Vaginal Mesh Repairs: International Study to Assess Long-Term Safety

05/06/2014


A new post-market study sponsored by Boston Scientific Corporation began at the Florida Bladder Institute in March 2014. This study will be conducted at many study centers throughout the United States and Australia. Dr. Joseph Gauta, Board Certified in Female Pelvic Medicine & Reconstruction Surgery is Principal Investigator at the Florida Bladder Institute. The Study titled: “A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Uphold LITE vs. Native Tissue for the Treatment of Women with Anterior/Apical Pelvic Organ Prolapse” will compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior/apical pelvic organ prolapse with or without concurrent cystocele. The purpose of this study is to look at how safe and how well this surgical mesh treats pelvic organ prolapse (POP). Participants will be followed for three years after their surgery.

POP occurs when the tissue and muscles that hold pelvic organs in place are stretched or weakened and the organs move from their natural positions to press against the vaginal wall. The condition is strongly linked to labor and vaginal childbirth. It can also be related to prior pelvic surgery and anything that causes increased pressure in the abdomen, such as obesity, respiratory problems with a long-lasting (chronic) cough or constipation. For some women, POP becomes a painful or uncomfortable problem in which surgery is an option for treatment.

The difficulties associated with repair of cystocele were cited by Ahfelt as early as 1909, and reinforced nearly a century later by Weber et al (2001) who reported recurrence rates as high as 70% in a widely cited randomized controlled study (RCT). Clark et al estimated that up to 60% of surgical recurrences occur at the same anatomic site as the original repair, highlighting the limitations associated with plicating and/or suspending weakened connective tissues to one another.

The main goal of POP surgery is restoration of normal anatomy to achieve proximal vaginal suspension, mid-vaginal lateral attachments and distal vaginal fusion to the urogenital fascia and perineum. Women undergoing pelvic reconstructive surgery for POP hope to achieve relief of symptoms, restoration of normal anatomy, maintenance of vaginal capacity for sexual function and improvement in the quality of life.

POP of the anterior and posterior vaginal wall, and vaginal apex, are among the most challenging and common aspects of traditional pelvic reconstructive surgery. As life expectancy increases, significantly greater numbers of women will present with POP and stress urinary incontinence (SUI) requiring surgical intervention. Women face an 11% lifetime risk of requiring major surgery for POP.

In recent years, surgical methods such as vaginal mesh repair (VMR) have become available as an option for treating more advanced and challenging cases. Vaginal mesh repair, by augmenting native tissues with polypropylene mesh, is the most well established surgical alternative to native tissue plication. Despite a risk of mesh complications (3% - 13%), VMR is quicker and technically easier than trans-abdominal placement using sacral colpopexy.

UpholdTM Lightweight Surgical Mesh (Uphold LITE) is an FDA 510(k) cleared mesh implant intended for tissue reinforcement and stabilization of fascial structures of the pelvic floor in vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect. Uphold was designed as a VMR that would limit mesh exposures by placement through a horizontal, inverted crescent vaginal incision near the urethrovesical junction. The amount of mesh is approximately 75% less than other kits and apical support is achieved via sacrospinous ligament fixation (SSLF). Use of synthetic mesh grafts in surgical repair of vaginal prolapse has been shown to significantly increase success rates and reduce recurrent prolapse.

In 2008, the U.S. Food and Drug Administration (FDA) issued a Public Health Notification (PHN) to inform doctors and patients of safety concerns related to urogynecologic surgical mesh devices used in the treatment of POP and SUI, and to provide recommendations on how to prevent risks and how to counsel patients. Following the 2008 PHN, the FDA has continued to monitor the outcomes of female pelvic floor repair with surgical mesh. The FDA has also conducted a review of scientific literature to learn more about safety and effectiveness data. The result was a 2011 update to the 2008 PHN. In the 2011 PHN update, the FDA determined that serious adverse events are not rare, contrary to what was stated in the 2008 PHN.

The FDA is considering regulatory changes that may better our understanding of how safe and how effective surgical mesh used in female pelvic floor repair procedures can be, including POP repair. One way the FDA is looking at how safe and effective surgical mesh devices are is by requesting that the device companies conduct clinical studies.

This study will be conducted in partnership with the American Urogynecologic Society (AUGS) under the Pelvic Floor Disorders Outcome Registry (PFD Registry). The purpose of this registry is to gather information to help understand and improve the lives of women with pelvic organ prolapse.

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