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Media Ignore Impact Of Unsafe Medical Devices — Unless The Company CEO Is A Celebrity Billionaire Like Elizabeth Holmes
Nov 19, 2015 | Health News Health
By Trudy Lieberman
James Stewart’s recent New York Times story about Elizabeth Holmes, the rising star in the high-tech galaxy turned media celeb, raises an important press question in this time of the 21st Century Cures Act Are the media interested in covering problematic and potentially unsafe drugs, devices, and other medical products ... -
Mesh Technique is Still in Use at Borders General Hospital
Nov 19, 2015 | The Southern Reporter
An Independent Review of transvaginal mesh implants was set up by the former Cabinet Secretary for Health and Wellbeing, Alex Neil, to assess the evidence relating to surgery using synthetic mesh implants for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in Scotland. -
Mesh Survivors Warn Women – Just Say No To Doctors
Nov 19, 2015 | The Southern Reporter
Outwardly, Marion Garland and Lizzy Ford appear to be happy-go-lucky, quick to laugh and very healthy ladies. However, because of an operation which they underwent to fix an embarrassing problem, they have been left with life-changing symptoms, coping with pain 24/7. It affects their work, their leisure pursuits and their relationships...
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Nov 19, 2015 | Health News Health
By Trudy Lieberman
James Stewart’s recent New York Times story about Elizabeth Holmes, the rising star in the high-tech galaxy turned media celeb, raises an important press question in this time of the 21st Century Cures Act.
Are the media interested in covering problematic and potentially unsafe drugs, devices, and other medical products only when celebrity is involved?
The Cures Act, you may recall, weakens already weak regulation of new medical technologies — which include the kinds of products that Holmes’s company Theranos is introducing to make it easier to draw blood from squeamish patients. (Theranos has claimed it does not need FDA approval for its blood tests even though the FDA has asserted its authority over them.) And as I’ve repeatedly noted, media coverage of the Act moving rapidly through Congress has been sorely lacking.
Not so in the case of Theranos and its new methods for testing and analyzing blood. Stewart wrote: “The attention lavished on Ms. Holmes has been effusive… but that so many eminent authorities…appear to have embraced Theranos with minimal scrutiny is a testament to the ageless power of a great story.” Michael Cherny, an analyst at an investment bank and early skeptic of Theranos’s claims, told Stewart. “It all fit together perfectly: the college dropout, the fear of needles, the humanitarian mission. She checked all the boxes.” The money box was checked, too. The company has raised more than $400 million in venture capital and has been valued at $9 billion. Holmes’s stake is worth half of that.
Her story fit together so perfectly that she has been the subject of two profiles: one in the New Yorker and one in Fortune, and she snagged an interview with Charlie Rose. Glamour named her one of its women of the year. ReCode, a tech news and analysis site, ranked her five news cover appearances for Fortune, Forbes, Inc., T: The New York Times Style Magazine, and finally the Wall Street Journal whose not-so-flattering expose popped her bubble. (ReCode ranked that one number one.) Even after the Journal brought to light many problems with Thernaos and its blood-testing method, the press seemed reluctant to let go of a good story. New York Magazine used this headline — “Silicon Valley’s Most Inspiring Company May Be a Fraud” — to note the company’s troubles. The Washington Post framed its gentle Q and A as a “Comprehensive guide to Theranos’s troubles and what it means for you.”
What’s wrong with framing such stories about life and death devices and drugs around the glamour of celebrity? It leaves out too much crucial information. Elizabeth Holmes’s brief career at Stanford and her net worth substitute for real reporting that warns patients about harmful products. No one appears to have died or been injured from the Theranos way of testing blood, but that’s not the case with dozens of other devices, some of which are still on the market. I didn’t see any explainer Q and As after two Reuters reporters exposed financial scams involving another questionable device, the pelvic mesh. The mesh has been the subject of some 100,000 lawsuits and has resulted in women incurring thousands of dollars in medical costs to have the mesh removed and repair damage it may have caused. There was no celebrity in this story about mostly poor women now drowning in debt to fix a problem caused by a device they were told was safe.
