SAN DIEGO – An expert witness called by attorneys defending Johnson & Johnson in a lawsuit alleging the company sold pelvic mesh kits to treat incontinence in women knowing the devices caused injuries told a court on Monday the Prolene materials in the devices do not degrade.
“I’ve taken the crust off the mesh and you can see the extrusion lines made during manufacturing,” said Steven MacLean, principal engineer for Exponent. “This tells me the crust is not degraded Prolene. The crust and the fiber are starkly different. There is no evidence, and I’ve done 100 (explanted) mesh cleanings of degraded material on the outside of the (mesh) material.”
MacLean studied mesh samples taken from explanted surgeries of patients. MacLean said cracking in mesh materials observed by some scientists under microscope had been misinterpreted as degraded mesh.
The trial in the San Diego Superior Court is being streamed live courtesy of Courtroom View Network.
Pelvic mesh degrading after being implanted in the human body has been a central contention of attorneys for the California Attorney General’s Office in its lawsuit against Johnson & Johnson.
The state of California, through its Attorney General Xavier Becerra, is suing Johnson & Johnson over a pelvic mesh device called Prolift, made by its 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.
Trial resumed in the case on Monday after a two-week vacation by Superior Court Judge Eddie Sturgeon.
MacLean, a materials researcher with Exponent, an engineering and scientific consulting company based in Menlo Park, told Ali Mojibi, the attorney for Johnson & Johnson, he worked to evaluate polypropylene, one of the ingredients of Prolene mesh, testing its strength, stiffness and stretching ability.
He said he was being paid $495 per hour for his testimony. MacLean said Exponent had been paid for its consulting work up to $1 million over the past five years.
“You’re here to speak on (mesh) degradation?” Mojibi asked.
“I am,” MacLean said.
“What is Prolene?” Mojibi asked.
“Prolene is a resin compound,” MacLean said. “Polypropylene is one ingredient of Prolene.”
MacLean said testing of the mesh implanted in dogs had revealed no degradation of the materials.
Sutures removed after seven years of being implanted in dogs showed there was no degradation found in the sutures, MacLean said.
One of several exhibited reports of tests performed on dogs read "no degradation in explant."
An exhibited slide showed one of the fibers from the dog test that appeared to have numerous surface cracks. MacLean said despite this, no degradation was found.
“It (fiber) is not degraded because of a particular weight test,” he said. “We should have seen molecular weight loss (in the fiber). These are not degraded even though it (fiber) looks cracked.”
MacLean said pristine mesh samples also exhibited elasticity, the ability to stretch and bounce back into shape.
Since 2012, numerous lawsuits have been filed by individual women who had mesh devices implanted and 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.