Posted July 31st, 2013 FiDA highlight
By Doug Allen
CHARLESTON, W.Va. – Physicians dominated the second day of testimony Tuesday in the
country’s first federal trial to determine if a transvaginal mesh manufacturer
is responsible for injuries to a patient. A doctor who consulted for C.R. Bard
Inc. testified that the company knew the resin used to manufacture the mesh
should not be permanently implanted in the human body but refused to disclose
that to surgeons.
Cisson
v. C.R. Bard Inc. is a bellwether case for the more than 23,000 cases involving
transvaginal mesh combined in the U.S. District Court for the Southern District
of West Virginia. Judge Joseph R. Goodwin is overseeing all of the cases.
In 2009, Dr. Brian Raybon implanted Bard’s Avaulta
Plus device into Donna Cisson, the patient at the center of the lawsuit. He
spent several hours on the witness stand Tuesday, describing Cisson’s condition
and the steps he took to treat it.
Cisson suffered from symptoms like
involuntary loss of gas and urine and was diagnosed with pelvic organ prolapse
and stress urinary incontinence, Raybon said. He recommended the Avaulta Plus,
and Cisson, a nurse, agreed.
“I liked it,” said Raybon, referring
to the mesh device. “I felt like it was a good system at that time, and I
thought it was appropriate for Mrs. Cisson.”
The urogynecologist from
Georgia said he felt confident in the mesh product based on the information he
had at the time. He had consulted with Bard on the Avaulta brand for several
years, and gained notoriety as the first surgeon to implant an Avaulta product
in a patient in the United States.
Concern Grows over Complications
It was only after patients began showing up with
complications requiring multiple surgeries to remove the mesh
that Raybon discovered the company that manufactured the resin used to make the
mesh told Bard it was not to be permanently implanted in the human body.
“How could (Bard) use it with that
(warning)?” he asked, when pressed by Cisson’s attorneys. “That’s the part that
really concerns me about this. I was astounded when I saw (the warning).”
Under cross-examination, lead defense
attorney Lori Cohen pressed Raybon on his failure to contact Bard to ask about
the warning, which was disclosed on a Chevron Phillips Material Safety Data Sheet (MSDS)
for the resin, once he found out about it.
The jury of four men and four women
listened intently as Raybon became visibly agitated and raised his voice while
explaining why Bard’s lack
of disclosure of the MSDS sheet caused him great concern.
“As someone who spent four or five
years at Bard teaching other physicians (about Bard products), and there‘s this
MSDS sheet around,” he said. “I’m really concerned I’ve put something in these
patients that shouldn’t have been put in. I’m sorry … it was a little
irritating to work with someone four or five years, and they didn’t tell me.”
‘Transvaginal Mesh is a Bad Idea’
Late in the afternoon, Dr. Lennox Hoyte, whose
response to a question from an attorney caused the first trial to end in a mistrial,
returned to the witness stand. Hoyte is a professor of urogynecology and pelvic
reconstructive surgery at the University of South Florida, and the chief of
urogynecology and robotic surgery at Tampa General Hospital
After being recognized by the court
as an expert witness in female pelvic medicine and reconstructive surgery,
Hoyte demonstrated how prolapse affects women, using a 3-D model of a woman’s
pelvis and a sock.
Hoyte said 50 to 60 percent of women
who deliver a baby vaginally will develop some sort of pelvic organ prolapse
over time. He also said that he’s performed more than 400 mesh repair
operations since 2009, and about 100 of those involved Bard’s Avaulta line.
The
net-like device at the heart of the lawsuit includes small mesh “arms” that
extend from the device to help hold it in place. Hoyte said he believes the
arms are the problem.
“It’s dangerous to go after the arms
(during revision surgery)
because of the location,” he said.
The
mesh implant allows fatty tissue, nerves, blood vessels and muscles to grow
through and around it, and Hoyte said it’s not easy to remove. Hematomas
(collections of blood) can form, and the vaginal flesh becomes ingrown so
tightly around the mesh that surgical removal can destroy so much tissue that
the vagina can be difficult to reconstruct.
“Armed transvaginal mesh is a bad idea,” he
said. “It never made sense to me. … I always had a feeling the mesh would
shrink and cause pain to patients.”
Testimony continues today, with
defense attorneys cross-examining Hoyte on Day 3 of what is scheduled to be a
12-day trial.
Doug Allen is a freelance
reporter based in Aspen, Colo. His work has appeared in local and national
print and radio outlets, including The Washington Post and Aspen Public Radio.
Last modified: July 31, 2013
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