SAN DIEGO – During a second day of testimony on Wednesday in California's case against Johnson & Johnson over a pelvic mesh device, Dr. Bruce A. Rosenzweig, a gynecologist and urinary tract specialist with the Rush University Medical Center in Chicago, described for the court what happens when pelvic mesh inside a woman’s body deforms.
“Does mesh deformation lead to complications?” attorneys for the state asked.
“Yes,” Rosenzweig said. “Mesh can rope and curl; it can fold its edges and fray off (into particles).”
The result, Rosenzweig said, can be acute pain in the groin.
The trial in the San Diego County Superior Court is being streamed live courtesy of Courtroom View Network.
The state of California, through its Attorney General Xavier Becerra, is suing Johnson & Johnson over a pelvic mesh device called Prolift, made by subsidiary Ethicon, for allegedly causing vaginal injuries in women and allegedly for selling the product by the use of deceptive marketing practices. Prolift appears as a clear polypropylene mesh with eight thin connecting arms.
Since 2012, numerous lawsuits have been filed by individual women who had mesh devices implanted who later alleged they suffered intense pain and side effects that required the devices to be surgically removed with great difficulty.
Washington State sued Johnson & Johnson earlier this year in a similar case, but the company agreed to pay $9.9 million to settle with no admission of wrongdoing. The case in San Diego is the first at trial by a state attorney general over the implant devices and seeks damages under unfair competition and false advertising laws.
The company reportedly sold 42,000 Ethicon pelvic mesh devices between 2008 and 2014, designed to help a sagging bladder condition called pelvic organ prolapse, or POP.
Rosenzweig said particles of the mesh can actually break off inside the body.
“They (particles) stick through the vagina, leading to pain, or can migrate to other areas of the body where they should not be,” he said.
In addition, Rosenzweig said the pore size of the polypropylene mesh can shrink because of stretching inside of the body, increasing scarring and causing the formation of a scar plate in the vaginal region.
When asked about the impact of what is called “roping” by the mesh, Rosenzweig said a narrowing of the mesh makes it difficult to urinate and creates increased pressure under the urethra.
An exhibited slide said an 8.5 percent change in the weight of the mesh can result once implanted and photos showed cracking of the vaginal sling.
“It (sling) can become stiffened, hardened, brittle,” Rosenzweig said. “It leads to chronic pain and pain during intercourse.”
Erosion of the mesh in the vaginal tissue can lead to scar plating and contraction of the mesh, Rosenzweig explained. He agreed that polypropylene is not an inert substance---it has the ability to degrade and change inside the body.
“Does the roping lead to harm in women?” he was asked.
“Yes,” Rosenzweig said.
“What is the most common symptom?”
In addition to pain and inflammation, shrinkage, contracting, bridging and deformation, Rosenzweig said the mesh can also cause bacteria to adhere to the mesh, leading to infection.
“Did the company disclose the risk (of complications) in marketing materials?” Rosenzweig was asked.
“Yes,” he said.
“Did it say it was caused by the properties of the mesh itself?”
Rosenzweig said complications could continue as long as the mesh remained in the body.
“Can erosion be severe?”
“Can it result in having to remove a large portion of the mesh?”
TVT, or tension-free vaginal tape, used in implant mesh devices was invented by a Swedish obstetrician Dr. Ulf Ulmsten in the 1990s. Johnson & Johnson paid Ulmsten and a company MedScand $22.5 million for the rights to market the device.
Rosenzweig said a study in 2011 of retropubic and transobturator slings found complications in 42 percent of women monitored, and 20 percent of those were serious complications.
An exhibited instruction for use said the adverse reactions from slings was “transitory,” or temporary, and not chronic.