J&J Transvaginal Mesh Case Update: Company Witnesses

Over the last few days, several Ethicon (a division on J&J) company witnesses have been on the stand. First, Scott Ciarrocca, the product manager for Prolift transvaginal mesh, testified that no clinical studies of Prolift transvaginal mesh were conducted before it was marketed and sold.

Next, Dr. Piet Hinol, Ethicon’s medical director, took the stand. His testified that Ethicon (J&J) knew of the adverse events, like erosion, chronic pain, and pain during intercourse before marketing Prolift transvaginal mesh. He further testified that the company was already working to improve the product before it was ever sold but marketed it anyway. Dr. Hinol also confirmed Mr. Ciarrocca’s testimony that no clinical studies in humans were conducted to determine if the mesh was safe (that the pore size of the mesh would not cause shrinkage or contraction, which leads to erosion and other adverse events). He also stated that these complications, especially erosion, could occur years after implantation of Prolift transvaginal mesh.

The third company witness was Gene Kammerer, a principal Ethicon (J&J) scientist. He also confirmed that Ethicon (J&J) knew of the problems surrounding shrinkage and contraction (erosion and chronic pain) before Prolift transvaginal mesh was marketed and sold. And despite his efforts to convince the company to use a different mesh, which was thought to lead to less shrinkage and less adverse events, Ethicon (J&J) marketed and sold Prolift transvaginal mesh anyway.