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OPINION: Kendall Stanley — Say what?
Apr 23, 2018 | Petoskey News-Review
By Kendall P. Stanley
Consider this for a moment – a woman is paid to have a vaginal mesh removed so she can then join lawsuits against mesh makers by saying it had to come out. All worked out through doctors, lawyers and investing firms. -
'The Bleeding Edge': Film Review | Tribeca 2018
Apr 23, 2018 | The Hollywood Reporter
By Frank Scheck
Watch enough documentaries, and you'll find yourself having trouble getting out of bed in the morning. You'll certainly think twice before undergoing a medical procedure, especially on the heels of Kirby Dick's documentary about the hazards of so-called "innovative" medical devices. -
Handling Urinary Leakage
Apr 23, 2018 |
By Libby Mitchell
A woman’s bladder shouldn’t leak. It should be able to contain your urine inside your body until you are ready to expel it no matter how far you run, how high you jump, how many times you sneeze, or how hard you laugh. -
Women are left in crippling pain after NHS birth control implant inserted into thousands 'disintegrates' inside them
Apr 23, 2018 | The Daily Mail
By Lois Rogers
When mother-of-five Laura Linkson, then 35, was offered a new form of sterilisation on the NHS that didn’t involve surgery, she didn’t hesitate.
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OPINION: Kendall Stanley — Say what?
Apr 23, 2018 | Petoskey News-Review
By Kendall P. Stanley
Consider this for a moment – a woman is paid to have a vaginal mesh removed so she can then join lawsuits against mesh makers by saying it had to come out. All worked out through doctors, lawyers and investing firms.
https://www.petoskeynews.com/news/opinion/opinion-kendall-stanley-say-what/article_6822bbe0-6424-5a2a-b54e-619aae8639d9.html
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'The Bleeding Edge': Film Review | Tribeca 2018
Apr 23, 2018 | The Hollywood Reporter
By Frank Scheck
Watch enough documentaries, and you'll find yourself having trouble getting out of bed in the morning. You'll certainly think twice before undergoing a medical procedure, especially on the heels of Kirby Dick's documentary about the hazards of so-called "innovative" medical devices. Chronicling the unnecessary pain and suffering of patients caused by complications of devices and procedures that received little or no testing, The Bleeding Edge is a terrifying eye-opener. The Netflix-produced documentary recently received its world premiere at the Tribeca Film Festival.
"When it comes to medical devices, we built a system that doesn't work," says David Kessler, a former FDA commissioner. The agency's mission goes back many years, as demonstrated by a vintage PSA featuring actor Raymond Massey that proclaims, "Help stamp out quackery!"
Dick (The Invisible War, The Hunting Ground) and producers Amy Ziering and Amy Herdy concentrate on just a few examples of the $400 billion medical device industry. The first involves Essure, a permanent birth-control device that is claimed to be 99% effective at preventing pregnancy. Unfortunately, it often produces such complications as cramps, bleeding and worse. The documentary includes an excerpt from a video of an Essure approval meeting in which doctors' questions go unanswered and several of the participants joke openly about the lack of rigor in the process.
Then there's vaginal mesh, commonly used in gynecological surgeries even though the FDA didn't require human studies before approving it. The mesh, purposely designed to inflame scar tissue to hold it in place, becomes rigid and almost impossible to remove. One female patient says that, not long after mesh was inserted, her husband suffered a cut penis when they attempted intercourse. The members of a support group talk about sex lives destroyed and marriages ruined. Onscreen graphics inform us that mesh lawsuits have cost its manufacturer Johnson & Johnson $300 million in the last decade. But that's a drop in the bucket compared to its revenues of $683 billion during the same period.
Another problem is robotic surgery, performed remotely by doctors who are too often insufficiently trained in the procedure. "The story of how the robot came into healthcare is the story of what's wrong with healthcare today," says a Johns Hopkins University professor. Several women describe undergoing hysterectomies performed by doctors using the "da Vinci robot" that went disastrously wrong. One of them suffered pain and bleeding for weeks before three feet of her colon literally fell out of her body.
Hip replacements composed of such metals as cobalt often produce horrific aftereffects. An orthopedic surgeon who received one himself began experiencing tremors, cognitive issues and serious psychological problems. It was determined that the metal had seeped into his tissue and bloodstream. Amazingly, the product is still commonly being used.
It all boils down, naturally, to lax oversight and insufficient regulatory practices. The FDA's "Premarket Notification" system stipulates that a new medical device can be approved without testing if it is equivalent to an existing device — even if the prior device has been recalled.
