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Ethicon Media Monitoring 1/17/2019
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Doctors accused of ‘gaslighting’ Scottish mesh victims
Jan 17, 2019 | The Scotsman
By Kevan Christie
Scots campaigners have accused specialist surgeons in the US of “gaslighting” victims of mesh implant surgery by sending a signed letter arguing lawsuits by four states against product manufacturers are wrong. -
What’s Added to Hernia and Pelvic Polypropylene Mesh?
Jan 16, 2019 | Legal Examiner
By Jane Akre
Hernia mesh is made of polypropylene (PP), a cheap polymer that comes from the petroleum industry. -
Women Suffer Depression and Self-Harm from Mesh Implants, Study Finds
Jan 16, 2019 | Mesh Medical Device News Desk
By Jane Akre
It may not come as a surprise to the many readers of Mesh News Desk (MND) who have been implanted with a polypropylene surgical mesh to treat incontinence and prolapse, but many women suffer complications and depression as a result. -
Hundreds keen to share experiences of surgical mesh misery
Jan 17, 2019 | New Zealand Doctor Online
By Keira Stephenson
...The volume of surgical mesh sold for stress urinary incontinence and pelvic organ prolapse has declined in the past three years - likely due to public attention on...
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Doctors accused of ‘gaslighting’ Scottish mesh victims
Jan 17, 2019 | The Scotsman
By Kevan Christie
Scots campaigners have accused specialist surgeons in the US of “gaslighting” victims of mesh implant surgery by sending a signed letter arguing lawsuits by four states against product manufacturers are wrong.
The term which is used to describe a person who psychologically abuses another by questioning their sanity was used by the Scottish Mesh Survivors group who are looking to bring the manufacturers of mesh implants to account. More than 20,000 women in Scotland have had the implants in the past 20 years but some have suffered painful and debilitating complications.
Eileen Baxter, 75, from Loanhead, Midlothian, was the first woman in Scotland to have sacrocolopexy mesh repair – an implant to fix a pelvic organ prolapse – listed as an underlying cause of death when she passed away last August.
Her son Mark Baxter said: “I don’t think enough has been done into the dangers of mesh implants – I think the doctors have been ignorant as to the potential effects. We’ve had no updates around my mother’s case and there’s unanswered questions.”
Tens of thousands of women in the US are suing device makers Johnson & Johnson and its Ethicon Inc. subsidiary through consumer-protection lawsuits by four states including Washington and California.
Patients say they knew nothing about the potential complications – that have led to permanent pelvic pain, left some incontinent and ruined their ability to work.
Those who have filed lawsuits accuse the mesh manufacturers of duping doctors into performing and recommending operations that could not be reversed and had clear risks.
However, 63 specialist surgeons from Washington last week signed a letter to the state Attorney General arguing the lawsuits were wrong and that they were never deceived and the case is based on a misconception about how dangers posed by medical procedures are assessed.
Elaine Holmes, from Scottish Mesh Survivors, said: “This is merely gaslighting mesh victims.
“The mesh industry is worth billions to manufacturers and they have spent the last two decades doing all they can to protect that lucrative business despite worldwide concern over the numbers of injured women.”
Neil Findlay MSP said: “Mesh is one of the greatest health care scandals of our times and its victims deserve transparency and justice. Mesh manufacturers have damaged lives not just in the US but across the world.”
https://www.scotsman.com/news/doctors-accused-of-gaslighting-scottish-mesh-victims-1-4857704
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What’s Added to Hernia and Pelvic Polypropylene Mesh?
Jan 16, 2019 | Legal Examiner
By Jane Akre
Hernia mesh is made of polypropylene (PP), a cheap polymer that comes from the petroleum industry.
At least one trial gave us a closer look at how that polymer is treated before it is made into a permanent medical device – surgical mesh – used for hernia repair and for prolapse and incontinence implantable mesh treatments in women.
In the 2014 trial of Huskey v Ethicon (2:12-cv-05201), a pelvic mesh case filed in the Southern District of West Virginia, a chemical scientist told jurors that Prolene is treated with Procol LA-10, a lubricant to promote tissue passage and reduce tissue drag. Santonox R is an added antioxidant that protects the PP from thermal oxidation during the making of the mesh threads.
Another added lubricant is Calcium Stearate. DL TDP is an added as an antioxidant to improve the long-term storage of the resin.
To complete the sterilization process, the mesh is exposed to ethylene oxide (EtO) gas, considered by the Environmental Protection Agency to be a carcinogen.
Any chemical used by U.S. workers is required by OSHA (the Occupational Health and Safety Administration) to be accompanied by a Material Safety Data Sheet (MSDS). That lets the plant understand how to protect workers who come in contact with the chemical.
The MSDS for PP resin for Marlex, a Phillips Petroleum polypropylene, clearly says:
“Do not use this Phillips Sumika Polypropylene Company material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Phillips Sumika Polypropylene Company or under an agreement which expressly acknowledges the contemplated use.”
Lawyers for Phillips Sumika might craft such language to protect the company from any liability associated with complications that might arise from the medical devices made from its proprietary polypropylene.
Note* implanted surgical mesh, whether for hernia or pelvic repair, is not a temporary or brief fix. It is a permanently implanted medical device!
Once implanted polypropylene undergoes a degradation process. Oxidation is incited by the inflammatory process which begins as the body reacts to the presence of the implant and presumably whatever the polypropylene has been treated with and the bodily fluids and tissues nearby.
