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Day 17 Linda Gross v. Ethicon: Complication Rate Was Known and Acceptable says Medical Director

Thanks go out to Courtroom View Network for access to this trial.

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.

Dr. David Robinson, Ethicon Medical Director Worldwide - Nov 2005 to Dec 2010, from LinkedIn

Dr. David Robinson, Ethicon Medical Director Worldwide – Nov 2005 to Dec 2010, from LinkedIn

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.”

Pore size measurement and mono filaments, Ethicon

Pore size measurement and mono filaments, Ethicon

Pre-Launch

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.

David Robinson, courtesy Courtroom View Network

David Robinson, courtesy Courtroom View Network

Mesh Shrinkage

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.”

 

D17   erosion rate 18.6 percent  huge robinson told

 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.

Using the Prolift mesh, the preliminary erosion rate was found to be 15.6% higher than the 15% criteria that had been established as the uppermost limit for complications.D17 ws court

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

Prolift Registry

Jonathan Meek, from LinkedIn

Jonathan Meek, from LinkedIn

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.

Replace Prolift

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.”

D17 looking for new material  tvm was not a ringing success it was going to require understanding

 

 

 

 

 

“The scientific knowledge about the uses of meshes in surgery is still in its infancy” D17 still in its infance what we know about the use of meshes in surgery HUGE 2006the company acknowledged in a Gynecare  report, “Characteristics of Synthetic Materials used in Prolapse and Incontinence Surgery.

 

Scott Jones, Sales Ethicon

Scott Jones, Sales Ethicon

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.”

 

2 Comments

  1. Carol Fonken says:

    I am a friend of Linda’s from SD. I appreciate the coverage you are providing. Linda is a great person. Our thoughts and prayers are with she and Jeff as they are going thru this stressful time. They have actually been going thru it since 2006 when she had her surgery! I have known Linda for 25+ years. I have worked with her in various areas of the hospital and she was always an asset to any area she worked in. I get so angry that such a supposed simple mesh repair has changed her life so drastically. Jane, I understand you have roots in Veblen. I grew up there. Again, thanks for the coverage.

  2. I am grateful to Courtroom View Network and Jane Akre for making the information from this trial public: as it should be. There is a conference in Washington, DC February 20-22, 2013, Selling Sickness, that I invite you to. We will be discussing the toxic health ecosystem that allowed medical device companies to market their “innovations” prior to proven safety and effectiveness and block harmed patients from prompt and full justice and compensation. This must be fixed or our nation will continue to allow failed devices to compete with functional devices and our economy will continue to suffer. Taxpayers cannot be expected to absorb the costs of treating patients like human guinea pigs to satisfy corporate profits.

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