Mesh Medical Device News Desk, December 12, 2016 ~ A study published in JAMA Surgery confirms the common adage among the mesh aware community, the more transvaginal pelvic mesh present in a body, the more likely there will be complications.
The question posed by the study is – What is the association between the amount of synthetic vaginal mesh used with mesh erosion and repeated surgery after POP repair and SUI surgery? Mesh erosion risk was seen more in patients receiving POP repair surgery with mesh and concurrent slings.
Published in November in JAMA Surgery (Journal of the American Medical Association) the primary authors are Dr. Bilal Chugtai, MD, Weill Cornell, New York-Presbyterian Hospital, NY; Matthew Barber, Cleveland clinic and Jialin Mao, MD Weill Cornell Medical College, Department of Healthcare Policy and Research.
Based at inpatient and ambulatory surgery centers in New York State, the women had surgery for POP (pelvic organ prolapse) or SUI (stress urinary incontinence) between January 1, 2008 and December 31, 2012. There was a one-year followup of the 41,604 women involved. The average age was 56.2.
They were divided into four groups:
POP repair with mesh & a mesh SUI sling
POP repair with mesh and no SUI sling
POP repair without mesh but with SUI sling
Sling for SUI alone
Researchers concluded the combined use of a POP mesh and SUI mesh slings had the highest erosion and repeated intervention risk. A mesh sling alone had the lowest erosion and complication rate.
They conclude there is a response based on the amount of mesh used for the surgery.
Reiterating what Dr. M. Tom Margolis stated about five years ago at the FDA Expert panel on pelvic mesh, THE MORE MESH, THE MORE MESS.
Researchers here conclude: “There is evidence for a dose-response relationship between the amount of mesh used and subsequent mesh erosions, complications, and invasive repeated intervention.”
Placing a mesh SUI sling at the same time as a POP procedure is probably a combination leading to the highest potential risks.
Dr. Chughtai reports receiving a grant from AUGS for his research, (See it here).
Dr. Chughtai and Autoimmune Issues
Dr. Chughtai also submitted a paper to the 2016 AUGS conference – Long Term Systemic Effects of Vaginal Mesh: Seeking the Truth (here).
The objective is whether there is any potential link between the development of autoimmune disorders and synthetic polypropylene mesh repairs using national claims data.
He cites as the source a “consumer website” (Akre, 2014) assuming he means Mesh Medical Device News Desk.
Using the New York State Department of Health Statewide Planning and Research Coopertive Systems (SPAARCS) data, 2,257 women who had mesh placed between January 2008 and December 2009 were compared to women undergoing routine screen colonoscopy or vaginal hysterectomy (without slings). The average age was 62.2 year.
Autoimmune diseases included Hashimoto’s thyroiditis, pernicious anemia, Grave’s disease, autoimmune hemolytic anemia, multiple sclerosis, ALS, Guillain-Barre Syndrome, among others, was determined at six month, one year and five years periods. The women were followed through 2014.
Conclusion– Mesh-based surgery was not associated with an increased risk of developing autoimmune disease over the entire followup time period.
Two of the six authors reports financial relationships with Boston Scientific, Astors, Allergan. Dr. Chughtai reports nothing to disclose.
Dr. Chughtai et al may want to check with the informal, autoimmune registry data being gathered by researchers at UCLA. See the link to Mesh News Desk here. And women, as well as men with hernia mesh, report anecdotal stories of their reaction to pelvic and hernia mesh, both made with polypropylene, on Mesh News Desk (here).
Generally scientific curiosity and the subsequent hypothesis begin with these anecdotal reports. ##