Celebrity also leaves out discussion of the systemic questions—how a device got approved, how it has been regulated, are the manufacturers following the rules? Two days before Stewart’s story appeared New York Times staffer Andrew Pollack reported on FDA inspection reports that flagged gaps in the company’s quality assurance procedures and documentation. Pollack noted that for the 12 months ending in September 2014, the agency had issued nearly 1,000 post-inspection reports to medical device companies. There were 251 cases in which the agency said a device company lacked adequate procedures for handling customer complaints. That number alone invites reportorial scrutiny. (To its credit, NBC Nightly News did report on inspection reports and warnings in its September segment on the Bard recovery filter.) But don’t look for such revelations when celebrity frames the story.
This focus obscures a more basic question: are the devices made or promoted by today’s media stars really the right ones for Americans? Do they encourage overuse plus the additional cost to the healthcare system that such overuse brings? The lengthy Twitter chat between ProPublica’s Charles Ornstein and Dallas Mavericks owner Mark Cuban, who also stars as a “shark” investor on Shark Tank, is a case in point. Last spring Cuban tweeted that those who could afford it should have their blood tested for everything every quarter to create a baseline for their own personal health. Ornstein countered that Cuban’s advice was a recipe for false positive results and unnecessary treatments that could cause harm, and the chat went back and forth from there. Putting the chat in context of what’s happened to Theranos, one wonders if a test that makes drawing blood a snap feeds right into advice like Cuban’s. In other words, sales and celebrity go hand in hand, and making more sales is what the soon-to-be-newly-shaped FDA rules are designed to encourage.
Do deaths and harm from unsafe medical products matter? At one time in our journalist past, deaths caused by unsafe drugs and devices did make headlines precisely because they were unsafe. Reporters didn’t rely on celebrities and pretty CEOs as reasons to examine drugs and devices and the companies that made them. As the saga of Theranos shows, waiting for a celeb to emerge can lead the public—patients, investors, and the medical profession itself—down the wrong path. But in this age of Dancing with the Stars and Shark Tank, no one seems to care. The celebrities matter more.
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Mesh Technique is Still in Use at Borders General Hospital
Nov 19, 2015 | The Southern Reporter
An Independent Review of transvaginal mesh implants was set up by the former Cabinet Secretary for Health and Wellbeing, Alex Neil, to assess the evidence relating to surgery using synthetic mesh implants for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in Scotland.
In June last year, Mr Neil asked the acting chief medical officer to request all NHS boards in Scotland to consider suspending routine mesh implant procedures for pelvic organ prolapse and stress urinary incontinence.
NHS Borders stated: “Following the Scottish Government directive in July 2014, only patients already on the waiting list for a mid-urethral sling using synthetic material and those enrolled in a multicentre randomised controlled trial (SIMS study) have had these procedures for stress urinary incontinence.
“The patients who were already on the waiting list were all offered a further appointment and given the information and consent leaflet prepared by NHS Scotland. In addition, the patients also received a locally-prepared information leaflet on TVT-O [tension-free vaginal tape-obturator]. The majority of patients who were already on the waiting list decided to go ahead with the operation.”
Last month, Health Secretary Shona Robison welcomed the publication of an interim report into the use of transvaginal mesh implant procedures.
It includes evaluation of both the efficacy and the extent and causes of adverse incidents and complication rates associated with these types of surgery.
We asked NHS Borders, through a Freedom of Information request, how many of these operations had been carried out.
Over four years, the numbers were as follows:
l 2011 – 151 TVTO implants and 1 Apogee and 3 Gynecare mesh PS
l 2012 – 115 TVTO mesh implants
l 2013 – 113 TVTO mesh implants
l 2014 – 16 TVTO mesh implants to March 2014.
Since July 2014 to date, 40 procedures involving synthetic vaginal mesh had been performed, mostly for patients involved in the SIMS study and have been randomised to either the TVT-O or Altis tape procedures.
