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Ethicon Media Monitoring 9/7/2017
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AM Presses Health Secretary on Steps to Help Mesh Injured Women
Sep 6, 2017 | AM Deeside
Alyn and Deeside AM has grilled the Health Secretary on steps taken to help mesh-injured women and to prevent further suffering to others. -
Assassination by Pacemaker: Australia Needs to Do More to Regulate Internet-Connected Medical Devices
Sep 7, 2017 | The Conversation AU
By Bruce Baer Arnold
In the future, people are going to be just a little bit cyborg. We’ve accepted hearing aids, nicotine patches and spectacles, but implanted medical devices that are internet-connected present new safety challenges. Are Australian regulators keeping up? -
Endometriosis Left Me in Agony. Now Doctors Must Take Women Seriously
Sep 7, 2017 | The Guardian
By Brydie Lee-Kennedy
I am writing this while lying in a semi-foetal position with a cold cloth on my forehead and a heat pack on my abdomen
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AM Presses Health Secretary on Steps to Help Mesh Injured Women
Sep 6, 2017 | AM Deeside
Alyn and Deeside AM has grilled the Health Secretary on steps taken to help mesh-injured women and to prevent further suffering to others.
Carl Sargeant first took up a campaign to help the cause after being approached by affected constituent Maxine Cooper of Connah’s Quay.
She is one of many women suffering excruciating complications after insertion of Tension-Free Vaginal Tape (TVT) or Tension-Free Vaginal Tape Obturator (TVTO) procedures to cure incontinence or prolapse. Men who have the tape inserted to correct hernias are also affected.
Mr Sargeant wrote to Health Secretary Vaughan Gething in July asking for an urgent review of mesh procedures in Wales. He also asked him to look into increasing awareness of symptoms among GPs so that complications can be properly diagnosed and evidenced.
Mr Gething’s response, received yesterday (September 5), says that he sympathises with Maxine and others who are experiencing serious complications.
He says that the evidence is mixed and while some experience debilitating problems many appear to experience significant benefits from the procedures without ill effect. The advice from the Chief Medical Officer for Wales is that the current evidence does not support the total withdrawal of the use of mesh or tape.
Mr Gething says: “Any accounts of harm or complications with such procedures must be carefully considered and possible complications reflected as potential risks to women considering an operation, as part of a fully informed consent process. A number of safeguards regarding the use of these products have been put in place since concerns emerged.”
He also says that he has asked a task and finish group to consider the latest recommendations made in Scotland and England in the light of practice already adopted within NHS Wales. This will determine whether there is any further action the Welsh Government needs to consider taking within Wales. The working group will report to Mr Gething and he will keep Mr Sargeant updated.
Carl Sargeant said: “I’ve replied to the Health Secretary today (Wednesday) to say I’m happy to hear that a task and finish group will look into this issue and look forward to receiving updates in due course.
“I’ve also asked for the Health Secretary’s response to concerns I have and asked that the task and finish group look into them.
“Women affected feel the evidence Mr Gething mentions may be flawed as currently women only receive follow-up appointments for a year post-procedure. Many women’s complications begin years later so I have asked whether there are plans to increase the post-procedure monitoring period.
“Mr Gething states that complications are reflected as potential risks to women considering the operation. Current feedback suggests risks are not being thoroughly communicated so I have asked what measures are in place to ensure that they are.
“My original letter asked what steps are being taken to make GPs aware of the symptoms of mesh complications. At the moment women presenting with complications are waiting years for a diagnosis, if they get one, by which time in many cases the injuries have progressed until they are irreparable.
“I look forward to hearing the Health Secretary’s response on these critical concerns.”
Maxine Cooper’s symptoms have worsened since July. She is due to have the first of several mesh removal and repair procedures under expert Sohier Elneil in London on September 20.
“If health professionals know this can go so wrong then they shouldn’t use it,” she said of the mesh.
“I’m now on morphine the pain is so bad and have been off work so long I’m terrified I will lose my job.
