Health Canada just issued important safety information on surgical mesh for use in the repair of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
According to Healthy Canadians, the information was meant for distribution to hospital departments of surgery, gynecology, urology, emergency medicine, internal medicine, intensive care, and other involved professional staff.
The information is an update regarding complications tied to the transvaginal implantation of surgical mesh to treat POP and SUI. According to Healthy Canadians, a notice was issued to hospitals, a so-called “NtH,” advising health care professionals about complications tied to these procedures when done transvaginally and using surgical mesh.
The update indicated that Health Canada continues to receive complication reports, some serious and life altering, tied to the use of these devices in these surgeries. Although the mesh for surgical treatment of POP and SUI may have some shared risks and complications, the management of their complications as well as the incidence and severity of injuries, differ.
Regarding the use of surgical mesh in POP and SUI procedures, reported complications include acute or chronic pain, mesh erosion (extrusion or exposure), infection, voiding dysfunction, dyspareunia (pain during sexual intercourse), organ or blood vessel perforation, neuromuscular damage, bleeding or hemorrhage, and recurrent POP or SUI. Another complications involve mesh contraction, which leads to vaginal tightness and/or shortening. Revision surgery may be required and, even multiple revision surgeries, may not fully correct every complication, according to Healthy Canadians.
Health Canada recommends that healthcare professionals provide information to their potential mesh candidate patients about POP and SUI procedures and transvaginal mesh. According to Health Canada, physicians should conduct pre-operative counseling, discussing all treatment options—surgical, non-surgical, with mesh, and without mesh—so that patients are completely aware of the risk-benefit profile of all of the available options. Patients should be provided with written documentation including device labeling, when available, wrote Healthy Canadians.
Should mesh be considered, patients should be advised of the mesh route—abdominal or transvaginal—as well as the potential complications involving the placement of the mesh particularly, perforation, acute or chronic pain, erosion, infection, dyspareunia, urinary problems, and vaginal stricture, Healthy Canadians indicated. Patients should also be advised that complete mesh removal may never be possible, despite multiple surgeries.