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Ethicon Media Monitoring 9/21/2017
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Surgery horror: ‘I was only 33 but I felt like a granny’
Sep 21, 2017 | Health 24
By Mandy Freeman
Transvaginal mesh is used to correct incontinence – it’s innovative, simple, non-invasive and works well to keep a woman’s organs in place… Or so the manufacturers want people to believe. -
MPs join fight against the nightmare of surgical mesh
Sep 21, 2017 | Chester Chronicle
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Failing medical implants are causing hundreds of thousands of people misery
Sep 20, 2017 | The Conversation
By Thomas J Joyce
Thousands of women across the world have been left in terrible pain after being implanted with transvaginal mesh – a device to treat urinary incontinence or prolapse. How did a medical implant that has caused so much damage to these women’s bodies and lives come to be sold?
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Surgery horror: ‘I was only 33 but I felt like a granny’
Sep 21, 2017 | Health 24
By Mandy Freeman
Transvaginal mesh is used to correct incontinence – it’s innovative, simple, non-invasive and works well to keep a woman’s organs in place…
Or so the manufacturers want people to believe.
These women, however, tell a different story.
Transvaginal mesh
The mesh is made from a synthetic plastic material called polypropylene. According to a previous Health24 article, this plastic is implanted through the vagina and although the procedure is becoming more common, it is also regarded as dangerous to some women.
It’s used to fix pelvic organ prolapse and stress urinary incontinence, conditions usually associated with childbirth, hysterectomy or even menopause.
However, this seemingly innovative procedure and product has also been the subject of class action lawsuits against the manufacturer Johnson & Johnson in Australia and the UK for a number of years.
Women have opened up about how it has affected them.
‘I was only 33 but I felt like a granny’
“I was told it was a 20-minute procedure and, if it ended the misery of incontinence, it would transform my life,” Cat Lee, 43, told the Huffington Post. “It was a type called TVTO, or Tension-Free Vaginal Tape Obturator.”
Unfortunately the surgery didn’t help her incontinence. She recalls, “I was so ashamed and humiliated. I’d gone back to work, six months after having Charlie [her second child], but I was still wetting myself. On [one] occasion, as I marched across the campus, I felt a rush between my legs. I’d wet myself and it had soaked right through the pad I’d been wearing. I was only 33, but I felt like a granny. I even had to ask a colleague to buy me some new tights, although I was too embarrassed to tell her why.”
Her husband, Gordon, became her carer and their sex life suffered. “As for sex, it was strictly out of bounds because of the pain. I even suggested he could sleep with someone else. Luckily, he refused, saying it was me he loved.”
Ten years later, she says the “so-called simple” vaginal mesh surgery ruined her life.
“Luckily, we didn’t want any more kids, but I don’t feel like proper mum to Charlie. I can only do the school run a few times a week and then, he has to walk alongside my mobility scooter. I can’t play with him like other mums and I don’t feel like much of a wife either.”‘My sex life has ended and I’m only 41’
“Sometimes the pain was so bad it was as if my insides were being ripped apart. I had so many scans and investigations which showed nothing: I now know that the mesh is only visible on a translabial ultrasound scan,” Kate Langley, 41, told Helen Carroll and Jo Waters of the Daily Mail.
She had the surgery in 2012 and has been admitted to hospital 53 times since.
“When my specialist first suggested TVT surgery, I’d got to the stage where I had to wear incontinence pads so I thought: ‘Great! I can get back to normal life.’”
Four days later she was readmitted to hospital with agonising pain. “I was in and out of hospital over the coming weeks, always in crippling agony. The ongoing discomfort made it difficult for me to walk.”
A couple of years after her surgery, Langely began to suffer from urinary tract infections every few months.
“Two-and-a-half years after the op I had to give up my child-minding business, due to spending so much time in hospital. They didn’t discover the problem was the mesh until April 2015 – that September, rather than have a long wait to have it removed on the NHS, I saw a private surgeon my wonderful extended family paid for: I was told the mesh had torn into my bladder, urethra and a main nerve.”