Since surgical mesh is approved using the Food and Drug Administration’s 510(k) clearance process, there was never any requirement to find out how this smorgasbord of chemicals reacts once implanted forever in the body.
Unfortunately, we are finding this out through the adverse event reports of complications called into the FDA.
https://herniamesh.legalexaminer.com/health/medical-devices-implants/whats-added-to-hernia-and-pelvic-polypropylene-mesh/
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Women Suffer Depression and Self-Harm from Mesh Implants, Study Finds
Jan 16, 2019 | Mesh Medical Device News Desk
By Jane Akre
It may not come as a surprise to the many readers of Mesh News Desk (MND) who have been implanted with a polypropylene surgical mesh to treat incontinence and prolapse, but many women suffer complications and depression as a result.
A new study from Canada reports women with complications from a mid-urethral mesh sling (MUS) procedure have an elevated risk of new onset depression and thoughts of suicide when compared to women who do not have complications.
Image: Pain by Jade R
The MUS remains the standard treatment for stress incontinence (SUI), used in about 90% of procedures. Doctors still have no way to determine who will suffer from a complication, thought to range from 3 to 30 percent.
The MUS can be placed transvaginally through the retropublic space or the obturator space. The latter is thought to present an increase in complication rates.
THE STUDY
This large study of 57,611 women was conducted by researchers from Western University Department of Surgery in London, Ontario, the Department of Epidemiology and University of Edmonton. Dr. Blayne Welk, MD, a urologist at Western University, is the lead researcher.
The study is published in the January 9, 2019 Journal of the American Medical Association (JAMA).
Dr. Welk told The Star that while the vast majority of women do quite well after surgery, those who do have complications face a challenge.
“They can be serious and they can be life-changing in some cases.”
Altogether the 57,611 women received a mid-urethral sling from 2004 to 2015. Among this group, nearly 1,586 needed to undergo surgical revisions or removal due to complications.
Those who had to undergo a surgical correction had a significant – 21% – increased risk of depression.
Women under the age of 46 had a 38% increased risk of depression.
Interestingly, for women older than 66, researchers found no significant difference in depression risk and had no greater risk of self-harm or suicide while younger patients, 46 to 66, had a 2.4 greater risk of self-harm. Patients under the age of 46 had a 1.7 fold increased risk of self harm behavior such as attempted suicide that led to an emergency room visit or admission to a psychiatric hospital.
Polypropylene vaginal mesh can affect sexual intimacy and make sex painful.
Welk told The Star “The big challenge with these complications is that in some cases they can be very hard to correct completely, and then the second thing is there’s an element of decisional regret for a lot of women who have these procedures done. I’ve seen a lot of patients referred with complications and a lot of them, they were quite emotional about it and described a long journey trying to find someone to evaluate them and help them with the complications.”
Another study Dr. Welk led in 2015 found that over a ten year period of time, about three percent of Ontario women needed a corrective surgery, either a revision or removal.
STILL BEING USED
Many readers of Mesh News Desk have told us they were not told about the mesh complication rate, had no true informed consent, and in some cases did not even know they were having mesh implanted. After reporting a complication, some women are turned away from their implanting doctor, essentially fired, or told the pain is in their head.
Dr. Welk agrees, women need support from doctors who need to better recognize mesh injuries.
“I think this sort of reinforces the message that we need to make sure women do have timely and appropriate evaluation for complications if they do occur and that people keep in mind that they might need support for psychiatric illness that may be occurring at the same time.”
British Columbia resident Noni Wideman is a mesh implant survivor who is very familiar with the emotional trauma over mesh. In her LinksonMesh Facebook page she discusses the emerging science about the body’s reaction to polypropylene and takes to social media to share in the mesh injured community.
She tells MND, she feels let down by the study.
“I was dismayed that he failed to consider the depression and suicidal thoughts of women suffering painful, crippling life-altering and threatening complications who have not had their mesh complications accurately diagnosed and not found skilled mesh removal specialists to remove their mesh. Pre-mesh removal surgery, when hope and help are not offered, is more frightening, more depressing than when mesh removal surgeries have been done.”
“Post-surgery there is always hope for healing. Without skilled intervention and validation of pain and sickness, without mesh removal offered to them, the women I have talked to are voicing suicidal idealizations more than those who have had surgeries and mesh pain isn’t as complete as the women expected or hoped for. The study failed to tell the whole story. the study failed to encompass the women waiting for validation, waiting for mesh removal approvals with verified skilled surgeons.”
With the news about lawsuits and settlements, women are increasingly having doubts about using a mid-urethral mesh sling (MUS) as an incontinence treatment. Some doctors soften the pitch for a mesh medical device by telling women it is a “new” mesh. It is still made of polypropylene as it always has been with some variation in pore size in some cases.
Women continue to be implanted.
https://www.meshmedicaldevicenewsdesk.com/women-suffer-depression-and-self-harm-from-mesh-implants-study-finds/
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Hundreds keen to share experiences of surgical mesh misery
Jan 17, 2019 | New Zealand Doctor Online
By Keira Stephenson
...The volume of surgical mesh sold for stress urinary incontinence and pelvic organ prolapse has declined in the past three years - likely due to public attention on ...
Access to full text unavailable – subscription required.
Story can be found here: https://www.nzdoctor.co.nz/article/news/hundreds-keen-share-experiences-surgical-mesh-misery
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