HACKENSACK, N.J. (Legal Newsline) – The trial over a woman’s allegations against a medical manufacturer over a mesh implant device that allegedly caused her intense pain and physical damage on March 27 focused on the perceived risks and benefits of the device.
Mary McGinnis of North Carolina had Avaulta, a device with tentacle-like arms made of polypropylene, implanted into her pelvic region in March 2009 to treat bladder issues.
McGinnis later sued New Jersey-based C.R. Bard contending the company sold its Avaulta product to patients knowing the implant device was risky and that proper prior clinical studies and backup data were lacking.
Streaming video coverage of the trial at the New Jersey Superior Court in Bergen County was provided to Legal Newsline by Courtroom View Network.
C.R. Bard defense attorney Lori Cohen of the Miami law firm of Greenberg Traurig LLP asked witness for the plaintiff Dr. Anne Weber if any surgery to the pelvic region involved a risk of dyspareunia (painful intercourse), one of the conditions allegedly suffered by McGinnis.
“Yes,” Weber, a noted gynecological author and teacher, agreed.
“Any time there is surgery, there is a risk of permanent dyspareunia?” Cohen asked.
“No, I don’t agree with that,” Weber responded.
McGinnis' allegations include that the polypropylene mesh inflamed the tissue and that the device was too large, causing body erosion and contraction that resulted in the formation of scar tissue.
“It’s the tissue-mesh combination, it’s the foreign body reaction,” Weber explained. “It’s the inflammation working on the mesh fibers to contract (the implant).”
“Do you agree that mesh contraction does not always negatively impact the patient?” Cohen asked.
“No, I don’t agree with that,” Weber said.
Cohen asked Weber if the spine and hip pain reported by McGinnis were conditions with options for treatment to alleviate the pain.
Weber responded that a part of McGinnis’ hip complaints were related to the fact the mesh implant altered the sets of muscles on both sides of the body, or the trans-optimum frame muscles, which are used to walk.
“The damage that has been done there is irreparable,” Weber said. “Arthritis is treatable. The damage from the mesh is not.”
However, Cohen got agreement from Weber that McGinnis also suffered from degenerative disc disease.
“To a mild degree,” Weber told Cohen.
Weber also agreed with Cohen’s assertion she was not an expert at interpreting X-rays of spinal conditions.
Attorney for McGinnis, Adam Slater of Mazie, Slater, Katz & Freeman in Roseland, New Jersey, during cross-examination asked Weber if by using the Avaulta product, the benefits outweighed the risks and met acceptable standards.
“No,” Weber answered.
“Did clinical (product) data meet standards?” Slater asked.
“No, quite the opposite,” Weber answered.
Under further questioning, Weber testified that for the perceived benefit to balance risk, the use of Avaulta should have been limited to women with the most severe cases of prolapse and recurrent prolapse. She said McGinnis did not have a severe enough condition.
“Only then would the benefit favor using something like Avaulta, and that’s not Mary McGinnis,” Weber said.
“What happens with a mesh contraction?” Slater asked.
“An interaction between the mesh and tissue in which the tissue is encased in collagen that becomes a rigid scar plate,” Weber said. “It causes the mesh to become smaller in size than when it went in.”
Weber answered no to both questions if the more-traditional method of using sutures to treat prolapse would have caused tissue damage like mesh allegedly did, or be as difficult as mesh to remove.
During further testimony, Dr. Shlomo Raz, a noted pelvic reconstructive surgery physician who had surgically removed pieces of mesh from McGinnis in 2016, told the courtroom he once used mesh implants he cut himself but not devices like Avaulta, which he said come in kit form. He added he had abandoned the use of mesh approximately four years before.
“I abandoned mesh after seeing complications in the long run,” he said.
Raz disputed a 2014 American Urogynecologic Society report touting mesh as improving the quality of life for millions of women.
“The same people would now say mesh results are not better than what we had done before,” Raz said.
The trial continues with Judge James DeLuca presiding.