An audit of all the patients having the procedure at the BGH in 2013 was performed, which brought up the following problems:
l Failure – 3% still suffered from urinary incontinence at the six-week follow-up appointment.
l Voiding Difficulty – 8% had voiding difficulties after their operation. (5% needing a catheter overnight, 1% needing a catheter for 48 hours, 2% needing a catheter for 1 week) and 2% of patients had the tape divided.
l Tape Exposure – 10% had evidence of mesh exposure at the six-week follow-up appointment. (9% required mesh trimming).
l Leg or Groin pain – 5% reported groin pain at the six-week follow-up appointment.
l Urinary tract infection – 2% had evidence of a urinary tract infection after their operation.
Around 11,000 women in Scotland have had the procedure, and MSPs have been told that as many as one in five can go wrong, with the interim report noting mesh implants “carry a risk of complications which, in some cases, are life-changing and cannot be corrected”.
An NHS Borders spokesperson said: “If a patient declines the standard mid-urethral sling procedures for urinary stress incontinence, and instead opts for one of the alternative procedures, then she will be referred to the regional referral centre in Lothian for an appointment with the relevant consultant.”
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Mesh Survivors Warn Women – Just Say No To Doctors
Nov 19, 2015 | The Southern Reporter
Outwardly, Marion Garland and Lizzy Ford appear to be happy-go-lucky, quick to laugh and very healthy ladies.
However, because of an operation which they underwent to fix an embarrassing problem, they have been left with life-changing symptoms, coping with pain 24/7. It affects their work, their leisure pursuits and their relationships with their families.
And they have one mission. To make sure no more women go through what they have had to.
Marion, 51, from Galashiels, and Lizzy, 52, from Innerleithen, went to their GPs due to incontinence, which stemmed from a bladder prolapse.
They were both passed on to the BGH, where they underwent an operation in which tape, or transvaginal mesh, would be implanted to permanently fix the problem.
However, they say they were not fully warned of all possible side-effects. Marion Garland to go with operation story at the BGH.
And, for the two Borders ladies, this was only the start of their problems. They say the polypropylene mesh started a foreign body reaction – a response of biological tissue to any foreign material in the tissue – which left them in terrible pain.
Lizzy, who was the first of the two to go through the operation, said: “Five and a half years down the line, my life has changed. I’m not the same person. I have chronic pain every day.
“I’ve had to give up my work, I’ve had to give up my social life (I was a biker). I’m now using two sticks and a mobility scooter and a walker. I’m 52 years old and I feel like I’m in the body of an 80-year-old.
“The operation wasn’t even a success, I’m still on medication, so I’m actually worse than I was.”
When Lizzy reported the pain after her operation, she was told there was nothing wrong with the tape.
She said: “I got sent to see a psychiatrist and it was all made out that the pain was in my head and it had nothing to do with the mesh whatsoever.
I was told nobody else had ever suffered any side-effects from this operation ... I was the only one.”
Lizzy learned to live with her pain, but fell upon a story in a national paper about ladies who were taking their fight against mesh implants to the Scottish Parliament.
She said: “As I read their stories and got in contact with Scottish Mesh Survivors, it turns out that I’m just one of many.
“In a way, it’s an amazing experience to be able to know that I’m not on my own now. And that has actually saved my life, knowing I’m not on my own.”
Through Scottish Mesh Survivors, Lizzy met Marion, who was also told by her consultant that she, too, was the only one who suffered side-effects.
Marion asked her consultant questions regarding the mesh implants before she agreed to the operation.
She said: “I was reassured big time, I was told it was a ‘Gold Standard’ operation.
“I had the operation on December 14, 2011. From the moment they stood me up, I had horrendous pain. I actually thought they had dislocated my hip at one point, the pain was so bad.
