Friday, June 28, 2013

Prolift Vaginal Mesh Sold Without Undergoing Clinical Trials

This was the description made by Jonathan Meeks, worldwide marketing director of Ethicon, over the material for the Prolift vaginal mesh. The company painted such scenario in a copy of Meek's internal memo presented during the trial of Linda Gross against Ethicon.

This particular mesh was the petroleum-based synthetic mesh material that was used by Ethicon for its Gynemesh PS, intended for the treatment of hernia disorders. In his email, Meeks admitted that the chosen artificial material was the best of a bad lot regarding integration and retraction and that there was a need to develop grafts that mimic the mechanical properties of human tissue.

In her testimony, Dr. Anne Webber, a doctor presented by the plaintiff, said that Ethicon was aware before the launching of the Prolift that the mesh material used would cause an inordinate number of complications. Yet, even with this knowledge, no clinical trials were made on the Prolift.

 Ethicon officials, despite warning from their researchers, insisted on launching the product in March 2005. It relied on the performance of another product, the Gynecare PS, which led Dr. Weber to conclude that this was unreasonable and may lead to a new set of complications.

Read More: Prolift Mesh Kit Was Never Subject to Clinical Trial