Is the Prolift mesh still used today in the U.S?
If you listen to the defense team representing Ethicon and Johnson & Johnson, one could get the impression Prolift is still used - all of the language is in present tense, they suggest it's been used on 35,000 women in the glossy brochures. That has nothing to do with whether or not its on the market today, argued Dan Ball for Ethicon.
We should be able to counter those impressions argued the plaintiff attorneys.
Fact: Prolift and three other pelvic meshes were voluntarily removed from the market by Ethicon in June 2012 for financial reasons, "commercial viability," according to the company.
See background story on Mesh News Desk here.
No Judge Hass ruled, the plaintiffs will not be able to tell jurors it's off the market for whatever reason.
Jones points to a document - GYNECARE Prolift SYSTEM BROCHURE- TOTAL ANTERIOR AND POSTERIOR PELVIC FLOOR REPAIR SYSTEM, an industry document that contained anecdotal reports about seven case studies from ten authors and over 200 participating international prolapse surgeons.
Christy Jones for Ethicon
Jones- "The infection rates have been exceptionally low and only typical antibiotic psophylaxis is required. There is a section on infection. It says there have been ‘very few known cases of infection related to Gynecare Prolift System.' "
Dr. Anne Weber, from Linda Gross trial. Cameras are now allowed in this Mo. case.
Weber - “And the principal is to remove the infected material and we know with the Prolift that is not possible.”
As a practical matter Jones continued, there is literature to support the conservative management of infections with in the presence of monofilament polypropylene?
“That’s what it says, said Weber. That would mean the mesh could stay in place and be treated, just the treatment option of Dr. Simpson in the Budke case. And many of those doctors chose to do a small incision in the office under sedation correct?
“I don’t agree with many, that's a key concept, says Weber. “I imagine that’s intensely uncomfortable.”
Jones- "That’s what doctors have reported? Yes, said the doctor. Jones- "It goes on to say the best prevention is strict adherence to the surgical technique guidelines with full-thickness incision, good tissue handling, no vaginal trimming, tension free would closure and keeping the mesh flat and tension free."
Weber answered, "That's anecdotal, the women go away from their practices. That's what they report but it is not a comprehensive summary of what women experience.”
Jones- "This document was used by experienced doctors."
Dr. Vince Lucente
Weber- "They're all Ethicon consultants. It raises sincere concerns about their scientific honesty!
Dr. Weber pointed to the scientific integrity of other doctors who have financial relationships with Ethicon - Dr. Vince Lucente, Miles Murphy, Dennis Miller. members of the Nordic TVM group included a Dr. Altman and Falconer who published that 15% of their patients experienced minor complications from mesh.
Slater in Linda Gross trial
In a re-direct, Adam Slater pointed out an article referred to a low rate of mesh exposure by Prolift doctors. They too were consultants to Ethicon. Yes, said Dr. Weber.
Was that an accurate statement, asked Slater? “My opinion is mesh exposure rates even in the hand of experienced Prolift users were not low," said Weber.
As Slater was wrapping up he asked Dr. Weber if Gynemesh Prolene soft is indicated to be put through the vagina?
Dr. Anne Weber, from Linda Gross trial
Weber said, "No, they changed it to restrict to abdominal implantation only!”
Editor's Note: This is news that has not been mentioned during this trial. Around the time Ethicon removed Prolift from the market, instructions on the Gynemesh Prolene Soft were changed by the FDA. Today it is recommended it should only be implanted abdominally, not transvaginally to avoid the risk of infectioion.
The defense felt this opened the door to it being withdrawn from the market. and the statement enraged Ethicon attorney Dan Ball who called it a "cheap shot."
"He's always going on the edge or past the edge of your rulings," said Ball referring to Slater. They got around it not being sold and said its not used in the vagina anymore, how clear could it be? Ball asked.
Slater insisted he didn't mention the FDA, this was not part and parcel of withdrawing Prolift and flat Gynemesh is not the same thing as a Prolift System mesh kit.
Judge - "I do not want to declare a mistrial… there is something you can appeal for sure. Probably at this point MO would say this is a post remedial matter and you can’t talk about it. I don't want to declare a mistrial. Stay out of the onion patch or I will declare a mistrial."