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Ethicon Media Monitoring 02/16/2017
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First Ethicon Hernia Mesh Trial Set for 2018
Feb 16, 2017 | DrugWatch
By Michelle Llamas
Ethicon will defend against claims that its hernia mesh caused serious injuries in a trial slated to begin in 2018, according to court documents. -
Derryn Hinch has won Senate approval for an inquiry into gynaecological mesh devices
Feb 16, 2017 | Newcastle Herald
By Joanne McCarthy
THE Senate will hold an inquiry into how gynaecological mesh devices that have left some women with catastrophic injuries were approved for sale in Australia.
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First Ethicon Hernia Mesh Trial Set for 2018
Feb 16, 2017 | DrugWatch
By Michelle Llamas
Ethicon will defend against claims that its hernia mesh caused serious injuries in a trial slated to begin in 2018, according to court documents.
The trial is the first Ethicon will face over its Physiomesh Flexible Composite Mesh. The plaintiff, Matthew Huff, was one of the first to file a lawsuit after Ethicon pulled the hernia mesh from the market in 2016.
According to the company, it stopped selling the product because of higher rates of hernia recurrence and re-operation compared to similar products. Ethicon issued a voluntary recall in Europe and other countries, but only a “market withdrawal” in the U.S.
Two years after Huff initially received the mesh in 2013, he developed severe pain, fever, chills and nausea. Huff went to the hospital where doctors found infection surrounding the implant.
Huff’s lawsuit claims he suffered abscesses and an intestinal fistula — a condition where organs abnormally fuse together — that required additional surgery to treat.Physiomesh ‘Unreasonably Dangerous’
Originally cleared for sale by the FDA in March 2010, Physiomesh is a flexible net-like mesh made of polypropylene plastic. The mesh has two layers of Monocryl, an absorbable material that protects against inflammation and adhesion.
Instead, lawsuits claim, the coating may lead to major complications.
“The product, Ethicon Physiomesh Composite Mesh, was defective, unreasonably dangerous, and not suitable for implantation in Matthew Huff,” the lawsuits states. “Huff has suffered severe and serious problems and complications…caused by the product.”
The judge initially scheduled Huff’s case for trial on July 31, 2017, according to court documents. But lawyers on both sides petitioned for more time because of “the complex issues in this case.”
Other plaintiffs have since filed suit against Ethicon claiming similar injuries linked to Physiomesh.Multiple Companies Face Hernia Mesh Lawsuits
Ethicon is not the only company that faces a growing number of hernia mesh lawsuits.
C.R. Bard faced thousands of injury claims linked to its Kugel Hernia Patch. Bard first recalled the patch in 2005 because it could cause bowel perforations and fistulas. The first lawsuits followed soon after.
In 2010, a jury ruled in favor of plaintiff Christopher Thorpe and found the Kugel Hernia Patch defective. The jury awarded Thorpe $1.5 million in damages.
In 2011, Bard agreed to settle 2,600 Kugel lawsuits for $184 million.
Maquet Getinge’s Atrium subsidiary also faces lawsuits linked to its Atrium C-QUR mesh line. Like Physiomesh, C-QUR is a coated mesh.
The polypropylene C-QUR mesh is coated in Omega 3 fatty acids (O3FA) fish oil. Atrium’s marketing materials claim the O3FA coating “has been shown to minimize tissue attachment to mesh.”
Instead, lawsuits and studies claim that the fish oil coating may cause inflammation and adhesions — thick scar tissue.
Trials have yet to be scheduled for the Atrium cases.
.https://www.drugwatch.com/2017/02/15/ethicon-hernia-mesh-trial-set/
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Derryn Hinch has won Senate approval for an inquiry into gynaecological mesh devices
Feb 16, 2017 | Newcastle Herald
By Joanne McCarthy
THE Senate will hold an inquiry into how gynaecological mesh devices that have left some women with catastrophic injuries were approved for sale in Australia.
The Senate voted for the inquiry on Wednesday after Senator Derryn Hinch compared the registration, in 2005, of transvaginal mesh devices for women experiencing prolapse after pregnancy and childbirth with the approval of morning sickness drug Thalidomide in the 1960s which caused birth defects in children.
The registration of mesh products was “one of the greatest medical scandals and abuses of mothers in Australia's history”, he said in a speech to Parliament in November during which he vowed that a Senate inquiry would be held.
“Once again the drug companies and the so-called watchdogs like the Therapeutic Goods Administration (TGA) are letting victims down,” Senator Hinch said 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.
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”.
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.
The inquiry will consider the Therapeutic Goods Administration’s role in investigating the suitability of the devices for use in Australia, on-going monitoring of the devices and knowledge of the number of women suffering negative impacts because of the mesh implants.
It will also consider the information provided to women before receiving the devices and what assistance there is to women experiencing severe injuries as a result of mesh.
The inquiry will report to the Senate in November.
http://www.theherald.com.au/story/4472081/senate-approves-inquiry-into-mesh-video/
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