Day 17 Linda Gross v. Ethicon: Complication Rate Was Known and Acceptable says Medical Director
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February 5, 2013 ~ On this Day 17 as the Linda Gross v. Ethicon trial plaintiff presentation wraps up, the former Medical Director for Ethicon Women’s Health and Urology (Gynecare) was brought to the stand via his videotaped presentation.
David Robinson was involved in all aspects of the decision to sell Prolift in March 2005, the same transvaginal mesh placed in Linda Gross, 47, one year later with devastating results.
Robinson said the benefits should always exceed the risks of any device before it is sold.
And if there were complications?
“It would be my job to assess why we were seeing what we’re seeing to make a decision what the causation was and go from there.” Robinson said.
Q:”Would a woman having to self-catheterize for a year be a serious complication?”
Robinson:”I raised it as an issue for them to discuss.”
On tape Adam Slater, attorney for Linda Gross, asked him which studies made up the decision to launch Prolift.
The French team’s TVM study looking at the implantation technique was one, a retrospective study of 687 patients, and 2.5 years of freestanding Gynemesh studies.
Gynemesh was the name of the Ethicon mesh that would be put in the Prolift “kit” containing pre-cut mesh and implantation tools – the first kit used as an innovative Prolift Pelvic Floor Repair System.
It was designed to make a grid of collagen that tissue would grow in to support pelvic organs that had prolapsed.
Early studies showed the mesh would shrink and contract. This complication occurring in a woman’s pelvic floor could cause chronic pain and there has already been testimony that Ethicon did not study how to remove mesh if complications occurred.
Slater:” How much contraction was understood to occur with the Prolift mesh?”
Robinson: “The exact percentage wasn’t known for sure, it would shrink or contract in the 30% range, that was my working assumption.”
Adverse Event Reports Coming In
The French TVM study showed an erosion rate for mesh of 18.6%, a US study showed 13%.
At a meeting August 13, 2010, Ethicon execs including David Robinson discussed a study by Dr. Cheryl Iglesia that had to be halted prematurely. The study is here.
Slater to Robinson: “Do you think 15% is a high erosion rate?
Robinson: ” It’s a rate that fell in the range we were familiar with 10-19% had been seen.”
Courtroom Day 17
In an email sent from Jonathan Meek (marketing) to David Robinson, about setting up a Prolift registry in Australia, Meek asked Robinson to review it from a clinical perspective.
“Dave,” the email asked, “from a clinical point of view, is there a legal risk if someone captures complication data on it? Robinson answered, “I don’t know about a legal risk but we clearly have a world wide customer quality risk. When any adverse event is captured in a registry it has to be reported to worldwide customer quality and ultimately a decision made regarding its reportability.
“Consequently if none of our competitors are keeping registries, our complication data may appear increasingly accurate but with decreasing appeal.”
July 2006 was the same month Linda Gross was implanted with the Prolift mesh.
Discussions within the company show that Ultrapro was considered to be the replacement for the Prolift. “Their main concern is the Prolene Soft material (Gynemesh PS used in Prolift) over time contracts creating the potential for failures and/or erosions.”
“The scientific knowledge about the uses of meshes in surgery is still in its infancy” the company acknowledged in a Gynecare report, “Characteristics of Synthetic Materials used in Prolapse and Incontinence Surgery.”
Scott Jones, Sales
Appearing briefly via his deposition was Scott Jones, Marketing at Ethicon. He testified that he was not aware that Ethicon offered training to surgeons on how to manage erosion complications. He admitted mesh removal was a “complicated procedure.”
Jones would bring a brochure to doctors in order to sell them on the new Prolift procedure but he admitted there was no long-term data to provide to prospective surgeons.
Jones: said a 10 percent complication rate was not rare. He admitted as the market became flooded with pelvic meshes his company introduced mesh to physicians with a “lower skill set.”