Pelvic mesh expert, Dr. R of Chicago (name withheld so defense lawyers can’t make red herring plays with it) testified for plaintiffs against Ethicon this week. He said lightweight mesh is safer than the old heavyweight mesh Ethicon used in TVT Abbrevo to treat stress urinary incontinence in the plaintiff. He made several points, as the brunt of his testimony supported the plaintiff’s attorneys’ basic assertions that Ethicon’s TVT Abbrevo mesh caused plaintiff Coleen Perry more problems than it solved, that the TVT Abbrevo is a defective product, and that Ethicon had a mesh product similar to Abbrevo which her surgeon could have used with a greater chance of success. After suffering ongoing pain which she attributed to her pelvic mesh sling, Mrs. Perry had additional surgery to remove as much of the Abbrevo sling as was possible.
The Plaintiff’s Expert
A urogynecologist, Dr. R also testified that he has performed thousands of surgeries on women for stress urinary incontinence (SUI) and pelvic organ prolapse (POP), including at least 2,000 surgeries for SUI. A 20-year expert in gynecology and urogynecology, he is an expert in the evaluation, treatment, and management of female urinary incontinence, genital prolapse and lower urinary tract dysfunction. Chicago Health Medical Group reports that the doctor believes urinary disorders can be managed both surgically and through non-surgical methods like behavioral therapy, electrical stimulation and pharmacotherapy. He has been featured on Fox News Chicago, ABC Channel 7 News, and in national magazines, including Redbook, Woman’s World, and Good Housekeeping.
Defective Product Testimony
“The Proline Soft (another mesh sling made by Ethicon) would have been safer than the heavyweight laser cut mesh in this case,” the doctor testified at Perry vs. Ethicon in Bakersfield, Calif. Mrs. Perry is suing Ethicon for failing to adequately warn her of the mesh complications she said she has suffered as a result of being implanted with Ethicon’s TVT Abbrevo mesh – a so-called mini sling – to treat stress urinary incontinence.
Dr. R said that in his Chicago practice, “About 75 percent of the mesh complications I take care of are mid urethral slings. . . I’ve experienced treating the complications associated with heavyweight mesh.”
Ethicon ignores Doctor Suggestions
The doctor also testified about an internal Ethicon report in 1998 that concerned the company’s mesh sling products. “Ethicon,”he said, was “asking doctors what they would find important in a mesh. Doctors responded that it should be soft and flexible, but it should have big enough pores that tissues could grow in, that it should resist infection, that it should be easy to remove if there are problems, that it should have a color to it so it would be easier to implant, but more importantly more easy to find. . .”
By contrast, the mesh placed in Mrs. Perry was laser cut and therefore at least 1/3 less flexible than machine cut mesh, it was small pored, making it more difficult for tissues to grow in, it was more difficult to remove because it was heavier and therefore caused more foreign body reaction and scarring as the body reacted more severely than it would to a lighter weight mesh, to reject the foreign substance.
Ethicon: This Mesh is “Far from Ideal”
The doctor also read into testimony the conclusion of Ethicon’s own developers of the mesh used in Mrs. Perry. Ethicon wrote in their own evaluation: “This mesh is far from ideal.’”
Ethicon ignores its own Doctor Experts
The doctor was also asked to read what Dr. Piet Hinoul, Ethicon’s worldwide medical director, had written in interdepartmental correspondence “[T]hat lightweight mesh is better than heavyweight mesh because it decreases inflammation, redness and swelling. It reduces scarring and it reduces pain in women. And (that) the company has known this (Dr. R’s emphasis) for years.”
Meanwhile, Ethicon was telling doctors that its TVT Abbrevo mesh was lightweight. Ethicon told doctors exactly that on the company web site. Just last week the web site said the mesh was lightweight, the doctor testified. Asked if he had looked at the web site recently, he said he looked at it again yesterday, (Feb. 1, 2015) and Ethicon had removed the lightweight designation from its web site.
The plastic mesh used in Abbrevo weighs 105 grams per meter square, more than half the weight of lightweight mesh, which is at least twice as heavy as what Ethicon itself considers lightweight mesh.
Lightweight vs. Heavyweight Mesh
The doctor had reviewed several hundred pages of Ethicon company documents, including those of Ethicon’s worldwide medical director Piet Hinoul, who wrote that a decrease of complications is a very important concern for surgeons; therefore the company needed to make the mesh softer than it had its original mesh, less stiff and lighter, in order to reduce complications.
Several Ethicon documents referenced by plaintiffs’ attorneys indicated that lighweight, large pored mesh is superior to heavyweight, small pored mesh to treat women for stress urinary incontinence. The Abbrevo is heavyweight, small pored mesh, and it is laser cut as opposed to machine cut, raising questions of its ability to maintain a proper flexibility and not turn more rigid and cause more erosions than the softer, machine cut mesh. Dr. R testified that the lighter weight also causes less foreign body reaction, and that the larger pores allow for better integration with body tissues when the plastic ‘meshes’ with the human body.
Testimony from the doctor also showed that the heavyweight mesh used in the TVT Abbrevo implanted in Mrs. Perry is the same mesh material that Ethicon began using in hernia mesh repair in 1974, and this heavyweight mesh is the same material the company used for Mrs. Perry’s TVT Abbrevo mesh, despite the company claiming Abbrevo is a lightweight mesh.
