February 4, 2013 ~On this Day 16 of Linda Gross v. Ethicon,
German mesh researcher Dr. U. Klinge appeared on the stand. Dr. Klinge, a hernia surgeon who has performed 300 surgeries, also worked as an Ethicon consultant on new mesh material for 10 years.
He has authored more than 100 articles and worked with mesh biocompatibility in the body for more than 20 years.
As an Ethicon consultant he provided the science that brought many hernia meshes to the market. He says the science was never done on the Prolift to adapt the hernia mesh (Gynemesh PS) to a woman’s pelvic area.
Thanks extended to Courtroom View Network for access to this trial!
In July 2006, Linda Gross was implanted with the Prolift, a new procedure using the Gynemesh PS hernia mesh. It would be sold pre-cut in a kit with implantation devices, an innovative new product made by the Ethicon division of Johnson & Johnson.
Back in 1998 Dr. U. Klinge, in his studies with Professor Klosterhalfen at The Technical University of Aachen, found that a “modification of polypropylene (PP) meshes could be helpful to prevent major and minor complications of surgical PP-meshes” here.
Working with Ethicon at its Norderstadt, Germany facility, something called “porosity” was seen to be critical for a successful implant. Porosity is the amount of space left inside a piece of mesh in its “pores” even after it undergoes a stress like movement.
The larger the space, the less fibrotic tissue would grow across the pore. Scar tissue is inflexible that bridges the gap but also leads to mesh shrinkage and eventually pain when placed in the pelvic floor, a complication that never ends.
Ethicon had not developed any pore size specification, according to an email from Ethicon R&D engineer Scott Ciarocca to Dan Burkley, who did porosity testing for Ethicon.
When Ethicon funded a study in 2002, Dr. Klinge told the jury the company was very aware that the pore size of mesh under 1 mm would cause fibrotic bridging scarring across the pore hole have a scar plate that could lead to shrinkage and complications.
Q: “Was Gynemsh PS safe to be placed in woman’s tissue?”
A: ” It is not as safe in design and never had a chance to be.”
Q: “What is the general basis of that opinion of the structural disadvantage of this mesh?
A: “You have rather small pores that are even made smaller by filaments across the pores. You have complete columns of pores and this together leads to an incorporation of the device into scar formation. That means by matrix of scar shrinkage and entire area of mesh is integrated into the scar plate in the area of the pelvic floor, this is disastrous.”
Q: ” Was Ethicon aware before launch of Prolift in 2005 of this problems?
Searching for a New Mesh for Prolift
Ethicon was on an active search for a better mesh material, documents showed, a year before it launched Prolift. In a email from French scientist working for Ethicon, Michel Cosson to Scott Ciarocca, R&D for Ethicon confirmed internally, the company felt it needed to improve the mesh.
Erosion and retraction were occurring along with the main concern, shrinkage leading to pain and dyspareunia or pain with sex.
With mesh equal to about four football fields of suture material, in 20 years it will still be reacting.
“Even after 20 years, the tissue is still reacting to the mesh,” said Professor Klosterhalfen on the biological response to surgical mesh in a June 2, 2006 Ethicon Expert meeting on mesh for pelvic floor repair.
Despite claims by Ethicon that the Prolift was specifically designed for pelvic floor repair, an email shown to the jury sent internally admitted “we pulled a mesh out of our existing bag of tricks” meaning the prolene soft mesh that made up the Gynemesh used in Prolift had previously been used for hernia repair.
Dr. Klinge: ” I thought we made it clear with our experiments you need a specific design for a specific indication and a specific area therefore it is not suitable to just put mesh from one area in another.”
Q:”Based on your work with biomaterial sciences, tissue response and your work in this field for 20 years as well as the internal documents from Ethicon, do you have an opinion whether Gynemesh and Prolift is a defective product?”
A: “Yes, it was a defective product.”
Q: “Was it unreasonably dangerous when it was sold in 2005?
A:”Yes, they never should have sold it.”
On Cross Examination, William Gage, an attorney for Ethicon established that 91% of all meshes sold today are polypropylene (PP). Dr. Klinge agreed it is appropriate for use on the pelvic floor if you have the correct construction of the PP, that is greater than 1 mm pore size.
Dr. Klinge has implanted hernia but not pelvic floor mesh.
Mr. Gage established that somewhere between 5 and 20 million people worldwide have been implanted with PP mesh.
Q: “You remember talking about foreign body reaction and chronic inflammation, fibrotic bridging where scar tissue builds around pores and causes problems for the patient? It’s well known response that all meshes call chronic and inflammatory response after implant?
Q: “You knew about that but you implanted it anyway because you know benefit exceeded the risks?”
A: “From a risk balance that can be done as I told you that is a discussion at our conferences every year.”
Q: “The reason it’s been a discussion is since 1985 is because no perfect mesh has been built yet has it?”
A:”There will never be a perfect mesh that fulfills all these requirements.”
Referring back to the work of Dr. Thomas Muhl, who appeared on the stand in the trial last week, it was established when a mechanical load is placed on mesh, similar to what happens in the body especially the pelvic region, the pores will disappear.
In 2007, Dr. Muhl devised machinery to replicate human forces on mesh in the body. With a 1.65 lb- force the good pores disappear completely.
“If you place it in a place where there is movement, the good pores will disappear and a complete fibrotic bridging of the entire mesh area will occur,” said Dr. Klinge.
Good pores were referred to as those that did not cause fibrotic bridging and were larger. In this study 75% would cause fibrotic bridging, scar plate and shrinkage. Muhl proposed software to measure the pore size under various stresses.
Stress tests could have and should have been done, said Dr. Klinge.
“Yes, always when you intend to use mesh in an area you cannot rule out is tension-free, where there is some mechanical load, you have to look at what happens to pores in case this stress will appear,” he told the jury.
Was Ethicon aware of the 2007 study? An Ethicon internal email showed the jury it was.
Other Images from the Day: