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Ethicon Media Monitoring 5/11/2017
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Potential senate inquiry into prolapse mesh
May 11, 2017 | Starts at 60
Senator Derryn Hinch has backed calls for a senate inquiry into what he calls “one of the greatest medical scandals and abuses of mothers in Australia’s history.” -
‘Vaginal mesh implant has destroyed my life — it’s just so hard to go on’
May 11, 2017 | The Daily Telegraph
By Leesa Smith
STELLA Channing was a self-confessed gym junkie who really “loved life” and lived it to the absolute fullest. -
MY VAGINA HELL: Mum left in constant agony by dodgy ‘broken glass’ implant
May 10, 2017 | Daily Star
By Michael Havis
A SELF-described "gym junkie" has spoken of her agony after an implant left her feeling like she had broken glass in her vagina. -
Papantonio: Medical Hernia Mesh – A Health Disaster
May 10, 2017 | The Ring of Fire
Each year hundreds of thousands of hernia surgeries are performed in the United States and many years ago, a product came out to the market called the “Kugel Mesh Patch.” -
Appeals court upholds Boston Scientific win in pelvic mesh case
May 11, 2017 | Mass Device
By Brad Perriello
A federal appeals court yesterday upheld a win for Boston Scientific (NYSE:BSX) in a product liability lawsuit brought over its Uphold pelvic mesh.
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Potential senate inquiry into prolapse mesh
May 11, 2017 | Starts at 60
Senator Derryn Hinch has backed calls for a senate inquiry into what he calls “one of the greatest medical scandals and abuses of mothers in Australia’s history.”
The calls come from women who have been left with catastrophic injuries after being treated with mesh trans-vaginal implants for pelvic organ prolapse, a common condition in women who have given birth.
The Therapeutic Goods Administration approved the first of more than 40 different mesh devices for trans-vaginal surgery to treat prolapse in 2005, despite no scientific evidence of their safe use in prolapse cases and warnings dating back to 2003 of the need for controlled trials on mesh devices.
Victims of the devices, whom Hinch has said were “treated like mushrooms: kept in the dark and fed bullshit by doctors, hospital administrators, the drug companies and even the TGA” have emerged from across Australia to tell their stories of how the devices have destroyed their lives.
Perth mum Stella Channing told Sydney Morning Herald that the mesh used to treat her pelvic organ prolapse, in what she was told would be a simple proceed requiring an overnight stay in hospital has eroded inside her, trapping and scarring the pudendal nerves and leaving her in constant “unbearable” pain. She says that the surgery has “totally destroyed” her life, leaving her unable to work, walk properly, or even pick up her grandchildren.
There is only one surgeon, located in America where lawsuits against makers of the mesh abound, able to operate to rectify the injuries caused by the product.
The Project reported that state health complaint agencies refused to disclose the number of complaints received about the products, and the TGA has advised the Newcastle Herald that it “did not receive any material evidence to enable investigation of a manufacturer”, outraging Australian Pelvic Mesh Support Group founder Caz Chisholm.
https://startsat60.com/health/senate-inquiry-launched-into-prolapse-mesh
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‘Vaginal mesh implant has destroyed my life — it’s just so hard to go on’
May 11, 2017 | The Daily Telegraph
By Leesa Smith
STELLA Channing was a self-confessed gym junkie who really “loved life” and lived it to the absolute fullest.
Now the Perth mum-of-three is housebound and in constant excruciating pain in her vagina, rectum and legs after having a vaginal mesh implant to treat her post-childbirth prolapse.
But instead of helping her condition she has endured a living hell for the past almost six years, as the implant slowly disintegrates inside the once active 58-year-old.
“What is the point to my life? I just feel like I no longer add any value anywhere,” she tells Kidspot. “My future looks bleak.”
Removing the mesh is not an option as Stella says there’s no surgeon in Australia trained in the procedure.
“Only one doctor in America is trained to do a full removal but not only can I not sit for that long on a plane — I can’t even afford the airfare.”
What is a vaginal mesh implant?
