Incidence of Placement and Removal or Revision of Transvaginal Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence in the Ambulatory Setting before and after the 2011 Food and Drug Administration Notification

Abstract

Introduction: In July 2011 the FDA issued a notification stating that serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare. This statement did not include any conclusions on mesh for stress urinary incontinence. The notification was reported widely in the popular media and public opinion appeared to turn against transvaginal mesh of all types not specific to pelvic organ prolapse. We evaluated changes in practice that occurred after the notification.

Methods: We used the California, South Carolina, Illinois and Maryland SASD to determine the incidence of transvaginal mesh implantation procedures for pelvic organ prolapse and stress urinary incontinence as well as the incidence of mesh revision or removal procedures for these indications.

Results: A total of 20,323 mesh related procedures were performed for pelvic organ prolapse and stress urinary incontinence in 2011. The total number of transvaginal mesh implantations for prolapse decreased from early to late 2011. The total number of revision or removal procedures increased by 49.1% and 15% for prolapse mesh and slings, respectively. There was an increase in revision or removal procedures for slings as well as for all mesh (each p <0.001).

Conclusions: The FDA notification was associated with increased revision or removal procedures for mesh placed for stress urinary incontinence despite the notification warning only against mesh for pelvic organ prolapse. Patients may rely on popular media for medical knowledge. Better patient education may help patients make choices regarding surgery in accordance with the FDA notification.

Keywords: pelvic organ prolapse; stress; suburethral slings; surgical mesh; urinary bladder; urinary incontinence.