Prosima pelvic mesh prototype, Marcus
MND, September 29, 2015 ~ Continuing on what would be the final day of the Plaintiff’s case in Cavness v. Ethicon (Cavness v. Kowalczyk et al., case # DC-14-04220), Dr. Michael Margolis, a California urogynecologist and mesh removal expert took the stand for the second day to continue his damaging testimony about the pelvic mesh implanted in Carol Cavness.
Prosima was marketed by J&J’s Ethicon division in January 2010. Two years later it was quietly taken off the market but not before it was implanted in an unknown number of women to treat pelvic organ prolapse (POP).
Dr Margolis had a dim prediction about the pain symptoms Ms. Cavness still experiences, three years after her implant in April 2012. It's the same chronic pain thousands of other women with pelvic mesh implants feel every day.
MESH CAUSES OTHER PROBLEMS
Dr. Margolis likened it to a tennis net, pull one portion and the rest will follow. In the pelvic area, when a mesh is implanted it will shrink and contract and pull causing a distortion. That’s what happened to her, said the urogynecologist.
It’s called a de novo prolapse because it affects an adjacent area of the vagina adversely. Dr. Margolis insisted the Prosima mesh placed at the back of the vagina caused a prolapse, not unlike a hernia, between the vagina and rectum called an enterocele.
“I’m not the only one who believes that,” he said pointing to the literature.
Richard Freese, Freese & Goss
Interestingly, the Plaintiff attorney, Richard Freese pointed to a study by the inventor of the Prosima, an Australian doctor Marcus Carey and published in October 2007. It says new prolapse in nonrepaired compartments accounted for 58 % failures in 12 months. See it here.
The study noted, further studies are required to establish the role of the surgery described in this study.”
Dr. Marcus Carey, U of Melbourne AU
Did those further studies ever occur, Mr. Freese asked Dr. Margolis. They did not, he said .
Another study from The Netherlands echoes the same finding. In “Development of de novo prolapse in untreated vaginal compartment after prolapse repair with and without mesh: a secondary analysis of a randomized controlled trial”, here, published Feb. 11, 2012 in BJOG.
The authors said that mesh-augmented prolapse repair in only one vaginal compartment is associated with a higher de novo prolapse rate in the untreated compartments compared with native tissue repair.
“We strongly discourage any preventive use of mesh in unaffected compartments because the long-term effects and complications of vaginal mesh are not yet fully known" it concludes.
That study was published in February 2012, two months before Carol Cavness was implanted. Did Ethicon warn her doctor or the U.S. Food and Drug Administration? Was it included in the IFU (Instructions for Use) that go to the treating physician?
No, they did not, said Dr. Margolis.
MESH CAN’T BE REMOVED
Ms Cavness wanted to attempt another mesh removal. She had already had two excisions by Dr. Michael Carley who thought he got all the mesh out. Dr. Margolis said another attempt was advised. When he examined her in December 2014, he found obvious mesh erosion inside the posterior vaginal wall and dense, thick scar tissue along the entire posterior vaginal wall to the top of the vagina. That would be expected to be found in a woman who had three surgeries, he said.
But the likelihood of success was dim.
“I informed her all of the mesh cannot be removed. I told her it’s appropriate to try and get it out but I’m not a soothsayer we all know you’re never going to get it out. I told her she’s going to have to live with pain for the rest of her life.”
Dr. Margolis likened it to being shot in the chest. When you remove the bullet, you’re not fine. “You’ve done damage and that damage is permanent,” he said referring to the continuum of inflamed tissue which causes nerve entrapment, pain, and dysfunction of the bladder and bowel.
Is this chronic pain, asked Mr. Freese. “She meets all the criteria for chronic pain syndrome.”
Ms. Cavness is going to have to live with pain for the rest of her life, he added saying that the Life Care Plan, that forecasts a succession of medical needs in the future and admitted into evidence during yesterday’s testimony, was accurate and proper.
He added that smoking has no correlation to pelvic pain. The Defense pointed out the Plaintiff is a smoker. Smoking is not contraindicated in any Ethicon promotional brochure for Prosima.
CROSS EXAMINATION – AN UNCOMFORTABLE EXCHANGE
Kat Gallagher, Attorney for J&J
The afternoon cross exam conducted by Defense attorney Kat Gallagher with Dr. Margolis was an uncomfortable exchange with her punctuating a series of questions, some with attitude, and Dr. Margolis answering with as few words as possible.
