J&J Federal Trial – Transvaginal Tape Risks Outweigh Benefits
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.
Tuesday in the trial of Huskey v. Ethicon, the fourth jury trial over Johnson & Johnson’s controversial transvaginal meshes, Dr. Bruce Rosenzweig, an expert for the plaintiff, told jurors he had implanted 15 or 20 of the polypropylene slings.
He stopped doing them after seeing patient complications and today only does the burch procedure using sutures. Today he also treats patients with mesh complications and has seen about 1,000 patients so far, he estimated.
Transvaginal meshes were developed in the last 15 years to shore up sagging pelvic organs and the urethra as a treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). They are made of J&J’s Prolene polypropylene (PP).
To a reasonable degree of medical certainty, the doctor testified that the risks of using a polypropylene TVT-O outweigh the benefits. Why? He told the jury he’s seen the complications specifically in the meshes used to treat incontinence in about 200 patients.
The arms of the obturator pass through about three or four muscle groups through the inner thigh, muscles that help with walking and balance. Problems include pain, trouble voiding or urinating, hardened, stiffened, shrunken and contracted mesh that degrades and leads to foreign body reaction. Upon removal the mesh “looks brittle and fragmented” he told the jury of seven.
The problems are particularly prevalent when the mesh is considered a heavyweight.
The greater the weight, measured in the number of grams in meters square, the more foreign body response (FBR). It’s not unlike a splinter in the body. When a portion is left behind the body tries to wall off the foreign body creating chronic foreign body reaction. In the obturator space, the obturator nerve is susceptible to the irritation caused by this reaction which results in pain.
As proof, the plaintiffs showed an article by Dr. Todd Heniford, a hernia doctor and long-time J&J “opinion leader” or consultant. Heniford had even produced a video for the company extolling the virtues of a lighter weight mesh when compared to traditional hernia mesh, but that video was not entered into evidence in this case. Even his article, “The Argument for Lightweight Polyproylene Mesh in Hernia Repair” Dr. Heniford confirmed that Prolene mesh (the proprietary name for J&J’s version of mesh) is considered heavyweight.
Add to that problem, said Dr. Rosenzweig, is the pelvic mesh put into Mrs. Huskey was laser cut, not mechanically cut. The doctor opined that process stiffens the mesh. An internal study presented in an exhibit compared laser cut mesh to mechanically cut mesh.
“At one inch of stretch the laser cut TVT was 3 times stiffer than machine cut mesh” further irritating nerves and muscles and furthering mesh erosion, it said.
INSTRUCTIONS FOR USE
Called the IFU, those are the instructions that accompany any medical device.
A physician is supposed to read and understand the IFU before advising patients on a risk-versus-benefit analysis. It is also intended to tell a physician who is a good candidate for a procedure and who is contraindicated, or not a good candidate.
Dr. Rosenzweig was provided a list of warnings that could be in the IFU – chronic pain, dyspareunia, nerve and muscle damage, the need for future surgeries, degradation and shrinkage, foreign body response, “Are these complications associated with the TVT-O?” Yes, that is correct.
But according to the doctor, none of the complications appear in the IFU for the TVT-O and he received none of these warnings when he attended training by Ethicon in Belgium a decade ago.
Instead, the doctor said the IFU downplays complications saying they can be managed in a day or so. “I’ve seen patients that have leg and groin pain and chronic pain syndrome that lasts much longer than 24 hours and are not managed with mild analgesics.”
In an email presented in court dated January 29, 2009, Meng Chen, the Associate Medical Director at Ethicon, spoke up to her colleagues about the characterization of complications as ‘transitory.’ She said in the email, “Pardon me what I see each day, these patient experiences are not transitory at all.”
Also missing from the IFU were contraindications – warnings that the TVT-O should not be used in pregnant women, younger women who are still growing, women who might want future pregnancies and thin, active women, such as Jo Huskey.
On cross examination, Christy Jones, representing Ethicon, provided her version of glowing endorsements of the TVT products. Medical societies such as the American Urogynecologic Society (AUGS) and American Urological Association (AUA) among others, have concluded synthetic PP slings are an appropriate treatment choice for women with stress incontinence, said Jones.
In fact, Jones said two separate organizations say monofilament polypropylene mesh is the “most extensively studied in history” and there are a lot of studies on mid-urethral slings with more than 2,000 in the literature.
Some of the studies offer evidence that is “moderate,” said Rosenzweig in response.
While medical school rarely teach the burch and fascia procedures, Jones said transvaginal tape remains the current “Gold Standard” with over 3 million mid-urethral slings placed worldwide.
DEFECTIVE IN INSTRUCTIONS?
Product liability is all about proving a product is defective – defective in design, in manufacture and/or in instructions.
The plaintiffs must prove by the preponderance of the evidence, (more likely true than not true), that one or all three occurred. Since the “end user” of the instructions is the doctor, who then advises the patient, the plaintiffs brought the implanting physician to the stand via videotape to see what she knew in advance of putting a TVT-O into Jo Husky in February 2011.
Huskey was a physical therapy assistant and was extremely active. She had lost 50 pounds and wanted to keep it off. Hiking, walking with her husband and doing 8 miles on an elliptical machine were all part of her routine. But she also had incontinence and went to see Dr. Gretchen Brykit in January of 2011.
The partner in her Illinois practice, Dr. Derin S. Rominger had trained Dr. Byrkit on how to use the TVT-O and he had received his training on its use in 2006 from a “preceptor” or doctor/consultant working for J&J.
Dr. Rominger said he and Dr. Byrkit still worked together as they had during her training calling it “more efficient” that way. He attends every procedure she performs though Jo Huskey was never his patient. He still uses the TVT-O while Dr. Byrkit says she implants “zero to two a month” and has so since she started using the mesh, but she didn’t remember when that was.
Dr. Byrkit said she discussed potential complications with her patient – those listed in the IFU – but admitted she probably had not read the IFU since she started doing procedures with the TVT-O. She had never attended an Ethicon training program but relied on Dr. Rominger for her training. Jo Huskey had signed an informed consent form.
No there was not a contraindication for a patient in the IFU who was an active exerciser. If there had been would Dr. Byrkit have still used the TVT-O on Mrs. Huskey?
“I don’t think I would,” said Dr. Byrkit. #