Nine FDA scientists who expressed safety concerns about the agency's lax regulatory process were spied on and eventually let go. Meanwhile, the medical device industry employs an army of lobbyists and many FDA commissioners and other employees go to work in that industry after leaving the agency. Needless to say, things are only getting worse in the Trump era and under current FDA head Scott Gottlieb. Frighteningly, Gottlieb gained confirmation only after promising to recuse himself for one year from any decisions involving the no less than 20 healthcare companies for which he's worked.
The Bleeding Edge occasionally suffers from its overemphasis on individual cases. It doesn't add much to our understanding of the problem, for instance, to watch a homeless Hispanic woman desperately struggling financially after her health was ruined by Essure, although it obviously adds a human face to the problem.
The film concludes by informing us that no one from the FDA or any of the companies involved agreed to be interviewed. Their silence is both telling and infuriating.
https://www.hollywoodreporter.com/review/bleeding-edge-1105081
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Apr 23, 2018 |
By Libby Mitchell
A woman’s bladder shouldn’t leak. It should be able to contain your urine inside your body until you are ready to expel it no matter how far you run, how high you jump, how many times you sneeze, or how hard you laugh. However, the truth is that for some women, leaks happen. Childbirth, aging, injury, weight gain or even genetics can cause female incontinence. So, what’s a woman to do? “You may leak a little, but if it doesn’t bother you it’s fine,” said Jolyn Hill, MD, an urogynecologist with University of Utah Health. “But if it’s bothering you then it’s time to take action.”
The most basic action you can take is to limit how much liquid you consume. In recent years a belief has been pushed that the more liquid – specifically water – you drink, the healthier you are. However, that isn’t really the case. “There really is no science behind the idea that you have to drink 8 glasses of water a day,” said Hill. “The best thing to do is to drink when you are thirsty. Your body is a great thermometer of when you need water.”
Another action you can take is to reduce the number of bladder irritants in your diet. These are foods and drinks that may cause discomfort in your bladder or increase your urinary urgency. “The most common bladder irritants are coffee, tea and soda,” said Hill. “But foods that are spicy, or high in acid can also be irritating.”
There are times when limiting liquids and diet alterations aren’t enough. In that case, it’s best to see a doctor to determine what is causing your leakage, and the best treatment. “There are two primary causes of leakage,” said Hill. “One is called stress urinary incontinence. This is when the muscles of the urethra aren’t as supported as they used to be. The other is urgency urinary incontinence. It’s not a problem with the anatomy, but with signals being sent between the brain and the bladder.”
Your doctor may want you to work on strengthening your pelvic muscles to reduce the risk of leaking. This can be done with exercises like Kegels. You may also be referred to a pelvic floor physical therapist to help with other exercises to improve strength. “Your doctor may also recommend a device called a pessary to help brace the urethra,” said Hill. “Some women may wear these only when exercising, while other may prefer to wear them more regularly.”
Surgery is another option when it comes to treating leakage. Mesh can be placed under the urethra to support it. “This type of mesh is not the type making headlines for safety issues,” said Hill. “This type of mesh is approved by the FDA and has a very small risk for complications.”
https://healthcare.utah.edu/healthfeed/postings/2018/04/leakage.php
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Apr 23, 2018 | The Daily Mail
By Lois Rogers
When mother-of-five Laura Linkson, then 35, was offered a new form of sterilisation on the NHS that didn’t involve surgery, she didn’t hesitate.
The procedure involved having an Essure device — essentially tiny metal and plastic springs — inserted into her fallopian tubes to stop eggs moving from the ovaries to the womb. The implant can be inserted via the vagina and into the tubes in as little as ten minutes.
Laura was one of thousands of women in Britain given Essure. Nine years later, she bitterly regrets having the procedure, which has effectively crippled her, she says.
In some women, the devices have ‘migrated’ or disintegrated, and the nickel titanium metal alloy and polyethelene terephthalate (PET) plastic fibres they are made from, have caused debilitating allergic reactions or cut into tissue, leaving women in excruciating pain or suffering nerve damage.
‘It started with me needing a stick, then a mobility scooter and now I’m in a motorised wheelchair,’ says Laura. ‘Some days I can’t get out of bed because of the pain.’
She’s been told the device has broken up inside her body. ‘There are at least three fragments which have set up all sorts of long-term problems, but it doesn’t seem there is any doctor in England with the expertise to get them out,’ she says.
Laura, a former legal clerk from Southampton, is pinning her hopes on a referral to a Dutch specialist who uses an imaging technique called fluoroscopy to locate the tiny 1-2 mm fragments.
