Court records reveal that long before the Prolift vaginal mesh was made available to the market, there were already opposition and dissent coming from a number of experts from within the company. Members of the research team believed that the mesh used for the Prolift was not fit for implantation on the human body. These doctors claim that Ethicon executives were aware of the product’s defects and yet insisted on launching Prolift vaginal mesh despite the warnings.

The suggestion of Gene Kammerer, a principal scientist in the development of the Prolift was to use another type of mesh for the Prolift. He was strongly recommending the use of the UltraPro, which he believed may reduce the scar contraction and lower the density of the scar formation resulting in fewer cases of erosion and recurrence of prolapse.

The use of the UltraPro, according to Kammerer, may create a more stable matrix and past experiences have shown that a lower inflammatory response may be exhibited especially in the early stages of the implant. The UltraPro was more absorbable and left behind less material than the Gynemesh PS, Kammerer further added.

Through an e-mail sent to Scott Ciarocca, a member of the Research & Development of Ethicon, Dr. Michel Cosson, one of the leading scientists working on the Prolift vaginal mesh, expressed his concern by saying that there is a need to improve the mesh. He was bothered by the shrinkage of the mesh which may result to pain and dyspareunia, in addition to mesh erosion and retraction.

A stronger dissent was provided by Dr. Uwe Klinge, a hernia surgeon who was hired by Ethicon as consultant and considered to be an expert in the biocompatibility of surgical mesh. Ethicon executives were warned by Dr. Klinge of possible complications during their meeting in 2005 which took place months before the launching of the Prolift vaginal mesh.

That the Gynemesh PS, the material used for its hernia repair, was not suitable for implantation on a woman’s pelvic area was the position of the doctor. A mesh with a pore size of less than one millimeter, according to Dr. Klinge, may cause fibrotic bridging scarring and create a scar plate that may lead to shrinkage and other complications.

The study conducted in 1988 with Professor Klosterhalfen of the Technical University of Aachen was referred in order to demonstrate the importance of porosity. The quantity of space left inside the pores of the mesh after being exposed to stress-like movements is the definition of porosity. There were less chances of mesh shrinkage if the space between pores were larger since less fibrotic tissue would develop, according to the results of the study.

Dubbing it as a new and unique innovation in the treatment of pelvic organ prolapse, Ethicon insisted on launching the Prolift vaginal mesh implant in 2005 in spite of the opposition coming from distinguished doctors and researchers. In 2006, Linda Gross underwent vaginal mesh surgery using the  Prolift and started experiencing serious problems after only a few years which has resulted to the filing of a vaginal mesh lawsuit against the Johnson & Johnson subsidiary.

References:

meshmedicaldevicenewsdesk

bloomberg.com