First, she wanted to know aren’t there many causes of pelvic pain? Yes there are.
Kat Gallagher: We can agree smoking has a negative effect on the body, she asked, proceeding. “One of the things it does is to reduce vascularity, it constructs blood vessels so oxygen is not getting to the body and that can affect how a person heals.” (Ms. Cavness is a smoker.).
She continued, “Are you aware of the literature that smoking increases the risk for mesh exposure.” No, he said. "You have a responsibility to keep up with the literature in your field don’t you," she asked. He agreed.
Dr. M. Tom Margolis, urogynecology
The Defense attorney talked about the FDA’s Safety Communication of 2011. Dr. Margolis answered there was also one in 2008.
She said, “We're talking about 2011. Are you with me?”
“Proceed,” said Dr. Margolis.
Ms. Gallagher suggested some patients have a good outcome with a Prosima implant.
"That’s a possibility," said the doctor.
The FDA expert panel in September 2011 had concluded that mesh used to treat incontinence (SUI) was safe, she reminded Dr. Margolis.
He said, “They concluded use of the sling was safe up to one year. Some societies came out in favor of polypropylene mesh. “I can think of one where paid consultants to Ethicon they submit an opinion paper that used to represent the urogynecology society, which they do not.”
Kat Gallagher continued. “Is it fair to say you disagree with the FDA on the use of mesh for SUI. Let’s talk about the basis for your opinions okay? You’ve never performed any studies on mesh degradation?
You’ve never published on mesh degradation?
Gallagher: “What is GPC- gel permeation chromatography, another way to measure degradation. Are you familiar with that?
“No,” he said. See here.
Gallagher: “My point is there is a set of people who measure degradation and that’s not something you do right?”
“Correct.” Dr. Margolis said that was lab work and not his field as a surgeon.
Gallagher established that Dr. Margolis has never implanted a Prosima or an UltraPro, the other lighter weight mesh mentioned in this trial as a better alternative.
Gallagher: “And you wouldn’t implant it would you?
Margolis: “Not if I could avoid it.”
Changing course Kat Gallagher suddenly asked whether Dr. Margolis had any idea the total amount he’s been pain in this case.
He said he had no idea.
CAVNESS PAIN PRE-MESH
Kat Gallagher pointed out that it was pain that brought Ms. Cavness to the emergency room on April 21, 2012, before she ever had a Prosima pelvic floor mesh implant. She recounted that the Plaintiff had been listing an 80 lb. item and the pain was so bad she was prescribed hydrocodone. The pain also created an immediate need to do surgery three days later, she said.
“Let the records speak for themselves” he said sternly.
Coming back, Gallagher asked if he was aware other doctors don’t agree with Dr. Margolis that more mesh is left behind.
Dr. Carley did not anticipate she will need further surgeries because he believed he got out all of the mesh. The source of her complications he doesn’t believe are related to mesh. The pain doctor said “unknown etiology” to explain the pain. Dr. Phillipe Zimmern, who did find more mesh on her third removal attempt, said the source of her pain has not been explained.
Dr Margolis said again, he would let the record speak for itself.
Their exchange was not productive.
“No more questions your honor,” said Kat Gallagher, closing the cross exam.
Once more the Plaintiffs wanted to establish that Cavness is disabled. Dr. Margolis described it as a “Progressive diminution,” which will take years as opposed to decades.
Ms. Gallagher asked Dr. Margolis if the mesh was in a different spot, said Mr. Freese, are you surprised?
“No not at all, mesh fragments and breaks off, it moves around and migrates, it erodes and moves around it changes its orientation. Once implanted it doesn’t stay the way it was when it was put in. It breaks off and satellite lesions break off. “
“That’s all I have, your honor.” And with that the Plaintiff rested without putting the Plaintiff on the stand.
Judge Molberg told the jurors after a brief afternoon break that both sides have agreed to a stipulation between the parties, an agreement to certain facts.
As a final word, the Plaintiffs’ attorney read, the net worth of Johnson & Johnson.
“The audited net worth of J&J based on financial statement prepared December 2014, in their Form 10-K annual report of the U.S. Securities and Exchange Commission is $69,752,000,000. The audited network of Ethicon as of December 2014 for internal use only is $2,912,443,000.”
In the late afternoon hours, the Defense began its case. #