Pharmaceutical

Use of transvaginal mesh to correct POP declined since FDA’s 2011 warning

vaginal mesh sling Use of transvaginal mesh to correct POP declined since FDA’s 2011 warning  Did the U.S. Food and Drug’s Administration’s (FDA) warning about the risks associated with using transvaginal mesh to repair pelvic organ prolapse (POP) have any impact on surgical practices? According to a recent survey of nearly 300 specialists, use of transvaginal mesh to repair recurring POP has been declining since the FDA issued the warning in July 2011.

Dr. Catherine Matthews of the University of North Carolina at Chapel Hill and her team of researchers presented their survey findings at the American Urogynecologic Society’s 33rd Annual Scientific Meeting in Chicago.  Of the 281 physicians who responded to the survey, which was completed in November 2011, 23 percent said they intended to decrease their use of transvaginal mesh.

One fifth of the physicians surveyed reported using transvaginal mesh only to correct cases of recurring prolapse, 5.9 percent said they did not use any form of vaginal mesh, and 7.7% said they referred patients to a another physician to discuss the use of mesh. More than half of the responding physicians (53.7 percent) said they planned to include more information about the use of transvaginal mesh in their patient counseling.

Although surgeons are using mesh less often to correct recurring prolapse, the survey indicated the same physicians were using mesh more often for primary abdominal repair of prolapse. The survey also found specialists were more likely to use transvaginal mesh than generalists.

According to the FDA’s 2011 warning, transvaginal mesh complications increased fivefold since 2008. During that period, the agency received 2,874 cases of injury associated with the mesh devices (out of 3,979 injury reports filed since January 2, 2005). The report stated that 1,503 reports were associated with POP repairs and 1,371 associated with SUI (stress urinary incontinence) repairs.

In the three-year period from 2008 to 2011, the most frequently reported injuries associated with transvaginal mesh were mesh erosion (also called mesh exposure, extrusion, or protrusion); pain (often intense and constant); dyspareunia (painful sexual intercourse); infection, bleeding, urinary problems, and organ perforation. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring and shrinkage, and emotional distress. Seven deaths were also attributed to transvaginal mesh in that three-year period, three directly (two bowel perforations and one hemorrhage) and four indirectly from post-operative medical complications.

Sources:

Renal & Urology News
U.S. Food and Drug Administration