The mesh is a hammock made from a plastic called polypropen. It has four hooks that are put into your hips to secure it to your bladder.
The idea is to help the pelvic floor muscles keep the internal organs in place, but more than 200 women have reported an “adverse event” to the Therapeutic Goods Administration as a result of the procedure.
In 2005, the TGA approved the use of pelvic mesh in Australia, but instead of trialling the product before making the decision, the Australian regulator simply followed the US’s approval in 2002.
The TGA later admitted the approval was “not mature” and “lacked rigour”, Fairfax reported.
‘The doctor told me it was low risk’
A month before Stella had her operation in 2011, the TGA issued a high risk warning about the Johnson & Johnson mesh kit that she has.
“But I only found this out after the operation. The doctor told me it was low risk,” she says.
The following year, Johnson & Johnson announced they would cease global supplies of meshes. However, other meshes are still being used.
More than 200 women have filed complaints
A federal Senate Inquiry is now gathering evidence into what Senator Derryn Hinch has described as “one of the greatest medical scandals and abuses of mothers in Australia’s history”.
The inquiry is looking into just how many women are suffering from the mesh implants.
One mother who appeared on The Project described the unbearable sensation as wearing a “steel tampon”.
A Facebook support group for mesh-injured women has grown to more than 700 members.
‘I knew something was wrong when I woke up’
Stella knew as soon as she woke up after the surgery that something wasn’t right.
“I asked them why I had holes in my buttocks — I was told I was just getting tape from my vagina to my rectum. I didn’t know I was going to have long arms like crochet hooks blindly going through my pelvic nerves.”
Stella’s mesh immediately started eroding but the surgeon had no solution to stop her bleeding and horrific pain.
The distraught mother compares the sensation to burning petrol and broken glass in both her vagina and rectum.
From a fun-filled life to loneliness
As Stella’s condition keeps worsening as time painfully ticks by — she eventually had to quit her job two years ago.
“I’ve gone from earning $80,000 a year to living on a disability pension,” she tells Kidspot.
Her life has gone from being very busy and fun to extremely isolating and pointless.
“I can no longer go out to socialise and people don’t know what to do when you are like this — so they just drift off,” she says.
“If I have to go grocery shopping I need to use a cane because I need to take the pressure off my pelvis as much as I can.”
Stella’s debilitating situation, which no amount of drugs helps to alleviate, has seen her spiral into a deep depression.
“I have thought about ending it but the only reason I haven’t is because of the impact it will have on my kids. I just couldn’t do that to them — especially my daughter who lives with me.”
‘If I cook a meal — I cry from the pain’
Michaela was just 16 when her mother had the operation and has seen her go from bad to worse.
“She wrote a victim impact statement saying that even when she goes out all she think about is her mum at home in pain.”
Stella was so much into fitness that just five months before the disastrous operation she completed her Certificate 4 in Personal Training.
Yet now she is in agony from just standing — let alone the short morning walk from her bed to the sofa.
“If I cook a meal — I’m crying the whole time that I’m making it from the pain.”
‘I live in distress and sadness — they are my overriding emotions’
An extremely proud grandmother of four beautiful boys — she hasn’t even been able to enjoy that precious time with her grandkids.
“I only see them about four times a year because I can barely hold them — let alone babysit them.”
At the time that I was talking to Stella — she was lying on her side on her bed.
“My rectum, vagina, buttocks and legs are burning and it’s got worse the more I have spoken to you,” she says.
“I live in distress and sadness — they are my overriding emotions.”
It is as this point that I wish Stella well and hang up the phone with a very heavy heart.
If you or anyone you know needs support please contact Lifeline.
http://www.dailytelegraph.com.au/lifestyle/parenting/vaginal-mesh-implant-has-destroyed-my-life-its-just-so-hard-to-go-on/news-story/c9a78c04bbbaf0c32689ab2d0108658d
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MY VAGINA HELL: Mum left in constant agony by dodgy ‘broken glass’ implant
May 10, 2017 | Daily Star
By Michael Havis
A SELF-described "gym junkie" has spoken of her agony after an implant left her feeling like she had broken glass in her vagina.
