor instability, conditions that may arise as aresult of perineal lacerations).

In addition to being medically unnecessary, FGM interferes with healthy genital tissue and can leadto severe consequences for a woman’s physical and mental health. Its practice has therefore been

considered by international and regional human rights bodies as a violation of a person’s right to thehighest attainable standard of health. When performed with informed consent, restoring the anatomyand physiology (to the extent possible) through deinfibulation may therefore be seen as a necessarypart of upholding a woman’s right to health and ensuring access to health-care goods and servicesneeded by women to enjoy the full extent of this right.

IMPLEMENTATION REMARKS

Providers conducting deinfibulation must be adequately trained on how to carry out this surgicalprocedure. Nonetheless, the relatively simple nature of this surgical procedure would allow for the

training of mid-level health workers to perform deinfibulation, with the consequent reduction of therequired human and financial resources.

Available qualitative evidence shows that the lack of knowledge among health workers regardingdeinfibulation is not only an important reason why providers may avoid performing deinfibulation,even in contexts in which it has been requested, but it also affects women who describe theproviders’ inexperience as a significant source of fear (). The GDG therefore noted that adequatehealth-care provider training is a crucial and urgently needed step in the implementation of thisrecommendation.


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Recommendation : Either antepartum or intrapartum deinfibulation is

recommended to facilitate childbirth in women living with type III FGM,

depending on the context

Strength of recommendation: Conditional (very low-quality evidence)

Given that both antepartum and intrapartum deinfibulation appear to be comparable in terms ofobstetric outcomes, the decision about the timing of the procedure should be based on the followingcontextual factors:

preference of the woman

access to health-care facilities

place of delivery

health-care provider’s skill level.

SUMMARY OF EVIDENCE SEE WEB ANNEX: GRADE TABLES

Evidence on the timing of deinfibulation for childbirth in women with type III FGM was extractedfrom a systematic review investigating the effects of antepartum or intrapartum deinfibulation onthe outcomes of childbirth (). The review included five retrospective, observational studies: twoconducted in the United Kingdom (, ), two in Saudi Arabia (, ), and one in Sweden ().

The analysis was limited to the two case–control studies (, ) that directly compared the timingof deinfibulation – antepartum and intrapartum. The findings show that duration of labour, perineallacerations, postpartum haemorrhage, and rates of episiotomy were not significantly different basedon the timing of deinfibulation (very low-quality evidence).

RATIONALE

According to the available evidence, obstetric outcomes appear comparable irrespective of the timingof deinfibulation – antepartum or intrapartum – between women living with type III FGM who aredeinfibulated and women who present in labour with no infibulation (low certainty).

Given the above, and due to the paucity of direct evidence on women’s preferences regarding thetiming of deinfibulation, members of the GDG considered that the decision should be founded on thefollowing contextual factors.

. Preference of the woman: Women should be consulted on their preferences. For example, if a

client places high importance on the postoperative aesthetic results, antepartum dein

who guidelines eng

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