Greater Manchester EUR Policy Statement on: Labiaplasty GM Ref: GM027 Version: 3.0 (15 Nov 2017)

Greater Manchester EUR Policy Statement on: Labiaplasty GM Ref: GM027 Version: 3.0 (15 Nov 2017)

Commissioning Statement Labiaplasty Policy Exclusions Labiaplasty carried out as the result of obstetric trauma in the period of care immediately following the trauma (usually expected to be done within 72 hours). This does not apply to procedures as part of gender realignment - please refer to the NHS England commissioning policy for details on gender realignment surgery. Where labiaplasty is clinically indicated as part of the treatment pathway for the correction of female genital mutilation, this is considered part of the treatment pathway and is excluded from this policy. Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect). Policy Inclusion Criteria Labiaplasty is NOT commissioned for aesthetic reasons. Funding may be considered on an individual patient basis: Where there is objective evidence of significant anatomical distortion as a result of obstetric trauma (where the repair was not undertaken at the time of trauma) OR For revision surgery (where the immediate repair post obstetric trauma was clinically unsatisfactory) OR For other trauma and vulval diseases OR For revision labiaplasty where the original surgery was privately funded, if there is sufficient supporting evidence of functional problems. Funding Mechanism: Individual funding request (exceptional case) approval: Requests must be submitted with all relevant supporting clinical evidence. Clinical Exceptionality Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. Exceptionality means a person to which the general rule is not applicable. Greater Manchester sets out the following guidance in terms of determining exceptionality; however the over-riding question which the IFR process must answer is whether each patient applying for exceptional funding has demonstrated that his/her circumstances are exceptional. A patient may be able to demonstrate exceptionality by showing that s/he is: Significantly different to the general population of patients with the condition in question. and as a result of that difference They are likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition. GM Labiaplasty Policy v3.0 FINAL Page 2 of 16

Contents Commissioning Statement... 2 Policy Statement... 4 Equality & Equity Statement... 4 Governance Arrangements... 4 Aims and Objectives... 4 Rationale behind the policy statement... 5 Treatment / Procedure... 5 Epidemiology and Need... 5 Adherence to NICE Guidance... 5 Audit Requirements... 6 Date of Review... 6 Glossary... 6 References... 6 Governance Approvals... 6 Appendix 1 Evidence Review... 8 Appendix 2 Diagnostic and Procedure Codes... 14 Appendix 3 Version History... 15 GM Labiaplasty Policy v3.0 FINAL Page 3 of 16

Policy Statement Greater Manchester Shared Services (GMSS) Effective Use of Resources (EUR) Policy Team, in conjunction with the GM EUR Steering Group, have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document. In creating this policy GMSS/GM EUR Steering Group have reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR). Equality & Equity Statement GMSS/CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. GMSS/CCGs are committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, GMSS/CCGs will have due regard to the different needs of protected characteristic groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GMSS EUR Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their starting point is considered to be further back than any other group. This will be reflected in GMSS evidencing taking due regard for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact policyfeedback.gmscu@nhs.net. Governance Arrangements Greater Manchester EUR policy statements will be ratified by the Greater Manchester Association Governing Group (GMAGG) prior to formal ratification through CCG Governing Bodies. Further details of the governance arrangements can be found in the GM EUR Operational Policy. Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by: reducing the variation in access to treatments/procedures. GM Labiaplasty Policy v3.0 FINAL Page 4 of 16

ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. promoting the cost-effective use of healthcare resources. Rationale behind the policy statement Labiaplasty is an increasingly sought after aesthetic procedure and demand on NHS services to provide it is increasing. As this is a predominantly aesthetic procedure this policy has been developed to target a scarce resource at those cases where there is a clinical indication for surgery. Treatment / Procedure Labiaplasty is a surgical procedure that removes excess tissue from the labia, usually the labia minora, although both can be reduced. The idea is to make the labia smaller and it is performed in hospital, usually under general anaesthetic and is done in one of two ways, either by reducing the edges of the labia, or by snipping out a 'V' shape wedge of tissue. The remaining edges are then carefully sewn back together taking care to obtain as natural a result as possible. The demand for labiaplasty on the NHS is increasing; however, as this is essentially a cosmetic procedure carried out on healthy tissues it is not routinely commissioned. On rare occasions it may be carried out for functional reasons, such as: When the labia are directly contributing to recurrent disease or infection. When repair of the labia is required after trauma. Figure 1: External female genitalia Epidemiology and Need This is an aesthetic procedure so the exact incidence and prevalence is not known, as labiaplasty is requested mainly to address a perception of abnormality but demand for this treatment on the NHS is increasing. Adherence to NICE Guidance NICE have not currently issued guidance on this treatment. GM Labiaplasty Policy v3.0 FINAL Page 5 of 16

Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request. Date of Review Five years from the date of the last review, unless new evidence or technology is available sooner. The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review. Glossary Term Aesthetic Gender realignment (aka gender reassignment) Genital Labia Labiaplasty Meaning Concerned with beauty or the appreciation of beauty. 13The process whereby a person s physical sexual characteristics are changed by means of medical procedures such as surgery or hormone treatment. Relating to the reproductive organs. The inner and outer folds of the vulva, at either side of the vagina. A plastic surgery procedure for altering the labia minora and the labia majora. References 1. GM EUR Operational Policy Governance Approvals Name Date Approved Greater Manchester Effective Use of Resources Steering Group 17/09/2014 Greater Manchester Chief Finance Officers / Greater Manchester Directors of Commissioning 20/10/2014 Greater Manchester Association Governing Group 04/11/2014 Bury Clinical Commissioning Group 04/02/2015 Bolton Clinical Commissioning Group 28/11/2014 Heywood, Middleton & Rochdale Clinical Commissioning Group 21/11/2014 Central Manchester Clinical Commissioning Group 15/01/2015 North Manchester Clinical Commissioning Group 12/11/2014 Oldham Clinical Commissioning Group 04/12/2014 Salford Clinical Commissioning Group 04/11/2014 South Manchester Clinical Commissioning Group 14/01/2015 GM Labiaplasty Policy v3.0 FINAL Page 6 of 16

Stockport Clinical Commissioning Group 03/12/2014 Tameside & Glossop Clinical Commissioning Group 05/11/2014 Trafford Clinical Commissioning Group 18/11/2014 Wigan Borough Clinical Commissioning Group 05/11/2014 GM Labiaplasty Policy v3.0 FINAL Page 7 of 16

Appendix 1 Evidence Review Labiaplasty GM027 Search Strategy The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; and the relevant Royal College and any other relevant bespoke sites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below: Database General Search (Google) Medline / Open Athens Royal College Website Other Result Provider websites (not cited) A large multicenter outcome study of female genital plastic surgery Goodman MP, Placik OJ, Benson RH III, Miklos JR, Moore RD, Jason RA, Matlock DL, Simopoulos AF, Stern BH, Stanton RA, Kolb SE, and Gonzalez F J Sex Med 2010;7:1565 1577 What's normal? Influencing women's perceptions of normal genitalia: an experiment involving exposure to modified and nonmodified images C Moran,et al, BJOG An International Journal of Obstetrics and Gynaecology Volume 121, Issue 6; May 2014 ;Pages 761 766 What motivates her : Motivations for considering labial reduction surgery as recounted on women s online communities and surgeons websites Zwier S, Sex Med; 2014;2:16 23 Is elective vulvar plastic surgery ever warranted, and what screening should be done preoperatively?, Goodman MP, Bachmann G, Johnson C, Fourcroy JL, Goldstein A, Goldstein G, and Sklar S. J Sex Med 2007;4:269 276. Aesthetic Genital Surgery: Female Genital Aesthetic Surgery (Aesthetic Genital Surgery, Designer Vaginas), British Association of Plastic and Aesthetic surgeons BJOG release: Expectations and experience of labial reduction, Royal College of Obstetricians and Gynaecologists Ethical opinion paper: Ethical considerations in relation to female genital cosmetic surgery (FGCS), Royal College of Obstetricians and Gynaecologists (added at review November 2015 Armed Forces Interim Clinical Commissioning Policy: Labiaplasty, Vaginoplasty and Hymenorrhaphy, NHS England Summary of the evidence Most studies agree that this is an aesthetic procedure with very limited numbers of cases where surgical intervention is medically indicated. Expert opinion designates this as an aesthetic procedure and notes that alternative approaches to dealing with perceptions are not readily accessible. Increasing awareness of an idealised normal is also leading to increased demand. There are very few situations where this procedure is medically indicated, these are usually related to trauma. GM Labiaplasty Policy v3.0 FINAL Page 8 of 16

