DALLAS – Mesh News Desk reported that plaintiff’s expert Dr. M (name withheld to avoid red herring arguments from defense counsel) continued to testify for a second day, September 29, 2015. It would be the final day of the Plaintiff’s case in Cavness v. Ethicon (Cavness v. Kowalczyk et al., case # DC-14-04220).
A California urogynecologist and mesh removal expert, Dr. M continued his testimony about the pelvic mesh implanted in the plaintiff. He opined that the pain she continues to experience three years after her April 2012 implant is the same chronic pain felt by thousands of other women with pelvic mesh implants.
Mesh Proliferates Problems
Dr. M compared the plastic mesh used in women to a tennis net. He said if you pull one portion, the rest will follow, that implanted pelvic mesh shrinks, contracts, pulls, causing distortion. He testified that this is what happened to the plaintiff.
de novo prolapse
Dr. M testified that the plaintiff’s implanted Prosima mesh causes what is called de novo prolapse, which means the mesh adversely impacts an adjacent area of the vagina. Dr. M insisted the Prosima mesh placed at the back of the plaintiff’s vagina caused a prolapse, similar to a hernia, between the vagina and rectum, called an enterocele. “I’m not the only one who believes that,” said the doctor, referring to studies of Prosima.
Dr. Marcus Carey, U of Melbourne AU
The plaintiff’s attorney Rich Freese referenced a study by Australian Dr. Marcus Carey – inventor of the Prosima – published in Oct. 2007. The study says new prolapse in non-repaired compartments accounted for 58% of failures in one year. See it here. The study called for further studies to establish the role of the mesh surgery. Asked by Mr. Freese if those studies occurred, Dr. M said they did not.
A study from The Netherlands rendered a similar finding: “Development of de novo prolapse in untreated vaginal compartment after prolapse repair with and without mesh: a secondary analysis of a randomized controlled trial.” It was published Feb. 11, 2012 in BJOG. The authors said 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.
Study Conclusion discourages Mesh Use
The study concludes: “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.” The study was published February 2012, two months before the Plaintiff was implanted with Prosima. Mr. Freese asked if Ethicon warned the woman’s doctor or FDA, and was this information included in the IFU (Instructions for Use) that go to the treating physician? Dr. M answered, “No.”
Mesh not Removeable
The plaintiff wanted to attempt another mesh removal despite already having had two excisions by Dr. Michael Carley, who thought he had removed it all. Dr. M said another attempt was advised. When he examined her in December 2014, he found what he called “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. He said that would be expected to be found in a woman who had had three surgeries.
Dr. M testified: “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. M 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, dysfunction of the bladder and bowel.
“Is this chronic pain?” asked Mr. Freese. Dr. M answered, “She meets all the criteria for chronic pain syndrome.”
He added that smoking has no correlation to pelvic pain. The Defense had pointed out the Plaintiff is a smoker, but her attorneys noted through questioning that smoking is not contraindicated in any Ethicon promotional brochure for Prosima.
Cross Cross Examination
Kat Gallagher, Attorney for J&J and Ethicon, cross examined Dr. M late in the day. Mesh News Desk noted, “The afternoon cross exam conducted by Defense attorney Kat Gallagher with Dr. M was an uncomfortable exchange with her punctuating a series of questions, some with attitude, and Dr. M answering with as few words as possible.”
Ms. Gallagher wanted to know if there were many causes of pelvic pain. Dr. M said, Yes.
Ms. Gallagher: We can agree smoking has a negative effect on the body. (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. Are you aware of the literature that smoking increases the risk for mesh exposure.”
“No,” said Dr. M.
“You have a responsibility to keep up with the literature in your field don’t you,” she asked. Dr. M agreed.
Ms. Gallagher suggested some patients have a good outcome with a Prosima implant, and Dr. M admitted, “That’s a possibility.”
The FDA expert panel in September 2011 had concluded that mesh used to treat stress urinary incontinence (SUI) was safe, Ms. Gallagher reminded Dr. M.
Dr. M responded: “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.”
Ms.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? She established that no, the doctor had not, and he had not published on mesh degradation.
Ms. Gallagher then asked, “What is GPC – gel permeation chromatography – another way to measure degradation. Are you familiar with that? “No,” said Dr. Ma. See here.
Ms. Gallagher: “My point is there is a set of people who measure degradation and that’s not something you do right?” Dr. M agreed.
Ms. Gallagher established that Dr. M has never implanted a Prosima or an UltraPro, a lighter weight mesh mentioned in this trial by the plaintiff’s attorneys as a better alternative.
Gallagher: “And you wouldn’t implant it, would you?” Dr. M answered: “Not if I could avoid it.”
Ms. Gallagher asked whether Dr. M had any idea the total amount he’s been pain in this case. He said he had no idea.
Plaintiff Pain prior to Mesh Implantation
Ms. Gallagher pointed out that it was pain that brought the plaintiff 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 lifting an 80 lb. item and that the pain was so bad she was prescribed hydrocodone. The pain also created an immediate need to do surgery three days later.
“Let the records speak for themselves,” Dr. M said sternly (according to Mesh News Desk).
Ms. Gallagher next asked if Dr. M were aware other doctors don’t agree with him that more mesh is left behind.
Ms. Gallagher said Dr. Carley did not anticipate the plaintiff will need further surgeries because he believed he got out all of the mesh. He doesn’t believe the source of her complications 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. M again said he would let the record speak for itself.
“No more questions your honor,” said Kat Gallagher, closing the cross exam.
Re-Direct Exam of Dr. M
Through questioning from attorney Rich Freese, Dr. M described the plaintiff’s pain as a “Progressive diminution.”
Mr. Freese noted that Ms. Gallagher had asked Dr. M if the mesh was in a different spot, and asked him was he surprised that it was.
Dr. M said, “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.” The plaintiff’s side then rested without putting the plaintiff on the stand.
The Defense then began its case late in the afternoon. Stay tuned. . .
- Mesh Medical Device News Desk: Plaintiffs Rest their case
by Matthews & Associates