SAN DIEGO – A pelvic reconstructive obstetrician and gynecological surgeon on Monday told a California court about the complications of the use of mesh in women, including excruciating pain, infection and tissue damage, in a trial against Johnson & Johnson over alleged injuries from its mesh product.
“It’s called the chandelier,” said Dr. Michael Margolis. “The pain can be so bad the patient jumps off the table and hangs from the chandelier. It’s really severe pain.”
Margolis, who practices at El Camino Hospital in Los Gatos, appeared as an expert witness for the state in a trial to determine if Ethicon, the vaginal mesh sling maker and subsidiary of Johnson & Johnson, ignored the risks and damage the devices were causing women to make money.
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 a pelvic mesh device called Prolift, 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 over the implant devices 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.
Margolis told the court he gets paid $400 per hour to meet with attorneys and study background materials, $800 per hour for deposition testimony and $3,000 per day for trial testimony, a total of $40,000 so far.
Potential mesh complications displayed by Monica Zi, deputy attorney general with the California Department of Justice, included urinary dysfunction, dyspareunia (painful intercourse), chronic pain, erosion, infection and possible injury to a sexual partner. The polypropylene devices can result in vaginal stiffening and the formation of scar tissue as the body attempts to reject the material.
Margolis has performed removal of mesh implants from patients.
“I see (mesh) shrinkage causing the mesh to contract and roll,” he said.
He added the implant can look totally disfigured from its original shape when it was implanted.
Margolis said one of his patients who had carried an implant for 12 years had experienced obstruction of the urethra, chronic inflammation and fibrosis.
“Was it a J&J device?” Zi asked.
“Yes,” Margolis said.
“How did you know?”
“I had access to the medical records.”
Margolis said complications can result a few months after an implant is performed or can take as long as 15 years to result in complications. The most common time period is five years.
Mesh implant patients can experience pain in the vagina, bladder, groin, leg and the sciatica area.
“Any point where the sling touches the tissue,” Margolis said. “The pain is often severe.”
Margolis said removal of the mesh usually involves a major surgery and can be difficult to accomplish.
“Do you always try to remove the mesh?” Zi asked.
“No,” Margolis answered. “Not when the risk outweighs the benefits. I have to calculate if the mesh is accessible (to remove).”
“Do you ever refuse to do a (mesh) removal?” Zi asked.
“Absolutely, if it’s not warranted or the patient is a poor candidate for example with heart disease, or if the risks are great,” Margolis said.
Margolis said one of his most difficult moments is to face a patient in pain and say, “I can’t help you.”
He said removal of all the mesh from an implant is often impossible.
“It (mesh) is like rebar in a sidewalk, once the cement is dried,” he said.
“Why is it (removal) so difficult?” Zi asked.
“It’s cemented into the tissue,” Margolis said. “It’s glued in. The (sling) arms go off into a surgical no-man’s land.”
Margolis said it’s possible to remove all the mesh from a patient if the procedure takes place a few weeks after the implant. After four weeks, it becomes difficult to remove the mesh entirely.
Margolis said the Prolift device sticks to a greater area of tissue than lesser sling devices. He indicated that Ethicon had provided no information on how to remove mesh devices in the late 1990s when they were being introduced and he had to learn the procedures on his own.
“This (sling) was a novel device and there was no reference point,” he said.
Margolis told Zi that sales reps for sling companies such as Ethicon frequently make calls on him both at his office and in the operating room where he does surgical procedures.
He said a rep first called on him in 1998 touting the new sling device as an excellent way to cure stress incontinence in women that was quick and easy. He declined to use it.
“I had concerns there would be a high risk of injury to adjacent organs and it would become infected,” Margolis said.
Under cross-examination, Johnson & Johnson attorney William Gage asked Margolis if he had made $931,000 testifying in mesh litigation cases over the past several years. Margolis said he thought it was approximately $700,000.
Gage said Margolis’ son worked for a law firm - Kline & Spector of Philadelphia - that dealt with mesh cases.
“Is this pure coincidence?” Gage asked.
“You have to ask Kline & Spector,” Margolis said. “He (son) was hired for a summer job.”
“You’ve done no lab research on polypropylene?” Gage asked.
“None,” Margolis said.
“No studies on trans vaginal mesh?”
“To date, nothing,” Margolis said.
Gage said Margolis declined to provide defense attorneys with a list of doctors who supported his views on vaginal mesh.
“I said I would have to ask them (doctors) for their permission,” Margolis said. “I was not asked to do it, so I have not.”
Margolis agreed with a statement from Gage that implants in some women had proven to be safe and effective.
“Some, yes,” Margolis said.