SAN DIEGO – A product testing engineer with Ethicon, Johnson & Johnson’s pelvic mesh subsidiary, said on Monday in a trial to decide if the company allegedly marketed incontinence devices knowing they caused harm, that sling products did not change shape during stress testing.
“They (state of California) are alleging that the mesh ropes and curls,” said William Gage, an attorney representing J&J. “Studies will show it does not.”
Gage asked Dr. Katrin Elbert, Ethicon senior principal engineer, if the mesh distorted its shape during testing.
“Roping, curling, we didn’t see it,” Elbert said. “We were applying loads and there was no permanent deformation. It (mesh under stress test) went back to its original configuration.”
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 its subsidiary 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.
Elbert, called as a witness for Johnson & Johnson, indicated the testing and government approval to place pelvic slings on the market is a detailed and highly regulated process in which requirements for agencies like the Food and Drug Administration (FDA) must be satisfied.
“We have to make sure we’re in compliance,” Elbert told Gage. “Our design control process is compliant with FDA regulations. As project lead, my job is to make sure we meet the requirements.”
Elbert oversaw the approval process for devices, including the TVT-Abbrevo, a modified version of the TVT-Obturator used to treat urinary stress incontinence, and the Gynecare transobturator mid-urethral sling introduced in 2004.
A third product called the Gynemesh PS (Prolene Soft) device introduced in 2002 is used to treat pelvic organ prolapse, or POP, to help support a sagging bladder.
Elbert, who called the mesh a “knitted textile,” said it can be cut for use either mechanically or by laser.
Patients were instructed to cough to judge the impact on the devices, Elbert explained.
“The cough is a high-pressure event and we would see what the loads were (for mesh),” she said.
In addition, Elbert said tension tests were conducted on the mesh to see its reaction and if it would retain its original shape.
“We did 10 times (normal pressure) and still were not seeing deformation of the mesh,” she added.
Elbert was also involved she said in the writing of instructions for use (IFUs) on the products.
State’s attorneys have argued the IFUs left out important potential complications of the devices, including warnings they could be “life-changing” or “permanent life-time” complications.
On cross-examination, Daniel Osborn, deputy attorney general with the California Attorney General’s Office, said testing of the TVT-Obturator had not been performed with a live patient.
“That’s correct,” Elbert said.
The devices were tested using animals and cadavers to do implants to see how they would react in a human body.
Elbert said she had observed and taken part in testing of the mesh by implanting it in cadavers.
Osborn asked Elbert if a cadaver lab test would tell the tester how the device could work in the body of a live human.
Elbert explained that such testing produced valuable information.
“It (cadaver testing) does give us information that is absolutely relevant to the subsequent performance (of mesh) in a live woman,” she said.
Elbert told Osborn using a different substance than the synthetic prolene for the mesh was not considered as it had been used for a number of years and there was no need to change to a new material.
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 slings.