Transvaginal mesh implants independent review: interim report

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

2.1 Clinical indications

2.1.2 Stress Urinary Incontinence

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 stress urinary incontinence may occur. The problems can be mild, moderate or severe and can lead to a considerable loss 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;
• Pharmaceutical 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 transvaginal mesh tapes;
• Transobturator transvaginal 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 and 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 associated with the retropubic mesh tape procedure. 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 through 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 enterocoele) 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 ant wall prolapse with implant, usually mesh
• Posterior colporrhaphy with implant: repair of post wall prolapse with implant, usually mesh
• Vaginal hysterectomy;
• Vaginal colpopexy/hysteropexy; vaginal vault support without mesh

Vaginal colpopexy/hysteropexy with implant: approach suspension with mesh;

Sacrocolpopexy/Sacrohysteropexy: Abdominal approach suspension with mesh (this procedure is outwith the remit of this Review)

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 to offer. In NHSScotland it is obligatory to use the guidance from the National Institute for Health and Care Excellence's (NICE) interventional procedures programme. This programme includes a range of procedures from 2005 - 2009 for both SUI and POP^[2]. In addition NICE published a detailed clinical guideline in 2013 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

Transvaginal mesh used can be one of a range of type: absorbable synthetic; 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 are a range of methods to use 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 Urogynaecological 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