Urology
Volume 79, Issue 1 , Pages 12-14, January 2012

Evidence-based Medicine for Polypropylene Mesh Use Compared With Native Tissue Vaginal Prolapse Repair

  • Donald R. Ostergard

      Affiliations

    • Corresponding Author InformationReprint requests: Donald R. Ostergard, M.D., F.A.C.O.G., Department of Obstetrics, Gynecology and Women's Health, Division of Urogynecology, 550 S. Jackson Street, Second Floor, Louisville, KY 40202

University of Louisville, School of Medicine, Louisville, KY

Received 14 June 2011; accepted 22 July 2011. published online 25 November 2011.

Article Outline

A review of the current medical literature for the use of polypropylene (PP) mesh for vaginally performed prolapse repair, including only those studies reporting prospective, randomized, controlled trials compared with native tissue repairs was undertaken. Five full manuscript publications and 4 studies still in abstract form were all consistent with PP mesh producing better anatomical results for cystocele repair, but when functional results in terms of the patient's quality of life are considered, no significant difference is found between PP mesh and native tissue repairs. PP mesh use results in better anatomical results in the short term but at a cost of repeated surgeries because of erosions and other complications. Patients do not recognize any added benefit from the use of these prostheses in their daily lives.

 

Polypropylene (PP) mesh and other biological materials are in widespread use for the repair of pelvic organ prolapse by the vaginal route despite the lack of evidence-based medicine to confirm their usefulness. This clinical commentary explores the degree of prolapse found in patients without pelvic floor complaints, the varying definitions of cure of prolapsed, and the revision of the definition of what constitutes success in pelvic floor repair. Randomized, controlled clinical trials comparing PP mesh prolapse repair with native tissue repairs are summarized.

Anterior vaginal repair using native tissue has been quoted as having success rates of between 30% and 100%, with the definition of anatomical cure directly influencing the rate of success. Recently, information has appeared in the literature about what degrees of prolapse can be seen in patients attending a clinic for routine annual examinations who have complaints related to the pelvic floor. As seen in Table 1, 98% of these patients had no symptoms when the leading edge of the vaginal wall was at or above the hymen.1

Table 1. Normal vaginal wall anatomy in 1004 patients1⁎
Stage 024%No movement
Stage 138%To 1 cm above the hymen
Stage 235%At the hymen
Stage 32%Beyond the hymen

⁎ Caused by rounding of numbers, does not add up to 100%.

This information has suggested to vaginal prolapse researchers that the currently used definitions of anatomical success in terms of vaginal prolapse repairs needs to be changed to more closely reflect the ambulatory, asymptomatic population. The hallmark article on anterior vaginal repair that speaks to this point is that by Weber et al2 and its subsequent reevaluation of its 1-year data by Chmielewski et al.3 Table 2 compares the success rates from the original article and its reevaluation. In the interim, Barber et al4 reported on the varying definitions of success of surgical procedures with the requirement that the presenting part be above the hymen and having the worst success rate at 19.2-57.6% in the 18 different definitions reviewed. If the definition of success was the leading edge was located at the hymen, 94% were successful. If no retreatment was used as a criterion, 97% were successful, and if the patients were without bulge symptoms, 92% were successful. They concluded that the “absence of vaginal bulge symptoms postoperatively has a significant relationship with a patient's assessment of overall improvement, while anatomical success alone does not.”

Table 2. Anterior vaginal repair from the original weber article and its reevaluation2, 3
Original Article Reevaluation
Anatomical success definition2 cm above the hymen At the hymen
Anatomical success rateStandard repair30%At the hymen90%
Ultralateral repair46%No bulge symptoms95%
No retreatment⁎100%

⁎ One patient retreated at 19 months.

The influence of the definition of anatomical success is evident with the very large increase in success rates with a more liberal definition of the anatomical requirement for success. The reevaluation also includes elements of the effect of the repairs on the quality of life of the patients by adding the presence or absence of bulge symptoms. After all, it should be the patient who defines success in terms of their ability to go about their daily lives without any symptoms of prolapse. The additional category of no retreatment is also important, because that patient makes the decision about retreatment and may decide about whether to undergo a repeat surgery depending on the degree of bother caused by the existence of a recurrent bulge.

To date, 5 studies have been published in the medical literature using prospective, randomized, controlled research designs comparing the use of PP mesh vs native tissue repairs.5, 6, 7, 8, 9 Three of the studies have a mixture of primary and recurrent prolapse treatments ranging from 16-26% of the patients. One of the studies consists solely of recurrent prolapse surgeries. Although there is variance with the commercial type of mesh used—whether it is a kit or uniquely fashioned and which quality of life questionnaires are used—there are commonalities between the studies. Each of these studies, except one, show that PP mesh produces better anatomical results that are significant when compared with native tissue repairs. However, when the patients are queried using various questionnaires regarding their quality of life postoperatively, no significant differences are found between the PP mesh group and those treated by native tissue repairs. This would indicate that the patients do not appreciate any value added benefit from the use of PP mesh in terms of their daily symptoms or their quality of life. This is true for both studies with mixed primary and recurrent cases and the one with only recurrent cases. All follow-up periods are for 1 year and the definition of success in each is no prolapse reaching stage 2 or higher.

