Transvaginal mesh controversy-where to from here? — YRD

Transvaginal mesh controversy-where to from here? (1505)

Marcus Carey 1
  1. Royal Women's Hospital, Parkville, VIC, Australia

Vaginal prolapse is a condition in which the bladder, uterus and/or bowel protrude into the vagina, typically due to loss of natural support for the pelvic organs and the vaginal vault in women who had undergone a prior hysterectomy.  In the normal female anatomy, direct support for the vaginal vault is provided by the parametrium (cardinal and uterosacral ligaments) and paracolpium fibers. These fibers act like suspensory ligaments and arise from the fascia of the piriformis muscle, sacroiliac joint and lateral sacrum, and insert into the lateral upper third of the vagina.  Indirect support for the vaginal vault is provided by the levator plate, formed by the fusion of the right and left levator ani muscles between the rectum and coccyx. Pelvic organ prolapse and vaginal vault prolapse occurs after failure of these direct and indirect supporting mechanisms and is frequently accompanied by weakness of the muscular pelvic floor and suspensory fibers of the parametrium and upper paracolpium. 

In developed countries around one in nine women undergo surgery for pelvic organ prolapse. In the United Sates, more than 400,000 operations for prolapse are performed on over 300,000 women annually for pelvic organ prolapse. Anterior and/or posterior colporrhaphy (native tissue repair) are the most commonly performed operations for pelvic organ prolapse.1, 2 Anterior and/or posterior colporrhaphy was performed on 68.6% women undergoing prolapse surgery in 2003.1 Many different vaginal, abdominal and laparoscopic procedures have been described to treat pelvic organ prolapse and there is currently no consensus on the most effective operation.

The lifetime risk of 11.1% for surgery to treat pelvic organ prolapse or urinary incontinence or both was reported by a study from a United States health maintenance organization and further surgery for recurrent prolapse and/or urinary incontinence was required in 29.3 Dissatisfaction with native tissue repair (traditional colporrhaphy) for pelvic organ prolapse resulted in increased usage of mesh to augment vaginal repair procedures in order to obtain higher success rates. This peaked in 2010 and 2011. In 2010 around 196,000 (65%), 70,000 (23%) and 34,000 (11%) women underwent native tissue vaginal repairs, trans-vaginal mesh repairs and sacral colpopexy procedures respectively for pelvic organ.4 However, the use of mesh placed via a transvaginal incision during vaginal repair procedures is controversial. Studies have reported significant problems (e.g. pain, dyspareunia and mesh exposure) with the use of mesh during vaginal prolapse. As a result of recent FDA (Food and Drug Administration) warnings about the usage of trans-vaginal mesh there has been a marked decline in trans-vaginal mesh usage and renewed interest in native tissue repair, sacral hysteropexy and sacral colpopexy. The role of trans-vaginal mesh should be limited to experienced surgeons for selected cases of anterior compartment prolapse (e.g. recurrent cystocele, stage III or IV cystocele).

Sacral colpopexy is widely considered to be the gold standard operation for pelvic organ prolapse particularly in cases of recurrent vaginal prolapse and prolapse of the vaginal vault following hysterectomy. The use of sacral colpopexy (especially laparoscopic and robotic procedures) to treat pelvic organ prolapse has increased in recent years coinciding with a dramatic decline in trans-vaginal mesh use as a result of recent Food and Drug Administration (FDA) warnings. In the United States the number of laparoscopic sacral colpopexies procedures performed for prolapse exponentially increased during the 10 years from 2003 to 2012.5 Among urologists in the US, in 2012, 70.1% of sacral colpopexies were performed by laparoscopy.

Prolapse of the uterus has traditionally been managed by vaginal hysterectomy and usually performed concomitantly with some form of vaginal surgery to re-support the vaginal apex (e.g. sacrospinous ligament fixation, trans-vaginal utero sacral ligament suspension).  Up to 44% of women undergoing prolapse surgery have a concomitant hysterectomy. However, many patients with uterine prolapse are now requesting conservation of the uterus at the time of prolapse surgery.  More recently laparoscopic and robotic procedures to re-support the uterus have been described.

Around 35% of women will require concomitant surgery for stress incontinence. Typically a TVT or TOT procedure is performed.  However, recent research has questioned the value of concomitant anti-incontinence surgery for occult stress incontinence.

As a result of the ageing of western population it is anticipated that the rate of prolapse surgery will increase by 45% over the next 15 years. Very elderly patients, who are not sexually active, with prolapse requiring surgery can be safely and effectively managed by a colpocliesis procedure. In selected cases this can be performed under local anaesthesia. Vaginal pessaries will continue to have an important role in the management of prolapse. More research on vaginal pessaries is needed in order to develop more effective pessaries than currently exit.

 

Summary

Recent trends in POP surgery and the future role of mesh:

·         Dramatic reduction in trans-vaginal mesh

·         Renewed interest in native tissue repair and sacral colpopexy (laparoscopic and robotic)

·         Trend towards uterine preservation (laparoscopic and robotic hysteropexy)

·         Around 35% of women will require concomitant surgery for stress incontinence but a trend away from concomitant surgery for occult stress incontinence

·         Trans-vaginal mesh in the anterior compartment only by experienced surgeons in carefully selected patients (e.g. recurrent cystocele; stage III and IV cystocele)

·         Increasing use of colpocliesis for elderly patients

·         Future advances in synthetic meshes, biological meshes and potential role of stem cells

·         Increasing interest in qualitative research when evaluating POP surgery outcomes

  1. Boyles SH. Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol. 2003, 188; 108-15
  2. Shah AD, Kohli N, Rajan SS, Hoyte L. The age distribution, rates, and types of surgery for pelvic organ prolapse in the USA. Int Urogynecol J 2008; 19:421-428.
  3. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997; 89: 501-6.
  4. Food and Drug Administration (2011) Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. Available at: http://www.fda.gov/MedicalDevices/Safety/Alerts
  5. Eltermean DS, Chughtai BI, Vertosick E. et al. Changes in Pelvic Organ Prolapse Surgery in the Last Decade among United States Urologists. J Urol 2014; 191: 1022-7.