Stella Channing got a vaginal mesh implant to treat her post-childbirth prolapse – having been told it was "low risk".
But as soon as she woke up after surgery in 2011, the mum-of-three knew something was up with her implant.
It had immediately started eroding, but the surgeon had no way to ease her agony or to stop the bleeding.
Mrs Channing compares the sensation to burning petrol or broken glass in her vagina and her rectum.
The 58-year-old, from Perth, Australia, told the parenting website Kidspot of her pain.
"My rectum, vagina, buttocks and legs are burning and it’s got worse," she said.
"If I cook a meal — I’m crying from the pain the whole time I’m making it."
"Only one doctor in America is trained to do a full removal," Mrs Channing added.
"But not only can I not sit for that long on a plane — I can’t even afford the airfare."
The mesh is a plastic hammock with four hooks that lock onto the hip to secure it to the bladder.
But more than 200 Aussie women have filed complaints about them and a federal Senate Inquiry is now probing them.
For Stella, the agony was such that she had to quit her $80,000 (£45,000) job, sacrifice her social life and give up exercising.
"I no longer go out to socialise; people don’t know what to do when you are like this — so they drift off," she said.
"If I go grocery shopping I need to use a cane because I need to take pressure off my pelvis as much as I can."
In the UK, more than 800 women are taking legal action against the NHS over the implants, the NHS reports.
http://www.dailystar.co.uk/news/latest-news/613065/vagina-mesh-implant-pain-australia-surgery
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Papantonio: Medical Hernia Mesh – A Health Disaster
May 10, 2017 | The Ring of Fire
Each year hundreds of thousands of hernia surgeries are performed in the United States and many years ago, a product came out to the market called the “Kugel Mesh Patch.” That hernia patch was a horrific product that was made of a plastic chemical polymer and had a ring around the patch that would break and dislodge in a patient’s skin, abdomen, or intestines. America’s Lawyer Mike Papantonio talks about medical device companies that continue to produce experimental medical devices.
Transcript of the above video:
Electing to have surgery is not a decision that most people take lightly because they understand how risky any procedure can be. Medical errors are one of the leading causes of preventable deaths in the United States, and most of those occur on the surgical side. On top of that, there are complications that can arise from anesthesia, the possibility of infections, and even the amount of pain that patients have to suffer when they go through a surgical procedure. But in some cases, surgery is the only option, and that’s the case with most hernias.
Each year hundreds of thousands of hernia surgeries are performed in the United States. There are numerous types of hernias, but the two most common hernias are ventral hernias and inguinal hernias. A ventral hernia is a bulge that occurs at an abdominal wall muscle; and an inguinal hernia is a hernia near the groin.
Many years ago, a product came out to the market called the “Kugel Mesh Patch.” That hernia patch was a horrific product that was made of a plastic chemical polymer and had a ring around the patch that would break and dislodge in a patient’s skin, abdomen, or intestines. People suffered debilitating injuries and even died from this product. Turns out that was only the tip of the iceberg.Since the Kugel Mesh days, medical device companies have continued to produce devices that supposedly have “innovative” technologies in them that are nothing more than marketing ploys that involve little to no science and a whole lot of experimental medicine and marketing. Thanks to the FDA’s medical device clearance process, which is totally inadequate, these devices don’t have to be independently verified as to their safety. For example, a company called Atrium released a product called C-QUR mesh. The C-QUR mesh was a mesh patch that was coated with Omega 3 acids. Basically fish oil goo is the best way to describe it.
This “goo” causes severe reactions inside the human body and leads to infections, adhesions, and can even cause a person to die. On top of that – not only does the product employ a bogus design, but the company itself has been in trouble with the FDA for contamination issues surrounding the way it handles these products. Then, Ethicon, a subsidiary of Johnson & Johnson, that’s always in the news for defective products these days, they make a product called Physiomesh that uses a chemical coating on top of its mesh. This chemical coating was touted to doctors as something that would help surgical wounds heal better. Turns out that it did just the opposite. It caused healing problems and increased infections.