“But the nurses told me that it’s just a little bit of pain and you think that you’re being a crybaby, and if others are suffering like this, maybe it’s just the way it is until it gets better,
“So you convince yourself it’s just you. I’ve never felt pain like that in my life, but had to tell myself it’s just me.”
However, by Christmas Day, the pain had got so bad, she was out of bed for only three hours.
She said: “On Boxing Day, my husband took me into A&E. They told me it was period pain. I left quite angry, dragging my left leg and in pain. My own GP, whom I went to as soon as they opened after the holiday, examined me. She found blood in my urine and my pelvic region inflamed. I was put on two extremely strong antibiotics and she arranged to get me an emergency appointment with my consultant.
“The day before this meeting, something burst inside of me. Excruciating pain that I could not describe ... for 10 minutes I could not move, talk or even breathe properly.
“But that evening was the first time since the operation that I could sit down. I had hoped this was the start of getting better and told my consultant all this the next day.
“He agreed that was probably the case and that my tape was fine. I told him about dragging my leg, but I was assured that I would be healing now.
“But by the end of January 2012 I was back begging him to take it out. My left leg, hip and groin were absolute agony. I could not walk, sleep or do anything normal and my husband and children had to take care of me.”
The surgeon offered to trim the mesh, but Marion, who had found out more about the mesh on the internet, refused.
She said: “I had Googled mesh problems, especially in the small hours when sleep was impossible. What I found horrified me. I grew to understand that if problems were apparent so soon, the mesh should be taken out in one piece if possible.
“If mesh is cut or trimmed its fibres start to degenerate much quicker, travelling into the body and causing further problems and as there are now two ends, these can irritate and cut tissue.
“No-one understood my pain. My doctors didn’t understand how I was in so much pain, my surgeon wouldn’t listen, my family were just looking at me because I looked the same, but inside, I was a mess.
“I was in constant pain, 24/7, and I couldn’t sleep. Even to this day, I need to put pillows between my knees when I sleep, because if my knees touch, I get a shooting pain, because the mesh is nipping my insides.
“It’s no way to live. My life is not the same, I used to go hillwalking with my husband, I can’t do this now. I have to seriously think about what I’m doing each day, because the tiredness, the leg pain, the internal pain ... you have to try to adapt your life to it.
The hardest thing is that moment when you know you are never going to be the person you were, and that is a horrific moment. If I had been knocked over by a bus, I would have accepted it better.”
Both ladies are now telling their story to ensure women can be made aware of the dangers.
Marion said: “If you are going through the operation, ask if they are putting polypropylene into you. If they are, say no.
“This is plastic. It hardens, it shrinks, it starts to give off chemicals inside your body.
“They don’t want to call it mesh or tape any more, they are midurethral slings – just a fancy name for what is an oil industry by-product.”
“A slightly longer operation can be done using your own tissue and there is no foreign body reaction. “If I had done this, I’d have been fine, even if the operation hadn’t worked. If it had failed, I could have tried it again, I wouldn’t be in any pain, I wouldn’t have foreign-body reactions, I wouldn’t be sitting here worried that I am going to develop rheumatoid arthritis, fibromyalgia, lupus, or any such auto-immune disease. The only perfect mesh for the human body is your own tissue.
“If there are women in the Scottish Borders who have had this incontinence operation and they are worried in any way, if they have any questions they want to ask, they should get in touch with Scottish Mesh Survivors.
“I don’t know what the future holds for me, but with this still in me, it’s not going to be healthy. I’m not healthy.
“If I get to retirement age, I think I’ll be doing quite well.”
Marion is considering an operation to remove the mesh. But, understandably, she is scared.
She said: “I’m terrified of this operation. I need it out, but I know how bad it is afterwards.
“They make it sound like they are taking out a ribbon, it’s not. They have to take out a swathe of your insides when they take out this tape. You can be left in worse pain than you were before the operation.
“And you have to wait until you heal to see if they can do another operation to fix the original problem.
“It’s not guaranteed.
“I have to think about it, financially, workwise and family-wise.
“It’s a big decision.”
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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