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The Lancet - 12 June 2012

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60400-0/fulltext?_eventId=login

 

RECONSTRUCTIVE SURGERY AFTER FEMALE GENITAL MUTILATION - STUDY

 

Pierre Foldès MD, Dr Béatrice Cuzin MD, Armelle Andro PhD

Background

Women who have undergone female genital mutilation rarely have access to the reconstructive surgery that is now available. Our objective was to assess the immediate and long-term outcomes of this surgery.

Methods

Between 1998 and 2009, we included consecutive patients with female genital mutilation aged 18 years or older who had consulted a urologist at Poissy-St Germain Hospital, France. We used the WHO classification to prospectively include patients with type II or type III mutilation. The skin covering the stump was resected to reveal the clitoris. The suspensory ligament was then sectioned to mobilise the stump, the scar tissue was removed from the exposed portion and the glans was brought into a normal position. All patients answered a questionnaire at entry about their characteristics, expectations, and preoperative clitoris pleasure and pain, measured on a 5-point scale. Those patients who returned at 1 year for follow-up were questioned about clitoris pain and functionality. We compared data from the 1-year group with the total group of patients who had surgery.

Findings

We operated on 2938 women with a mean age of 29·2 (SD 7·77 years; age at excision 6·1, SD 3·5 years). Mali, Senegal, and Ivory Coast were the main countries of origin, but 564 patients had undergone female genital mutilation in France. The 1-year follow-up visit was attended by 866 patients (29%). Expectations before surgery were identity recovery for 2933 patients (99%), improved sex life for 2378 patients (81%), and pain reduction for 847 patients (29%). At 1-year follow-up, 363 women (42%) had a hoodless glans, 239 (28%) had a normal clitoris, 210 (24%) had a visible projection, 51 (6%) had a palpable projection, and three (0·4%) had no change. Most patients reported an improvement, or at least no worsening, in pain (821 of 840 patients) and clitoral pleasure (815 of 834 patients). At 1 year, 430 (51%) of 841 women experienced orgasms. Immediate complications after surgery (haematoma, suture failure, moderate fever) were noted in 155 (5%) of the 2938 patients, and 108 (4%) were briefly re-admitted to hospital.

Interpretation

Reconstructive surgery after female genital mutilation seems to be associated with reduced pain and restored pleasure. It needs to be made more readily available in developed countries by training surgeons.

Funding

French Urological Association.

Introduction

Most international health organisations would like to see an end to female genital mutilation.1, 2 Between 130 and 140 million women worldwide have undergone female genital mutilation in the past 10 years, including 92 million girls in Africa. Every year, an estimated 3 million girls are at risk of undergoing the procedure.3 Female genital mutilation is widespread in Africa, but also occurs in immigrant communities in Europe and North America. It has medical, psychological, and psychosexual consequences, which have been described in detail.4—7 Nor should one forget the unacceptably high number of young girls who die as a result of life-threatening infections such as tetanus or haemorrhage; in areas of Sudan where antibiotics are not available, a third of the girls undergoing female genital mutilation are estimated to die from infection.8—10 Efforts to end this procedure started decades ago, but require major social changes. Repairing the mutilation is an interim solution.11

Women with female genital mutilation rarely have access to reconstructive surgery to improve their lives. According to the WHO classification, type III mutilation corresponds to the “narrowing of the vaginal orifice with creation of a covering seal by cutting and appositioning the labia minora and/or the labia majora, with or without excision of the clitoris (infibulation)”.12 The WHO goes on to state that women who have undergone type III mutilation require defibulation before delivery. Functional improvements have been described after this defibulation procedure, mainly in Somalian populations.13—15 The surgical techniques described in the present Article were initially developed in the context of humanitarian medicine in Burkina Faso. In France, reconstructive surgery has been available on the French national health service since 2004. Surgery was initially offered to women with pain sequelae, but has since been extended to women wishing to improve their sex lives or their physical appearance. In an earlier study,15 which ran from 1992 to 2005, we were able to restore a visible clitoral mass in 394 (87%) of 453 patients, and 75% of women reported a genuine short-term improvement in clitoral function.16 Most patients had undergone type II mutilation, that is, partial or total removal of the clitoris glans and the labia minora, with or without excision of the labia majora (excision).

However, patient satisfaction and outcomes were not measured over the long term. Here, we aim to assess both the immediate and long-term outcomes of reconstructive surgery for female genital mutilation to help women to improve their sex lives, recover their identity, and reduce pain. These were the objectives expressed by the women themselves, as described in our earlier publication16 and subsequently corroborated in a survey.17

Methods

Patients

Between 1998 and 2009, we prospectively included consecutive patients with female genital mutilation aged 18 years or older who had consulted a urological surgeon (PF) at St Germain Poissy Hospital, St Germain en Laye, France. Our study complied with all the French ethics requirements that were then in force, and was done according to French research guidelines. Approval from the Institutional Review Board (IRB) was not necessary since this study was done before it became mandatory in France in Feb 21, 2012. Patients were informed orally and in a written form about efficiency and side-effects of surgical procedure. Our surgical ward receives patients with female genital mutilation who want to have their mutilation repaired. Most of the patients present themselves, but a few are referred. Our work was never publicised, and this study was done in a pragmatic setting, with no particular changes to our usual practices.