“This is ruining mine and thousands of other women’s lives.”
http://www.deeside.com/presses-health-secretary-steps-help-mesh-injured-women/
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Sep 7, 2017 | The Conversation AU
By Bruce Baer Arnold
In the future, people are going to be just a little bit cyborg. We’ve accepted hearing aids, nicotine patches and spectacles, but implanted medical devices that are internet-connected present new safety challenges. Are Australian regulators keeping up?
A global recall of pacemakers has sparked new fears and splashy headlines about hacked medical devices. But the next 20 years of medicine will normalise the use of intelligent implants to control pain, provide data for diagnostic purposes and supplement ailing organs, which means we need proper security as well as access in case of emergency.
Pharmaceuticals and medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA), an arm of the national Health Department.
Can we rely on Australia’s medical devices regime? Recurrent criticisms by parliamentary committees and government inquiries suggest the regulator may be struggling.The job of the TGA
The TGA regulates medical devices such as stents, pacemakers, joint implants, breast implants, and the controversial vaginal mesh that has featured recently in the media (and a Senate inquiry) over claims it seriously injured patients.
The role of the TGA is vital, because defective devices can result in injury or death. They have a major cost for the public health system and affect patient quality of life. They often result in litigation, sometimes with billion-dollar settlements.
In undertaking its mission, the TGA looks to information from manufacturers and distributors, from overseas regulators and its own staff.
Like counterparts such as the US Food and Drug Administration, TGA staff are under pressure to get products into the marketplace and reduce “red tape”.The TGA and cybersecurity
Wireless medical devices need greater security than, say, an internet-connected fridge. It is axiomatic that they must work.
We need to ensure that information provided by the devices is safeguarded and that control of the devices – implantable or otherwise – is not compromised.
To do that, we can use existing tools such as robust passwords, encryption and systems design. It also requires product vendors and practitioners to avoid negligence. Regulators must proactively foster and enforce standards.
Put simply, bodies like the TGA need to deal with software rather than simply bits of metal and plastic. It is unclear whether the TGA has the expertise or means to do so.Solutions, not panic
The past decade has seen a succession of inquiries into the TGA, including the 2015 Sansom Review and 2012 Senate PIP Inquiry. Each has demonstrated that the TGA is not always keeping up with its task.
Problems are ongoing: think defective joint implants, breast implantsand vaginal mesh. But there are some potential paths towards improvement.
Accountability
One solution is to ensure the TGA is more accountable.
Currently, if someone wishes to bring a claim alleging a device was improperly permitted, the TGA has immunity from civil litigation about regulatory failure.
Removal of immunity will force it to focus on outcomes. That can be reinforced by giving it independence from the Department of Health, making it report direct to Parliament and ensuring the openness emphasised by the Pearce Inquiry.
Regulatory capture
Medical products regulation in Australia has been a matter of penny wise, pound poor. The TGA is funded by fees from the manufacturers and distributors that it regulates, in addition to some government funding.
It needs a discrete budget that recoups costs but is not dependent on companies that complain regulation is expensive. It needs enough resources to do its job well in the emerging age of the internet of things, including access to independent expertise regarding cybersecurity and devices.
A device register
How many devices have been implanted and how many removed? The lack of data about medical devices is a problem.
The government has so far not embraced recommendations for a comprehensive device register, one allowing timely identification of what was implanted and by whom.
Such a register would provide a means for determining problems with devices or medical practice. We need timely, consistent reporting of problems on a mandatory basis, as well as recall and transparentinvestigation of what went wrong.
Disclosure of interests
The inquiry into vaginal mesh revealed the WA Branch of Australian Medical Association had a financial interest in a device that may have seriously affected numerous women.
There must be full disclosure of such interests, with meaningful sanctions where disclosure has not been made. This requires action by the TGA, professional bodies and the government.So, what about assassination by wireless pacemaker?
The cybersecurity of medical devices is a matter for everyone.
We need the TGA to work with manufacturers, distributors and health professionals to mandate best practice. Should, for example, manufacturers and practitioners ensure that implants do not rely on default passwords that are easily crackable? What about access by emergency services?
There is a fundamental need to develop and enforce a national safety standard regarding all wireless implants. For that we need thoughtful policy, not just headlines.
