HACKENSACK, N.J. (Legal Newsline) – Plaintiff Mary McGinnis told a jury March 29 how her life had changed because of the polypropylene mesh implant she had surgically placed in 2009, which instead of propping up a sagging bladder as intended, allegedly caused tissue inflammation and intense burning pain, necessitating removal by surgery.
Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.
“I never knew what severe pain was until I had the mesh,” McGinnis said.
McGinnis stood during much of her testimony because of the discomfort she said results when sitting and recounted for the jury her life. She had tears in her eyes at one point describing how the implant and resulting pain made sexual intercourse with her husband, Tom, impossible.
McGinnis, who underwent a number of surgeries and also had to undergo vaginal reconstruction allegedly because of the use of the mesh, is suing C.R. Bard Co., the New Jersey manufacturer of the implant device called Avaulta, in New Jersey Superior Court in Bergen County. In addition to the personal physical damage, suffering and medical expenses, the suit also states the company marketed the product ignoring potential risks and without performing the proper clinical studies of the product beforehand.
The plaintiff alleged the implant caused tissue inflammation that hardened into scar tissue and that the mesh implant shrunk and changed shape, inflicting pain through the back, arms, legs, neck and groin.
McGinnis, 70, of North Carolina was 62 at the time of the implant. She operates a child care for small infants and described how her work ability was degraded because of the implant device.
“I would tell parents bringing their child for an interview, 'I can no longer lift your child, but I can love your child,'” McGinnis said.
She said that to try and lessen the pain, she would apply coconut oil to the vaginal region to attempt to make the tissue supple.
“If I could feel a scrunching-up, that’s when I knew I was headed for an attack,” she said.
Adam Slater of Mazie, Slater, Katz & Freeman in Roseland, New Jersey, McGinnis’ attorney, asked her to describe an attack.
“Sharp pains in the vagina,” she said. “They radiate out and can go in any direction they want, sharp thick pains that shoot up. You realize nobody can help me - I have to tough it through. The pain is unending; the burning is horrible. It’s beyond debilitating. It hurts so much you can’t cry.”
She said she relied on heating pads or tried to sleep at night with cold packs.
"I could take Xanax, which helps to relax, but the pain is still there,” she said.
McGinnis credited her physical therapist Emily Wegmann for keeping her going.
“I feel she saved my life,” McGinnis said. “She manipulated inside the vagina and it kept me walking. On a human level, you never get used to it. It’s more invasive than a gynecologist.”
Attorneys representing C.R. Bard again attempted to establish that McGinnis’ pain was not due to the implant but a pre-existing degenerative arthritic condition of the hip and spine called osteoarthritis.
“You had a hysterectomy in 1982?” Lori Cohen of the law firm of Greenberg Traurig LLC asked McGinnis.
“That’s correct,” McGinnis said.
“Is it fair to say in 2003, that was the last orthopedic surgeon you saw?” Cohen asked.
“Yes,” McGinnis answered.
“Later, you did see an orthopedist for your knee,” Cohen said.
“He said it was mild and not to worry about it,” McGinnis said. “That was the end of it.”
“You haven’t seen anybody for your spine, correct?” Cohen asked.
“Correct,” McGinnis said.
McGinnis agreed she had some arthritis in her back.
“I’m 70,” she said. “It doesn’t bother me.”
An exhibit projected on a screen showed the medical consent form giving Dr. Elizabeth Barbee, a North Carolina gynecologist who had received training from C.R. Bard in 2007 and 2008 to perform the mesh implants, the go-ahead to install the device in McGinnis in 2009.
The document said in part “the most frequent complaints include erosion through the vagina, pain, infections, recurrence of prolapse and pain during intercourse. Although rare, complications can have serious consequences.”
McGinnis said she read the document carefully and signed it after Barbee gave her reassurances.
“I relied on Dr. Barbee’s judgment that it (the risk) was rare and treatable and went ahead and had the surgery,” McGinnis said.
McGinnis, who described the post-implant pain as “unrelenting,” said during a later procedure to attempt to treat the condition, the pain was so unbearable she tried to leap off an examination table and had to be physically restrained by two nurses and an assistant.
“I tried to get into a pain management clinic, but because I had the mesh they wouldn’t touch me,” she said.