Full details of the Evidence Review are contained with Appendix 1. The evidence Levels of evidence Level 1 Level 2 Level 3 Level 4 Level 5 Meta-analyses, systematic reviews of randomised controlled trials Randomised controlled trials Case-control or cohort studies Non-analytic studies e.g. case reports, case series Expert opinion 1. LEVEL 3: CROSS SECTIONAL STUDY / REVIEW A large multicenter outcome study of female genital plastic surgery, Goodman MP, Placik OJ, Benson RH III, Miklos JR, Moore RD, Jason RA, Matlock DL, Simopoulos AF, Stern BH, Stanton RA, Kolb SE, and Gonzalez F, J Sex Med 2010;7:1565 1577 ABSTRACT Introduction: Female Genital Plastic Surgery, a relatively new entry in the field of Cosmetic and Plastic Surgery, has promised sexual enhancement and functional and cosmetic improvement for women. Are the vulvovaginal aesthetic procedures of Labiaplasty, Vaginoplasty/Perineoplasty ( Vaginal Rejuvenation ) and Clitoral Hood Reduction effective, and do they deliver on that promise? For what reason do women seek these procedures? What complications are evident, and what effects are noted regarding sexual function for women and their partners? Who should be performing these procedures, what training should they have, and what are the ethical considerations? Aim: This study was designed to produce objective, utilizable outcome data regarding FGPS. Main Outcome Measures: 1) Reasons for considering surgery from both patient's and physician's perspective; 2) Pre operative sexual functioning per procedure; 3) Overall patient satisfaction per procedure; 4) Effect of procedure on patient's sexual enjoyment, per procedure; 5) Patient's perception of effect on her partner's sexual enjoyment, per procedure; 6) Complications. Methods: This cross sectional study, including 258 women and encompassing 341 separate procedures, comes from a group of twelve gynecologists, gynecologic urologists and plastic surgeons from ten centers in eight states nationwide. 104 labiaplasties, 24 clitoral hood reductions, 49 combined labiaplasty/clitoral hood reductions, 47 vaginoplasties and/or perineoplasties, and 34 combined labiaplasty and/or reduction of the clitoral hood plus vaginoplasty/perineoplasty procedures were studied retrospectively, analyzing both patient's and physician's perception of surgical rationale, pre operative sexual function and several outcome criteria. Results: Combining the three groups, 91.6% of patients were satisfied with the results of their surgery after a 6 42 month follow up. Significant subjective enhancement in sexual functioning for both women and their sexual partners was noted (16Tp16T = 0.0078), especially in patients undergoing vaginal tightening/perineal support procedures. Complications were acceptable and not of major consequence. Conclusions: While emphasizing that these female genital plastic procedures are not performed to correct abnormalities, as there is a wide range of normality in the external and internal female genitalia, both parous and nulliparous, many women chose to modify their vulvas and vaginas. From the results of this large study pooling data from a diverse group of experienced genital plastic surgeons, outcome in both general and sexual satisfaction appear excellent. 2. LEVEL N/A: PSYCHOLOGY STUDY What's normal? Influencing women's perceptions of normal genitalia: an experiment involving exposure to modified and nonmodified images, C Moran,et al, BJOG An International Journal of Obstetrics and Gynaecology Volume 121, Issue 6; May 2014; Pages 761 766 GM Labiaplasty Policy v3.0 FINAL Page 9 of 16

