Thousands of women sue over alleged surgical mesh infections

Pelvic organ prolapse (POP) is a condition where a woman's pelvic
organs can move out of place, sometimes causing organs to bulge or slip
into the vagina. One of the methods of treatment includes implanting a
surgical mesh to help hold everything in place. But now, some patients
are claiming the mesh is creating even more problems. Soon after
her surgery, Susan Harrison had a string of infections that caused
intense pain, leaving her weak and unable to pick up and play actively
with her young grandchildren. The discomfort and fatigue often kept her
from her job as a kindergarten classroom assistant.
For years,
Harrison thought it was just an unfortunate consequence of the surgery
to repair weak muscles in her pelvic region. But she discovered five
years after her 2006 procedure that she was one of thousands of women
who say their pain was caused by surgical mesh implanted to fix the
problem.
"I felt so bad, I felt sad thinking that I had to spend the rest of my life living this way," Harrison said.
Pelvic
organ prolapsed occurs when muscles and tissue of in the pelvic floor
area weaken. It can happen because of age, childbirth or other reasons
and can cause pain and bladder leakage. Some women can develop the
condition after childbirth, a hysterectomy or menopause, according to
the Mayo Clinic.
Non-surgical
treatments include practicing kegel exercises, which strengthens the
pelvic muscles by exercising the muscles around the opening of the
urethra, vagina and rectum, the Food and Drug Administration
said. In some cases, a pessary is used. A pessary is a removable device
that is put inside the vagina to help strengthen the pelvic region.
For
some women, surgery may be required, the FDA added. Doctors consider
which organ or organs have prolapsed and how severe they have moved, the
woman's desire to still haven children, their age, their sexual
activity and how severe their symptoms are. Surgery entails putting the
organs back where they belong and can require simple stitches or using
surgical mesh.
While many women benefit greatly from the mesh
surgery, the FDA has warned some can suffer complications, and many
women have sued, claiming manufacturers should have warned of potential
harm. But some doctors have said the FDA's warning - and the lawsuits
against the manufacturers - are misguided. The doctors blame
inexperienced surgeons.
Harrison's case is among more than 6,000
federal lawsuits against some of the biggest manufacturers of pelvic
mesh products. The cases have been consolidated in a federal court in
West Virginia, with some trials to begin this year.
The lawsuits
accuse the companies of inadequate testing, failing to disclose
potential risks and fraudulently promoting the mesh as a safe medical
device. The manufacturers deny those allegations in court documents.
Some companies have said in statements their testing was rigorous, that
their products are safe and effective and that they're working with the
FDA. Some companies declined to comment, citing ongoing litigation.
The lawsuits seek unspecified compensation for pain and suffering, reimbursement of medical costs and punitive damages.
Harrison
had most of the mesh removed in October 2011. She said she still feels
weak and has bladder leakage that requires her to take extra precautions
when she leaves the house, but she feels better than she has in years.
Lynn
Waits, a former police officer-turned-nurse from Covington, Ga., had
incontinence and pelvic collapse after having two children. She said she
experienced bleeding and severe pain immediately following her mesh
surgery in 2008.
The incision next to her vagina never fully
healed and she could feel the mesh if she touched that spot, she said.
She continued to have bleeding for two years until she finally went to
another doctor and had the mesh removed in 2010, she said.
She
still has shooting pains, a constant achiness and can't take a long car
ride without discomfort, which she blames on the mesh. The experience
has also changed her marriage.
"Since I had surgery, sex is out. I'm celibate," she said. "Now it's a very platonic relationship. You get used to it."
Kathy
Barton's doctor suggested the mesh when she mentioned that she had
bladder leakage when she laughed or coughed. Shortly after the surgery,
it felt like razors were slicing her organs and a sharp edge of the mesh
cut her boyfriend during sex, she said. Even though she eventually had
it removed, the 55-year-old west Georgia woman still has pain she
believes is caused by the mesh.
The women interviewed for this article who had problems with the mesh were made available by their lawyers.
When
pelvic mesh products were introduced, they were seen as a high-tech
improvement over traditional surgery using stitches and a woman's own
body tissue, which also can have complications. Since similar mesh was
already used in other types of surgery, including for repairing hernias
as far back as the 1950s, the products received fast-track approval from
the FDA without the tests that the agency requires for first-of-a-kind
devices.
The FDA cleared the mesh - often a soft, lightweight
porous plastic - for pelvic organ prolapse in 2002, and the agency said
in a 2008 public notice that problems were "rare." In July 2011,
however, the agency said it erred in its initial assessment and
estimated the most common problems occur in 10 percent of women within a
year of surgery.
The mesh can be inserted through the vagina or
through an incision in the abdomen, though the latter is less common and
has significantly fewer complications, the FDA said. The problems
involve shifting and erosion of the mesh, as well as infections.
A
year ago, the FDA ordered several dozen manufacturers to conduct
rigorous studies to track the complication rates with their surgical
mesh products over time. Some companies have undertaken those studies,
while others chose to stop producing certain products.
Dr. Cheryl
Iglesia, a surgeon in Washington who was on the FDA panel, said things
have come a long way over the last year. A national registry to track
pelvic prolapse surgeries should help identify problems more quickly -
whether they're caused by patient complications, surgeons with
inadequate experience or the mesh itself, she said.
Some doctors
have also been reconsidering when to use the implantation, and the mesh
products have become smaller and lighter, she said. She uses the newer,
smaller mesh products on some of her patients.
"To some degree, the marketing of the mesh may have been ahead of the science," she said.
Dr.
Vincent Lucente, a Pennsylvania doctor who specializes in female
reconstructive pelvic surgery, is among a group of doctors who have
spoken out against the FDA's warnings. The main problems with the mesh
products are caused by surgeons who don't have enough training, he said.
Publicity from the lawsuits scares women into refusing treatment with
the mesh even though they could benefit from it, he said.
"It is a
tragic moment in our field where there's public sentiment and
perception being developed by lawyers and not by physicians," he said.
"The innovation - and the skill sets to use the innovation - is
outpacing the skill sets that the surgeons have, and no one is trying to
close that gap."
Lucente believes there should be a credentialing process to ensure expertise, as there is for other surgical procedures.
Pamela
Danek, a 52-year-old teacher from Vestal, N.Y., had surgery in July
2007 to repair a prolapsed uterus and cervix. The doctor didn't use
mesh, and within three weeks the problem returned, she said. After a
second surgery to remove her cervix, she was in a lot of pain. She went
to Lucente in August 2008 and he implanted the mesh. After that surgery,
she was able to exercise again and her life returned to normal, she
said.
"I do understand that there are people who have suffered
from the mesh, but in my case it's been very positive and
life-changing," she said. "I'd hate to see the whole product go away.
... It's amazing when it's done correctly what a positive impact it can
have on a woman's life."
One of the lead attorneys representing
women suing the mesh manufacturers, Athens, Ga.-based lawyer Henry
Garrard, said problems may arise because some surgeons don't know much
about mesh, but he said it's the manufacturers' responsibility to
educate doctors about their products. For the most part, his clients
have not sued individual doctors, he said, because he claims the
problems are caused by the mesh products themselves.
The cases
have been consolidated in West Virginia because that's where a lot of
them were initially filed, Garrard said. Several thousand other lawsuits
have been filed in state courts, he said. In what is believed to be the
first lawsuit of this type to go to trial, a California jury in July
awarded a California woman $5.5 million in her case against C.R. Bard.
A
trial for five bellwether federal cases against Bard is set for June
and trials for American Medical Systems, Boston Scientific and Johnson
& Johnson subsidiary Ethicon are staggered over the next year.