Essure was first marketed in the UK in 2009. Last August the manufacturer, Bayer, instructed hospitals to stop using it. Although there had been a growing number of complaints, Bayer insisted the product was being withdrawn for ‘commercial reasons’.
It said the CE European safety approval mark on Essure had expired and no renewal would be sought.
However, some NHS hospitals have continued to use up old stock, even though the Essure website now warns of side-effects including ‘perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and allergic or hypersensitivity reactions’.
‘We’ve been contacted by women who say they have had Essure implants since hospitals were instructed to stop using them,’ says Jan Faulkner, who runs Life After Essure, a group campaigning on behalf of more than 300 affected women.
‘It is very worrying — there have been more than 30,000 complaints about Essure in America, but hospitals here have just carried on using it.’
She has written to more than 40 hospital trusts in Britain to find out how many have continued to Essure implant devices.
‘Blackpool responded saying they are no longer implanting Essure but we know they have recently because I am helping a lady who had it done there.’ (Blackpool Teaching Hospitals NHS Trust told Good Health it could not discuss individual patients but said it is no longer using the device.)
Separate inquiries by Good Health showed that the Rotherham NHS Foundation Trust in South Yorkshire had given Essure to one woman who, according to a hospital spokesman, had said she wanted the device despite the ban.
A spokesperson for NHS Grampian told us: ‘Three women chose to go ahead with the Essure procedure after detailed discussion with our clinical staff.’
She admitted that one of the three is experiencing continuing pain and is due to have a surgical investigation.
Essure is one of a number of medical innovations approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) for NHS patients, with minimal testing. The problems share striking similarities with vaginal mesh tape, used to treat incontinence. In some women the mesh disintegrated, and shards of the material have sheared into surrounding tissue and nerves, as Good Health has highlighted.
Complaints from patients injured by faulty devices have too often fallen on deaf ears. Publicity about these kinds of issues led Health Secretary Jeremy Hunt to recently announce a review into the official response to the complaints.
Baroness Julia Cumberlege, a former health minister, has been asked to chair the review into three areas — vaginal mesh, the birth defects caused by Primodos, a hormone-based pregnancy test, and birth defects linked to the anti-epilepsy drug sodium valproate.
On Friday, Laura will join Jan and five other injured women for a meeting with Baroness Cumberlege in the hope that she will ‘see that the problems with Essure follow the same pattern as the problems with these other devices and should be added to her review’, says Jan.
The group will be joined by Carl Heneghan, a professor of evidence-based medicine at the University of Oxford.
‘Only three months before Essure was removed from the market, MHRA officials were claiming they couldn’t understand what the problem was,’ he says.
‘We’ve been here many times before. We need to fix this problem of defective medical devices once and for all instead of having repeated investigations which agree there’s a safety problem but everyone hopes will go away on its own.’
Jan, 45, a mother of five from Warrington, Cheshire, has only recently recovered from her own Essure nightmare.
Immediately after the devices were implanted in 2008, a scan showed one had ‘gone missing’. She was offered a second sterilisation with different clips, but unbeknown to her, the Essure devices were not removed.
‘I started getting agonising pains in my back and my joints, and had strange rashes but when I complained, the doctors laughed at me,’ she says. ‘They blamed the menopause.’
She was finally referred for surgery to remove her fallopian tubes in 2016 because of the pain. ‘I couldn’t believe it when they told me they had also taken out both the original Essure devices. I hadn’t known they were still inside me. But the relief was instant.’
The five other women attending the meeting include Charlene Baldwin, 38, a mother of five from Rochester, Kent, who like most of the others, had a hysterectomy to alleviate symptoms following the Essure procedure nine years ago.
She suffers periodic paralysis several times a week in reaction to material from the device left in her body. ‘My children sometimes have to help me to eat,’ she says.
Dr Bas Veersema, a gynaecologist of the University of Utrecht, has pioneered a technique using high-resolution imaging for Essure removal and says his team has extracted 2,000 damaged devices from women.
‘What doctors don’t realise is that they fragment when you remove them,’ he says.
‘We have found all sorts of abnormalities you would not expect. Sometimes the device will perforate the womb or the fallopian tube, sometimes calcified deposits form around them or they blow up the fallopian tube with a build-up of fluid.
‘Scientifically we don’t really know if these fragments cause an inflammatory reaction, but we think they do.’
Bayer continues to insist the device is safe, as does the MHRA (which says women should report any problems to the Agency).
http://www.dailymail.co.uk/health/article-5649033/Women-left-crippling-pain-NHS-birth-control-implant-inserted-thousands-disintegrates.html
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