16TP16T < = ABSTRACT Objective: Examine women's perceptions of what is normal and desirable in female genital appearance. Design: Experiment with random allocation across three conditions. Setting: Community Sample: A total of 97 women aged 18 30 years. Methods: Women were randomly assigned to view a series of images of (1) surgically modified vulvas or (2) nonmodified vulvas, or (3) no images. They then viewed and rated ten target images of surgically modified vulvas and ten of unmodified vulvas. Main outcome measures: Women used a four point Likert scale ( strongly agree to strongly disagree ), to rate each target image for looks normal and represents society's ideal. For each woman, we created two summary scores that represented the extent to which she rated the unmodified vulvas as more normal and more society's ideal than the modified vulvas. Results: For ratings of normality, there was a significant effect for condition (16TF16TR2,94R = 2.75 16TP16T 0.007, = 0.082): women who had first viewed the modified images rated the modified target vulvas as more normal than the nonmodified vulvas, significantly different from the control group, who rated them as less normal. For ratings of society's ideal, there was again a significant effect for condition (16TF16TR2,92R = 7.72, 0.001, = 0.125); all three groups rated modified target vulvas as more like society's ideal than the nonmodified target vulvas, with the effect significantly strongest for the women who had viewed the modified images. Conclusions: Exposure to images of modified vulvas may change women's perceptions of what is normal and desirable. This may explain why some healthy women seek labiaplasty. 3. LEVEL N/A: PSYCHOLOGY STUDY What motivates her : Motivations for considering labial reduction surgery as recounted on women s online communities and surgeons websites, Zwier S, Sex Med; 2014;2:16 23 ABSTRACT Introduction: Increasing numbers of women are seeking labial reduction surgery. We studied the motivations for considering labial reduction surgery as recounted on women s online communities and surgery provider s websites. Aims: The study analyzed motivations for considering labial reduction surgery expressed by women on online communities, looked at the role of the women s age and nationality, compared findings with motivations indicated on the websites of an international sample of surgery providers, and identified similarities to and differences from what is known from extant studies. Methods: Quantitative content analysis of the posts of 78 American, British, and Dutch women on online communities, and 40 international surgery providers websites about labial reduction surgery was conducted. Main Outcome Measures: Main outcome measures concerned the incidence and prominence of different motivational categories (functional/emotional and discomfort/enhancement related). Differences in motivations as a function of age, national background, and women s vs. surgeons stated motivations were tested. Results: Emotional discomfort regarding self-appearance and social and sexual relationships was found to be the most frequent and most prominent motivation for considering labial reduction surgery on women s online communities, regardless of age and national background. Functional discomfort and desired emotional enhancement ranked second. Very few age or national differences were found. The surgeons websites recognized functional discomfort more and elaborated upon emotional issues in sexual relationships less than members of the online communities. Conclusions: Feelings of emotional and psychosexual distress in addition to functional distress are a highly prevalent motivation among women considering labial reduction surgery. Emotional distress GM Labiaplasty Policy v3.0 FINAL Page 10 of 16

appears to be greater and more freely emphasized when women communicate on online communities, while functional issues appear to receive greater notice on surgery provider s websites. 4. LEVEL 5: EXPERT OPINION Is elective vulvar plastic surgery ever warranted, and what screening should be done preoperatively?, Goodman MP, Bachmann G, Johnson C, Fourcroy JL, Goldstein A, Goldstein G, and Sklar S. J Sex Med 2007;4:269 276 ABSTRACT Introduction: Elective vulvar plastic surgery was the topic of a heated discussion on the list-serve of the International Society for the Study of Women's Sexual Medicine. At the suggestion of a board member, it was determined that this discussion might of interest to journal readers in the form of a published controversy. Methods: Six people with expertise and/or strong opinions in the area of vulvar health, several of whom had been involved in the earlier online discussion, were invited to submit evidence-based opinions on the topic. Main Outcome Measure: To provide food for thought, discussion, and possible further research in a poorly discussed area of sexual medicine. Results: Goodman believes that patients should make their own decisions. Bachmann further states that, while that is a woman's right, she should be counselled first, because variations in looks of the vulvar region are normal. Johnson furthers this thought, discussing the requirement for counselling before performing reinfibulation surgery on victims of female genital cutting. Fourcroy emphasizes the need to base surgical procedures on safety and efficacy in the long term, and not merely opportunity at the moment. Goldstein and Goldstein state that, based on the four principles of ethical practice of medicine, vulvar plastic surgery is not always ethical, but not always unethical. Sklar pursues this thought further, pointing out specific examples in regard to the principles of ethics. Conclusion: Vulvar plastic surgery may be warranted only after counselling if it is still the patient's preference, provided that it is conducted in a safe manner and not solely for the purpose of performing surgery. 5. LEVEL 5: EXPERT OPINION Aesthetic Genital Surgery: Female Genital Aesthetic Surgery (Aesthetic Genital Surgery, Designer Vaginas), British Association of Plastic and Aesthetic surgeons Aesthetic surgery of the female genitalia, or 'designer vaginas', includes a number of surgical procedures designed to improve their appearance. It is claimed that, occasionally, sexual function may be enhanced. The availability of such surgery in the UK is limited. With a growing acceptance of surgery designed to alter appearance, and the increasing availability of explicit images of naked women, a number of women are requesting surgery to alter their intimate appearance feeling that they compare unfavourably. There are other women who claim that the size or shape of their vagina or external genitalia prevent them or their partner from achieving full sexual satisfaction. The most commonly requested procedures are labial reduction ('labiaplasty') and vaginal tightening ('vaginaplasty') operations. Other procedures include liposuction to the mons pubis; fat injections to the labia majora or mons in order to give a more youthful appearance to these areas; removal or reduction of skin around the clitoris ('hoodectomy'), to improve clitoral sensitivity; and reconstruction of the hymen for cultural reasons. Laser therapy has been described for the removal of labial wrinkles; and hair transplantation for hypotrichosis of the mons pubis. Labial reduction includes a number of operations designed to decrease the size and degree of protruberance of the labia minora, or 'inner lips' of the vagina. The most common reason for women to request this operation is because the labia are perceived to be too large and aesthetically un-pleasing. A small number of women state that the large size of their labia make them noticeable in tight clothing, or make sports such as cycling uncomfortable. Others have problems with penetration. GM Labiaplasty Policy v3.0 FINAL Page 11 of 16

