Women Claim This Surgery Has Cost Them Their Happiness, Sex Lives And Hundreds Of Thousands Of Dollars


“I pretty much cry myself to sleep every night.”

Posted on May 25, 2017, 06:38 GMT

Caz Chisholm is one of
the hundreds of women at the centre of what has been dubbed
the “greatest medical scandal” in Australia’s history and is
the subject of an ongoing Senate inquiry, as well as multiple
court battles between patients and pharmaceutical
companies.

In January 2014 Chisholm was told by her gynaecologist that
urogynaecological surgical mesh was the best treatment option
for her urinary incontinence (poor bladder control).

“I just wanted to be able to run around with my son and kick
a ball,” the Perth mother told BuzzFeed News.

Urogynaecological meshes, sometimes known as transvaginal
meshes, are used to treat two main conditions affecting
women.

One is urinary incontinence, and the other pelvic organ
prolapse – when the connective tissue securing the vagina and
uterus to the pelvis gives way after childbirth. In the
latter case the mesh is implanted under the urethra (the tube
that empties urine from the bladder).

The meshes come in different shapes and sizes such as
‘sling’, ‘hammock’, ‘tape’ and ‘ribbon’ and can be
non-absorbable which means the mesh will remain in the body
indefinitely. This means it is considered a permanent
implant.

“[The doctor] didn’t really explain many of the side effects
or possible complications and I just had such immense trust
in her,” Chisholm said.

The plastic net-like implant was put through her vagina to
support the urethra.

She woke up from the surgery with an “excruciating pain” in
her legs which spread throughout her pelvis and pubic area.

“Even six weeks afterwards I was scared of going for a swim
because I didn’t think I could recover if I fell over.

“I felt like I had crawling ants in my pelvic region and I
was told it was a nerve thing.”

Her vulva turned white with the skin disease lichen sclerosus which can
be itchy, painful and cause permanent scarring.

“I was bleeding from scratching it… I was sent to a
dermatologist who just gave me a steroid cream.”

Steroid cream is the approved treatment method for that
condition.

Nine months after the operation Chisholm was still sleeping
with a pillow between her legs and regularly changing the
position in which she slept to ease the pain.

“I [had also] lost all feeling in my clitoris.”

She decided the symptoms
could be related to her implant.

“My anxiety was through the roof at this point, so I went
online and found women with issues similar to mine, and I
realised the only way I could recover from this was to get it
fully removed.”

She set up Australians Pelvic Mesh Support Group on Facebook
in November 2014 and it has since connected more than 800
women around Australia, many of whom meet up regularly in
person to support each other.

“A lot of us have been told that we are imagining it because
women are always treated like hypochondriacs,” Chisholm
said.

She could not find a surgeon in Australia who would remove
the entire implant but she, and dozens of other Australian
women, found their only option for removal in the United
States.

Mesh implant patients travel from around the world to St.
Louis, Missouri, to see obstetrician-gynecologist Dionysios
Veronikis.

Veronikis said he has performed more than 1,000
mesh removal surgeries since 1994, and seen a rapid increase
in patients over the past five years.

“A society is sometimes judged by the way it treats its women
and children… and I think this was a dark chapter,”
Veronikis told St Louis Post-Dispatch.

“These women’s lives are altered permanently.”

Chisholm spent A$35,000 on the trip and operation.

“I am a single mum and I was working part-time… I had to
get a personal loan and borrow money off my parents and I’m
still paying that off now.

“I was there for about three-and-a-half weeks and when I got
back to Australia it took me about six months before I could
actually function normally, and I have never really got back
to where I used to be.

“I can’t walk for longer than 45 minutes.”

Chisholm was worried about permanent nerve damage, however
the feeling has returned to her clitoris.

“The thing with these devices is quite often women are
injured and have painful sex,” she said. “There are some
women in the group whose husbands have left them [because of
the impact the mesh had on their sex lives].”

Unfortunately for Chisholm the original complication, urinary
incontinence, had morphed into urge incontinence – a sudden
and strong need to urinate.

“Sometimes I actually wet the bed now.”

Other potential treatment options for urinary incontinence
include behavioural therapy, medications, botox
injections and surgery.

She had a polyproplene mesh implant inserted into her vaginal
wall to treat a pelvic organ prolapse.

From the moment she woke up from her transvaginal mesh
implant surgery in 2006, her life has been defined by
debilitating pain.

