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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."
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.