Day 6 – Sept. 28, 2015 – of the latest trial against Ethicon in Dallas brought testimony from Dr. M (name withheld to prevent defense lawyers’ red herring arguments), a urogynecologist from the San Francisco bay area, double board certified in Ob-Gyn and Urogynecology. Dr. M testified that he has done more than 25,000 surgical procedures, including 5,000 to 6,000 for stress urinary incontinence and the rest – some 14,000 – related to POP (pelvic organ prolapse). He also performs about six surgeries a week to remove plastic mesh from women.
Note: Much of this story comes from Mesh News Desk.
Dr. M testified that he has never implanted transvaginal synthetic mesh systems into any human being “because of the well known and well established irreversible and magnificently bad complications associated with transvaginal polypropylene mesh systems, which is well described in the literature.”
Like removing Rebar from Sidewalk
Dr. M said trying to remove mesh was like trying to remove rebar from the sidewalk without damaging the plumbing below. He told the jury that the risks of Prosima substantially outweighed the potential benefits to any patient, including the woman in this case. He said her injuries are permanent and irreversible because of the design defect of the Prosima, because of its heavy weight, its shrinkage capacity (around 30 percent), its degradation, the chronic foreign body reaction it elicits. By way of analogy, he crumpled up a sheet of paper to show how mesh contracts, folds, shrinks.
Foreign Body Reaction, Scarring, Contamination
“It distorts the normal anatomy and it causes new prolapse where there wasn’t prolapse before,” Dr. M testified. “It’s impossible to safely remove it all. Foreign body reaction causes it to scar into place.” He added, “You’re stuck with it for life.”
Dr. M also testified that the bacterial contamination from mesh and subsequent inflammatory response release noxious degradation products, enzymes and macrophages that attack the mesh, the invader foreign body.
IFU – Instructions for Use
One of the plaintiff’s attorney’s, Rich Freese, asked Dr. M if Ethicon put any of this information in its IFU? “No,” said Dr. M. In fact, he explained, Ethicon called the inflammatory reaction “transitory,” and claimed that the mesh remained “soft and pliable.” Dr. M testified: “It’s 180 degrees opposite. It’s not true.”
Dr. Michael Carley
Dr. Michael Carley, affiliated with Baylor-Health Texas, first saw the plaintiff June 14, 2012, two months after she had been implanted with Prosima pelvic mesh to treat a prolapsing pelvic floor. He testified prior to Dr. M.
Dr. Carley said the woman complained of pain. She was concerned about holding her job as an airline mechanic if she could not resolve the pain. Her pain had not responded to conservative treatments. She elected to remove the mesh. Dr. Carley consequently removed as much mesh as he could July 9, 2012, in the first of the plaintiff’s two mesh removal surgeries.
Dr. Carley removed several fragments of pink-red soft tissue adhered to synthetic material consistent with transvaginal (pelvic) mesh. 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, the pain did not resolve despite surgery. The plaintiff reported stabbing pain in August. Conservative treatments such as pelvic floor exercises, steroids, anti-inflammatories, Celebrex or hydrocodone failed to resolve the pain.
By January, 2015 the plaintiff still had pain and vaginal discharge. 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.”
David Robinson, Ethicon Worldwide Medical Director
Testimony further revealed that David Robinson, MD, Ethicon’s worldwide medical director said in a February 2008 email, “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.”
Defective Product Case Points
The improvements, however, were never incorporated into a new mesh for Prosima. Under Texas law, a plaintiff must show a safer alternative existed. Dr. M testified that Ethicon’s UltraPro was lighter, using about 38% less mesh than the Prosima, and it was half the weight, was softer, more elastic, partially absorbable. Evidence was entered that Ethicon gushed in an internal report about UltraPro: “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. M and the plaintiff’s attorney Rich Freese established Ethicon knew that it had a problem with the heavier Prosima. Did it tell the FDA or the woman’s implanting physician in letters, in an IFU product label? “No, they didn’t,” said Dr. M.
The jury was shown a July 2012 article ‘Pain complications of mesh surgery’ by Lisa Rogo-Gupta and Shlomo Raz, MD. 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. Inert means, the immune system doesn’t know it’s there.
Mesh Remains in the Woman
Mesh News Desk reports that despite a third mesh removal attempt by Dr. Philippe Zimmern of Dallas, Dr. M insisted all of the mesh cannot be removed, based on his 17 years experience “trying to dig this stuff out.”
Dr. M testified: “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.” Dr. M said the woman received absolutely no benefit and all of the risk.
Dr. Weisberg of Ethicon
Attorney Rich Freese reminded the jury of the words of Dr. Martin Weisberg of Ethicon. Seven years before Ms. Cavness 2012 implant, Dr. Weisberg had 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? ”
Dr. M told the jury the native tissue repair done by Dr. Carney worked and is holding “perfect. She didn’t need the mesh,” he testified.
Life Care Plan
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. She estimated the total lifetime costs at $570,383.50, and said she considers these numbers conservative.
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, the lifecare plan was based on the medical records and the plaintiff’s present disability.
Dr. M, who examined the Plaintiff as recently as two days ago, has said Ms. Cavness likely will need two more surgeries for mesh complications in her lifetime.
Ethicon’s Prosima Mesh
This is the first trial for Ethicon’s Prosima pelvic mesh used to shore up the pelvic floor from a prolapse. The plaintiff, 60, has been present in the courtroom every day.
She is represented by David Matthews of Matthews & Associates, 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.