SAN DIEGO – In a trial to determine if Johnson & Johnson injured women by selling pelvic mesh devices the company allegedly knew were dangerous for profit, a pathologist on Thursday said the mesh can distort once it’s implanted and such devices can also migrate in the body.
“Polypropylene is not inert; the mesh is migrating, moving through the tissue and can become exposed,” said Dr. Vladimir Iakovlev, a Toronto-based researcher with St. Michael’s Hospital and an expert witness for the state. “The nerves around the mesh can be affected by it and this will be felt as pain. The likelihood of affecting nerves is higher (with mesh).”
Attorneys for Johnson & Johnson and its pelvic mesh maker and subsidiary Ethicon attempted to undercut Iakovlev's testimony by portraying him as a highly paid frequent witness against the pelvic sling industry.
The trial in the San Diego Superior Court is being streamed live courtesy of Courtroom View Network.
The state of California, through its Attorney General Xavier Becerra, sued Johnson & Johnson over the Prolift pelvic mesh device, made by Ethicon, for allegedly causing vaginal injuries in women and allegedly for selling the product through the use of deceptive marketing practices. Prolift is a clear polypropylene mesh with eight thin connecting arms. The case in San Diego is the first at trial by a state attorney general and seeks damages over allegations of unfair competition and violation of false advertising laws.
The company reportedly sold 42,000 Ethicon pelvic mesh devices between 2008 and 2014. The mesh is designed to help a sagging bladder condition called pelvic organ prolapse, or POP.
Two of the products at issue are called Prolift and TVT (tension-free vaginal tape) slings.
During questioning by Monica Zi, deputy attorney general with the California Department of Justice, Iakovlev said that like medications, the side effects of having a sling device implanted in the groin can vary widely among patients.
“Every patient will be at risk for complications, but we don’t know who,” Iakovlev said.
Foreign body inflammation as the body attempts to reject the mesh is a common occurrence, also infections result, Iakovlev explained.
“Scarring results as chemicals (in the body) are spewed out to degrade the foreign body (mesh) which can damage tissue,” he said.
Iakovlev said scarring that extends along the implanted mesh forms into a plate-like structure and continues to fill with scar tissue, also forming bridges from one fiber to another.
“Normal tissue is pristine,” he said. “Scarring is like a patch to hold the tissue together. “The amount of scar tissue with mesh is larger and the likelihood of scarring is higher.”
Iakovlev added that continued inflammation can shrink the mesh.
"What is erosion?” Zi asked.
“The mesh migrates moving through tissue,” Iakovlev answered. “It (mesh) becomes exposed.”
“Can erosion take place even if mesh is properly placed?” Zi asked.
Iakovlev said mesh changes shape, including folding or curling, bunching together.
“The muscles contract and expand, the mesh can fold after surgery or bunch together, even years later,” he said.
Iakovlev indicated that mesh that bunches up, forming a ball can expose the patient to the same prolapse (sagging bladder) condition the mesh was intended to solve, while damaging tissue.
“Can polypropylene degrade in the body?” Zi asked.
“Yes,” Iakovlev said. “Polypropylene doesn’t disappear, it changes over time. On its surface, there can be cracks.”
Degraded mesh can show a different core section, unlike its surface, which Iakovlev likened to a cross-section of a tree.
“The (mesh) material doesn’t stay the same,” he said. “It will influence whatever happens to the surrounding tissue. Polypropylene will continue to degrade over the long-term.”
Iakovlev said studies had shown that sutures made from a material called polyvinylidene fluoride, or PVDF, did not degrade the way polypropylene does. Such substances are considered biocompatible.
Under cross-examination, Carolyn Kubota, the attorney for Johnson & Johnson, questioned Iakovlev about his qualifications.
“Would it be fair to say you have not conducted any materials scientific testing?” she asked.
“Yes,” Iakovlev said.
“You’ve never done mechanical (mesh) tests?”
Kubota asked Iakovlev if he could say degradation of mesh caused it to lose its mechanical properties.
“I can say it (mesh) has different behavior,” Iakovlev said.
“Are you able to say it’s lost its mechanical properties?” Kubota asked.
“There is surface cracking, so there is a change,” Iakovlev said.
“You have never measured mechanical properties.”
“Is it fair to say you have not tested (mesh) mechanical function?”
“That’s correct,” Iakovlev said.
Kubota asked Iakovlev how much he made to testify in court. He said $950 per hour.
She produced a list of law firms that Iakovlev had provided plaintiff services for.
“There are 193 names on the list,” Kubota said.
“Possibly,” Iakovlev responded.
Iakovlev agreed he had worked on 200 cases for plaintiffs involved in litigation against mesh manufacturing firms in addition to Ethicon, including C.R. Bard, a New Jersey firm, Boston Scientific in Massachusetts, and others.
District Judge Eddie Sturgeon is presiding.