January 14, 2013 ~ During day three of the trial that’s put the spotlight on Johnson & Johnson (J&J) and its transvaginal mesh, Prolift, the primary care doctor for patient Linda Gross outlined the countless procedures she has faced to remove synthetic mesh that continues to cause crippling pain.
MDND thanks Courtroom View Network for the live video stream of the proceedings.
The 47-year-old woman is the first of about 2,000 plaintiffs in the New Jersey Superior Court, the home turf for Johnson & Johnson and its medical device division Ethicon.
Gross is no longer able to work as a hospice nurse. She cannot sit for more than a few minutes.
Despite 22 procedures, with nine to remove the mesh, Gross remains in debilitating pain and has a pain pump to deliver narcotics, believed to be a permanent solution. She has used a catheter 3 to 4 times a day for six years in order to urinate. Gross and her law firm, Mazie, Slater, are suing Ethicon saying the company was deceitful and negligent in withholding important information her doctor should have been provided about the defective product.
Transvaginal mesh is marketed as “minimally invasive” using a hammock of petroleum-based polypropylene mesh sewn into a woman’s pelvic floor to hold up organs that have prolapse. Gross was implanted with the J&J Prolift on July 13, 2006, one year after it was launched with no human trials.
Dr. Clark Likness from Watertown, South Dakota is a family medicine practitioner who delivered Gross’ three boys in 1985, 86 and 90. On the stand Monday he testified two of the three boys she delivered were babies slightly turned around. She had three episiotomies or cuts to widen the birth canal which is not an unusual procedure. Birth trauma can be one of the causes of pelvic organ prolapse.
Dr. Likness said Gross suffered no pelvic problems after any of the births.
However in 2001 Gross had a hysterectomy and records shows she experienced stress urinary incontinence. A consulting doctor felt Gross had a rectocyle, a bulge into the rectum of the posterior wall of the vagina. The symptoms included an inability to defecate because the stool goes into the bulge.
After two attempts at repair using sutures which failed, the doctor suggested she have another surgery. On July 13, 2006 she had a cystocele, enterocele and rectocele repair surgery using the Prolift transvaginal mesh delivered in a pre-cut kit.
It had been launched one year earlier with no human trials.
STANDARD OF CARE
Also in the opening arguments, Ethicon attorney Christy Jones told the jurors that Gross had a compilation of serious problems and the Prolift was the best solution to put her organs back into place. The standard of tacking organs back in place was, for years, the standard of care omitting quality of life (QOL) issues, as internal company documents showed during Friday’s trial. Medical literature is beginning to recognize QOL as an important criteria for the success of the patient.
Two months after her surgery, Dr. Likness said Ms. Gross returned to his office reporting pain on the 10 scale from 5 to 10 along with abdominal bloating.
Attorney David Mazie of Mazie Slater asked: “Had she ever complained any type of pelvic pain prior to the procedure?
Dr. Likness: “No she had not. “
Gross now had repeated urinary tract infections, up to six to eight a year whereas previously she might have had one a year.
“She is miserable,” said her medical report.
“She was in severe pain agony she was suffering struggling even physically struggling spiritually and mentally with this, it had consumed her,” said Dr. Likness.
Both Dr. Likness and a consulting physician felt Gross was having an immunologic reaction to the foreign body plastic mesh which caused profound irritation, inflammation and swelling as the body mounted a campaign to get rid of it.
Dr Likness told jurors, “It’s a foreign thing. The body will react and it can be absolutely devastating. I felt she was mounting an immunologic response against the mesh. Her body was trying to reject it get rid of it kick it out of her body.”
Another physician consulted by Dr. Likness who had been participating in Ms. Gross’ care noted dyspareunia and chronic pelvic pain, after she had a “Partial excision of the Prolift vaginal mesh.”
He found a bunching of the mesh in the posterior side of her vagina. Dr. Likness also said the arms or wings of the mesh had contracted and gathered in the posterior wall of her vagina. Gross’ pain was coming from the spinal area on the left side, an area of the pudendal nerve which runs on either side of the pelvis and is responsible for delivering sensual feelings in the bodies of both men and women. It can also deliver sharp pain if it is damaged or trapped.
“Did she have any pudendal pain prior to the procedure? asked her attorney. “She did not” said Dr. Likness.
It was assumed the mesh was putting pressure on the nerve so it was partially removed. Her unrelenting pain continued as did the pressure and burning.
Pain medication didn’t seem to help with her condition.
Mazie: “How would you describe her reaction to the pain?
Dr. Likness: “It has consumed her yet there is a remarkable quality that amazes me. She is the only person I’ve seen with this pain. Frequently I ask myself how could I deal with that and she is an amazing person. She’s in severe pain yet continues to be patient, remains calm, hasn’t blown up, hasn’t screamed. She’s cried; she’s not intimate with husband; she lost her job and is not able to enjoy what she liked with her kids. It’s consumed her.”
Another doctor from the Mayo Clinic in Minneapolis removed a piece of mesh and another consult with a doctor in the Phoenix area found she had severe recurrent left pudendal neuritis and nerve pain and inflammation. He did a nerve block with almost immediate relief using a steroid and long acting lydocaine called Marcaine. The steroid works over many hours or days to decrease inflammation, and irritation around the nerve.
The Phoenix surgeon extracted more mesh from the space behind the vagina. Mesh was believed to be the reported 2 to mm of mesh that was pushing again an incision in the vagina trying to get out he thought. Dr. Likness said it went away.
Back at the Mayo Clinic, a surgeon performed another mesh excision of the Prolift mesh from the posterior vaginal well. On January 24, 2008, he found a long piece of mesh wrapped around and embedded in her ureter. The doctor put in a temporary stent to preserve her kidney so it did not shut down.
All in all, Gross had 22 surgical procedures from July 2006 to last year and during nine of them mesh was found from the back of the vagina to the abdomen.
“We’ve had mesh fibers poking thru posterior wall of the vagina. It’s been all over her pelvis. All over her even out of the pelvis into the lower abdomen behind your public bone.
David Mazie: “ Is mesh supposed to be there?
Dr. Likness: “No.”
Q:”Was it placed there?”
To relieve the persistent pain in her left buttocks, left peritoneal pain and neuritis, increased swelling and in the inner left leg, her medical team suggested Botox. It failed to work but neither did a spinal stimulator placed in Gross in February 2012.
Gross now has a pain pump to deliver narcotics, which are potentially addictive. Her lawyer said she has a life which outlines what she will need for the rest of her life. When asked if her doctor understood the source of her pain, an Ethicon attorney objected.
Dr. Likness went on. “I firmly believe they are related to her mesh implant July 2006 and subject to issues and concerns that have gone one ever since.”
Q: “Did Linda have any of these issues pre-Prolift surgery?
A:”No she did not.
Q:”Do you have an opinion if these are permanent in nature?
A:”I believe they are permanent at this stage.” #