Drs Raz and Ackerman: Risks and Benefits Lacking for Slings
Mesh Medical Device News Desk, November 7, 2017 ~ This well thought out opinion piece is voiced by two leaders who are well acquainted with the devastating injuries resulting from women implanted with mesh, “slings” and transvaginal mesh, used to treat incontinence and prolapse.
Writing in the International Brazilian Journal of Urology, in July-August 2016 is an Opinion Piece (here) by Dr. A. Lenore Ackerman and Shlomo Raz MD.
The authors, from Cedars-Sinai in Los Angeles and UCLA, say about half of all women will have some component of stress urinary incontinence in their lifetime and about 10% will undergo a surgical treatment.
As opposed to years past when the Burch colposuspension or autologous fascial pubovaginal sling was the norm, augmented polypropylene (PP) products have been adapted for medical use to become the preferred synthetic midurethral slings (SMUS) for the treatment of stress urinary incontinence (SUI).
By 2010, the SMUS was the standard of care worldwide because of the reported equivalent outcomes with Burch and fascial slings, their ease of use, faster recovery time and reduced cost.
PP mesh used for pelvic organ prolapse (POP) then followed, however, soon severe complications came to light and the first black box warning was issued by the FDA in 2008.
The more serious warning followed in 2011 (“complications are not rare”), and in January 2016 the FDA upgraded the alert on POP mesh moving it from a moderate risk class II to a high risk, class III.
At the same time, SUI mesh remains in class II or moderate risk even as more than half of the hundreds of thousands of lawsuits have been filed against SUI mesh alleging its defective.
At UCLA, of the nearly one-thousand patients seen over the past five years for TVM (transvaginal mesh) complications, 77% were related to the mid-urethral sling.
More than half of the adverse event reports filed with the FDA (MAUDE database) are associated with SUI repairs.
The FDA said it “continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report abut that usage at a later date.”
While true patient informed consent involves understanding the benefits, safety and efficacy, as well as risks and severity, “Both of these are lacking for SMUS”, say the authors.
There are limitations in any dialogue regarding mid-urethral sling complications – dyspareunia, urethral and bladder perforation, vaginal scarring and stenosis, mesh extrusion, vaginal bleeding- have been discussed in the literature, but here the authors focus on chronic pain.
Chronic pain may not just be found in the groin area and reports of pain elsewhere often are not included in a risk/benefit analysis. Neither does chronic, debilitating pain that develops a year or more after implantation. There are no treatment plans for this type of pain.
Often women turn to a full or partial mesh removal but even with excision “approximately one-quarter of these patients will not improve or will even worsen, living with constant debilitating pain.”
Almost everyone agrees that complications from synthetic mid-urethral slings are under-reported, but by how much?
Quality of life (QOL) issues such as cystitis, voiding dysfunction and neurologic symptoms are often dismissed in long-term assessments. Shame, hopelessness, regret, anxiety,and frustration, can result impacting personal relationships and creating self-image problems.
Failures may not be felt by the patient until years after an implant yet a recent Cochrane Review only addressed four outcomes after one year among 84 clinical trials. That means most of the data is short-term with limited clinical relevance.
The authors do not seek a ban on mid-urethral slings but only to highlight that little is known about the risks of mesh-augmented procedures in SUI management. Are the risks justified? Is there that much to gain by using synthetic mesh over a Burch colosuspension and autologous fascial sling?
Advocating SMUS as a quick fix for everyone may be growing the divide between patients and physicians and add to the emotional devastating of the injured patient.
“As a community we must take this public outcry seriously, acknowledge our lack of insight into these complications, and pursue a deeper understanding of the pathophysiology of poor outcomes after SMUS.”
The physicians argue that it may be time to return to bioethics and the “first, do no harm” when it comes to treatment. For an inconvenience like incontinence, it may be better not to do something rather than risk causing more harm than good. ###