Tuesday, June 5, 2012

Mesh Vaginal Repairs vs. Natural Tissue Repair

A recent study published in the International Urogynecology Journal discussed the relative merits of repairing prolapses using synthetic vaginal mesh or xenografts (a tissue graft from a donor of a different species) vs. using the natural pelvic tissues in the repair. The question the study aimed to answer was whether natural tissue augmentation actually improved the outcome of pelvic organ prolapse repair or whether using synthetic mesh resulted in an improved outcome.

Information Regarding Pelvic Organ Prolapse

There are a variety of pelvic floor disorders which arise primarily from structural damage to this area instead of from an actual breakdown of the organs in question. As many as fifty percent of women who have given birth—as opposed to one in ten men—will experience some level of pelvic organ prolapse over her lifetime. This specific study compared 108 pelvic repairs done with tissue-inductive xenografts or polypropylene mesh—89 and 19 respectively—to 59 pelvic repairs done with native tissues.

Study Participants

The study sought to measure the prolapse recurrence and time to subsequent failure in all those women involved in the study. When the study began, 41% of the women suffered significant prolapse, 55% had a major bulge in the pelvic floor and another 20% had been diagnosed with a cystocoele or prolapsed bladder. Repairs of cystocoeles are overwhelmingly unsuccessful, yet a large portion of those undergoing the surgery suffer without complaint rather than return to their original surgeon with complaints. In fact, in a study done among Kaiser Permanente North West female patients, almost 30% out of 150,000 women returned for at least one subsequent surgery, yet it was felt many more suffered a return of the prolapse. Many women over the age of 60 simply lose faith in the treatments their doctors and surgeons are offering so quit returning. Therefore, while the prevalence of pelvic prolapse certainly increases with age, doctors see fewer and fewer older women returning for consultations on this medical issue.

Why Repair of Bladder Prolapse is Problematic

Bladder prolapse repair is problematic for a variety of medical reasons. The study found that female pelvic anatomy is both complex and misunderstood due to a century of “mechanically misdirected surgical strategies.” In the normal female anatomy the pelvic floor muscles absorb most of the pressure-induced stress however the body has difficulty compensating for the damage to those muscles. The connective tissues suspend and stabilize the female organs, allowing the pelvic floor muscles to work more effectively.

The surgical strategies for re-suspending the organs that have dropped due to muscle damage sustained at childbirth depend largely on the relative strength of these connective tissues. Unfortunately these tissues are not structurally suited to “chronic loadbearing,” making the surgical repair of pelvic prolapse very difficult. Any weakness of the connective tissues make the odds of a positive surgical outcome much less no matter how skilled the surgeon.

Weakness in Surrounding Tissues

In looking at a separate eleven-year database of women who had undergone sutured vaginal paravaginal repair, it appeared to have a relatively high success rate in “curing” prolapsed bladder—nearly 70%. However, due to the significantly increased surgical technique entailed in this type of paravaginal repair as opposed to an anterior colporrhaphy or mesh-augmented paravaginal repair, surgeons question whether that extra surgical effort is justified. General surgeons who routinely repair hernias have identified weakened connective tissues adjacent to the sutures a significant element in unsuccessful surgeries. Based on this, surgeons are questioning whether this same issue should be addressed in the case of pelvic prolapse repair. Surgeons also feel that collagen weaknesses can develop in women who have suffered from pelvic prolapse for a considerable length of time. The study theorizes that taking action to shore up these connective tissues could improve the overall durability of the pelvic prolapse repair.

Using Mesh for Treatment of Pelvic Organ Prolapse

The first bio-mesh tissue treatment for pelvic organ prolapse was licensed in Australia; prior to this point such surgeries were done by re-suturing the woman’s natural tissues using something known as a “three point” technique. Once the mesh was introduced for use in prolapse cases it became the favored method with fewer surgeons using the natural tissue during repair. Four of the study cases used a heavier-weight mesh normally used in hernia repair due to the fact that these four women collectively had sixteen prior failed surgeries. There was no evidence in this particular study that the weight of the mesh had any bearing on the eventual outcome.

Relative Success of the Study Surgeries

The analysis regarding the success of the surgery was examined in the short term as well as longer term—initially at six months post-op, then at 13-24 months and even later at ten years. The potential variables, including age, body mass index, stage of pelvic prolapse, prior failed surgeries, severe urinary incontinence and suspected collagen weakness were felt to be spread equally throughout the different groups. Both surgical techniques relieved the discomfort felt by the women suffering from pelvic organ prolapse with approximately 75% of the study subjects stating they were also relieved of their prior urinary incontinence. Thirteen women who suffered persistent urinary incontinence following the original surgery opted to have a follow-up procedure in which a bladder sling was surgically inserted.

Mesh Delivers a Supposedly “Perfect” Surgical Outcome yet Brings Safety Concerns

The suture-only method was considered successful in 41 out of the 59 test subjects, or 69.5% at ten years. While mesh augmentation delivered what the surgeons considered “perfect” anatomic outcomes, the mesh had to be removed in three of the nineteen women. As a whole, there were 8 post-operative surgical complications. Three of those occurred in the native tissue repairs and five in the repairs using synthetic mesh. Although the beginning hypothesis in this study was that strengthening the anterior vaginal wall with a synthetic product would not significantly improve the long-term durability, study results refuted this. The use of any form of augmentation (mesh or xenografts in this case) showed significant improvement in surgical outcome over suturing native tissue alone. Unfortunately, there have been growing safety concerns regarding the use of vaginal mesh yet experiments with cadaver human dermis and porcine dermis do not appear to have the level of initial success that the mesh implant does.

The study states that pelvic reconstructive surgeons do not appear to have grasped the profound differences between the various materials available for pelvic organ prolapse repair. The theory is that these surgical implants will re-attach a sagging structure to the wall by attracting an ingrowth of soft tissue. While it seems logical to choose an inert, permanent material, many of these polypropylene and polyester synthetic meshes cause an inflammatory response in the body. Further, poor fixation of the implant can lead to stress against the surrounding tissues causing subsequent adverse health issues.

Conclusion of the Study

A truly durable repair in those with pelvic organ prolapse appears to demand that the site of support failure be repaired without tension and that the tissue bordering the site of the original tear be supported with an appropriate augmentation material. While the mesh implant is a near-perfect surgical solution, anytime a foreign material is introduced into the body there can be adverse reactions. Biomaterials make the pelvic organ prolapse surgery quicker and more standardized than those done with native tissues however the study concludes that more research is necessary.

Author: Sullo & Sullo Attorneys

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