Northern California Record

Wednesday, August 21, 2019

Surgeon talks complications, infection rates of pelvic mesh in J&J mesh trial

State Court

By John Sammon | Jul 31, 2019


Becerra

SAN DIEGO – A gynecological surgeon on Tuesday in a trial over a pelvic mesh product manufactured by a Johnson & Johnson subsidiary continued to compare the difficulty in removing pelvic mesh from a woman’s vagina like using a hammer and chisel to remove rebar in a sidewalk while protecting underground cables.

Pelvic reconstructive obstetrician and gynecological surgeon Dr. Michael Margolis, who practices at El Camino Hospital in Los Gatos, appeared for a second day as an expert witness for the state.

“Why did you not tell the FDA (Food and Drug Administration) that it’s rare for mesh to shrink to the point that it will cause (painful) symptoms?” asked Johnson & Johnson attorney William Gage.

“It was inconsistent with my experience,” said Margolis.

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.

Two of the products at issue are called Prolift and TVT (tension-free vaginal tape) slings. 

Margolis, who has been an outspoken critic of the devices as dangerous, began removing them in 1998 from women complaining of chronic pain and suffering from complications of erosion and mesh disfigurement, twisting and roping of the slings. The symptoms included inflammation and infection. Margolis said the difficulty of removing the mesh devices particularly a few months after implantation becomes difficult once the slings have cemented their way into the vaginal tissues.

He said in such cases removal of all the mesh, which sometimes can fragment into broken-off pieces, is virtually impossible to achieve.

Margolis was asked if he had said the sling implant procedure was likely to result in an infection.

“There is an increased risk of immediate post-operative infection,” he said.

He said such a procedure is not like treating a “clean wound.”

According to exhibited documents, the Centers for Disease Control (CDC) in 1982 adopted the American College of Surgeons' wound classifications classifying wounds according to a likelihood and degree of contamination during surgery. Vaginal surgery was classified as "clean contamination" carrying a risk of infection of 3 to 11 percent, as compared to "clean wounds," which carried a risk of infection from 1 to 5 percent.

An exhibited article stated that complications from synthetic mesh devices had caused up to a 35 percent removal rate, but added that erosion from mesh might not become apparent for years. 

However one study noted, “We did not find a single case of erosion” among a follow-up of 90 women who received TVT devices.

“Did I read that correctly?” Gage asked.

“You did,” Margolis responded.

Margolis agreed he was invited to speak to an FDA advisory committee in 2011 on the mesh devices. 

“Why did the FDA select you?” Gage asked.

Attorneys for the state objected to the question. Superior Court Judge Eddie Sturgeon sustained the objection.

Gage exhibited portions of Margolis’ earlier deposition testimony in which he was asked if it was true that even a properly placed vaginal sling can shrink to the point it would cause symptoms.

Margolis had stated at the deposition that it was true, but complications are rare.

Gage exhibited another study document that said, “All synthetic materials carry the common disadvantages of foreign body reaction and erosion. We did not find these complications to be a major problem in this study.”

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Johnson & Johnson San Diego Superior Court

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