Dr. Michael Carley, Baylor urogynecologist

Dr. Michael Carley, Baylor urogynecologist

Thanks to Courtroom View Network for access to a live feed in this Dallas courtroom of Judge Ken Molberg.  Carol Canvess v. Kowalczyk et al. #DC-14-04220.

MND, September 28, 2015 ~ Dr. Michael Carley, affiliated with Baylor-Health Texas, (here) first saw Carol Cavness June 14, 2012, two months after she had a Prosima pelvic mesh implanted to treat a prolapsing pelvic floor.

Her complaint was pain.  She was concerned her job as an airline mechanic would be further compromised if she could not resolve the pain soon.  Since her pain had not responded to conservative measures, she elected for a removal which Dr. Carley performed on July 9, 2012. It would be his first of two mesh excisions (removals)on the Plaintiff.

Dr. Carley removed several fragments of pink-red soft tissue adhered to synthetic material consistent with vaginal mesh.  In aggregate, the specimen came out in fragments that measured collectively  4.3 x 2.5 x .6 cm. The pieces were removed transvaginally from the posterior wall of the vagina.

A second removal yielded calcified nodules ranging in size from 0.1 to 0.3 cm in greatest dimension.

Unfortunately, that did not resolve the pain.  By August, Ms. Cavness reported stabbing pain. Conservative treatments such as pelvic floor exercises, steroids, anti-inflammatories, Celebrex or hydrocodone did not resolve the pain either.

Earlier the Defense suggested the removal surgeries and scar tissue formation from that may have caused her pain.  No, it did not, said the doctor.

By January, 2015 she still has pain and vaginal discharge and she was referred to pain management. Dr. Carley concluded,

There is a palpable foreign body in the patient’s right apex…”   He identified “several bead-like foreign bodies, unclear whether these represent synthetic mesh or not.”

 

DR MARGOLIS  – CRITIC OF POLYPROPYLENE MESH

Dr. M. Tom Margolis, urogynecologist

Dr. M. Tom Margolis, urogynecologist

There was nothing unclear about the testimony in the courtroom of Dr. Michael Margolis, a urogynecologist from the San Francisco bay area (here).  Double board certified in Ob-Gyn and Urogynecology, Dr. Margolis says he’s done more than 25,000 surgical procedures in his career including 5,000 to 6,000 for stress urinary incontinence and the rest- 14,000 or so were POP (pelvic organ prolapse) -related.

He does upward of  dozen surgeries a week with almost half mesh removals.  He made it very clear he, “Does not or ever has implanted transvaginal synthetic systems into any human being because of the well know and well established irreversible and magnificently bad complications associated with transvaginal polypropylene mesh systems, which is well described in the literature.”  

Likening it to trying to remove rebar from the sidewalk, he insisted passionately to the jury that the risks of Prosima substantially outweighed the potential benefits to any patient, including Ms. Cavness.  Her injuires are permanent and irreversible because of the design defect of the Prosima; the heavy weight of the Prosima and its Prolene PS mesh; the shrinkage capacity of Prosima (around 30 percent); the degradation of Prosima; the chronic foreign body reaction of Prosima.

He left no doubt to the Plaintiffs’ claims of a defective product grabbing a sheet of paper and crumbling it up in his hand to illustrate how mesh contracts, folds and shrinks.

“It distorts the normal anatomy and it causes new prolapse where there wasn’t prolapse before. It’s impossible to safely remove it all. Foreign body reaction causes it to scar into place.” he said, and that scar essentially locks the mesh in place. “You’re stuck with it for life.” he said.

Dr. David Robinson- Ethicon former Med. Dir.

Dr. David Robinson- Ethicon former Med. Dir.

Ethicon knew it had a faulty product an inner office email show. David Robinson, MD, the worldwide medical director said in February 2008, “Clinically there may be an impact of increased rigidity with any given mesh as it may increase vaginal stiffness postop with the potential to impair sexual function.  Suffice it to say, however, that all meshes we are working on for future use will be less rigid than our current Gynemesh PS.

But the improvements were never incorporated into a new mesh for Prosima. Under Texas law, the plaintiffs must show there was a safer alternative. Though he is no fan of polypropylene mesh, Dr. Margolis said the UltraPro was lighter using about 38% less mesh than the Prosima and was half the weight. It was softer, more elastic and partially absorbable.  Even Ethicon said in an internal report, “Without any negative side effects when compared to traditional heavyweight meshes!”  

