A panel of Food & Drug Administration (FDA) advisers are meeting to determine whether vaginal mesh is safe and effective. The Johnson & Johnson product is used to support weakened muscles—holding pelvic organs in place.
To date, about 500 suits have been filed against J&J. Plaintiffs claim the mesh causes excruciating pain that is comparable to or worse than childbirth. The product has been used for three decades, primarily to treat hernias, but only recently has its use been expanded to treat pelvic muscle weakness.
"As industry modified surgical mesh for these indications, none of the mesh has been evaluated for clinical data," Herbert Lerner, acting director in the FDA’s device approval center, said at the hearing yesterday.
The FDA had warned in July that there had been a rise in injuries related to the mesh and the device should be reclassified from moderate risk to high risk. The change would require new clinical data.