October 5, 2012 (Chicago, Illinois) — The risk for complications from transvaginal mesh (TVM) surgery appears to be minor in large-volume urogynecology practices, according to a new study.
Miles Murphy, MD, MSPH, from the Institute for Female Pelvic Medicine & Reconstructive Surgery in North Wales, Pennsylvania, presented the study results here at the American Urogynecologic Society (AUGS) 33rd Annual Scientific Meeting.
The retrospective review involved 1172 patients who underwent TVM surgery from 2006 to 2010. In 2011, the US Food and Drug Administration (FDA) issued a warning about the potential risks of such surgical procedures.
The FDA described serious complications from TVM surgery for the correction of pelvic organ prolapse (POP). With 1503 reports of these complications over 3 years, the FDA concluded that TVM complications "are not rare."
The FDA did not quantify the number of TVM procedures done during this 3-year period, nor did it capture the experience level of the implanting surgeon.
The study by Dr. Murphy and colleagues was designed to investigate the actual incidence of adverse events and other outcomes described by the FDA. Patients were treated for POP with TVM at a single center. The TVM procedures were done with the Prolift system.
In October 2006, the center began administering the Pelvic Floor Distress Inventory, the Pelvic Floor Impact Questionnaire, the POP/Urinary Incontinence Sexual Function Questionnaire, and the Surgical Satisfaction Questionnaire to all patients at their initial consultation.
The 1172 patients were evaluated at a short-term follow-up (mean, 3.6 months) and a 1-year follow-up. Twenty (1.7%) reported intraoperative complications and 44 (3.8%) reported postoperative complications. Dr. Murphy noted that there were no "visceral erosions in this series."
He went on to report the success rate, explaining that "there are a lot of ways to define success." The subjective success rate of the surgery was 92.8% and the anatomic success rate was 98.2%. He noted that "a lot of dissatisfaction is [from] persistent [overactive bladder disorder] symptoms."
Douglas Miyazaki, MD, from WomanCare Obstetrics & Gynecology in Winston-Salem, North Carolina, discussed the poster with Medscape Medical News. "The significant thing here is that it describes people who are well-trained doing the procedure," he explained.
Dr. Miyazaki noted that the 2.9% incidence of vaginal mesh exposures "is very different from earlier studies." He said the results suggest that TVM surgery is a good option with the right patient selection and surgical training.
Dr. Murphy concluded his presentation by stating that "members of AUGS need to correct the public perception that transvaginal mesh is toxic and dangerous for our patients."
Roger Goldberg, MD, MPH, from the NorthShore University HealthSystem in Evanston, Illinois, who moderated the poster session, suggested that all physicians, whether they like TVM or not, use the questionnaires to better judge the efficacy of TVM procedures.
Dr. Murphy and Dr. Goldberg have disclosed no relevant financial relationships. Dr. Miyazaki has been a physician instructor for the Gynecare (Johnson & Johnson) and American Medical Systems surgery companies.
American Urogynecologic Society (AUGS) 33rd Annual Scientific Meeting: Oral poster 3. Presented October 4, 2012.
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Cite this: Transvaginal Mesh Surgery Successful for Most Patients - Medscape - Oct 05, 2012.