Day 20 Linda Gross v. Ethicon: Medical Director Mesh Exposure 15%
Mesh Medical Device News Desk, February 8, 2013 ~ In presenting her case, Christy Jones, the attorney representing Ethicon, had to refute on this Day 20 what has been presented so far.
That is why she re-called Dr. Piet Hinoul, the former Medical Director of Gynecare Women’s Health and Urology, now with Wound Care at Ethicon.
His job as Medical Director, he told the jury, was to weigh the benefits versus risks of company products. His residency was in general obstetrics and gynecology. Dr. Hinoul had a urogynecology practice in Belgium which he began in 2001 before joining Ethicon in 2008.
Thanks to Courtroom View Network for access to this trial!
Dr. Hinoul first became aware of the TVM procedure in 2002- 2003 he said, turning frequently to the jury.
He had been using a lot of mesh in his practice and since Belgium is a small country he was noticed and received an invitation from the people at Ethicon to attend a professional education session. There, Hinoul witnessed three procedures by Professor Michel Cosson, a member of the French TVM Group.
After that Dr. Hinoul started performing prolapse surgery using Prolift. He then became a preceptor to teach other surgeons how to use Prolift mesh.
He found the problem was recurrence of prolapse.
STUDIES AVAILABLE BEFORE LAUNCH
With a slow, measured Southern drawl, Christy Jones, the attorney for Ethicon, asked Dr. Hinoul to recount the studies that were available before the launch of Prolift. There were four big studies but the Gynemesh PS study was an early one. Doctors would cut their own mesh to implant transvaginally. There were 88 patients at seven centers in the U.S. It showed an 84% success rate.
There were nine doctors in the TVM Group studying how to implant mesh with tools they were innovating. The TVM trial with one in France and one in the U.S. totaled 950 patients who had been implanted with a Prolift prototype.
“If you define recurrence according to anatomic definition, they would be around 80%.” Hinoul with Jones prompting later reversed himself to say the success rate was above 80% anatomically.
With respect to adverse events, a large review by the gynecologic surgical society looking at 10,000 cases, found a 10% exposure rate with half of the patients not symptomatic. The other half were symptomatic but Dr. Hinoul said that could be taken care of in the office.
Still, the actual Prolift, as it would be marketed, was never tested on any patients prior to its launch.
From both the Gynemesh PS study and the TVM study “cumulative exposure rates were in the range of 15%.”
Jones showed a published three-year prospective follow study with Piet Hinoul’s listed as one author. The study was published in the Journal of International Urogynecology in 2010.
Since then there haven’t been any new adverse events identified that had not been anticipated and the rate of complications have remained the same, said Hinoul.
“The majority of the adverse events take place in the first year, there are some exposures that will show up later. In the French study 6 still have an exposure and were not symptomatic and didn’t require treatment.”
After may more sidebars, more than any other day, Jones concluded the morning by asking if the risk/benefit analysis by Ethicon considered all risks – of fistula exposure, hematoma, potential contraction before launching Prolift. Hinoul said yes.
EXPERT CONSULTANT MEETINGS
Jones asked Hinoul the purpose of expert consultant meetings. He said key opinion leaders would be gathered with an opportunity to talk about the latest in their field.
During one meeting with the French TVM Group members in June 2, 2006, Professor Jacquetin said Prolift was excellent and showed no shrinkage, no vaginal distortion and elasticity.
Jones asked Hinoul, was there any mesh on the market that did not have the potential for complications. No such mesh existed he said.
Ultrapro was being used for hernia surgery but needed more clinical data to move forward, something be studied by the Lightening Project in 2007.
Ultrapro was thought to be “the most promising available mesh for pelvic floor repair” but Hinoul said further animal studies were needed and altogether it would take four years to bring Ultrapro to market. That was an explanation to counter the buzz within Ethicon that Ultrapro was the preferred mesh to use in the new Prolift launch in 2005, according to documents shown in the case so far.
Inside Ethicon, marketer, Jonathan Meek referred to PP as the “best of a bad lot re: integration, retraction...” .
He had no expertise to say that said Hinoul to the jury on Day 20.
In 2007, Ultrapro was used in the new product launch of Prolift +M which did seek FDA approval, unlike Prolift.
The difference was that Ultrapro has less total polypropylene (PP).
