Transvaginal Mesh – Does it Degrade? Defense Day One Hinges on Science
This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.
This is the first day for the defense in Huskey v. Ethicon the second bellwether trial in this federal court in Charleston, West Virginia.
After a Labor Day break, the lawyers working for Johnson & Johnson ( Ethicon) must present their case. The jury must decide if the Johnson & Johnson TVT-O, a polypropylene mesh sling is defective. Last April, the device was found to be defective in its design by a jury in Dallas.
The case for the defense this first day of their case, will hinge on science as they try to prove to the jury, Prolene, J&J’s brand name for polypropylene (PP) does not degrade in the body. That will be important to counter the plaintiffs’ case that degrading PP causes shrinkage, folding and hardening of the mesh which entraps nerves and causes chronic pain.
The jury pool is now down to eight as one woman had a “tragic loss” over the Labor Day weekend, according to Judge Joseph Goodwin who is overseeing this and 22,000 other similar cases filed against Ethicon, a division of J&J.
Dr. Shelby Thames was first to the stand. The PhD is retired from teaching at the University of Southern Mississippi, from the Palmer Science Research Center. It is also named after him, the Shelby Freeland Thames Polymer Research Science Center. Throughout the morning he would tell the jury about the science and chemistry of polymer science. It was established he is being paid $375 an hour.
Dave Thomas, an attorney for J&J, asked what does a polymer scientist do?
Poly means ‘many’, mer is ‘one’ says Dr. Thames. Polymers have unique characteristics they have huge molecules, you can make them strong, tough or soft if you understand the chemistry behind it.
“It’s all in the chemistry, so you have to know the chemistry,” he says in a folksy way.
Once you design a polymer on a piece of paper, then you then make it. You execute it in the lab and achieve a product. To determine if you created it properly you use an analytical tool, then test it to see if it has the properties you want. His specialty is in coatings with pigments, it has to adhere. It has to have physical properties to give it longevity in a multitude of environments. “It’s an awful lot of fun to study,” he says.
Dr. Thames has done no research with polypropylene (PP). He’s studied proteins, vegetable oils, biological materials from agriculture, hydrocarbon material and acrylic polymers cover the gamut in his $25 million facility.
That begged the question, had he ever received research dollars from Ethicon? No, he said.
Thomas: Are there things that can disrupt the polymer?
Yes, said the scientist. Heat can destroy them thermally, acid or base can cause PH changes, UV light can excite the molecules and degrade the polymer and by water. Some polymers have the tenacity to attract water. Dr. Thames added there is nothing in chemistry that is inert.
Ethicon’s Proprietary Prolene
Ethicon’s formula for its brand of Prolene is different from other manufacturers because of the selected additives.
Calcium stearate – a lubricant
DL TDP- added as an antioxidant to improve long time storage of the resin and to reduce potential oxidative reaction.
Santinox R- antioxidant promotes stability during extruding of fiber from the extruder.
Procol LA 10- another lubricant
CPC pigment- a copper-based colorant to provide enhanced visibility to the TVT device which is blue.
How is Polymer Made?
Dr. Thames explained you mix the polypropylene with these additives and then put them in an extruder until you get good distribution of the materials. There is a barrel at the end of the extruder that has the diameter of the fiber you want to extrude, like hamburger meat coming out of a grinder. The PP comes out in small strings, the fibers are extruded that way. That is now Prolene.
Does it leave marks on the material? Yes sir, there are extruder lines.
One study showed as an exhibit (Def. Exhibit #30884) was a study by Timothy Liebert and published in the Journal of Biomaterial Research in 1976. It showed Prolene was stabilized with the addition of antioxidants.
The important things that indicate change are tensile strength, molecular weight, toughness and elongation. Dr. Thames says in his analysis of explanted PP mesh there is no reduction in these qualities.
Have you ever found a decrease in molecular weight in explanted PP? “No. If there is no decrease in molecular weight there is no degradation of PP.
“Ethicon’s polymer is both strong and tough,” said the professor.
Ethicon’s 7-year Dog Study
Next the jury was shown the 7-year study on dogs implanted with Prolene sutures. Ethicon concluded that study in 1992 and it was part of the evidence reviewed by Dr. Thames (PL Exhibit # 23228) which was previously presented by the plaintiffs. In it dogs would be sacrificed at interval and the suture evaluated using infrared spectroscopy for molecular weight, tensile strength and elongation.
Scanning electron microscopy has an electron beam and a mirror and can produce an image up to 7-thousand times its actual size. If there is degrading suture you would find a loss of degradation, molecular weight and tensile function would be changed.
(*Editors Note- a mesh implant whether a tape to treat incontinence or a mesh for the pelvic floor to treat pelvic organ prolapse, involves much more mesh than is contained in a suture. As Dr. Tom Margolis, an expert in many plaintiff cases has testified, “The more mesh, the more mess.”)
An analysis showed there was a degradation in the Prolene and PVDF (another polymer) and a few cracks were found.
IR Microspectroscopy looked at fine pints under a microscope in a report by Ethicon dated October 15, 1992. It showed a possible evidence of slight oxidation.
“My feeling is we are looking at something that is not Prolene. It may be an acid solvent. Protein is in flesh and when they take the explants out and they don’t clean them you would expect to see protein from the flesh.”
Dr. Thames concludes after looking at the explanted suture from the dogs, the Prolene came out well.
The stiffness of the explanted material was reduced about 5 psi slight reduction in strength required for breakage of Prolene sample. As far as elongation, the sample elongated twice its original length. “It means not only did the Prolene not undergo elongation but it improved the elongation, so it was a tougher strand of Prolene then when it was implanted in the dog.
“Overall the properties were enhanced during the 7 year implantation.”
Dr. Thames explained the mesh was improved by being able to be plasticized.
“You implant this in an animal and the triglycerides in the body can plasticize and make more pliable a molecule like Prolene. Like hand lotion, you put a plasticizer on the hand to provide elasticity and lubricity when it is chapped. That’s what’s happening now. You are improving the PP implant.”
Thomas: “Comparing data from 7-year dog study and Exhibit 2026 which allows you to draw any reliable conclusions? Does polypropylene degrade?
“In my opinion, it does not.”#
What’s Left Out
These cases are as remarkable for what is left out that the jury cannot hear as what is allowed in. Most of that results from Motions in Limine where the scope of what is being tried will be determined Jurors cannot hear, for example, that in this very court there are in excess of 66,000 lawsuits filed against seven manufacturers. 21,754 name Ethicon, the division of Johnson & Johnson that makes the TVT-O mid urethral sling.
The fact that another jury already found the TVT-O to be defective will not be heard in this trial.
The fact that Johnson &Johnson destroyed tens if not hundreds of thousands of court documents that were on a litigation hold in these transvaginal mesh injury cases will not be introduced in this courtroom.
The systemic or autoimmune issues erupting among many women who have the polypropylene implants will not be introduced. This case is being tried on pain and dyspareunia (painful sex). The science is not there yet to back up the systemic issues but anecdotally the majority of women appear to be reporting such affects.