“Right from the get go I was in a world of pain with great
big bruises around my groin and buttocks,” the paramedic and
mother-of-four told BuzzFeed News.

The procedure was described by her doctor as minor, temporary
and uncomplicated, yet for the next decade Blieschke’s life
would include disheartening doctors appointments, repeated
surgeries and a desperate search for a solution to her
discomfort.

“[The implant] had been suggested over a different operation
which would have required six months off work, and I have a
daughter with special needs, she is Down syndrome, and I
didn’t want to go down that path,” she said.

“Not once was I told it was permanent. I was shown a little
piece of gauze-like curtain material… the problem is when
you implant it into bodies it goes as hard as cement within
weeks.”

Blieschke, who was 38, took three months off work as she was
bedridden with pain.

“The next month I kept bleeding and my partner could feel
something hard and sharp inside me when we were intimate, so
I went to the doctor and I was told that there was a fistula
[cavity] in my vaginal wall where a bit of the mesh had
eroded through, so the doctor trimmed it there and then,
which was excruciating.”

The mesh eroded through Blieschke’s vaginal wall eight more
times.

By this stage, she could smell necrotic flesh.

“It smelled putrid and I have since learned that I was having
a foreign body reaction, so my body was trying to get rid of
the mesh like a splinter that you reject.”

Blieschke said she was told by her surgeon there was no one
in Australia who could remove the entire device, and that he
attempted to partially remove the implant.

“He said it wouldn’t happen again, but 12 months later it
eroded through, and so in 2013 I had another two surgeries,
and by this stage I had been under nine general anaesthetics,
and I just had no idea what to do.”

Six years after the surgery, Blieschke was still working as a
paramedic where she had to stop taking painkillers during her
shift to be able to drive, causing the constant pain in her
joints to flare.

“By that stage, the arms of the implant were embedded in my
bowel and rectum and wrapped around my urethra, so the
surgeon said if they removed it I would have an urostomy and
colostomy bag.”

Blieschke ended up flying to St. Louis to see Dr Veronikis.

In January last year, Veronikis spent seven hours in surgery
to remove Blieschke’s implant, bar two small pieces that had
migrated into her groin and attached to blood vessels.

She paid A$50,000 upfront and took six months off work.

“I was only in the hospital for 24 hours, because American
hospitals are so expensive, and then I was in a hotel for
nine days with a catheter.

“[Veronikis] told me my entire pelvis was scar tissue.”

Blieschke has seen improvements since the removal but said
some days she still has to stay in bed.

“Now I’m just campaigning for women to have informed consent,
because surgeons are still putting mesh in them, and it
breaks my heart every time a new woman joins the [Facebook]
group,” she said.

She told BuzzFeed News she wasn’t joining a class action with
law firm Shine against the maker of her implant, Johnson
& Johnson, because patients had to have acted within a
seven year period.

A Senate inquiry launched in February
will hear from women affected by the implants and doctors,
and will also examine the Therapeutic Goods Administration’s
(TGA) “knowledge of women suffering from health problems
after having transvaginal mesh implants”.

Submissions to the inquiry close at the end of the month and
the committee will report in November this year.

Blieschke was one of the women who travelled to Canberra to
appeal to senator Derryn Hinch, who has subsequently backed
victims’ calls for the inquiry into mesh products. Hinch
described it as “one of the greatest medical scandals and
abuses of mothers in Australia’s history”.

“Once again the drug companies and the so-called watchdogs
like the Therapeutic Goods Administration are letting victims
down,” Hinch said in a speech to federal
parliament in November.

“[Patients were] treated like mushrooms: kept in the dark and
fed bullshit by doctors, hospital administrators, the drug
companies and even the TGA.”

Georgerudy / Getty Images

Last year The Newcastle Herald
reported that the TGA had been informed in 2003 that “no
peer-reviewed, good quality evidence [was] available to
determine the safety and efficacy” of incontinence mesh
devices.

“The safety and efficacy of the procedure cannot be
determined at the present time due to an incomplete and poor
quality evidence base,” a 2001 report from the Australian Safety and
Efficacy Register of New Interventional Procedures
said.

In the four years to June 2016, the
administration said it had received 99 adverse event
reports involving the meshes. The most frequently reported
side effects were pain and erosion, but others included
punctures or lacerations of vessels, nerve structures and
organs.

It was not until August 2014 that the TGA announced there
was “little evidence to support the overall effectiveness of
these surgical meshes as a class of products” and moved to
deregister devices that could not provide clinical proof of
safety and efficacy.