Ethicon’s own Documents show Heavyweight Problems
Testimony showed that Ethicon’s own documents indicate that lightweight meshes would result in less inflammation, less fibrosis, less pain than traditional heavyweight meshes and will keep the same mobility of tissues. In addition, heavyweight had erosion rates of 7% vs. 2% for the lightweight mesh.
Under continued questioning from the plaintiff’s attorneys, it was found that Ethicon continued to use the heavyweight, small pored, stiffer mesh – the same mesh it had begun using for hernia repair in 1974 – despite all the evidence from its own documents that the lightweight, large pored, more flexible machine cut mesh worked better for women.
Mesh weight is measured in the number of grams in meters square. The heavier the weight, the more foreign body response (FBR). Dr. Rosenzweig compared FBR to a splinter in the body. Like a splinter, when a portion of the plastic mesh is left behind, the body tries to isolate the foreign body, which creates a chronic foreign body reaction. In the obturator space, the obturator nerve is susceptible to the irritation caused by this reaction which results in pain.
Dr. R said that when he removes the mesh, as he has hundreds of times, it comes out degraded: “hardened, brittle, fragmented and rough, which is not the way it comes out of the box” before it’s implanted. He said removing the mesh is like trying to take steel wool out of concrete.
Laser cut vs. Machine cut Mesh
Ethicon originally machine cut the mesh, which left a softer edge that would seem to have caused fewer mesh erosions through the vagina. But in 2006 the company realized it was losing a lot of product on the cutting room floor; so the company began to laser cut the mesh. This saved money on the material costs for Ethicon, but the laser cut left a harder edge that had the effect of stiffening the mesh so that it did not behave the same way in the body. The stiffer edge could cause more erosion and more pain, because it fit more tightly, was less flexible in the body than it needed to be.
Treating Mesh Complications
Dr. R testified that “75 percent of the mesh complications I take care of are from sings. All the ones are over 55 grams, heavyweight mesh. I have treated the complications associated with heavyweight mesh.”
Dr. R testified that lightweight better because it reduces redness, scarring, foreign body reaction, pain.
He was instructed to review an August 1998 document where Ethicon was asking doctors what they would find important in mesh. They responded, he said, that it “should be soft and flexible but have big enough pores for tissue, should resist infection, be easy to remove, be colored so it that would be easy to find (blue). Had concerns it was not used long enough, that it could be stiff. He quoted Ethicon medical reviewers with concluding: “This mesh is far from ideal.”
Dr. R noted that Ethicon changed its company web site yesterday (Feb. 1, 2015), that the company had previously claimed and told doctors that TVT Abbrevo was lightweight mesh. But it is heavyweight mesh, 105 grams per square.
Machine vs. Laser Cut Mesh
In 2006, Ethicon changed from machine cut to laser cut mesh. They changed because they were wasting mesh from the cuts, but laser cutting made the mesh stiffer, according to an Ethicon study. Document from lead engineer Dan Smith discussed bench top testing of the laser cut mesh. They compared it with data that had already been established by Dr. Deets from Australia of various meshes.
Dr. R opined that laser cutting the mesh made it stiffer and increased the risk of complications. “Increasing the stiffness of heavyweight mesh increases the complications.” Because heavyweight mesh is already stiff, laser cutting it increases that stiffness.
Mid urethral sling products from other manufacturers – Ethicon looked at three others, though there were some 20 different mesh slings on the market. Ethicon concluded laser cut mesh was three (3) times as stiff as machine cut mesh.
Foreign Body Reaction
Dr. R explained that the foreign body reaction of the mesh creates problems for the person implanted with mesh. White blood cells come together to surround the mesh and try to draw it out from the body. If this becomes a significant foreign body response, much scarring can result, even causing a “plate scar” which goes completely around the mesh, causing inflammation and then more scarring which leads to more contraction and more stiffening of the mesh, bringing in more nerves and causing more pain.
Larger holes in the mesh weave allow good tissue to get in and work as it should Dr. R compared the small pores of the heavier mesh to pores clogged in one’s face. Larger holes, according to Ethicon’s own studies, show the lightweight mesh with larger pores works better, causes less scarring, inflammation, subsequent pain.
Defense attorney for Johnson & Johnson and Ethicon asked Dr. R at least a dozen questions about mechanical testing, cytotoxicity, biomaterials testing. Defense established that Dr. R had never done any bench testing on mesh, was not a materials expert on the plastic the mesh was made of, had not looked at explanted mesh under a microscope, hadn’t cleaned explanted mesh to examine it. The defense established that Dr. R is a pelvic floor surgeon, not a pathologist, had never performed pathology on explanted mesh or of sutures.
Defense trotted out several short term studies attempting to show the efficay of TVT Abbrevo, but in study after study Dr. R pointed out that 40 or 50 percent of the participants never followed up, never came back to the clinic where they were implanted, and Dr. R pointed out that in his experience, people with bad clinical outcomes tend not to return. Dr. R also pointed out under a barrage of studies that they were virtually all short term, that most studies didn’t last beyond two years and that most women didn’t start having problems with mesh until after two years. He also countered that a paper published last year showed that 75 percent of women who had a bad outcome with their mesh product did not return to the implanting doctor.