March 19, 2013

Synthetic or Native Tissue--Which is Better in the Repair of Posterior Vaginal Wall Prolapse Repair?



Women who have undergone menopause, childbirth or surgery are at particular risk for developing pelvic organ prolapse. As women age, their risk increases with approximately 11% of women requiring pelvic organ prolapse surgery by the age of 80. A history of smoking, being overweight or a compromised immune system can all increase the risk of pelvic organ prolapse as well as the risk of recurrence following surgery. A Current Urology Reports Journal article published in June, 2012 assesses the risks and benefits of using synthetic mesh when repairing posterior vaginal wall prolapse.

As many as 30% of women who undergo this surgery will experience a recurrence of POP. In an effort to lower this number, the procedures for using grafts to expand native tissue have been updated and in the past ten years the use of synthetic mesh has become more common. Surgical mesh kits designed specifically to repair anterior, posterior and vaginal vault pelvic organ prolapse have been FDA approved, although there is not enough post-market manufacturer’s data to thoroughly evaluate results. The data reviewed in the article listed above comes from publicly available research.

The posterior compartment is traditionally repaired using a sort of “folding” and suturing of the connective tissues to restore normal anatomy which is compromised when those tissues lose their elasticity and the organs drop from their normal positions. This “traditional” type of surgery typically has few complications and recurrence rates are low. Anatomic surgery is generally reserved for women with stage 0-1 of prolapse severity although approximately 35% have stage II. When failure is defined as prolapse beyond the hymen, presence of symptoms or recurrence, posterior pelvic organ prolapse repair cure rates are at least 90%, with recurrence following traditional methods at 3%. When synthetic mesh is used, complication rates are almost 17% and recurrence rates range from 4.1-16.9%.

Patients presenting symptoms of pelvic organ prolapse may need multiple-compartment repair requiring either a total vaginal mesh or combination of anterior-posterior mesh. Most complications noted occurred following anterior compartment or total vaginal repair using synthetic mesh. The complications occurred during the surgery, from the operating room to recovery unit or post-op. Complications ranged from puncture to bleeding and infection during or immediately following surgery. Delayed complications included mesh extrusion, retraction, chronic pain and sexual dysfunction.

In 2008 the FDA issued a safety communication which they later updated in 2011 regarding complication related to transvaginal mesh. Additional information was collected using the FDA database known as MAUDE or Manufacturer and User Facility Device Experience. Voluntary reports of adverse events involving medical devices such as surgical mesh are entered into this database although the data is not sufficient to compare rates across devices. The updated communication in 2011 was based on an analysis of 3,000 complication reports submitted between 2008 and 2011 and concluded that complications from transvaginal mesh were “not rare.” Further, the FDA stated there was little evidence to support the use of synthetic mesh over more traditional methods in the repair of pelvic organ prolapse. Since that 2011 FDA communication, lawsuits against manufacturers of synthetic mesh are on the rise with close to 700 cases being filed.

The authors of the Current Urology Reports Journal article state that the post-market studies requested by the FDA will result in a higher level of safety and efficacy data being made available which will in turn allow a thorough assessment of the use of synthetic mesh in posterior POP repair. Based on current data, however, traditional methods involving native tissue appear to have similar outcomes to synthetic mesh used in the repair of posterior pelvic organ prolapse however synthetic mesh has a higher risk of complications. The standard treatment for posterior compartment POP will remain traditional, using native tissue for a positive outcome and few complications.