The United States Food and Drug Administration convened in Gaithersburg, Maryland on September 9, 2011 to discuss the future of synthetic mesh products used for the treatment of stress urinary incontinence (SUI). The meeting comes on the heels of a second warning released, July 13, 2011 by the FDA following unprecedented reports of serious and disabling adverse events including deaths associated with trans-vaginal mesh for the treatment of pelvic organ prolapse.
According to the US Department of Health and Human Services, three-fourths of American women experience involuntary leakage of urine with 1 in 10 women undergoing surgery for the treatment of urinary incontinence or pelvic organ prolapse. Manufacturers of synthetic slings, cleared without rigorous clinical trials through the FDA’s 510(k) process, found an incredible untapped resource for financial growth by preying on American women, culturally averse to aging. Perhaps the most serendipitous outcome of this marketing venture is the universal acceptance of synthetic mesh for the treatment of SUI by entire professional medical organizations without scientifically supported clinical evidence to support the safety of these devices1, 3, 9.
Prior to the warnings released by the FDA in 2008 and 2011, scientists studying the effects of synthetic mesh in 2003 caution “the use of polypropylene mesh risks serious postoperative complications, e.g. urethral tissue erosion.” Additionally these researchers found significant migration of the mesh shortly after implantation. The material penetrating tissue most frequently and more deeply, polypropylene is the most commonly manufactured surgical mesh, currently used for the treatment of female SUI4. A 2009 study found persistent foreign body reactions with polypropylene used for the treatment of pelvic organ prolapse3. Another study states, “Unfortunately, the inflammatory reaction never subsides leading to chronic pain for many women.” This inflammatory response can lead to extensive scarring, altering the natural position of the bladder, rectum and vagina7. Perhaps this could account for many women in discussion forums who describe impaired sexual function, urination and bowel emptying in the absence of mesh erosion. Although many disabling adverse events develop more than three years postoperatively; few studies following patients beyond two years are found in the literature.
An American Urological Association Foundation, Health Policy Award funded study found, “most of the literature reporting results of slings does not meet specific scientific standards for outcome analysis in that it lacks a comprehensive assessment of postoperative complications and focuses primarily on the degree of improvement of stress incontinence.” Additionally the authors note much higher rates of complications were among randomly selected Medicare recipients who underwent sling procedures compared to the rates reported in the literature1. Other authors note an apparent lack of attention to postoperative complications1, 3, 9. An article published in Neurourology and Urodynamics estimates serious complications relating to slings for the treatment of urinary incontinence occur 20-fold higher than reported6.
To address the dramatic rise in voluntary reporting of disabling complications relating to synthetic mesh slings, the FDA presented a Cochrane analysis from the available research findings. These findings noted dramatic increases in complications at much later time periods, with very few studies following patients beyond 36 months. The FDA also acknowledged the difficulty in capturing post market serious adverse events through their voluntary reporting system10. Presently surgeons are not compelled to report adverse outcomes relating to these products though they are advised to submit events through the voluntary reporting system even if they are uncertain of causality.
The September 9th meeting ended with recommendations from an advisory panel. The panel discussion was led by medical experts extensively using synthetic mesh in their practices following a day long presentation which included the testimony of several patients harmed by mesh. Panel members including clinical faculty member to Harvard Medical School, George Flesh, M.D. and Susan Kolata, M.D., the first female urologist in the state of Arizona, advised the FDA that the current classification of the now widespread marketed synthetic mesh slings is sufficient, stating they “feel” they have plenty of experience with these devices to support the continued use. Based on this recommendation it appears mesh slings for SUI will remain on the market with manufacturers citing surgical incompetence as the source of disabling complications associated with their products. Industry representatives seemed quite assured by the panel’s advice allowing them to continue to arm a plethora of surgeons, who hold, a subjective opinion that they are uniquely qualified, technically proficient pelvic-floor specialists, with polypropylene synthetic mesh slings.
I spoke at this meeting as a mesh survivor, having suffered excruciating pain, bladder obstruction requiring multiple daily catheterizations and insurmountable medical expenses as a result of meaningless procedures, surgery and diagnostic testing. Leaving me to pay out of network fees, I traveled to Atlanta in November 2010 to have the sling removed via laparoscope. While many surgeons can insert mesh, very few can remove it effectively and sometimes the best can’t remove it at all.
I am disheartened by the panel’s recommendation though I realize the difficulty for these advisors, especially those distinguished as first female urologist or affiliates of prestigious medical schools, to acknowledge their extensive use of a product associated with untold carnage and human suffering, without substantive scientific evidence for safety. It must be difficult to admit using such a product without establishing a compelling medical necessity, to justify such risks.
Having met other women at the FDA hearing, including one who testified after losing her kidney recently from sling complications, I can say it has been very difficult for us too. Women harmed by synthetic mesh certainly expected their surgeons to use evidence based treatments, meeting established scientific standards and not a device approved on the “feelings” of some experts. American psychologist, Donald R. Gannon’s quote, “where facts are few, experts are many” certainly resonates now.
1. Anger, J.,Litwin, M., Wang, Q., Pashos, C., Rodriiguez, L. Complications of Sling Surgery Among Female Medicare Beneficiaries. Obstetrics and Gynecology. 3, 2007, Vol. 109, 707-714.
2. Weber, A., Abrams, P., Brubaker, L., Cundiff, G., Davis, G., Dmochowski, R., Fischer, J., Hull, T., Nygaard, I., Weidner, A.C. The Standardization of Terminology for Researchers in Female Pelvic Floor Disorders. International Urogynecology Journal. 12, 2001, 178-186.
3. Elmer, C., Blomgren, B., Falconer, C., Zhang, A., Altman, D. Histiological Inflammatory Responses to Transvaginal Polypropylene Mesh for Pelvic Reconstructive Surgery. Journal of Urology. 181, 2009, Vol. III, 1189-95.
4. Lin, L., Haessler, A., Ho, M., Betson, L., Alsinod, R. Bhatia, N. Dyspareunia and Chronic Pelvic Pain After Polypropylene Mesh Augmentation for Transvaginal Repair of Anterior Vaginal Wall Prolapse. International Urogynecology Journal. 1, 2007, Vol. 18, 675-678.
5. Samli, M., Demirbas, M., Guler, C., Aktepe, F., Dincel, C. Early Tissue Reactions in the Rat Bladder Wall After Contact with Three Different Synthetic Mesh Materials. BJU International. 93, 2004, Vol. 1, 617-621.
6. Deng, D., Ruttman, M., Raz, S., Rodriguez, L. Presentation and Management of Major Complications of Midurethral Slings: Are Complications Under-reported? Neurourology and Urodynamics. 26, 2007, Vol. I, 46-52.
7. Knight, D., Scott, P. How to treat pelvic organ prolapse in women. Australian Doctor. [Online] July 16, 2010. [Cited: September 1, 2010.] http://www,australiandoctor.com.au.
8. Estes, C., Wallace, S. Older People. [book auth.] B., Sidel, V. Levy. Social Injustice and Public Health. New York : Oxford University Press, 2006.
9. Wall, L., Brown, D The Perils of Commercially Driven Surgical Innovation. Am J Obstet and Gynecol (2010) 202:30:e1-4
10. FDA meeting: Obstetrics and Gynecology Medical Devices Panel: Holiday Inn Ballroom, 2 Montgomery Village Ave., Gaithersburg, Maryland