Bruce Baer Arnold is an Assistant Professor at the School of Law, University of Canberra
Bruce Baer Arnold does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond the academic appointment above.
https://theconversation.com/assassination-by-pacemaker-australia-needs-to-do-more-to-regulate-internet-connected-medical-devices-83357
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Endometriosis Left Me in Agony. Now Doctors Must Take Women Seriously
Sep 7, 2017 | The Guardian
By Brydie Lee-Kennedy
I am writing this while lying in a semi-foetal position with a cold cloth on my forehead and a heat pack on my abdomen. This is not an ideal position from which to do any type of work, but for me and the other 176 million endometriosis sufferers worldwide, it’s often all we can manage. This is why the updated guidelines from the National Institute for Health and Care Excellence (Nice), released today, are to be commended.
These guidelines emphasise the importance of doctors believing their patients when they tell them about their menstrual pain and other attendant symptoms. This seems like obvious advice, but the average time it takes to diagnose endometriosis is seven to eight years. That’s seven to eight years of mind-numbing pain, clotting, diarrhoea, chronic bloating, self-medicating and, often, extremely low moods and anxiety. It’s seven to eight years of potential damage to your chances of conceiving.
It’s estimated that endometriosis affects one in 10 people with uteruses worldwide and yet when I was diagnosed a decade ago, I knew no one else with the disease. I was 20 and had been in chronic pain since the age of 13. While the pain would reach its peak during menstruation, leading to me vomiting and passing out, it affected me all the time. There was sharp, stabbing ovulation pain, dragging, relentless back pain, stinging rushes of pain through my legs and arms. I medicated, then medicated some more, then went to bed for days with nausea and misery, wondering why my body had betrayed me.
Despite all this, I was comparatively lucky because my parents and my GP took my pain seriously. By the age of 20, I had tried every non-surgical treatment available and all that was left was a laparoscopy, an invasive procedure that remains the only effective way of treating endometriosis. I went under for four hours and when I woke up I was shown pictures of my insides, which had been scraped and lasered and prodded about.
It was not a pretty sight. My endometrium – the stuff that’s supposed to stay in your uterus until it exits your body – had spent seven years attaching itself to my bladder, fallopian tubes and bowel. It had scarred my right ovary. If left unchecked, this could have rendered me infertile, not to mention further destroyed my quality of life. I spent a difficult month recovering, during which I suffered from a severe bout of depression (a common side-effect of the surgery) and needed help walking until I could rebuild my abdominal strength.
I experienced around 18 months of reduced symptoms before they began to build up again. I have had surgery once since then and now have a piece of mesh behind my right ovary to prevent it from being trapped against my pelvic floor. When I decide to have a child, there is a strong possibility that I’ll need a third surgery if I hope to conceive naturally.
I have structured my life and my career around this disease. I’ve missed more social events than I can count and recently went to a wedding so medicated that I had to ask the friend next to me to keep me upright during the ceremony. I am the only person I know who doesn’t own a pair of jeans, but what seems like a kooky style choice is actually a result of my near-constant painful abdominal swelling, rendering anything with a tight waistband unwearable. I work as a freelance writer and editor partly because I need a job that I can do from home as there are days when I am physically unable to get out of bed (or, even worse, off the bathroom floor).
I spent my early 20s working minimum-wage jobs in bars, theatres and shops and the only way I got through shifts was by taking double the recommended painkiller dose and secretly throwing up in the staff toilets. Most sufferers are not as fortunate as me. They’re still doubling their doses and throwing up in your workplace because they don’t have any other options. They may not even know what’s causing their pain because the last doctor they saw recommended ibuprofen and sent them on their way.
This move from Nice is so welcome because endometriosis sufferers need to be believed. Treatment is a long road and it only gets harder the longer the disease is left unchecked. From my foetal position on the floor, I hope fervently that these guidelines make a difference.
Brydie Lee-Kennedy is an Australian-born, London-based columnist and writer for TV and theatre
https://www.theguardian.com/commentisfree/2017/sep/06/endometriosis-agony-doctors-women-guidelines-nice
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