By 2015, 72 of the 100 mesh products on the Australian market
had been delisted.

The Royal Australian and New Zealand College of Obstetricians
and Gynaecologists has warned against the polypropylene mesh’s
use for ­pelvic prolapse due to insufficient testing and
concerns over complications, but has stated it is safe to
treat continence conditions.

“I currently see three or four [mesh implant patients] a week
and my colleagues see a few too,” Vancaillie told BuzzFeed
News.

“It has been quite sad because a lot of these patients have
been fobbed off by doctors who tell them it will get better
and it is not getting better.

“These are patients with pain in the region and pain with
every function of the perineum, so anything to do with the
bladder, the bowel and intercourse.”

Vancaillie last month flew to Veronikis’ surgery in the US to
learn how to remove the implants.

“I learned his technique and it was quite amazing, so I asked
him if we could collaborate for patients in Australia,” he
said.

“He is essentially applying well established vaginal surgery
principles to this particular type of surgery, and he has
developed his own unique equipment to do so.”

Vancaillie is returning to St. Louis in June with two fellow
surgeons and a nurse from Prince of Wales hospital to “get
all the equipment” and fine tune their skills so they can
return to Australia and service patients here.

“The tendency in Australia is to take pieces of the mesh out,
rather than the entire thing, which is unfortunate,” he said.

“I have had two procedures for the two tissue anchors [part
of the mesh] which have migrated through my body, one of
which was in my bladder wall and one that had moved into my
rectal wall,” Turner told BuzzFeed News.

In 2007, her gynaecologist of four decades recommended a
“tissue fixation system” mesh device. Since its insertion,
she said she is $100,000 out of pocket as a result of
treatment costs and lost income. She has learnt to live with
constant pain and given up on romance.

“I am a single mum and I don’t have any relationships because
I can no longer have sex,” Turner said. “I do everything on
my own. I am limited going long distances travelling anymore.
I can’t walk around for more than half an hour maximum.”

For years she was told by doctors her health problems were
not linked to the mesh.

“I have pelvic pain, rectal pain, chronic fatigue, clinical
depression, joint pain generally all over, skin rashes,”
Turner said. “I have to wee standing up like a man to empty
my bladder.”

She can’t have an internal vaginal exam without going under a
general anaesthetic because it is so painful.

“I pretty much cry myself to sleep every night.”

The Facebook group has been validating for Turner.

“I realised I wasn’t imagining all of this, and talking to
other women reminds you that you’re not going mad,” she said.

“We meet up, but it is so hard not to get emotional.”

Turner told BuzzFeed News she had received legal advice that
it had been “too long” since her implant was inserted to
pursue legal action.

Jason Kempin / Getty Images

It is claimed the implants were not safe or fit for their
purpose and caused a range of complications including organ
perforation, pain, recurrent prolapse, recurrent stress
urinary incontinence and vaginal scarring.

None of the women interviewed for this article are involved
with that legal action.

Ethicon has faced legal action over its mesh products in
Canada (where there is an ongoing case over its hernia mesh implants) and
England (where 800 women are currently taking legal action
aginst both the National Health Service and Ethicon).

“Our priority is and always has been patient safety, and
pelvic mesh is backed by years of medical research,” an
Australian spokesperson for Johnson & Johnson told
BuzzFeed News.

The company “empathised” with patients suffering from these
conditions, she said, and their products had “helped millions
of women suffering from these conditions”.

“This is a complex court case. We are confident the evidence
will show that Ethicon acted responsibly and appropriately.”

In January 2016, Johnson & Johnson offered a settlement of US$120 million to more than
2,000 litigants in the United States.

Last month, a Philadelphia jury awarded $20 million to a
woman who claimed she was in constant pain because of her
Ethicon transvaginal mesh. A spokesperson for Ethicon said
the company would appeal the decision, but it was the fifth
major loss over the mesh products since 2014.

“Ethicon is vigorously defending litigation concerning the
use of our pelvic mesh products,” a Johnson & Johnson
spokesperson said this month. “We believe
the evidence shows the devices are safe.”

In Scotland, around 420 women are involved in civil
litigation against a different manufacturer of mesh
products, Endo.

Another 300 Australian women have
registered for a second class action against American
Medical Systems over 10 of its different mesh implants.

Gina Rushton is a breaking news reporter for BuzzFeed News
and is based in Sydney.

Contact Gina Rushton at gina.rushton@buzzfeed.com.


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