Transvaginal Placement Of Surgical Mesh Research Articles

A 14-year multi-institutional collaborative study of Chinese pelvic floor surgical procedures related to pelvic organ prolapse.

Background:It has been a global trend that increasing complications related to pelvic floor surgeries have been reported over time. The current study aimed to outline the development of Chinese pelvic floor surgeries related to pelvic organ prolapse (POP) over the past 14 years and investigate the potential influence of enhanced monitoring conducted by the Chinese Association of Urogynecology since 2011.Methods:A total of 44,594 women with POP who underwent pelvic floor surgeries between October 1, 2004 and September 30, 2018 were included from 22 tertiary academic medical centers. The data were reported voluntarily and obtained from a database. We compared the proportion of each procedure in the 7 years before and 7 years after September 30, 2011. The data were analyzed by performing Z test (one-sided).Results:The number of different procedures during October 1, 2011−September 30, 2018 was more than twice that during October 1, 2004−September 30, 2011. Regarding pelvic floor surgeries related to POP, the rate of synthetic mesh procedures increased from 38.1% (5298/13,906) during October 1, 2004–September 30, 2011 to 46.0% (14,107/30,688) during October 1, 2011–September 30, 2018, whereas the rate of non-mesh procedures decreased from 61.9% (8608/13,906) to 54.0% (16,581/30,688) (Z = 15.53, P < 0.001). Regarding synthetic mesh surgeries related to POP, the rates of transvaginal placement of surgical mesh (TVM) procedures decreased from 94.1% (4983/5298) to 82.2% (11,603/14,107) (Z = 20.79, P < 0.001), but the rate of laparoscopic sacrocolpopexy (LSC) procedures increased from 5.9% (315/5298) to 17.8% (2504/14,107).Conclusions:The rate of synthetic mesh procedures increased while that of non-mesh procedures decreased significantly. The rate of TVM procedures decreased while the rate of LSC procedures increased significantly.Trial registration number:NCT03620565, https://register.clinicaltrials.gov.

"Guidelines for Providing Privileges and Credentials to Physicians for Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: " Retraction.

Female Pelvic Medicine & Reconstructive Surgery 26(5):p 349, May 2020. | DOI: 10.1097/SPV.0000000000000809

Pelvic Organ Prolapse Surgery in Academic Female Pelvic Medicine and Reconstructive Surgery Urology Practice in the Setting of the Food and Drug Administration Public Health Notifications

To understand the effect of the Food and Drug Administration (FDA) public health notifications regarding transvaginal placement of surgical mesh for pelvic organ prolapsed (POP) on surgeon practice patterns in tertiary care academic medical centers. Surgical volume for procedures performed primarily by fellowship trained Female Pelvic Medicine and Reconstructive Surgery at a sampling of 8 academic institutions across the US were collected using current procedural technology codes for POP repair and revision surgeries from 2007 to 2013. SAS statistical software was used to analyze data for trends and to assess differences in number of procedures across years by performing Spearman correlation analysis and Pearson's chi-squared test. Significance of trend was defined as P <.05 for both analysis methods. There has been a substantial reduction in transvaginal mesh-augmented repair of POP since the FDA warning statements of 2008 and 2011. Mesh revision surgery has increased over this same period. However, the total number of interventions for POP has remained stable over the study period. Abdominal sacrocolpopexy has increased as a whole but represents only a small percentage of total cases. Surgical correction of POP comprises a large portion of Female Pelvic Medicine and Reconstructive Surgery practice that continues to evolve in the aftermath of the FDA public health notifications. The utilization of transvaginal placement of surgical mesh augmented POP repair has decreased among practicing urologists at a sampling of academic institutions across the United States. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study; however, such data may provide alternative insights into the reasons for the observed trends.

Guidelines for Providing Privileges and Credentials to Physicians for Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

The adoption of new technology or procedures into a clinician's surgical armamentarium is driven by multiple factors. Patient safety and anticipated long-term improvement in outcomes should be the primary objective that guides a surgeon's decision to deliver care involving new procedures. Surgically complex procedures require a balance of knowledge, surgical skill, and experience, with appropriate ongoing surgical volume and monitoring of outcomes and adverse events. Transvaginal placement of surgical mesh for pelvic organ prolapse has the potential to improve quality of life and anatomic outcomes (especially in the anterior compartment), but also has potential serious adverse events as outlined by the FDA's July 2011 Safety Communication. This document provides Guidelines for privileging and credentialing of physicians planning to implement or continue using this new technology in clinical practice.

Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996-2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.

Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns—positive reactions are possible

Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns—positive reactions are possible

Use of vaginal mesh in the face of recent FDA warnings and litigation

Choosing to use mesh in vaginal reconstructive surgery for pelvic organ prolapse or stress urinary incontinence is perplexing in the face of recent US Food and Drug Administration (FDA) warnings. In October 2008, the FDA alerted practitioners to complications associated with transvaginal placement of surgical mesh. Litigation is another concern. A Google search of "transvaginal mesh" results in numerous hits for plaintiff attorneys seeking patients with complications related to use of mesh. In light of a recent decision by the US Supreme Court and strategies by manufactures of medical devices to escape liability, it is imperative that gynecologic surgeons using transvaginal mesh document proper informed consent in the medical records. The purpose of this commentary is not to deter gynecologic surgeons from using transvaginal mesh when appropriate, but to provide an overview of current medical-legal controversies and stress the importance of documenting informed consent.

New Considerations in the Use of Vaginal Mesh for Prolapse Repair

The proliferation of mesh-based transvaginal prolapse surgical repair methods and products has generated increased scrutiny of the evidence-based foundation in support of these techniques. Recent developments in this arena include the publication of the Society of Gynecologic Surgeons Systematic Review Group, which concluded that supportive evidence for transvaginal mesh is limited, and a Public Health Notification from the Food and Drug Administration (FDA), regarding “serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.” This article reviews available literature regarding transvaginal mesh use, specifically regarding material, technique, and patient characteristics that may influence the rates of iatrogenic complications of transvaginal mesh prolapse repairs. Compliance with the FDA Public Health Notification is encouraged, and additional clinical practice guidelines are provided.