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Ethicon Media Monitoring 8/01/2017
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A Melbourne Senate inquiry public hearing into pelvic mesh has a curtain-raiser
Aug 1, 2017 | Newcastle Herald
By Joanne McCarthy
AUSTRALIA’S peak medical device regulator could reclassify all pelvic mesh devices as high risk after a decision by the European Commission, and following damning inquiries and investigations in England, Scotland and other European centres. -
Meeting takes place at Westminster into damage caused by 'mesh implants'
Jul 29, 2017 | The Glamorgan GEM
A Barry woman attended a special meeting in Westminster which addressed the serious damage that has been caused by medical ‘mesh implants’. -
Ethicon Physiomesh MDL Gets Underway with First Status Conference
Aug 1, 2017 | The Legal Examiner
By Roopal Luhana
On June 2, 2017, the U.S. Judicial Panel for Multidistrict Litigation (JPML) consolidated all federally filed Ethicon Physiomesh lawsuits into one court in the Northern District of Georgia. District Court Judge Richard W. Story was appointed to oversee the pre-trial proceedings.
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A Melbourne Senate inquiry public hearing into pelvic mesh has a curtain-raiser
Aug 1, 2017 | Newcastle Herald
By Joanne McCarthy
AUSTRALIA’S peak medical device regulator could reclassify all pelvic mesh devices as high risk after a decision by the European Commission, and following damning inquiries and investigations in England, Scotland and other European centres.
The Australian move comes only three days before a Senate inquiry public hearing in Melbourne into how pelvic mesh devices were cleared for use in Australia and implanted in women without evidence of safety and efficacy, and nearly four years after the regulator, the Therapeutic Goods Administration, rejected a reclassification proposal.
In October, 2013 the TGA advised an internal working group which recommended making all mesh devices “high risk” that there was “insufficient evidence to support a change in classification”.
“The data isn’t robust enough to determine if there’s a significant problem with the actual devices or whether there are problems in particular patient groups or if the problems are as result of the manner in which the devices are being used in some circumstances,” said working group notes, obtained under freedom of information legislation.
In a statement on Monday the TGA said it was considering “up-classifying” all surgical mesh medical devices, including gynaecological mesh devices for incontinence and prolapse treatment, from IIb (medium to high risk) to class III (high risk).
The move would include stress urinary incontinence mesh devices regarded as “gold standard” by regulators, medical colleges and specialists’ groups. The TGA is also considering requiring device manufacturers to provide patient implant cards and consumer information for all implantable medical devices.
The working group minutes show the TGA rejected a patient card proposal, with a registry run by the TGA, after it was raised by the internal working group in October, 2013. The TGA said the move was “not possible as it is not within the TGA’s legislative bounds to establish (quasi) product registries”.
The working group was told the TGA’s American equivalent, the Food and Drug Administration, had mandated an active implantable device register 20 years earlier.
On Monday the TGA said the proposed moves follow an expert review of medical device regulations in September, 2016 which recommended the Australian regulatory medical device framework align itself with the European Commission.
The TGA has called on consumers and the health industry to comment on the proposals, with a deadline of August 25 when the Senate inquiry into mesh holds a second public hearing in Perth. The inquiry was called after a campaign by pelvic mesh survivors and the Newcastle Herald.
http://www.theherald.com.au/story/4824047/plan-to-make-all-meshes-high-risk/
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Meeting takes place at Westminster into damage caused by 'mesh implants'
Jul 29, 2017 | The Glamorgan GEM
A Barry woman attended a special meeting in Westminster which addressed the serious damage that has been caused by medical ‘mesh implants’.
Some women who have received the treatment suffered serious health problems and endured bouts of depression.
Mesh implants have been inserted into women suffering from health problems such as incontinence, or prolapse caused by childbirth or hernias. Men can also receive the implants.
Mrs Pauline Inch attended a parliamentary meeting at Westminster on July 18 hosted by Owen Smith the MP for Pontypridd which was addressed by leading gynaecologists, urologists, and ‘Sling the Mesh’ campaigner Kath Sansom.
Pauline, who knows of sufferers in Barry and Bridgend, told The GEM: “The meeting in Parliament was chaired by Owen Smith and there was a panel of eminent surgeons.
“It was well attended by over 120 women from all over the country who had suffered from an implant at some time in their lives.
“We heard that incidents had been under-reported because staff were worried how it would reflect on them.
“We also heard that the old way of surgery had very little failures compared to the mesh method, but the mesh was deemed cheaper and more cost effective.
“Even that has not been really true because of the additional cost of medication to help the patient through the painful life that they have to endure afterwards.”
Alternatives treatments can include using ‘bulking agents’ such as collagen, pessaries or tissue grafts.