It was lighter with a 4 mm pore and a monocryl fiber to help it lay flat. The monocryl fiber was intended to absorb over time.
Gynemesh PS pore size was 2 mm, Hinoul said when asked by Jones. Hinoul says the pore size needed for tissue integration into the mesh is 75 microns which is less than 1 mm.
The doctor was asked whether Ethicon put any weight on the work of Dr. Thomas Muhl who testified earlier in the trial that pressure on the mesh would make the pore openings disappear causing scar and fibrotic bridging which would be very painful. Hinoul discounted the tests by Dr. Muhl and Dr. U. Klinge, who testified on Day 16. The Ethicon consultants from Norderstedt, Germany did extensive testing on the pore size of mesh to determine which would provide support but not overwhelm the pelvic floor. Dr. Klinge had testified the company was looking to replace Gynemesh PS (used in Prolift). Previous testimony has established that Ethicon did not measure the pore size of mesh under pressure but on Day 20 Piet Hinoul said that kind of testing had not been implemented at Ethicon because it didn’t represent what happens in the body.
Continuing to show just how involved the Medical Director was in marketing, Slater showed a document marketing Prosima mesh, which was launched in 2009. “This tension-free concept is something we own” said the Medical Director in an email.
It also said, “Let’s use the concept, doctors like the sound of it.”
On the pore size of mesh, Slater pointed out a company email that said it’s not accurate to report an exact pore size.
Dan Berkley who oversaw such things within the company said in April there was no written test measure or procedure for pore size and that there were no distinct pore size specifications for Prolift.
Hinoul said that was not true.
Earlier in the trial, a published study by the Daniel Altman had been raised and with it questions about Ethicon’s “editing” of the work before publication.
Slater had elicited comments that Altman had been told his study would not go forward without heavy input from Ethicon and Slater showed the comments suggested to Dr. Altman by company officials before its publication in the New England Journal of Medicine.
Jones asked Hinoul whether Ethicon participated in the funding of the study. Yes, said Hinoul and it was sent to Ethicon for review as is customary when a company funds a study. But he denied the company “changed anything about the data points” and said all changes were suggest to Altman but “it was clearly stated these are for you to take or leave and it’s as independent as it should be.”
In the patient brochure there is an explanation about a “minimum to slight inflammatory reaction which is transient and is followed by the deposition of a thin fibrous layer of tissue which can grow through the interstices of the mesh, thus incorporating the mesh into adjacent tissue.”
Soft-selling the inflammation aspect, Dr. Hinoul explained it was similar to the inflammatory response you get like a cut on your hand.
“The acute rush of white blood cells that goes away. It’s a permanent implant so there will be a chronic foreign body response to sustaining this scar. It’s nothing to do with big white blood cells that could indicate fever or anything like that.”
Showed the smiling woman on the blue brochure, Hinoul said its purpose is to “facilitate a conversation” between a woman and her doctor about the information in the brochure, what the possible treatment options options are.”
He suggested a woman might ask a doctor for more information on any complications she might read about.
Jones asked if the patient brochure was intended to be a substitute for a consultation with the doctor. No, said Hinoul.
Finally Jones wanted to establish that when Ethicon decided to market Prolift in 2005 and 2006 did it take into account all potential complications?
“Absolutely” said Hinoul.
The pace picked up considerable as Slater questioned the witness.
Establishing the mystery left by Ethicon witness, urogynecologist, Dr. Miles Murphy who was unaware at the time of his November deposition that his practice partner, Dr. Vincent Lucente, had gone to Ethicon to secure funding to establish a patient registry. Dr. Hinoul confirmed there was a registry initiated by Dr. Lucente, the prime investigator.
With a storm bearing in on the East Coast, Slater continued at lightning speed.
Dr. Hinoul said he doubted a woman would go on the Internet to come back to her doctor and say “I want this procedure.”
Dr. Hinoul’s process is to examine the patient and explain her options, then bring in the opinion of her general practitioner and explain it again. Slater said there are patients who find the patient brochure a compelling document and that it, combined with a doctors encouragement, could help make her decision.
“Come on, it’s almost Miller time,” he joked to the doctor trying to hurry him up. The jury laughed.
“She could read this and have it finalize her decision right?” asked Slater. Hinoul said, “I’m sure some read it and don’t get it (the procedure).”#