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"Fake news rules the world today. It certainly applies to the use of mesh in female pelvic health," writes Gopal H. Badlani, MD.
Fake news rules the world today. It certainly applies to the use of mesh in female pelvic health. The litigation wiped out two of the prominent companies from the market and threatens the availability of product after the recent FDA ban of its use in the vaginal repair of anterior compartment prolapse. Points to ponder:
Is the product defective? Obviously not, as it is “safe” to use for slings, in an abdominal approach, and in men for inguinal hernia and abdominal wall repair.
Is the ban because complications with use in vaginal surgery are higher? Not according to the literature, where depending on the series, a ballpark exposure rate of 10% is quoted for both abdominal and vaginal approaches for pelvic organ prolapse. In a large cohort study, among 41,604 women who underwent vaginal mesh surgery, the risk of exposure was highest in the anterior vaginal mesh plus sling group (2.72%; 95% CI: 2.31%-3.21%) and lowest in the stress urinary incontinence sling group (1.57%; 95% CI: 1.41%-1.74%) (JAMA Surg 2017; 152:257-63).
Is it because litigation is higher against the anterior compartment repair? Once again, two-thirds of the cases are against a sling procedure.
Is it because there is no difference in the outcomes of tissue-based repairs and mesh use? Unless you accept the “new” definition of success “as long recurrence does not protrude outside the vagina and the patient is not bothered,” every randomized trial has proven that anatomic success with mesh is superior to tissue-based repair.
Are patients demanding that mesh not be used? A plethora of articles suggest patients’ perspective is based on TV news or advertisements for litigation. Despite guidelines and position papers from all leading organizations, which emphasize mesh’s use based on physician training and informed discussion with the patient, many individual health care networks and countries have placed a blanket ban on the mesh use.
In the Q&A with Dr. Eric Rovner, he has presented an experienced surgeon’s perspective. In all the controversy, what is not emphasized is the operating surgeon’s responsibility. It is well established that the rate of complications relates to the trifecta of host factors, product, and the surgeon. Since it is not polite to blame the surgeon or the patient, it must be the product!