There are an additional 4 studies available to date only in abstract form.10, 11, 12, 13 Two of these consist solely of primary surgeries and report significant differences between the mesh and native tissue repair groups for anatomical success.10, 11 The data reported in these abstracts is inconsistent; however, one of them shows nonsignificant differences between PP mesh and native tissue repair at 2 years, but the patient numbers are small.13 Five of the abstracts describe the questionnaires used to determine functional differences between PP mesh and native tissue repair groups, and no significantly different functional parameters were found between the 2 groups.

Using a prospective, randomized study design, one article related mesh use in the anterior compartment to the risk of developing stress incontinence postoperatively. Urodynamically, they demonstrated a lowering of the maximal urethral closure pressure and an increased risk of de novo stress incontinence in the mesh group (32%) compared with standard anterior colporrhaphy (8%).14

No comparative studies using PP mesh have been reported for use in the posterior compartment. Only one prospective study exists using a prospective, randomized, controlled design with porcine intestinal submucosa as the prosthesis.15 Graft augmentation with porcine intestinal submucosa produced significantly decreased success (54%) compared with standard posterior colporrhaphy (86%) or site-specific repair (78%). The usefulness of PP mesh in the posterior compartment remains unknown.

As physicians treating pelvic organ prolapse, we should base decisions on surgical techniques, and the use of prostheses on evidence-based medicine, rather than on the power of advertising from the manufacturing companies that rush their products to market and make unsubstantiated claims without adequate prerelease testing. PP mesh use results in better anatomical results in the short term but at a cost of repeated surgeries for erosions, de novo stress incontinence, and other complications. Patients do not recognize any added benefit from the use of these prostheses in their daily lives when they define success or failure of their individual surgeries. In each study where PP mesh has been compared with native tissue repairs in the anterior compartment, both methods of repair show no difference in postoperative pelvic floor symptomatology between groups. There is discordance between the physician's surgical goals and the goals of the patient. Physicians would like to see a “perfectly anatomical vagina” postoperatively, but given that 98% of patients attending a clinic for annual examinations have asymptomatic “prolapse” to the hymenal ring, the definition of “prolapse” needs to be redefined. “Prolapse” to the hymen is within normal limits, and should not be treated surgically unless the patient is symptomatic.

On July 13, 2011 the FDA stated in regard to anterior repair with mesh that although “mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomical benefit may not result in better symptomatic results.”15 With regard to apical and posterior vaginal repairs, the FDA stated: “There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.”

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References 

  1. Swift S , Woodman P , O'Boyle A , et al.  Pelvic Organ Support Study (POSST): the distribution, clinical definition, and epidemiologic condition of pelvic organ support defects . Am J Obstet Gynecol . 2005;192:795–806
  2. Weber AM , Walters MD , Piedmonte MR , et al.  Anterior colporrhaphy: A randomized trial of three surgical techniques . Am J Obstet Gynecol . 2001;185:1299–1306
  3. Chmielewski L , Walters MD , Weber AM , et al.  Re-analysis of a randomized trial of three methods of anterior colporrhaphy using more clinically relevant definitions of success . Int Urogynecol J . 2010;21(Suppl 1):S144–S145 [Abstract]
  4. Barber MD , Brubaker L , Nygaard I , et al. Pelvic Floor Disorders Network  Defining success after surgery for pelvic organ prolapse . Obstet Gynecol . 2009;114:600–609
  5. Nguyen JN , Burchette RJ . Outcome after anterior vaginal prolapse repair: A randomized controlled trial . Obstet Gynecol . 2008;111:891–898
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  8. Hiltunen R , Nieminen K , Takala T , et al.  Low-weight polypropylene mesh for anterior vaginal wall prolapse: A randomized controlled trial . Obstet Gynecol . 2007;110:455–462
  9. Withagen MI , Milani AL , den Boon J , et al.  Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: A randomized controlled trial . Obstet Gynecol . 2011;117:242–250
  10. Thijs S , Deprest J , De Ridder D , et al.  A randomized controlled trial of anterior colporrhaphy and Perigee™ as a primary surgical correction of symptomatic cystocele . Int Urogynecol J . 2010;21(Suppl 1):S142
  11. Vollebregt A , Gietelink D , Fischer K , et al.  One year results of colporrhaphy anterior versus a trocar guided transobturator synthetic mesh in primary cystocele repair: A randomized controlled trial . Int Urogynecol J . 2010;21(Suppl 1):S76–S77
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  13. Dyer K , Nguyen J , Simsiman A , et al.  The optimal anterior repair study (OARS): A triple arm randomized double blinded clinical trial of standard colporrhaphy versus paravaginal repair with xenograft or synthetic mesh . Female Pelvic Med Reconstr Surg . 2010;16(Suppl 2):S68–S69
  14. Ek M , Tegerstedt G , Falconer C , et al.  Urodynamic assessment of anterior vaginal wall surgery: A randomized comparison between colporraphy and transvaginal mesh . Neurourol Urodyn . 2010;29:527–531
  15. U.S. Food and Drug Administration . FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse . http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm Accessed July 17, 2011

PII: S0090-4295(11)02436-8

doi:10.1016/j.urology.2011.07.1438

Urology
Volume 79, Issue 1 , Pages 12-14, January 2012

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