Although most of the mesh has been removed, Langely is still in constant pain. “It couldn’t all be removed as it was so embedded – they think I will always have pain.”
“My sex life has ended and I’m only 41, so that puts a strain on our marriage. My not working hasn’t helped either as we’re in debt.”
‘I wish I’d just relied on exercises and sanitary towels’
“I knew the minute I woke up from surgery that something was wrong,” Dawn Martin, 55, told Radhika Sanghani of The Telegraph. “It felt like broken glass down there. I could barely empty my bladder. It was agony – and it didn’t stop. I called my GP in tears saying 'please sedate me so I don’t have to be in this pain anymore'. I thought it would never end.”
She had four children over five years when she was in her 20s. Two decades later and her incontinence just got worse.
“My sister-in-law had already had the surgery and said it was great. At the time my husband was having open heart surgery so I was too preoccupied to look into all the pros and cons. I thought it would be fine and would solve this one problem, but it was probably the worst thing I’d ever done,” she says, three years after she had the implant.
More than a year later after having the initial surgery, in 2015, the mesh was removed. Doctors discovered it had shrunk more than they’d expected, and was slicing through her urethra and into her bladder.
Although the mesh has been removed, Martin still has severe health problems. “I still have issues down there, and a total lack of libido. I’m also permanently exhausted. I don’t feel attractive anymore. I feel it’s aged me by 20 years. I feel like a completely different person. I wish I’d never had the surgery and just relied on exercises and sanitary towels.”
http://www.health24.com/Medical/Incontinence/Incontinence-in-women/surgery-horror-i-was-only-33-but-i-felt-like-a-granny-20170921
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MPs join fight against the nightmare of surgical mesh
Sep 21, 2017 | Chester Chronicle
FLINTSHIRE'S MPs have both played in role in launching the All Party Parliamentary Group (APPG) on mesh.
Surgical mesh is used to treat incontinence, prolapse and hernias. It is made of polypropylene plastic which can shrink, twist, degrade and cut/erode into nearby tissues and organs causing chronic pain.
It is popular operation as it is a cheap and quick fix and takes less surgical skill than traditional, native tissue repairs. Delyn MP Hanson was elected co-chair of the APPG and will be working closely with chair Owen Smith MP to ensure its aims are achieved.
These are: ? Raise profile of mesh and the plight of mesh injured women; ? Campaign to bring forward NICE guidelines for mesh in SUI; ? Campaign to secure a national audit and registry for mesh interventions; and ? Advocate for the suspension of mesh as a first line treatment until NICE guidelines are revised.
The APPG will be working closely with the 'Sling the Mesh' campaign. They are calling for a full investigation and audit to be carried out into how many women have been adversely affected by vaginalmesh implants and tapes. They want the NHS to write to every woman who has had the operation. Until that review is complete and they have a full understanding of the scale of the disaster they will continue to demand that mesh implants are suspended.
Mr Hanson said: "Mesh implants have been increasingly used and the number of women in Delyn who have approached me with their concerns has dramatically increased recently.
That is why I felt it was important to help establish the all-party group on mesh. We will be working across the Commons to ensure that we have the loudest voice possible for women who have been harmed by this implant.
"We need to raise the profile of this campaign so more women feel they can come forward and help us push for clinical guidelines to be brought forward. Moreover, it will place more pressure on the Government in the
UK to do the right thing and suspend the use of mesh implants.
"This is only the beginning of the campaign in Parliament, but from the number of MPs wishing to join the group we can see that it has the best chance of delivering practical change. If anyone in Delyn has been impacted by mesh implants please contact me as I want to help as many people as possible."
Alyn and Deeside MP Mark Tami was among MPs joined by doctors, surgeons and academics in July when it was decided to set up the APPG.
He said: "I was glad to be a part of the setting up of the group. The pain and suffering that these women have had to endure is wrong and it is something that needs urgent attention.
