Transvaginal mesh implants independent review: final report

Chapter 2: The clinical uses of mesh for stress urinary incontinence and pelvic organ prolapse

Update Since Interim Report

The new or updated evidence that has been published since the publication of the Interim Report is from the National Institute for Health and Care Excellence ( NICE) on management of SUI in women. NICE guidelines are for information since the Scottish Intercollegiate Guidelines Network ( SIGN) applies in NHSScotland. However the SIGN guideline on the management of incontinence in primary care has been withdrawn as over 10 years old. The new information on POP is considered in the evidence section in chapter 5.

NICE is reviewing all its guidance for SUI and POP. To date they have published two reports: one on the clinical guideline, and the other concerning interventional procedures. NICE clinical guidelines are for information only in NHSScotland. Scotland is a partner in the NICE Interventional Procedures Programme and therefore their guidance applies in NHSScotland.

The revised guideline for urinary incontinence n women was published in November 2015. The change in the guideline relative to the 2013 version is that there is new evidence from three randomised controlled trials that found a benefit for pelvic floor muscle training.

In October 2016 NICE published interventional procedures guidance on single-incision short sling mesh insertion for SUI in women (IPG262). This stated that, given the current evidence, the procedure should not be used unless there are special arrangements in place for clinical governance, consent and audit or research. NICE encouraged further research into single-incision short sling mesh insertion for stress incontinence in women and may update the guidance on publication of further evidence.

2.1 Clinical indications

2.1.2 Stress Urinary Incontinence

SUI is the condition where urine leaks with coughing, sneezing, laughing or with lifting and exercise. A woman's bladder and urethra (water pipe/outlet of urine) are supported by pelvic floor muscles and ligaments. If the support is weakened, for example by childbirth, then SUI may occur. The problems can be mild, moderate or severe and can lead to a considerable reduction in quality of life. There are several non-surgical and surgical treatment options for women with SUI.

Non-surgical options include:

• physiotherapy, including pelvic floor exercises;
• diet;
• stopping smoking;
• pharmacological treatment;
• continence pessaries;
• absorbent products;
• catheterisation; and
• no treatment.

Surgical options include:

• colposuspension (otherwise known as bladder neck suspension);
• urethral injection therapy;
• suprapubic sling;
• retropubic mesh tapes;
• transobturator mesh tapes; and
• single incision mini-slings.

There are two main types of vaginal mesh tape procedure for SUI. They are:

Retropubic mesh tape procedure

This was the first mid-urethral tape procedure introduced, whereby the synthetic material is inserted through a small incision on the anterior vaginal wall, emerging through two small incisions in the lower abdomen above the pubic bone.

Transobturator mesh tape procedures

This procedure was developed to minimise the potential for bladder and bowel injuries. The synthetic material is inserted through a similar incision on the anterior vaginal wall, emerging through a small incision in each groin area.

Single incision mini-slings are miniature slings delivered via a single vaginal incision into the obturator muscles.

2.1.3 Pelvic Organ Prolapse

The pelvic organs (uterus, vagina, bladder and bowel) are supported by the pelvic floor muscles, fascia and ligaments. There is rarely a single cause for a prolapse, although the following are often involved: childbirth, menopause, ageing, other pelvic problems and/or surgery, long-term coughing, constipation, repeated heavy lifting or manual work and being overweight. Prolapse may arise in the front wall of the vagina (cystocele), back wall of the vagina (rectocele and enterocele) or the uterus / top of the vagina (uterine prolapse or vault in women who have had prior hysterectomy). Many women have prolapse in more than one compartment at the same time, or may experience prolapse in different compartments over a period of time. The effects can be mild, moderate or severe. There may be local discomfort with the feeling of dragging, heaviness, or a need to push the prolapse back; or there may be effects on the urinary, bowel and sexual functions for a woman.

There are several non-surgical and surgical treatment options for women with POP.

Non-surgical options include:

• physiotherapy, including pelvic floor exercises;
• diet;
• stopping smoking;
• vaginal pessary; and
• no treatment.

Surgical options include:

• anterior colporrhaphy: repair front wall without mesh;
• posterior colporrhaphy without mesh; repair posterior wall without mesh;
• anterior colporrhaphy with implant; repair of anterior wall prolapse with implant, usually mesh;
• posterior colporrhaphy with implant: repair of posterior wall prolapse with implant, usually mesh;
• vaginal hysterectomy;
• vaginal colpopexy/hysteropexy; vaginal vault support without mesh

vaginal colpopexy/hysteropexy with implant: vaginal vault support with mesh; sacrocolpopexy/sacrohysteropexy: abdominal approach vaginal vault support with mesh.

2.2 Guidance for surgery ( NICE and professional bodies)

As part of the surgical training for gynaecologists, urologists and urogynaecological sub- specialists there is a need to be familiar with the range of procedures to offer as treatment when discussing symptoms with patients. These procedures include the options noted above, some of which will be initially tried in General Practice before a referral to a specialist. The specialist will be aware of the range of professional advisory documents on the procedures that can be offered. In NHSScotland it is obligatory to use the guidance from the NICE Interventional Procedures Programme. This programme includes a range of procedures from 2005 to 2016 for both SUI and POP ^[2] . In addition NICE published a detailed clinical guideline in 2006 with updates in 2013 and 2015 on urinary incontinence management in women ^[3] which can be used when arranging services in NHSScotland. The professional societies including British Society of Urogynaecology ( BSUG ^[4] ), the British Association of Urological Surgeons ( BAUS ^[5] ) and the Royal College of Obstetricians and Gynaecologists ( RCOG ^[6] ) provide specialist training and professional guidance, plus a method of recording activities and patient information and consent information.

2.3 Mesh products

Several types of transvaginal implants can be used in surgery for SUI and POP, including: absorbable synthetics; biological (usually made from cow or pig tissue); non-absorbable synthetic; or a combination of the different products. Non absorbable synthetic (permanent) mesh is usually made from polypropylene. There is a range of methods for using mesh, including:

• Mesh-inlay: the mesh is cut to the desired shape and size and placed through a single incision inside the vagina.
• Mesh-kit: pre-shaped mesh is placed using introduction needles or trocars that may require external skin incisions at several points.

The International Urogynecological Association ( IUGA)/International Continence Society ( ICS) definitions list can be accessed at the following web address:

http://c.ymcdn.com/sites/www.iuga.org/resource/resmgr/iuga_documents/iugaics_terminologyprosthese.pdf