The procedure is relatively simple, excising an area of the labia minora using a variety of incisions; and can be performed under local anaesthetic. Careful placement of the scar is important, however, in order to prevent painful scar contracture along the rim of the labia. 6. LEVEL N/A: COMMISSIONING POLICY Armed Forces Interim Clinical Commissioning Policy: Labiaplasty, Vaginoplasty and Hymenorrhaphy, NHS England Labiaplasty is generally a cosmetic procedure to change appearance alone and is not routinely funded. Requests for Labiaplasty will be considered for the following indications: Where the labia are directly contributing to recurrent disease or infection. Where repair of the labia is required after trauma. 7. LEVEL N/A: PRESS RELEASE BJOG release: Expectations and experience of labial reduction, Royal College of Obstetricians and Gynaecologists New research published in BJOG: An International Journal of Obstetrics and Gynaecology has found that women seeking labial reduction opt for the procedure because they feel stigmatised by social norms about how they should look and may have unrealistic expectations of the surgery. The incidence of labial reduction in the NHS has doubled in recent years and the study, from the University of Liverpool, looked at why women underwent the surgery, what they hoped to get out of the operation and their experiences afterwards. The study took place in an NHS hospital setting and identified women who had undergone labia reduction surgery over a two year period, 17 women were invited to take part and six accepted. The study found that the main reason the women requested surgery was because they viewed their presurgery appearance as defective and sought a normal genital look. The women tended to base their view of normal on social norms projected in the media that female genitalia should be invisible, with no protruding labia, and they requested the operation because they found their situation stigmatising. Clinicians may have a very different view of normality, based on healthiness and incorporating the natural variations that occur among women. However, the study highlighted that health professionals are delivering mixed messages about what is normal. The women s perception of being abnormal were inadvertently reinforced by being given reassurance of normality, alongside referral to a specialist for further investigation or surgical intervention. Another common theme was that the women felt their appearance impacted negatively on their sex lives and relationships. Those in the group that were sexually active found that their dislike of the way they looked created anxiety about having sex with their partner or starting a new relationship. By having the operation the women expected to see an improvement in their sex lives and, for some, there was also the hope that it would improve or save a relationship. Although the operation did have the effect of making the women less self-conscious, expectations of improved sex-life and relationships were not met for all women. Dr Ros Bramwell, of the Liverpool University research team, said I think a key issue here is what is meant by 'normal'. Health professionals may understand 'normal' as meaning healthy or within the average range. But knowing that there are other women who look like you do doesn't help if you still feel that the way you look is somehow abnormal and wrong. The problem is that clinical time is usually limited and we are dealing here with what are probably longheld attitudes and issues of self-esteem which are quite difficult to change. Further research is needed into potential psycho-educational interventions to help change women s perception of their need for surgery. Professor Philip Steer, BJOG editor-in-chief, said There is an growing demand for labia reduction and it is increasingly important for clinicians to understand the reasons why women believe they need this surgery. Often these reasons go beyond the realm of the gynaecologist to wider social and cultural norms reflected in the popular media. GM Labiaplasty Policy v3.0 FINAL Page 12 of 16

