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Ethicon Media Monitoring 02/03/2017
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Controversial implant approved by medicine watchdog accused of butchering Australian women
Feb 2, 2017 | Herald Sun
By Grant McArthur
A CONTROVERSIAL implant approved by Australia’s medicine watchdog is accused of butchering up to 4000 Australian women and leaving them in permanent pain. -
Derryn Hinch says he won't give up fighting for a Senate inquiry for women mesh victims
Feb 3, 2017 | Newcastle Hearld
By Joanne McCarthy
MESH products for women suffering birth complications, that were approved for sale without scientific evidence of their safety, have led to “one of the greatest medical scandals and abuses of mothers in Australia's history,” says Senator Derryn Hinch.
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Controversial implant approved by medicine watchdog accused of butchering Australian women
Feb 2, 2017 | Herald Sun
By Grant McArthur
A CONTROVERSIAL implant approved by Australia’s medicine watchdog is accused of butchering up to 4000 Australian women and leaving them in permanent pain.
A Federal Parliamentary inquiry is being considered to examine the safety of the mesh device and why it was approved by the Therapeutic Goods Administration without clinical testing.
A class action against pharmaceutical giant Johnson & Johnson will also see thousands of women seek hundreds of millions of dollars in compensation for disabilities allegedly caused by the dodgy surgical mesh. The Shine-led action could dwarf the $250 million settlement Johnson & Johnson paid out last year over its DePuy hip implant.
The mesh has been implanted in 100,000 Australian women since 2000 to overcome side effects of childbirth and urogynaecological issues. Medical reviews claim up to one in eight suffer complications.
Australia’s TGA still allows surgeons to implant the mesh despite bans, warnings and withdrawals in other countries and up to 100,000 pending lawsuits in the US.
Senator Derryn Hinch will next week push for a Senate inquiry into the use of the mesh and claims the TGA approved it without pre-market clinical testing.
“I believe this is the biggest medical scandal for Australian women since thalidomide in the 1950s and 1960s, when kids were born without arms and legs,” he said. “It has to be halted until it is proven safe because there are too many cases where this is crippling people for life.”
The inquiry would have power to subpoena witnesses from the TGA, manufacturers and surgeons and hear from women who claim to have been left with permanent injuries and disabilities caused by the mesh breaking, moving or dissolving into their bodies and damaging internal organs.
The TGA began monitoring the mesh’s use in 2008 as concerns emerged, but ruled complications were low and linked to surgeon skills rather than faulty devices.
After a warning by the US’s Food and Drug Administration and the withdrawal of products by Johnson & Johnson in 2012, the TGA launched a more extensive clinical review in 2013 of about 100 devices in Australia. All but 23 were delisted between August 2014 and November 2015.
“The TGA has implemented increased pre-market scrutiny for all applications for these devices,” it said in a statement when contacted by the Herald Sun. “All new applications for these devices will be selected for an application audit, and the audits will include assessment of the clinical evidence.”
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists has issued a statement warning against the polypropylene mesh’s use for pelvic prolapse due to insufficient testing and concerns of devastating complications, but believes it is safe to treat continence conditions.
Shine class action lawyer Jan Sadler said when the Federal Court case began in July, it would be alleged the products were unsafe and not fit for the purposes they were marketed for.
“The true tragedy of this product is that you can’t operate to get it out,” she said.
Johnson & Johnson’s Meshlin Khouri said the company was concerned by any patient experiencing an adverse medical event but maintained its mesh products were safe and backed by research.
http://www.heraldsun.com.au/news/victoria/controversial-implant-approved-by-medicine-watchdog-accused-of-butchering-australian-women/news-story/e764087cf7b2fd27a963cbf11d84331a
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Derryn Hinch says he won't give up fighting for a Senate inquiry for women mesh victims
Feb 3, 2017 | Newcastle Hearld
By Joanne McCarthy
MESH products for women suffering birth complications, that were approved for sale without scientific evidence of their safety, have led to “one of the greatest medical scandals and abuses of mothers in Australia's history,” says Senator Derryn Hinch.
He has backed mesh victims’ call for a Senate inquiry after comparing the release of mesh products from 2005 to the sale of Thalidomide in the 1960s that left children born with severe physical disabilities.
“Once again the drug companies and the so-called watchdogs like the Therapeutic Goods Administration (TGA) are letting victims down,” Senator Hinch said in a speech to Federal Parliament in November after meeting with women who suffered catastrophic injuries after they were implanted with transvaginal mesh products.
The women – some from the Hunter – were treated for prolapse after birth or pregnancy, and then “treated like mushrooms: kept in the dark and fed bullshit by doctors, hospital administrators, the drug companies and even the TGA”, he said.
The TGA approved the first of more than 40 different mesh devices for transvaginal (through the vagina) surgery to treat prolapse in 2005. It approved the devices despite no evidence of their safe use in prolapse cases and clear warnings in 2003 of the need for controlled trials on related mesh devices.
Eleven years later, in a letter to a patient advocate in 2014, the TGA conceded its assessment process for mesh devices had not been “mature” and lacked “rigour”. The letter coincided with belated TGA action requiring clinical evidence from manufacturers of the safety and efficacy of transvaginal mesh devices.
Senator Hinch’s office is collecting details of women who have suffered mesh injuries after the Federal Government queried the extent of the mesh problem, after telling Parliament he would “not let it rest” until a Senate inquiry was called.
The Australian Commission on Safety and Quality in Healthcare – established by the federal and state governments – held the first of four meetings with mesh victims in Brisbane in January, with further meetings planned for Perth, Sydney and Melbourne.
Gai Thompson, who received a mesh implant in 2008 and suffered serious complications, said she was grateful for Senator Hinch’s support.
In a report to the TGA in 2011 she said she could no longer have sex and her life after February, 2008 had become “a living nightmare”.
The report noted multiple urinary tract infections leaving her resistant to some antibiotics, chronic and severe pelvic pain, chronic bowel problems, incontinence, multiple areas where the mesh had eroded into her vagina, and that she was unable to stand for any length of time, suffered constant fatigue and stress, and had needed successive surgeries and treatments.
“For all this time we’ve been told we’re just the unfortunate ones we were warned about – the 0.01 per cent of cases that don’t go well. But there’s a lot of women who aren’t getting help,” Mrs Thompson said.
“It’s not just that this has happened. You’re shamed by it as well because of what it is. Talking about surgery in that part of a woman’s body, and what can happen when things go wrong, is not something people want to talk about,” she said.
“If it’s a hip issue where the TGA approved something without evidence, that seems to be settled far more quickly. But this has gone on for years and years.”
Women are asked to contact Senator Hinch’s office by emailing carly.gibbs@aph.gov.au
For details on the Australian Commission on Safety and Quality in Healthcare phone (02) 9126 3600 or email mail@safetyandquality.gov.au
http://www.theherald.com.au/story/4443127/hinch-backs-women-victims-of-medical-scandalphotos-video/?cs=12
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