We used the WHO classification18 to prospectively include women with either type II or type III mutilation (infibulation) with excision. We excluded patients with type III mutilation who had not undergone excision of the clitoris.

Procedures

All patients filled out a questionnaire at entry about their characteristics (age, country of origin, country of excision) and their preoperative clitoral pain and clitoral pleasure. We assessed the patients' expectations for pain and clitoral pleasure on 5-point scales (appendix). These scales pragmatically described the patients' sensations and had already been used elsewhere16 but were not validated. For clitoral pleasure, for instance, patients could choose between: never (no sensation), minor sensation, pleasant without orgasm, restricted orgasm (orgasm with less intensity than wished), and regular orgasm (“normal” orgasm).

 

The surgeon (PF) did a standardised surgical procedure on all the patients.18 The key surgical principle was to restore both clitoral anatomy and clitoral function19 (figure; a full description of surgical procedure is available in the appendix). Under appropriate general anaesthesia via laryngeal mask; we first created a circular “buttonhole” skin incision over the clitoral shaft stump. The skin covering the distal stump of the clitoris was resected sharply with scissors. The suspensory ligament was gradually transected close to the bone and as deeply as needed to allow sufficient downward mobilisation of the clitoris to bring it to the glans' anatomical position. The dorsal region neurovascular bundle was preserved. A first layer of suture was used to hold the extremity of the neoclitoral shaft in place to prevent retraction. Running or interrupted monocryl sutures were carefully placed inferiorly, passing from the residual fibrous layer surrounding the tunica to the vestibular mucosa and skin. Above the clitoris, the vestibular skin was closed with interrupted polyglactin stitches passing through the subcutaneous connective tissue on both sides and the periosteum in the middle. All the dissected spaces were infiltrated with local anaesthetic (6 mL of ropivacaine 7·5 mg/mL). If necessary, the preliminary procedures done to uncover the clitoral stump consisted of defibulation and removal of pseudocysts.

 

Excision, scarring, and reconstruction of female genital mutilation

(A) Scheme representing the anatomy of a non-mutilated clitoris. Effect of further cutting of clitoral glans is represented by a red line. (B) Example of a non-mutilated clitoris. (C) Fixed clitoris after scarring: the surgery consists of freeing the clitoris from the bone adherence that immobilises it and thwarts its dynamic physiology. (D) Example of type 2 mutilation with pseudoinfibulation. (E) Scheme representing the outcome after reconstructive surgery. (F) Example of aesthetic outcome at 1 year after reconstructive surgery, with an apparent functional clitoris, and aesthetic labia minora.

Patients were discharged within 2 days of surgery. About two weeks after surgery, they were examined and asked to come back in a year's time. We informed them that postoperative pain would last for about 2 weeks and that the wound would take 2 months to heal (epithelialisation), at which point they would be able to resume sexual intercourse. At the 1-year visit, women were questioned about pain and functionality. We compared the 1-year group with the total group at inclusion to check for representativeness.

Statistical analysis

We prospectively entered the data in Stata 10, and did post-hoc analyses. We worked on the assumption that missing data were not a reason for exclusion, and analysed all the variables in a pragmatic way, according to available data. We provide the numerator for each variable. We used the χ2 test to compare characteristics at inclusion. We took the year of attendance into account for all the preoperative criteria (Pearson test). We analysed the odd ratios and 95% CIs, and used logistic regression for the prognosis variables. Logistic was used for statistical analyses.

Role of the funding source

The sponsor of the study supported the data analysis and the English editing of the report, but had no role in the study design, data collection, data analysis, the writing of the report, or the decision to submit for publication. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Results

Surgery was done on 2938 women with female genital mutilation between Jan 1, 1998, and Dec 31, 2009. Most of them (2350, 80%) lived in France, and had access to the publicly funded health-care system. The mean age was 29·2 (SD 7·77) years, and age at excision was 6·1 (SD 3·5) years. (29%) patients attended the 1-year follow-up visit; 2072 women did not attend. Patients' characteristics did not differ between the initial group and the 1-year follow-up group (appendix). Patients came from French-speaking countries in West Africa, mainly Mali, Senegal, and Ivory Coast. 564 patients had undergone female genital mutilation in France. 146 (5%) of 2938 women (mainly from Djibouti, Ethiopia, and Egypt) had undergone type III mutilation with clitoral excision. 1762 (60%) 2938 of the women had type II mutilation accompanied by pseudo-infibulation and the remaining 35% had type II mutilation without pseudo-infibulation. 21 (<1%) of 2938 women had to have a pseudocyst removed before the clitoral reconstruction could take place.

The proportion of patients with female genital mutilation who had never experienced clitoral pleasure rose according to the year of attendance (table 1).

 

Conversely, the proportion of patients who experienced pain diminished according to the year of attendance (table 1). Younger patients reported less clitoral pleasure than did older ones, but no age-related difference was noted for pain (table 2). Immediate complications after surgery (haematoma, suture failure, moderate fever) were noted in 155 (5·3%) of the patients, and 108 (3·7%) were briefly re-admitted to hospital. Minor adverse events (pain, late wound healing, or wound secretions) were treated in outpatients with no readmission, but clear instructions and medications were given to patients at discharge. Minor adverse events with brief readmission were noted in 155 (5·3%) cases: pain (32), haematoma (97), suture failure (13), and moderate fever (13) with a retention rate of 3·7% (108). At 1 year, no complications were recorded.