Thus the suggestion that improved communication about normal genital appearance should begin at an earlier stage has merit as does the proposal that psychosocial elements be introduced to the referral process - both certainly warrant further investigation. Notes: BJOG: An International Journal of Obstetrics and Gynaecology is owned by the Royal College of Obstetricians and Gynaecologists (RCOG) but is editorially independent and published monthly by Blackwell Publishing. The journal features original, peer-reviewed, high-quality medical research in all areas of obstetrics and gynaecology worldwide. Please quote BJOG' or BJOG: An International Journal of Obstetrics and Gynaecology' when referring to the journal. Reference: Bramwell R, Morland C, Garden A. Expectations 8. LEVEL: N/A Ethical opinion paper: Ethical considerations in relation to female genital cosmetic surgery (FGCS), Royal College of Obstetricians and Gynaecologists Executive summary: General practitioners, gynaecologists and plastic surgeons are increasingly likely to be consulted by women and girls who are concerned about the structure and appearance of their genitalia. Clinicians have a duty of care to provide these women with accurate information on the diversity of morphology and appearance of the female genitalia and to suggest simple measures to relieve genital discomfort where no pathology can be identified. The importance of education, support and advice should be at the heart of clinical practice, with sympathetic appreciation of the female body insecurities that are rife in western society. The presentation of female genital cosmetic surgery (FGCS) as an unproblematic lifestyle choice is undesirable because it misleads women as to the need for and the efficacy of such surgical techniques. Key points are as follows: Fully informed consent is fundamental when offering FGCS, as is the case for all medical treatment. Clinicians who perform FGCS must be aware that they are operating without a clear evidence base. Women should be advised accordingly. Owing to anatomical development during puberty, FGCS should not normally be offered to individuals below 18 years of age. In general, FGCS should not be undertaken within the National Health Service (NHS) unless it is medically indicated. GM Labiaplasty Policy v3.0 FINAL Page 13 of 16

Appendix 2 Diagnostic and Procedure Codes Labiaplasty GM027 (All codes have been verified by Mersey Internal Audit s Clinical Coding Academy) GM027 - Labiaplasty Policy Excision of excess labial tissue P05.5 Reduction labia minor P05.6 Reduction labia major P05.7 With the following ICD-10 diagnosis code(s): Other plastic surgery for unacceptable cosmetic appearance Z41.1 Exceptions (ICD-10); the following in a primary or secondary diagnostic position: Sequelae of complication of pregnancy, childbirth and the puerperium O94.X GM Labiaplasty Policy v3.0 FINAL Page 14 of 16

Appendix 3 Version History Labiaplasty GM027 The latest version of this policy can be found here: GM Labiaplasty Policy Version Date Summary of Changes 0.1 12/05/2014 First draft for consideration by GM EUR Steering Group 0.2 29/05/2014 Amendments made by GM EUR Steering Group on 21/05/2014: Diagram of external female genitalia labeled and the colour removed. Draft policy approved for consultation following the above amendments. Policy published for consultation from 09/07/2014 to 03/09/2014. 0.3 25/09/2014 Amendments made by the GM EUR Steering Group on 17/09/2014 following a review of the feedback from the consultation: Amendment to section 4, mandatory criteria removal of the bullet point relating to significant functional impairment and the bullet point relating to trauma, defined as significant anatomical distortion as a result of obstetric trauma, other trauma and vulval diseases. Inclusion of female genital mutilation in the policy exclusions section. 17/09/2014 Policy approved by the GM EUR Steering Group subject to the above amendments. 0.4 08/10/2014 Branding change following creation of North West CSU on 1/10/2014. 1.0 17/09/2014 Policy approved for governance by GM EUR Steering Group - required amendments have been made. 2.0 18/11//2015 Annual review of policy by GM EUR Steering Group no material changes necessary to the current policy: Added that locally commissioned treatment as part of a pathway of care within a contract or service level and treatment as part of previously agreed and externally funding trial are excluded from this policy. Evidence Review section updated 2.1 20/01/2016 GM EUR Steering Group on 20 th January 2016: Mandatory Criteria updated to state that an IFR was not required for labiaplasty carried out as the result of obstetric trauma in the period of care immediately following the trauma (usually expected to be done within 72 hours). 2.2 05/04/2016 List of diagnostic and procedure codes in relation to this policy added as Appendix 2. Policy changed to GMSS template and references to NWCSU changed to GMSS. Date of review amended to read One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years) on Policy Statement and section 13. Date of Review. 2.3 14/12/2016 Appendix 2: Two diagnostic codes removed from the exceptions section: N90.8 - Other specified non inflammatory disorders of vulva and perineum Z91.6 - Personal history of other physical trauma GM Labiaplasty Policy v3.0 FINAL Page 15 of 16

3.0 15/11//2017 Review of policy by GM EUR Steering Group:: Policy moved to new format and criteria slightly reworded for clarity Date of Review: Standard wording on next review amended to state 5 years' The above changes were not considered to be material and therefore it was not necessary for the revised policy to go back through the governance process again. GM Labiaplasty Policy v3.0 FINAL Page 16 of 16