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Ethicon Media Monitoring 1/28/2019
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BBC News Reports on Influential Mesh Doctor and the Conflicts He Failed to Disclose
Jan 27, 2019 | Mesh Medical Device News Desk
By Jane Akre
The BBC reports on a doctor who blew the whistle on an influential Scottish gynecologist for failing to disclose financial conflicts of interest. -
A Wee Miracle? The Chair That Claims To Zap Your Pelvic Floor Back Into Shape
Jan 25, 2019 | Ten Daily
By Natasha Lee
Pelvic floor dysfunction is one of the most common issues affecting new mothers and, apparently, there's a new treatment where sufferers just sit while it does its thing.
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BBC News Reports on Influential Mesh Doctor and the Conflicts He Failed to Disclose
Jan 27, 2019 | Mesh Medical Device News Desk
By Jane Akre
The BBC reports on a doctor who blew the whistle on an influential Scottish gynecologist for failing to disclose financial conflicts of interest.
This story comes from Lucy Adams, a BBC Scotland reporter. She profiled Aberdeen University’s Professor Mohamed Abdel-fattah who, seven years ago, authored an influential research paper promoting TVT-O (transobturator) mesh as a treatment for incontinence.
The professor has now corrected that research paper after a whistleblower outed him as failing to declare $130,856 (US dollars) in funding from mesh maker Colpoplast. Funded by Coloplast, the study concluded there were no complications three years after TVT-O surgery.
Profesor Abdel-fattah is the Clinical Chair in Gynaecology at the University of Aberdeen who says the information about the research grant he received was “inadvertently omitted” from the original disclosure.
Coloplast was the manufacturer of the transobturator mesh, so named because it passes through the obturator space.
At the time it was the most commonly performed bladder surgery in Scotland, reports Adams, and it is also used in England. It has been found to be defectively designed in several U.S. product liability trials.
It’s estimated more than 100,000 women in the UK (20,000 in Scotland) had a polypropylene mesh implant. At the present time more than 800 women are suing the National Health Service and mesh maker, reports the BBC.
Researcher and gynecologist, Dr. Wael Agur, MD made the complaint of misconduct to the GMC, General Medical Council, citing that the study at the time was “highly influential” and has reassured the public and doctors that the use of mesh is safe.
“The women trusted us to do the right thing and we thought at the time that we were doing the right thing.”
Dr. Agur has worked with Scottish Mesh Survivors to have the procedure and products overturned in Scotland.
The Death of Eileen Baxter Ties to Mesh
In Scotland the government called for an immediate halt to the use of mesh until a new “restricted use protocol” is established after mesh was cited as contributing to the death of a Scottish woman, Eileen Baxter.
Baxter, 75, died last August in Edinburgh hospital of multiple organ failure, and an anterior rectal perforation and possibly sepsis after a sacrocolpopexy mesh repair, which was named as an underlying factor.
Her health had reportedly declined after the procedure five years earlier.
Sacrocolpopexy uses polypropylene mesh to attach the pelvic organs to bone to return the organs to their original position. Additional mesh is sometimes used and placed transvaginally, to position the bladder and the rectum. See more on Victoria Derbyshire here.
However, unlike most transvaginal mesh placements, a sacrocolpopexy mesh is implanted through the abdomen. It is still being used in both countries as well as the U.S.
An investigation into Baxter’s death is underway by medical personnel at NHS Lothian. The family will forward questions to the health board, according to a story in the Daily Record in December.
Despite a suspension on mesh implant in 2014 in Scotland, about 750 women have been implanted since then, writes reporter Marion Scott.
Mesh is still used in England but is restricted to a last resort.
https://www.meshmedicaldevicenewsdesk.com/bbc-news-reports-on-influential-mesh-doctor-and-the-conflicts-he-failed-to-disclose/
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A Wee Miracle? The Chair That Claims To Zap Your Pelvic Floor Back Into Shape
Jan 25, 2019 | Ten Daily
By Natasha Lee
Pelvic floor dysfunction is one of the most common issues affecting new mothers and, apparently, there's a new treatment where sufferers just sit while it does its thing.
According to the Continence Foundation of Australia, women who have given birth to even just one baby are three times more likely to leak urine and wet themselves than women who have not given birth.
Generally, 80-90 percent of women who have had a vaginal birth will suffer some form of dysfunction afterwards.
One of those sufferers is mother-of-one Le-Arne Barnett.
The 53-year-old told 10 daily that she couldn't go more than half-an-hour without having to go to the toilet.
Barnett said that if she didn't go and was forced to hold it in, she would experience immense pain that has only continued to get worse with age.
Sydney Gynecologist Dr Sonya Jessup told 10 daily that the trauma placed on a woman's pelvic floor muscles begins the moment she starts carrying a baby.
"That's because the head of the baby sits on the pelvic floor," Dr Jessup said.
Jessup went on to describe a woman's pelvic floor as a kind of "trampoline with a small hole in the middle of it".
"It's like a small triangular opening in a trampoline and is no bigger than two centimetres. In vaginal births, that's the hole the baby needs to pass through, and the baby's head is a lot bigger than two centimetres," she said.
It's while giving birth that a woman's pelvic floor muscle becomes stretched.Treatment options
In the past, treatments included encouraging women to strengthen their pelvic floor muscles through exercises, such a kegels, or, in more serious cases, having to undergo surgery.
Jessup said the surgical options once included placing a sling mesh to help stop the bladder from prolapsing.
But, after a series of complaints from women who were fitted with the mesh, a Senate inquiry was held into its safety and reliability. The results were damning.
The aftermath of the inquiry resulted in the transvaginal mesh used for pelvic organ prolapse via transvaginal implantation being removed from the Australian Register of Therapeutic Goods (ARTG). The other product that ended up being withdrawn was the mini-sling.
For Jessup, the ban prompted her to start thinking about other ways medical professionals could treat the issue.Take A Seat
"I thought there has to be something else out there," Jessup said.
It was while she was over in the UK that she came across The Emsella Chair.
The chair's high-intensity focused electromagnetic technology (HIFEM) to restore "neuromuscular control" down below in people who have incontinence. Stress urinary incontinence is the most common form of incontinence.
"The action is similar to kegel exercises, however, with far more intensity," she said.
For Barnett, who at the time of the interview had completed three sessions, the chair has been "life-changing".
"I noticed an immense improvement straight away," she said.
The manufacturers of the Emsella Chair often spruik a study which found the treatment improved symptoms in 77 percent of women for up to three months.
However, the sample size was small -- it involved 32 two patients with light and moderate urinary incontinence.
A 2015 academic review of treatment options published in medical journal Neurourology and Urodynamic said, "There is no firm evidence to support the benefits of using Magnetic Stimulation (MS) in the management of Urinary Incontinence (UI), although short-term outcomes suggest that MS improves UI symptoms in women."
The authors went on to suggest that larger, high-quality trials over longer periods are needed.
https://tendaily.com.au/lifestyle/health/a190124mui/a-wee-miracle-the-chair-that-claims-to-zap-your-pelvic-floor-back-into-shape-20190125
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