UltraPro was available at the time the Prosima was launched in January 2010.

Under questioning, Dr. Margolis and Cavness’ attorney established Ethicon knew full well that it had a problem with the heavier Prosima. Did it tell the FDA or Cavness’ implanting physician in letters, in an Instruction for Use (product label)?  No, they didn’t said the doctor.

The jury was shown a July 2012 article Pain complications of mesh surgery by Lisa Rogo-Gupta and Shlomo Raz, MD,  the father of mesh complications.  It said mesh shrinks 30 to 60 percent and mesh degradation begins immediately following insertion.”Mesh placed in vaginal surgery is not inert,” said the article (here).

Inert means, the immune system doesn’t know it’s there.

Dr. Shlomo Raz UCLA

Dr. Shlomo Raz, UCLA Urology

Otherwise, Margolis explained, the bacterial contamination and subsequent inflammatory response releases noxious degradation products, enzymes and macrophages that attack the invader foreign body, the mesh.

Did Ethicon put any of this information in its IFU? No, in fact they call the inflammatory reaction “transitory,” and that the mesh remained “soft and pliable.”  “It’s 180 degrees opposite. Its not true,” said Dr. Margolis in disgust.

MESH REMAINS BEHIND 

Despite a third mesh removal attempt by Dr. Philippe Zimmern of Dallas, Dr. Margolis insisted all of the mesh cannot be removed, based on his 17 years experience “trying to dig this stuff out.”

“She has dysfunction of the bowel, the bladder, scarring, contraction of vagina, erosion, dyspareunia. She’s suffered prolapse to new areas. She’s suffered three attempted explant surgeries and all the pain and suffering associated with them and the stuff is still there. It has not been removed,” he said of Ms. Cavness today.

She received absolutely no benefit and all of the risk, he insisted.

Cavness attorney reminded the jury of the words of Dr. Martin Weisberg of Ethicon. Seven years before Ms. Cavness 2012 implant he asked in an inner-office memo,  “Why would anyone spend any money on a device and take what they consider a risk of using a graft when they could get the same results for free with a native tissue?  If we are not confident that this will be better than what our marketing has been claiming is inadequate (native tissue repair) why bother pursuing? ”

Did the company follow his instructions?  No, they did not.

“This is exactly what happened to Carol. It breaks your heart.”

Dr. Margolis told the jury her native tissue repair done by Dr. Carney worked and is holding “perfect. She didn’t need the mesh.” he concluded.

LIFE CARE PLAN

Helen Kathryn Downs, Butler Snow, attny. for Ethicon

Helen Kathryn Downs, Butler Snow, attny. for Ethicon

What will the cost be to make life easier for the Plaintiff?  Registered nurse and life care planner, Leigh Anne Levy, told the jurors the Plaintiff will need outpatient and therapeutic care, long-term care, medications, diagnostic services for the rest of her life for her disability.

The total lifetime costs are $570,383.50, and these she considers conservative numbers.

On cross examination, Helen Kathryn Downs of Butler Snow, asked if Ms. Levy was offering any opinion whether the injuries were caused by the mesh?  No, said the RN, they make the plan based on the medical records and on her present disability.

Dr. Margolis, who examined the Plaintiff as recently as two days ago, has said Ms. Cavness likely will need two more surgeries in her lifetime. #

BACKGROUND

Prosima prototype

Prosima prototype

This is the first trial for Ethicon’s Prosima pelvic mesh used to shore up the pelvic floor from a prolapse.  The plaintiff, Carol Cavness, 60, is in the courtroom listening to the proceedings.

Cavness is represented by Tim Goss and Richard  Freese of Freese & Goss PLLC, Bill Blankenship of William F. Blankenship III PC, Richard Capshaw of Capshaw & Associates, Kevin Edwards and Peter de la Cerda of Edwards & de la Cerda PLLC, and Julie Rhoades and David Matthews of Matthews & Associates.

Ethicon is represented by William Massie Gage and Helen Kathryn Downs of Butler Snow LLP and Kathleen Gallagher of Beck Redden LLP. ##