The problems got so bad that they issued an Urgent Field Safety Notice voluntary recall in May of 2016. The reason that the company issued this recall is because their mesh products were causing an array of problems, which included the mesh beginning to bind with other internal organs, or the mesh falling apart causing the hernia to reopen and the patient being forced to have corrective surgery. In fact, these negative side effects became so severe that a clinical study on the product was actually terminated early because it was so dangerous.
We cover stories like this every week on America’s Lawyer where we tell you stories that corporate media can’t tell you because their advertisers won’t allow them to do that. Follow me on “America’s Lawyer.”
https://trofire.com/2017/05/10/papantonio-medical-hernia-mesh-health-disaster/
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Appeals court upholds Boston Scientific win in pelvic mesh case
May 11, 2017 | Mass Device
By Brad Perriello
A federal appeals court yesterday upheld a win for Boston Scientific (NYSE:BSX) in a product liability lawsuit brought over its Uphold pelvic mesh.
Plaintiff Martha Carlson alleged that her injuries were caused by the Uphold product after its implantation in 2010 in a Charlotte hospital. But the U.S. District Court for Western North Carolina found in October 2016 that Carlson failed to prove that Boston Scientific “acted unreasonably in designing and/or formulating the Uphold device proximately causing Martha Carlson’s injuries,” according to court documents.
The court also found that Carlson failed to prove that the Marlborough, Mass.-based company breached the implied warranty of merchantability. To be “merchantable,” a product must reasonably meet buyers’ expectations. Carlson appealed the district court’s decision that she didn’t present enough evidence to back her failure to warn claim and a later move to reconsider that ruling.
The district court initially found that Carlson never introduced evidence to prove that her physician read or relied on the DFU containing the allegedly inadequate warning. When Carlson asked the district court to reconsider, she introduced new evidence showing that her doctor did in fact read the DFU, but the North Carolina court ruled that she couldn’t prove that the allegedly inadequate warnings caused her injuries.
Yesterday the U.S. Court of Appeals for the 4th Circuit unanimously backed the lower court, finding that Carlson failed to link the directions for use for Uphold to her injuries.
Citing Carlson’s affidavit that she never would have consented to using the Uphold mesh had she known the risks and deposition testimony from the doctor, Judge Stephanie Thacker wrote that Carlson “cited zero evidence establishing that either she or Dr. [Michael] Kennelly so much as read the allegedly inadequate warning in the DFU.”
“Appellant argues that we should consider this newly submitted evidence in reviewing not just the district court’s ruling on the motion for reconsideration but also the MDL court’s summary judgment ruling. In doing so, Appellant asks us to completely disregard the Federal Rules of Civil Procedure governing summary judgment motion practice,” Thacker wrote, according to court documents. “The Federal Rules of Civil Procedure require parties to cite all evidence in support of their positions at summary judgment, thus permitting a district court to limit its review to such cited materials. Clearly, then, we cannot say that the MDL court erred in its summary judgment ruling based on the evidence appellant cited in opposition to summary judgment. The responsibility to comb through the record in search of facts relevant to summary judgment falls on the parties – not the court. We therefore affirm the MDL court’s partial summary judgment award.”
The appeals court also backed the lower court’s ruling on Carlson’s motion for reconsideration,
“At oral argument, appellant’s counsel asserted that in light of this late revelation, the MDL court’s summary judgment award constituted clear error causing manifest injustice. Not so. We have consistently affirmed denials of motions to reconsider summary judgment rulings where the motion is merely a vessel for the very evidence that was initially lacking in opposition to summary judgment. Significantly, the entirety of Dr. Kennelly’s deposition testimony was available well before summary judgment briefing, and the additional portions of testimony appellant provided to the district court for ‘reconsideration’ thus did not amount to the type of evidence constituting grounds for a valid motion for reconsideration,” Thacker wrote.
http://www.massdevice.com/appeals-court-upholds-boston-scientific-win-pelvic-mesh-case/
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