Pauline said that during the meeting, some of the women were able to recount stories about how devastated their lives had been following treatment.
She said: “The women were allowed to voice their feelings, and for two hours we listened to the torture that these ladies had to endure.
“The stories told at that meeting left most in the room with tears in their eyes, men in the room openly crying while listening to the ordeals of some women."
Pauline says she suffers horrendous pain. “The top of my legs hurt, my groin feels as if it has barbed wire in there, and it’s as if someone’s put a hatchet in my lower back.”
When she spoke to one surgeon about removing her mesh, he told her: “There’s nothing that can be done. No surgeon would come near you.”
The problem is too complex. Pauline’s mesh is now embedded in parts of her body.
She said she wanted to thank local Assembly Member Jane Hutt for her support over the last 17 years.
Prior to the meeting, Owen Smith MP said: “In seven years of being an MP, this is one of the worst medical issues I have come across.
“I was first contacted by a constituent suffering from chronic pain as a result of the procedure, and since getting in touch with the Sling the Mesh campaign I have been contacted by countless women who have shared their devastating stories following mesh surgery.
“It is my hope that the Government will take action to address this growing issue and immediately review mesh treatment.”
http://www.glamorgan-gem.co.uk/article.cfm?id=114988&headline=Meeting%20takes%20place%20at%20Westminster%20into%20damage%20caused%20by%20%27mesh%20implants%27§ionIs=news&searchyear=2017
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Ethicon Physiomesh MDL Gets Underway with First Status Conference
Aug 1, 2017 | The Legal Examiner
By Roopal Luhana
⦁ Roopal Luhan is an attorney with Chaffin Luhana LLP
On June 2, 2017, the U.S. Judicial Panel for Multidistrict Litigation (JPML) consolidated all federally filed Ethicon Physiomesh lawsuits into one court in the Northern District of Georgia. District Court Judge Richard W. Story was appointed to oversee the pre-trial proceedings.
The Judge has scheduled an initial case management conference for August 1, 2017. In a June 21, 2017, court order, the judge outlined the agenda for the conference and provided guidance for how the parties should prepare.Judge Gets the Ball Rolling on Ethicon Physiomesh MDL
The plaintiffs involved in this consolidated litigation have similar claims about Ethicon’s Physiomesh, namely, that they were implanted with the device and then experienced serious injuries. These include complications like pain, bleeding, infections, mesh migration, nerve damage, recurring hernias, among others, many requiring at least one if not more revision surgeries.
There are currently about 70 cases pending in Georgia, with more expected to be filed in the coming months. At the first status conference, the parties are expected to suggest ways that the litigation can proceed in a just, speedy, and inexpensive manner. They have also been instructed to confer prior to the conference to seek consensus on agenda items, such as a proposed discovery plan and a suggested schedule for joinder of parties, amendment of pleadings, and consideration of any class action allegations, motions, and trial.
The judge also directed counsel to submit a written statement, by July 25, 2017, indicating their preliminary understanding of the facts involved in the litigation, and the critical factual and legal issues. All outstanding disclosure and discovery proceedings have been stayed until the status conference.Ethicon Recalls Physiomesh in May 2016
The Ethicon Physiomesh is a small medical device used in the repair of ventral (abdominal) hernias. Doctors use the mesh to help “patch up” weakened and bulging tissues and to stabilize them for long-term repair. The mesh is supposed to help make the procedure easier and the hernia repair more stable, but reports have indicated that instead, it has caused a number of problems.
On May 25, 2016, Ethicon released an urgent field safety notice alerting hospitals, surgeons, and medical center personnel worldwide to stop using Physiomesh. The reason cited was that recurrence and reoperation rates after laparoscopic hernia repair using Physiomesh were “higher than the average rates of the comparator set of meshes among patients in these registries.”
Doctors noticed more recurrence rates than usual with this product, and more patients had to go through additional surgeries to fix the problems.
Ethicon released the product on the market in 2010. It advertised the product as being of superior design, with materials that were supposed to help reduce risk of inflammation and infection and increase incorporation into the body’s own tissues. Plaintiffs have stated in their complaints, however, that the mesh promotes infection and inflammation, as well as pockets of fluid, and leads to improper healing, scar formation, and abscess formation.
Several studies have supported plaintiffs’ claims. In a 2016 study, for example, researchers compared two different types of mesh used for hernia repair: Physiomesh and Ventralight ST mesh. They found that Physiomesh resulted in more recurrences of the hernias than the other mesh, and that it caused a significantly higher pain rate after three months.
http://newyork.legalexaminer.com/medical-devices-implants/ethicon-physiomesh-mdl-gets-underway-with-first-status-conference/
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