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THE DAILY ASTORIAN • THuRSDAY, JANuARY 10, 2019
Physicians criticize state lawsuits over pelvic mesh
By GENE JOHNSON
Associated Press
SEATTLE — Doctors
who specialize in female
pelvic medicine say law-
suits by four states, includ-
ing Washington and Cali-
fornia, over products used
to treat pelvic floor disor-
ders and incontinence might
scare patients away from the
best treatment options — or
maybe even push the prod-
ucts off the market.
Sixty-three Washington
surgeons signed a letter to
state Attorney General Bob
Ferguson, arguing his con-
sumer-protection
lawsuit
against Johnson & Johnson
and its Ethicon Inc. subsid-
iary is off-base. The lawsuit
says the companies failed
to disclose risks associated
with the products, but in
their letter the doctors said
they were never deceived
and that the case is based on
a misconception about how
they assess dangers posed by
medical procedures.
“We have served on
national and regional med-
ical societies in women’s
health,” wrote Dr. Jeffrey
Clemons, a pelvic recon-
structive surgeon in Tacoma.
“It is astonishing to us that
the AG is proceeding with
this lawsuit without first
availing themselves of the
significant experience and
expertise of this group.”
Doctors in California are
drafting a similar letter to
Attorney General Xavier
Becerra, and the president
of the American Urogyne-
cologic Society, which rep-
resents 1,900 medical pro-
fessionals, has issued a
statement expressing some
of the same concerns.
Clemons and two other
doctors who signed the
Washington letter have been
retained by defense coun-
sel as consultants in the
case, but Clemons said he
wrote it without payment or
assistance from Johnson &
Johnson.
At issue is “transvagi-
nal mesh” — plastic mesh
products that are implanted
to correct a variety of pelvic
floor disorders.
AP Photo/Ted S. Warren
Dr. Jeffrey Clemons, a pelvic reconstructive surgeon, holds a letter to Washington state
Attorney General Bob Ferguson that he helped draft and was signed by more than 60 surgeons.
AP Photo/Ted S. Warren
A sample of transvaginal mesh used to treat pelvic floor
disorders and incontinence in women.
They came on the U.S.
market in the late 1990s to
treat stress urinary inconti-
nence — a condition trig-
gered by physical activity
like coughing, sneezing or
running that is common and
sometimes debilitating in
women after childbirth. The
treatment involves using
a thin mesh strip, called a
“mid-urethral sling,” to sup-
port the urethra, the tube that
carries urine away from the
bladder.
The products were so
successful — one of the
most significant advances
in women’s health in recent
decades, the physicians said
— that companies began
developing similar mesh
products to treat another
condition, called pelvic
organ prolapse.
In such cases, pelvic
organs such as the uterus and
bladder drop from their nor-
mal position due to muscle
weakening. A sheet of mesh
can be used to support the
pelvic floor.
However, treating pelvic
organ prolapse with mesh
proved problematic after
those products were intro-
duced in 2004. They were
more likely to bring seri-
ous complications, includ-
ing permanent incontinence,
severe discomfort and an
inability to have sex.
The U.S. Food and Drug
Administration issued warn-
ings in 2008 and 2011, and
companies pulled most of
the transvaginal mesh prod-
ucts for organ prolapse from
the market.
Tens of thousands of
women have filed liabil-
ity claims against Johnson
& Johnson and other com-
panies, with some saying
they knew nothing about the
potential complications.
The doctors say Wash-
ington’s lawsuit conflates
the acceptable risks of using
pelvic mesh to treat incon-
tinence with the less tolera-
ble risks of using it for pel-
vic organ prolapse. They’re
worried it could force
mid-urethral slings off the
market, though the attorney
general’s office says that’s
not the goal.
Washington,
Califor-
nia, Kentucky and Missis-
sippi are pursuing lawsuits
that claim Johnson & John-
son deceived doctors and
patients, and that the sur-
geries ruined some wom-
en’s quality of life. They say
product marketing brochures
and instruction pamphlets
should have contained much
more detail about the risks.
The company updated
its instruction pamphlets in
2015 — effectively admit-
ting the earlier versions
were inadequate, Washing-
ton state says.
“The purpose of our law-
suit is to require Johnson &
Johnson to disclose to doc-
tors and patients the serious
risks associated with sur-
gical mesh,” Ferguson said
in an emailed statement.
“Johnson & Johnson knew
about these risks for years
and misrepresented them for
more than a decade, even as
it sold thousands of these
devices in Washington.”
Washington’s
lawsuit
seeks fines for each alleged
violation of the state’s Con-
sumer Protection Act, an
amount that could easily run
into the millions. The attor-
ney general’s office also
wants to bar Ethicon from
representing that its surgi-
cal mesh is superior to tra-
ditional treatments, such as
repair using the patient’s tis-
sue, and it says a key ques-
tion is whether the pamphlets
could have deceived the
least sophisticated surgeons,
not the most sophisticated.
In their letter last month,
the surgeons insist they were
never misled — nor could
they have been, because
they don’t rely on a com-
pany’s marketing materials
or instruction pamphlets to
divine the risks of medical
devices.
Instead, the letter said,
they rely on their education,
journals, conferences, text-
books and other unbiased
sources, and they counsel
their patients accordingly.
In declarations filed
in King County Superior
Court, some said Ethicon
paid for them to undergo
training that fully explored
the devices’ risks, and oth-
ers said they learned about
the uses and risks from those
specially trained doctors.
Clemons and the other
surgeons do not dispute that
some women have suffered
complications from the use
of mesh to treat inconti-
nence, but they say any sur-
gery has risks, and the risks
of that procedure are well
within accepted norms.
Millions of women world-
wide have been treated with
mid-urethral slings.
The letter cited a recent
large study of the English
National Health Service
database that found com-
plications prompted the
removal of mesh slings in
just 1.4 percent of patients
within the first year after sur-
gery, 2.7 percent within five
years and 3.3 percent within
nine years.
In fact, Clemons said,
the mid-urethral sling has
become the “gold standard”
among surgical options for
stress urinary incontinence
because it offers better out-
comes than other types of
surgery, can be performed
on heavier patients who oth-
erwise would be ineligible
for surgery, and requires less
cutting and recovery time.
The Washington Attorney
General’s Office said in a
court filing the fact that doc-
tors obtain also risk infor-
mation elsewhere does not
excuse the companies from
ensuring their instructional
pamphlets are “truthful and
complete.”
The office agreed that
many women have had pos-
itive outcomes with the
devices and said it does not
seek to restrict access to
them.
Nevertheless, the state
is relying on an expert wit-
ness, Dr. Bruce A. Rosenz-
weig, a gynecologist at Rush
University Medical Center
in Chicago, who insisted in
a deposition that polypro-
pylene mesh is an “unsafe
material to be placed perma-
nently in the female pelvis.”
That position is contrary
to the scientific literature,
according to the surgeons’
letter.
Clemons is a retired
Army colonel who spent a
decade as the chief of urogy-
necology and pelvic recon-
structive surgery at Madigan
Army Medical Center. He
serves on the board of the
American Urogynecologic
Society and has performed
about 1,250 mid-urethral
sling surgeries; he used to
cut his own mesh slings
before Ethicon’s came on
the market.
After filing the law-
suit, the Washington Attor-
ney General’s Office tried to
recruit him as an expert wit-
ness, he said. Although he is
a fan of Ferguson’s Demo-
cratic politics — Clemons
donated $550 to his re-elec-
tion campaign last month —
he declined.
“I’m not anti-Bob Fer-
guson at all,” Clemons said.
“I just disagree with him on
this.”
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