Welcome to PracticeUpdate! We hope you are enjoying access to a selection of our top-read and most recent articles. Please register today for a free account and gain full access to all of our expert-selected content.
Already Have An Account? Log in Now
Results of Two Studies Refute Transvaginal Mesh as Causing Autoimmune Disease and Cancer
May 16, 2017—Boston, Massachusetts—Results of two separate studies refute claims against transvaginal mesh as a cause of systemic disease and cancer.
The conclusion is based on results of two retrospective analyses of statewide administrative data covering over 4500 patients, and was presented at the 112th Annual Meeting of the American Urological Association (AUA), from May 12 - 16.
Bilal Chughtai, MD, of Weill Cornell Medical College, New York, explained that data are lacking regarding the systemic response to polypropylene mesh implantation.
Dr. Chughtai and colleagues sought a potential link between the development of systemic/autoimmune disorders and synthetic polypropylene mesh repairs.
Two separate control cohorts were created for comparison, including a colonoscopy cohort and a vaginal hysterectomy cohort (without pelvic organ prolapse repair or sling). Patients in the mesh cohort were individually matched to the control cohorts based on demographics, comorbidities, and procedure date.
The development of systemic/autoimmune disease was determined before and after matching for 6-month, 1-year, 2-year, and the entire follow-up duration (up to 5 years). Differences between groups were evaluated.
A total of 2257 patients underwent mesh based pelvic organ prolapse surgery over the 2-year period from 2008 through 2009. In control cohorts, 114,399 patients underwent colonoscopy and 9395 underwent vaginal hysterectomy.
When patients were matched based on demographics, comorbidities, and procedure time, mesh- based surgery was not associated with an increased risk of developing autoimmune disease during any of the evaluated time periods.
The second study sought to identify a potential link between carcinogenesis and synthetic polypropylene mesh repairs.
The 2-year time period of 2008 through 2009 was chosen because it was after the mesh insertion code came into use, yet allowed for long-term follow-up with respect to the outcomes of interest. Cancers were chosen based on the most common cancers in women based on data collected from the Centers for Disease Control and Prevention and National Cancer Institute.
Patients in the mesh cohort were individually matched 1:3 to a control cholecystectomy cohort based on comorbidities and procedure date. Carcinogenesis was determined before and after matching for 1-year, 2-year, and the entire follow-up duration (up to 5 years).
Differences between groups, defined by frequency of new diagnoses of malignancy, were assessed using chi-squared tests in the entire cohort and stratified Mantel Haenszel tests for paired data in the matched cohort.
A total of 2301 patients underwent mesh-based pelvic organ prolapse surgery, and 1699 undergoing the procedure were matched to 5097 patients undergoing cholecystectomy based on demographics, comorbidities, and procedure date.
Mesh-based surgery was not associated with an increased risk of developing a cancer diagnosis at 1 year (risk ratio 0.41, 95% confidence interval 0.23 - 0.75), 2 years (risk ratio 0.57, 95% confidence interval 0.39 -0.84), or during the entire follow-up period of up to 5 years (risk ratio 0.67, 95% confidence interval 0.53 - 0.84).
Session moderator Tomas L. Griebling, MD, MPH, of the University of Kansas Medical Center, Kansas City, concluded, “These studies show promise in understanding more about a woman’s sexual and urologic health…data indicating synthetic vaginal mesh does not cause either systematic disease or cancer, are important factors in patient diagnosis, treatment, and survival variances and is beneficial information for physicians to discuss with their patients.”
Additional Info
Disclosure statements are available on the authors' profiles:
Urology
The two studies referenced in this news piece, hopefully, will underscore the need to segregate surgical mesh from any attendant risks for either autoimmune disease or carcinogenicity. Both of these papers have looked at aspects of imputative post–mesh implant problems, and both with well-done epidemiologic controls dismiss the possibility of either mutagenicity/carcinogenicity or immune stimulation from the implantation of mesh.
Unfortunately, these two tenets have been a significant aspect of the ongoing mesh litigation phenomenon and have been cited as potential risks that exacerbate the inherent mesh complications that form the basis of these lawsuits.
Much has been made of the constituency of the mesh and its production parameters. Much of the quoted science related to the risk associated with mutagenic carcinogenicity or autoimmune phenomena has been based on this dated literature. These two new studies provide solid refutation of the logic that uses these dated studies as its basis. Patients should be informed of these studies and the de-risking of mesh procedures from these potential outcomes.