FDA Warnings on Urogynecologic Mesh: An Overview

This article will detail the original warnings the FDA issued regarding urogynecologic mesh when used in pelvic organ prolapse surgical applications. According to an article titled An Appraisal of the Food and Drug Administration Warning on Urogynecologic Surgical Mesh published in Current Urology Reports (2012 13:231-239), permanent surgical mesh has been used in various applications for several decades, having been used in the repair of hernias since the 1950’s.

The FDA’s July 2011 report on Urogynecologic Surgical Mesh defines surgical mesh as “a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists.” Beginning in the 1970’s surgical mesh made its appearance in abdominal surgeries for pelvic organ prolapse, then in the 1980’s surgeons began using synthetic slings in the treatment of stress urinary incontinence. It was not until 1996, however, that the FDA approved a type of mesh particularly for use in stress urinary incontinence surgical procedures. Some six years later, in 2002, the Federal Drug Administration approved surgical mesh as an application for the treatment of pelvic organ prolapse. 

Relevant FDA Communications on Urogynecologic Mesh

The following article will give the reader a comprehensive overview of the FDA’s communications to date concerning surgical mesh when used transvaginally in pelvic organ prolapse surgeries. The article An Appraisal of the Food and Drug Administration Warning and Urogynecologic Surgical Mesh, published in the Current Urology Reports (2012, 13:231-239) gives an overview of the FDA’s conclusions regarding the use of surgical mesh in POP surgeries. The first Public Health Notification issued by the FDA came out in 2008 after over a thousand women submitted adverse health reports following transvaginal surgery using gynecologic mesh. Three years later the FDA issued an update to that report regarding the safety and effectiveness of mesh in POP surgery. At this time the agency reviewed the currently available safety data and scientific research on gynecologic mesh.

This article states that it is estimated that over a third of pelvic organ prolapse surgeries implement surgical mesh and that 75% of all these surgeries were done transvaginally. These numbers come from the over 300,000 women who undergo pelvic organ prolapse surgery annually in the U.S. and over 260,000 who undergo a surgical procedure for stress urinary incontinence. The FDA states that as far as SUI surgeries go, “more than 80% were done transvaginally with mesh.” The FDA’s conclusion is that although POP surgery done transvaginally may restore the woman’s body anatomically, there are few if any benefits over surgeries which do not implement urogynecologic mesh. 

Corrective Surgical Procedures for Apical Prolapse

This article will discuss the various surgical procedures currently used in the treatment of apical prolapse. Apical prolapse is the descent of uterus, cervix or vaginal vault and affects millions of women worldwide. By the age of 80 to 85 years, as many as 19 percent of women will have undergone a surgical procedure to correct pelvic organ prolapse or stress urinary incontinence.

According to an article in the Obstetrics and Gynecology Board Review Manual titled Diagnosis and Treatment of Vaginal Apical Prolapse, “As the average life span of the population increases, problems related to pelvic support defects are seen with increasing frequency in women.”