ABC News 7.30 Australia
Click on the link and watch this short news video. It is essential to understanding the story below.
10/15/2012 By Matt Wordsworth ABC News 7.30 Australia (FiDA highlight added.)
Medical giant Johnson & Johnson is facing its third
class action in Australia in as many years.
The case filed in the Federal Court yesterday relates to
a product called transvaginal mesh.
It has helped many women who have suffered prolapsed
organs by assisting their muscles with support, but for a significant number it has caused
life-changing harm.
Lawyers believe
it could be the largest product class action in Australian legal history.
It has also cast fresh light on the system of approvals
because the mesh was
introduced without any pre-market testing, with surgeons leading the
call for change.
When Julie Davis was younger she had a plan to travel
the world, meet the man of her dreams and settle down to have a family.
She succeeded, but along the way she endured a traumatic
birth and some terrible consequences.
"I'd had a very bad forceps delivery with my first
child who's now 10 and I had to wait until all my children were born to fix a
very significant bladder prolapse," Ms Davis said.
"From my understanding it was the worst kind of
prolapse because the bladder was actually outside my body."
It is a common problem, but there was a relatively new
product to Australia - transvaginal mesh - that could be stitched in near the
top of the vagina to help the pelvic floor muscles support the internal organs,
much like a sling.
"The surgery
itself was way more traumatic and devastating than I had imagined," Ms
Davis said.
"I just felt unwell all the time, I was in pain, a
lot pain, discomfort down below. I also had this feeling - lack of energy, like
my body was fighting something all the time."
While her husband shouldered the load of earning an
income and running the household, Julie, who was only in her 40s, was forced to
use a mobility scooter.
For her, walking was painful, so too was sex, and the
emotional toll was almost too much.
"It did get to the point where I just actually was
chronically depressed and I had to go to see a GP and go on
antidepressants," she said.
"There was one point [when] I was driving my car
and I was just thinking, 'jeez, it would be easy just to turn the wheel at Curl
Curl headland and just go off' because I felt that desperate."
'Adverse events'
It was after this that Ms Davis sought out a new
surgeon, urogynaecologist Richard Reid.
He says the mesh was acting like a cheese grater in her
body and had literally rubbed a hole in the wall of her vagina.
"When the mesh is put underneath the bladder, the
bladder moves back and forth as it fills and it moves back and forth during
intercourse," Dr Reid said.
"Because
mesh scar is fundamentally quite fibrous and the bladder is very soft, we call
this compliance mismatch, which means the same as rubbing a piece of cheese
over a metal grater; the metal grater is obviously harder than the
cheese."
Research published last May in the New England Journal
of Medicine found mesh kits had "higher short-term rates of successful
treatment" but also "higher rates of surgical complications and
post-operative adverse events".
Two months later, in July 2011, the Food and Drug
Administration (FDA) in the United States issued a formal warning saying they
were a "greater risk" with "no evidence of greater clinical
benefit".
Johnson & Johnson
removed its product from sale earlier this year and class actions are already underway in America and
Canada, and now Australia.
Rebecca Jancauskas, who is representing Ms Davis as the
lead plaintiff in the class action, estimates as many as 20,000 Australian women may have had
transvaginal mesh implanted, and that is despite the product having undergone
no clinical trials.
"This prolapse mesh class action that we've
commenced in the Federal Court today has the potential to be the biggest
product class action that Australia has ever seen," Ms Jancauskas said.
Certain classes of medical devices may be sold without
adequate testing if they are going to be used in a similar way to existing
products.
Mesh kits had already been very successful in treating
urinary incontinence, an area where there is not the same friction from
internal organs.
"So the system was set up and the device companies
have used the system," Dr Reid said.
"I think that with the wisdom of hindsight, it
would have been more prudent for them to have done more testing before it was
released, but in many I see the primary fault is the system didn't think out
what was going to happen."
Previous class action
It is not the
first legal trouble for Johnson & Johnson in Australia.
Last year a class action was launched over its DePuy hip replacement device
which left hundreds of patients poisoned and seriously disabled.
In 2010 the company faced similar legal proceedings over its knee replacement
products.
Just like the mesh kits, neither product had undergone
pre-market clinical trials.
"Given that this is now the third product class
action that Johnson & Johnson has faced in three years, it should raise
some serious concerns about their product safety standards," Ms Jancauskas
said.
The company has issued a statement saying:
Johnson
& Johnson Medical continues to have confidence in the safety and efficacy
of these products.
The decision to discontinue these
products was based on their commercial viability in light of changing market
dynamics, and is not related to safety or efficacy.
This is not a product recall, and based on this notification it is not necessary for women
who have received one of these products to take any action.
For more than a decade, our
organisation has invested in the research, development and clinical study of
products to treat a wide range of pelvic disorders.
We remain committed to advancing
the standard of care for women's health and will continue to offer safe and
effective treatment options for women.
Some are angry at the Australian regulator, the
Therapeutic Goods Administration (TGA).
Senator Nick Xenophon, who was part of a parliamentary
inquiry into the hip devices, says he is concerned that similar problems are
still happening.
"Well this is another instance of regulatory
failure. The TGA is meant to be a watchdog of these devices but it's failed
time and time again," Senator Xenophon said.
"This is the third serious instance in the last 12
months. After the problems with hip replacements, breast implants and now this,
[it] indicates there are some serious systemic problems with the TGA."
And while America's FDA issued its warning to consumers
last year, there has been no such move from the TGA.
In a statement, it
explained that it held a detailed review in 2010 and found the complication rate was low and depended on the
skill of the surgeon, but that it would continue to monitor the situation.
Ms Davis says "it's been a tough road" and she
has now had her mesh surgically removed.
She and husband Tim are desperately hoping that after
four years and five surgeries, there is something to look forward to.
"I hope that we're over the hill now and start
rebuilding our lives again in the way that we planned to begin with," Mr
Davis said.
"We had great plans and great ideas of how we wanted to
build our life, with the children et cetera, and I feel that life has been
running away from us and we haven't been able to sit back and enjoy some of
it."
Statement from the TGA in response to ABC News 7.30 (Australia) - go to link above, please.