"A lot of these women got the procedure under false pretences, thinking they would be able to continue a normal life, pain-free. Also the fact there is no database or registry for women who have had this implant, is clearly wrong.
"A lot of companies have already stopped the manufacturing of such devices, and that in itself speaks volumes.
"Now the group has been set up we intend to look at what has gone wrong, how it was allowed to go so drastically wrong and ensure other women do not fall victim of it."
The group will meet every month and Mr Tami has urged constituents affected by mesh implants to get in touch with
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Failing medical implants are causing hundreds of thousands of people misery
Sep 20, 2017 | The Conversation
By Thomas J Joyce
Thousands of women across the world have been left in terrible painafter being implanted with transvaginal mesh – a device to treat urinary incontinence or prolapse. How did a medical implant that has caused so much damage to these women’s bodies and lives come to be sold?
Most people probably have a good idea of how drugs are tested and approved – through clinical trials and placebos – but they probably don’t know how medical implants make it onto the market. If a headache pill that works for four hours has undergone clinical trials, what about an artificial hip that has to last for 40 years inside you?
The truth is, that for most medical implants, no clinical trials are undertaken. Instead, most medical implants are approved on the basis of “substantial equivalence”. In other words, if your new implant is substantially equivalent to an implant already on the market, then it likely gets approved.
Clearly someone has to decide how close one implant is to another. And in my experience, they can be quite different from each other and still get approved. Indeed, when independently reviewed in the US, the substantial equivalence process was said to give no evidence that “the cleared device was safe or effective”.Three recent scandals
Many implant makers highlight the regulatory “burden” required to bring a new implant to market. However, despite these regulations, there have been three recent scandals involving medical implants: metal-on-metal hips, breast implants and mesh implants. Arguably, this shows that medical implant regulation isn’t working. At the very least, these scandals have left hundreds of thousands of people worrying about the long-term effects of defective implants in their bodies.
Many thousands of people have been left in pain, perhaps unable to work. Others have seen relationships break down and feel that their lives have been ruined.
There are many heartbreaking stories from patients who were told their lives would be changed for the better, not worse, and it seems reasonable to ask how this situation came about so that it can be prevented in future.Why do we have these scandals?
I think there are three main factors. First, despite some companies’ claims of a primary responsibility to their patients, most companies exist to make a profit, which means bringing implants to market quickly and selling as many as possible. Why spend money on a long, expensive clinical trial when regulations say you don’t have to?
The second factor is the regulators themselves. These organisations are often guided by their government to work with industry to bring innovative medical implants to market, both to benefit manufacturers (who provide jobs and pay taxes) and patients. If the pull is too much towards industry, this is known as “regulatory capture”. This is where a regulator that has been set up to act in the public interest, instead advances the concerns of the sector it is charged with regulating.
It is also interesting to consider the word “innovative”; why do medical implants need to be innovative rather than safer or longer lasting or less expensive? Innovative means that a patent can be obtained, which can then be used to generate income. A safer implant doesn’t appear to carry the same potential financial reward as an innovative implant.
The third factor is a lack of transparency over the approval process. If the implant was approved in the EU, the information is confidential. This makes it very difficult to assess how an implant was tested and what the test results were. So the main judgement on an implant’s performance will come only after implantation – maybe two, five, even ten years down the line. To me, if the implant is deficient, that’s too late. By that time, thousands of people will have been implanted with a substandard device.How to fix it
Of course, there are ways to make the system work better. For example, there could be phased introduction of new medical implants undertaken at specialist centres where all details of the implants and the procedures are fully tracked. Once the efficacy is shown after a certain amount of time, then the implant could be introduced more widely.
It is also important that regulatory capture is acknowledged. The priority for regulators should be stated as patient safety. If that means regulators stopping medical devices being implanted while patient concerns are investigated, then so be it.
Finally, transparency needs to be improved. We need to know what tests were done on implants and what the results were. With these changes in place, we might make implant scandals a thing of the past, not ongoing news.
http://theconversation.com/failing-medical-implants-are-causing-hundreds-of-thousands-of-people-misery-84230
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