January 16, 2013 ~ The worldwide medical director of Ethicon took the stand all day in the trial of Linda Gross v Ethicon in an Atlantic City courtroom. (Pelvic Mesh Litigation Case No. 291, Linda Gross v. Ethicon, No. ATL-L-6966-10, N.J. Super., Atlantic Co.).
The past president of the Flemish Society of Obstetrics and Gynecology from 2007 to 2008, Piet Hinoul had become the Director of Medical Affairs at Ethicon, a division of Johnson & Johnson that planned to bring the Prolift mesh to the market.
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Prolift is the mesh implanted in plaintiff Linda Gross in July 2006 after suture repairs had failed to hold up her falling pelvic organs following a hysterectomy. Almost immediately she was in intense pain which continues to this day. She must self-catheterize to pass urine three to four times a day, cannot sit for any time, and has had to give up her job as a hospice nurse. Gross has undergone 22 surgeries since the mesh was implanted, nine of which were mesh removal operations pieces of which were found around her body.
Her doctor believes she is permanently disabled.
Gross is suing Ethicon over what she calls a defective product and a failure to warn doctors about the dangers of mesh. She received a Prolift, an innovation in pelvic floor repair that came pre-cut in a kit with delivery and retrieval tools.
During the fifth day of her trial, attorney Adam Slater attempted to show that there was dissent within the company questioning whether the Gynemesh PS was the best mesh material to use in the new Prolift launch.
When Prolift was finally marketed in March 2005, Slater showed company internal documents that scientists within Ethicon were already working on replacing the Prolift’s Gynemesh PS (soft prolene) with another mesh, possibly the UltraPro.
The search for a better material was called Project Lightening.
Two months after Gross had the Prolift implanted documents show scientists were asking for a clear definition of erosion. The ideal mesh was 75 microns or less so the mesh would allow for blood vessel ingrowth and collagen fibers to grow into the mesh and cause the desired amount of fibrosis, but not too much.
A graphic shown to the jury said more than a year after Prolift was launched the company sought out customer complaints and a way to reduce the sexual functioning issues associated with the Prolift. They were looking for a “Quick Hit” modification to existing product, likely the Ultrapro. Hinoul took exception to the term “quick hit” adding that the Prolift had taken four or five years to make it to market.
In a power point presentation an Ethicon expert meeting June 2, 2006 had some of the leading experts in mesh gathered in Norderstead, Germany to talk about mesh. A project planned down the road would be called Thunder, as the group searched for the “holy grail” of pelvic floor repair mesh materials, said Slater, with a new weave to match the tissue properties of native tissue.
Project Thunder was ahead on the horizon to be developed in later 2008 or early 2009 as Ethicon sought out the perfect mesh. The list of high priorities underscored a perfect mesh. The group was looking for a mesh with no shrinkage and no long-term contraction, no fibrosis, no scar tissue, dyspareunia and no folding of the mesh.
“It’s a goal to have a better process, it’s a continuous process. We’re always testing, seeking what we can do next. These meetings are frequent and we invite all kinds of people whose opinions we respect” he told the jury.
According to Professor Klosterhalfen, considered an expert on mesh, the biological responses to surgical mesh continued to be a concern.
The huge surface area of meshes included more than 300 meters of suture. “Even after 20 years the tissue is still reacting to the mesh,” said his note indicating a foreign body reaction. And “Fibrosis is responsible for complications in mesh usage, there is less fibrosis with Vypro compared to polypropylene.
One of the critical elements of mesh complications was the pore size. Hinoul told the jury a pore size of 75 microns allows for blood vessels to grow into the mesh and for the needed scar tissue. But the trick was for the company to balance a minimum amount of fibrosis to give the mesh enough strength to do its job in creating a scar net of fortification. The downsize of the smaller mesh is fibrotic bridging and mesh shrinkage.
Some patients were reporting bridging and pain after their mesh implants and the company was talking about that internally. Dr. Klosterhoffen reported that even a 20% shrinkage of mesh could reduce the mesh size by 64% causing the woman to experience pain. Women were experiencing mesh erosion and shrinkage with the Gynemesh PS, the same mesh used in the new pre-cut kit known as Prolift.
But on the stand Slater asked Hinoul whether there was any way to predict who would react to a 64% mesh shrinkage and who would experience an inflammatory reaction to mesh.
Slater: “There is no way to know who is doing okay and no way to know who ends up with more pain and complications right?
Hinoul: “Overall you’d expect an acceptable scar.”
Slater: “That was the hope?”
Hinoul: “We knew,” Hinoul said with great assurance.
Hinoul added that luckily conditions that would lead to debilitating injuries and invasive surgery to remove mesh were very rare. Slater asked if Hinoul was aware of data that showed a 19.6% painful contraction rate for the mesh.
Hinoul: “Contraction with pain, I think we have to qualify that 19% I’d like you to show me those papers and numbers.”
An internal company power point presentation addressing the subject of shrinkage more than one year after the Prolift was launched also confirmed small porous mesh 1 mm or less were believed to offer less fibrotic bridging and increased shrinkage. Large porous meshes allow for better and faster tissue ingrowh and less shrinkage.
Hinoul said the Prolift was 2mm or more in pore size, but Slater asked, “There is no distinct pore size in Prolift mesh?”
Hinoul:”I don’t know.”
Slater: ”The hole openings vary in size and are not distinct in size and they are irregular.”
Hinoul: “I would not say that. It’s a textile, they seem to be the same.”
Even Dr. Michel Cosson, one of the French scientists working on the new transvaginal mesh said in an email polypropylene might not be improvable in terms of shrinkage, we may need a completely new material.”
By the afternoon, Slater showed a deposition that further exposed what the company knew and when it knew it. Playing a prerecorded deposition of deposition of Gene Kammerer, an engineer and Principal Scientist at Gynecare/Ethicon.
Two months before the launch of Prolift, Kammerer wrote an email to the Gynecare Marketing Group to see if there would be any interest in funding an exploration of using the, “UltraPro mesh for pelvic floor repair in place of the Gynemesh. I think this could be the next advancement for pelvic floor repair. Without going into too much detail here, I will just say that this mesh could reduce the scar contraction and lower the density of the scar formation resulting in fewer cases of recurrence of the prolapse and erosion.”
Kammerer felt the UltraPro created a more stable matrix and exhibited lower inflammatory response especially in the early stages after implant up to six months. Besides the UltraPro was more absorbable and left behind less material than the Gynemesh.
Regardless of all internal questions, Prolift was approved for market in March 2005 though Ethicon never sought or received U.S. Food and Drug Administration approval until three years later.
By February of the next year, Kammerer again wrote to Quentin Manley, a VP at Ethicon reminding him this would be an excellent opportunity to once again to check in with the consumers and to prepare to work on the “next generation of mesh.”
The UltraPro could control and reduce scar contraction and “we could get an enhanced product. The team wanted to move forward, then everyone got reassigned and the project went into limbo,” he said in his deposition.