Studies on Dangers of Transvaginal Mesh Ordered by the FDA
On January 4, 2012 the FDA issued an order requiring the manufacturers of transvaginal mesh to study its risks. Manufacturers such as Johnson & Johnson, CR Bard, and Boston Scientific will conduct studies on dangers of transvaginal mesh and report back to the FDA. The information gained from the studies will help the FDA decide whether transvaginal mesh devices should be reclassified as high risk.
While this recent action is short of an FDA recall on vaginal mesh, it is a sign that the FDA is concerned about vaginal mesh complications. If the FDA decides to reclassify transvaginal mesh, the process could take years. In the meantime, women considering transvaginal mesh surgery and women who have had transvaginal mesh surgeries should consult with their doctors about the warning signs of potential complications and how to treat them.
