Day Two- Ethicon Defends Questionable TVT Transvaginal Tape Science

So District WV federal court

Day Two Lewis v Ethicon ~

Fortunately jurors are allowed to take notes in this federal product liability lawsuits that puts Johnson & Johnson’s Ethicon unit and its popular tension-free tape, TVT, on the defensive. It was the war of scientific studies that may have had the overall effect of muddying the issue of whether the plastic implantable sling to treat incontinence is the “gold standard” accepted by most surgeons or not.

On this Day Two of the Lewis v. Ethicon in federal court in Charleston, WV, the ten jurors were presented with evidence of how polypropylene’s heavy weight and small pores reacts in the body and whether there are better alternatives.

Dr. Bernd Klosterhalfen

Researcher and consultant, Dr. Bernd Kloserhalfen continued his testimony on videotape from yesterday. The surgical pathologist from Germany was revered in his field, pointed out plaintiffs’ attorney Tom Cartmell. Even Ethicon’s former Medical Director of Gynecare Women’s Health and Urology, Piet Hinoul, in an email shown to the jurors, called him a “God of surgical pathology” for the opinions that he shared with Ethicon.

Klosterhalfen had made explanted mesh his specialty removing or explanting more than 1,000 hernia meshes from patients and 500 meshes gone wrong from women suffering complications with their transvaginal implants.

Mesh, especially polypropylene (PP) is regularly implanted in a woman’ pelvic floor to shore up sagging organs. The TVT or tension-free tape, the kind implanted in plaintiff Carolyn Lewis in 2009, is inserted through a woman’s vagina and hooked into her tissues to cradle a sagging urethra that allows urine to leak during exercise, coughing, or stress urinary incontinence (SUI).

Dr. Klosterhalfen said the TVT mesh, a heavy mesh with small pore,s has not changed since its inception in 1998 and it can incite a foreign body reaction, inflammation and shrinkage. Add biomechanical tension to the tape from exercise, stress, coughing or exertion and the mesh mess can shrink up to 64%.

The TVT mesh is the worst, said Dr. Klosterhalfen as he referred to images that showed enlarged microscopic images of cracking and degrading mesh. As the mesh degrades in the body small particles of polypropylene have been found in a woman’s vagina causing irritation and infection as the body tries to rid itself of the foreign invader. Nerves coming into contact with this mesh mess create the chronic pain seen in many women suffering transvaginal mesh complications.

explanted mesh

Under cross examination the lawyer for Ethicon, David Thomas, asserted there is no difference between small pore and large pore mesh as a cause of chronic pain.

“Do you believe the biocompatibility of mesh is more important than tissue reaction?” Yes, answered the doctor. “Do you believe a biomechanical mismatch enhances tissue reaction?” Again the answer was in the affirmative.

Klosterhalfen agreed lightweight mesh can have the same complications as heavyweight mesh. And no one has done any studies on how the pores of the mesh can change and collapse under biomechanical pressures, further exacerbating the complications by shrinking pore size and creating even more rigid scar tissue.

Meanwhile Dr. Klosterhalfen had nothing but a glowing report for a new pelvic floor mesh made by FEG Textiles of Aachen, Germany which he said had the “highest porosity of any mesh” and is “stable under mechanical stress” and it doesn’t degrade said the scientist. Under questioning Thomas establish the doctor is a paid consultant for the company who receives one percent of sales and is paid 20,000 Euros annually. When he spoke at an FEG conference to other surgeons, Dr. Klosterhalfen did not reveal his association with the company.

Under re-direct attorney Henry Garrard for the plaintiffs showed Dr. Klosterhalfen Ethicon’s own document about the future of mesh – "to change the material to fix the pelvic floor issues."

Garrard: "Please tell the jury what Ethicon says about large pores?"

Klosterhalfen: "Large pore mesh significantly decreases foreign body reaction and decreases connective tissue reaction. Lower weight mesh integrates into humans, decreases shrinking and bridging of mesh."

Channel 13, Charleston WV

Media Absent

Even though Channel 13, the CBS affiliate is literally out the backdoor of the courthouse, there were no television reporters, no reporters of any kind in the courtroom of Judge Joseph Goodwin today. Six manufacturers face more than 50,000 lawsuits filed making it perhaps the largest mass tort litigation ever filed.

Adam Slater, Mazie, Slater

Adam Slater

It seemed oddly out of place to hear attorney Adam Slater's voice fill the federal courtroom this afternoon. Slater is the New Jersey attorney who successfully concluded the first transvaginal case against Ethicon with an $11.1 million award, $7.76 of it punitive damages.

While that case is under appeal, plaintiffs' firms around the country have shared videotaped depositions with experts working within and for Ethicon.

Dr. Piet Hinoul, former Ethicon Medical Director from Linda Gross trial

In a taped deposition shown to the WV jurors, Dr. Piet Hinoul told Slater that marketing and sales were important to Ethicon. In fact, the positive message it had to sell was all that would be heard when the company presented a a meeting of the American Urogynecology Society.

Slater: "Did your company provide internal documents to AUGS and SUFU (Society for Female Urology & Urodynamics)?"

Hinoul: "I'd think not."

In a statement that seemed surprisingly contrary to the facts, Hinoul added he considers TVT to be a lightweight mesh. "Today no one would bring a heavy weight micro-pore mesh to the market," he told Slater.

Dr. Bruce Rosenzweig

Dr. Bruce Rosenzweig took the stand in the afternoon. The urogynecologist with Rush University and in private practice in Chicago used to use TVT in his practice. That was after he was chosen among an elite group of doctors who were flown by Ethicon to Belgium where he could attend a cadaver clinic to learn and eventually promote the use of TVT.

But Dr. Rosenzweig told jurors after about 15 to 20 TVT implants and 40TVT-O implants he stopped. Instead he turned to removing meshes and now has explanted about 200 from women with complications. What has he found?

"Curling, frayed edges, making a "U" or circle with tension," he said. Dr. Rosenzweig related the mesh changes to a garden hose, when it kinks water will stop just like an altered mesh will slow a woman's flow of urine.

"She can't urinate, she can't completely eliminate her bladder," he said to the jurors. Mesh shrinkage of 30 to 50% is not uncommon he said and not all mesh shrinks to the same degree. Chronic pain can also be incited from particle flakes from the polypropylene that get in a woman's tissue. "We don't know what kind of impact that has in the future" he said.

Other plaintiff attorneys have called that a "ticking time bomb" because no one knows the long-term implications of a mesh implant or fragments that remain behind from a partially removed mesh.

The doctor said the complication rate did not comply with his personal risk- benefit analysis. Dr. Rosenzweig has gone back to a Burch colosuspension or using a woman's own tissue to craft a pubo-vaginal sling. See his website video here.

Dr. Tom Margolis, another doctor in the San Francisco Bay area who removes mesh, will be on the stand Thursday. #