On July 13, 2011 the United States Food and Drug Administration (FDA) released a second warning against the use of synthetic mesh for the treatment or urinary incontinence and pelvic organ prolapse. For those suffering synthetic mesh complications, this warning serves as some validation for their suffering that has largely been ignored by the FDA, physicians and media. Some fear the announcement may not be stern enough as evidence about the perils of synthetic mesh could be found in any peer reviewed journal written for gynecologists and urologists long before this warning.
Synthetic mesh kits for the treatment of urinary incontinence and pelvic organ prolapse have rapidly become a routine procedure in surgical centers and hospitals throughout the United States. The mesh kits are associated with serious complications such as erosion and chronic pain syndromes, reported by some at rates of 53% and 30% respectively1. It is these and other major complications that have fueled a heated debate among pelvic floor specialists, gynecologists and urologists.
The U.S. Department of Health and Human Services (HHS) released a report on Urologic Diseases in 2004. According to the report nearly three-fourths of adult women report the symptom of urinary incontinence. Additionally 1 in 10 women will undergo surgical intervention for urinary incontinence or pelvic organ prolapse2. Device manufacturers have recognized this as a tremendous opportunity for profits, bombarding the market with synthetic mesh products.
Many of these products have been approved through the FDA's 510(k) process.
In 1996, the ProteGen Sling was approved after a 90 day study in rats. After high rates of erosion and complications the sling was withdrawn from the market in 1999. The ObTape by Mentor Corporation was approved as "equivalent" to the Tension-Free Vaginal Tape made by Ulmsten and has also been withdrawn. Despite recalls many comparable devices approved by the FDA as "equivalent" remain on the market without undergoing rigorous studies3.
Although the rates of major complications continue to rise, the media and women devastated by synthetic mesh remain relatively silent. On-line chat rooms and message boards may indicate why women aren't speaking out. The experiences of these complications are frequently marginalized by gynecologists and urologists practicing in tertiary care centers and smaller hospitals. Some women are told that such complications are very rare and they are just one of those unlucky ones. Others experiencing chronic pain from synthetic mesh are told that mesh isn't causing their pain. Women are frequently referred to general surgeons, physical therapists, orthopedists, psychiatrists and pain clinics. It is unclear if gynecologists and urologists are oblivious or deliberate in their lack of transparency regarding mesh complications.
Another reason for the silence of women experiencing chronic pain is the very personal nature of the complications. Women are conditioned by society to not speak of intractable rectal spasms, mesh eroding through the vagina, urethral pain, excruciating intercourse, groin and buttock pain or of urinary retention, incontinence and excruciating defecation.
A significant amount of women will undergo multiple procedures to remove the mesh. Women privileged with financial resources and health may find surgeons experienced in mesh removal by flying across the country and paying out-of-network fees. Women of fixed incomes or deteriorating health who are unable to travel for surgery end up in a continuing experiment in the hands of inexperienced surgeons lacking the technical capabilities to remove the mesh effectively.
As many gynecologists and urologists refuse or fail to recognize many mesh complications and patients are referred out, it is unlikely that complications are accurately reported. It is a reasonable assumption that the totality of complications, are grossly underrepresented in the literature. A study in Neurourology and Urodynamics, reports major complications are estimated to occur 20-fold higher than reported12. Others have reported that chronic pain, dyspareunia (painful intercourse) and erosion commonly occur more than three years postoperatively1. The delay in onset of major complications compromises the accuracy of many studies reporting lower complications as they commonly follow patients for 1 year or less.
Several experts report rising rates of disabling complications necessitating complete removal of synthetic mesh4,5,6. The delay in onset of complications and failure to report is very likely contributing to the high variability of complications among studies. Reports of chronic pain following sling placement range from 0-30%7.
In a blistering editorial published in the International Urogynecology Journal, Lewis Wall, M.D. and Douglas Brown, PhD. assert the American College of Obstetrics and Gynecologists unethically altered the practice bulletins, eliminating the word "experimental" in describing the use of these kits without evidence to support that these kits are safe or effective8. Dr. Lawrence, the presiding Vice President of ACOG attempted to defend the revision to the bulletin citing complaints by fellows of ACOG9. Anne M. Weber, M.D, author of the ACOG practice bulletin vehemently opposed the removal of the term "experimental" to describe synthetic mesh kits for the treatment of urinary incontinence and pelvic organ prolapse. She also acknowledged the lack of evidence to support the indiscriminate use of these kits. In what could be a professionally alienating statement she disclosed the real reason for the change in wording. This reason was also published in the International Urogynecology Journal. She disclosed the explanation she received from an ACOG staff member of the Committee on Practice Bulletins. It was explained to her that the committee recognized the wording would possibly deny payments for some physicians10.
Following the revision to the practice bulletin, the FDA released a Public Health Notification in October 2008 about the serious complications. Despite the warning, few women are adequately informed of the unknown long-term safety of these devices or the severe and disabling complications. A systematic review of mesh kits for pelvic organ prolapse and incontinence between 1950 and 2007 cautions "surgeons should counsel patients that device-related complications that may occur when using these procedures are not rare; most are related to the use of mesh and their management may necessitate surgical intervention under anaesthetic.11"
As synthetic mesh kits continue to ascend, potentially affecting 1 in 10 women, perhaps history will concur with the opinion of women already devastated by complications. The systemic, indiscriminate use of synthetic mesh products for the treatment of urinary incontinence and pelvic organ prolapse, is among the most egregious injustices perpetrated with the assistance of American Medical Association members and the United States Food and Drug Administration.