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J&J's DePuy pushes back at medical funding for hip implants
Sep 28, 2015 | Fierce Medical Devices
By Emily Wasserman
...The pushback comes a little more than a month after information surfaced about the medical funding industry's dealings with patients suing over vaginal mesh devices... -
Can electric pants help stop embarrassing leaks? Device uses electrical stimulation to strengthen pelvic floor muscles
Sep 28, 2015 | Daily Mail
By Jennie Agg
...Stephanie suffers from incontinence as a result of childbirth, and as the full-time mother from East Sussex recalls: 'There was no way I could run around with Jack in the park. Every time I'd try to play with him it was just . . . awkward.'...
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J&J's DePuy pushes back at medical funding for hip implants
Sep 28, 2015 | Fierce Medical Devices
By Emily Wasserman
Johnson & Johnson ($JNJ) is striking back at a surgical funding company for allegedly profiting on patients who are suing J&J over its all-metal hip implants and seeking corrective surgeries, a month after a new report shed light on the funder's questionable dealings with individuals involved in vaginal meshlitigation.
As Reuters reports, J&J's DePuy Orthopaedics unit is asking a federal court to make Texas-based medical funder MedStar reveal information so it can see whether the funder tried to "artificially inflate damages claims" for individuals suing over its all-metal ASR hip implants. Medical funding companies like Medstar cover underinsured or uninsured individuals involved in mass litigation cases by purchasing medical bills at steep discounts from doctors, hospitals or other providers. The funders then agree to pay for patients' corrective surgeries, as long as individuals accept a lien on settlements.
But the liens are often larger than expected, leaving patients or companies paying for corrective surgeries with a large bill. MedStar submitted claims of about $1.5 million for 11 surgeries that should have cost no more than $360,000, DePuy said in a federal court filing seen by the news outlet. And the funder is trying to collect twice as much as it paid to collect patients' medical bills and four times what DePuy would typically pay for care, it added
MedStar founder Dan Christensen is standing by the company's practices, saying claims in the DePuy hip implant litigation are "usual, customary and reasonable," he told Reuters. But DePuy said it needs to see the funder's records before it pays for care. And if the company doesn't like what it sees, it will leave plaintiffs responsible for picking up the tab, according to the Reutersstory.
The pushback comes a little more than a month after information surfaced about the medical funding industry's dealings with patients suing over vaginal mesh devices. At least several hundred women with claims against vaginal mesh manufacturers have used medical funders to finance surgeries, Reuters reported at the time. And in one case, Medstar and its affiliates charged mesh plaintiff Tracy Rizzo more than $60,000 for its services--about three times the amount the company paid to have the plaintiff's implant removed.
"I don't begrudge anybody their share," Rizzo said, as quoted by Reuters. "But when businesses are abusing already injured people, it is greedy, it is wrong and it shouldn't be allowed."
Meanwhile, DePuy is gradually resolving litigation over its all-metal hip implants. In 2010, the company agreed to fork over $2.5 billion to settle thousands of lawsuits claiming injuries by its ASR all-metal hip implants. But J&J/DePuy still face more 6,000 lawsuits over its Pinnacle hip implants, including some cases consolidated in a district court in Texas. When all is said and done, J&J will likely pay upward of $4 billion to resolve its implant cases, Carl Tobias, a product-liability law professor at University of Richmond, said earlier this year.
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Sep 28, 2015 | Daily Mail
By Jennie Agg
The great thing about having children when you're young is supposed to be that you'll have the energy to run around after them.
However, Stephanie Baldwin, 23, could only watch from the sidelines as her toddler Jack played in the park with her husband, Richard.
Stephanie suffers from incontinence as a result of childbirth, and as the full-time mother from East Sussex recalls: 'There was no way I could run around with Jack in the park. Every time I'd try to play with him it was just . . . awkward.'
Embarrassing leaks meant she had to change her clothes at least once a day. 'Every time I sneezed or laughed, I'd have an accident. I used to love running and doing yoga, but it became impossible.
'I never went out unless I was in a long top that covered up my bottom half. It affects how you feel about yourself.'
At least one in three women is affected by some form of incontinence, such as urge incontinence or overactive bladder, which means people cannot hold the need to go, typically because of a problem with the nerves around the bladder.
Stephanie has stress incontinence that results from damage to the pelvic floor muscles, the layers of muscles that lie across the base of the pelvis like a sling.
It is the most common type of incontinence in women, as these muscles are often damaged by the weight of a growing baby or trauma during childbirth. The menopause can also weaken the muscles as oestrogen helps keep muscles functioning.RELATED ARTICLESPrevious12NextEat to beat the menopause: There's no need for a...Secrets of an A-list body: How to get Myleene Klass's...ME AND MY OPERATION: Hi-tech ankle joint that gets you back...SHARE THIS ARTICLEShare
The pelvic floor muscles support the bladder and bowel. If the muscles themselves or the nerves that supply them are damaged, the muscles can lose their tone so they no longer support those organs, explains Dr Mark Slack, a consultant gynaecologist and urogynaecologist at Addenbrooke's Hospital in Cambridge.
'This means when women cough or jump, for example, the bladder and the urethra [the tube which carries urine out of the body] aren't held as they should be.'+3
She could only watch from the sidelines as her toddler Jack played in the park with her husband, RichardDr. O'Connor explains the different types of incontinenceLoaded: 0%Progress: 0%00:00PlayMuteCurrent Time0:00/Duration Time0:36Fullscreen
Many women wrongly assume nothing can be done for them. 'The common misconception is: "Oh well, I've just had a baby, I should expect this",' says Teresa Cook, a women's health physiotherapist and lecturer at the University of Bradford. 'But just because it's common, doesn't mean that women should put up with it.'
Women are advised to do exercises during pregnancy and afterwards to strengthen these muscles.
Even if a woman has no symptoms of incontinence after having babies, there can still be damage to the pelvic floor, says Teresa Cook. Then the fall in oestrogen around the menopause can lead to the muscles thinning and becoming less elastic, and so problems start.
Stephanie knew she had to exercise her pelvic floor, but admits she wasn't rigorous about it.
Her problems started soon after Jack was born - a bouncing 8lb 14oz - in 2011 after a four-day labour.
Over the following few months, she sought the help of a GP but was 'brushed off'. 'They would say "You just need to do your pelvic floor exercises." It was frustrating - I'd see a different doctor every time, and it's embarrassing to have to say: "I wet myself all the time." The exercises weren't working, and I did wonder if I was doing them wrong.' This is a common problem, says Dr Slack. 'We've done studies where we put electrodes on people to monitor their muscle movement and ask them to contract their pelvic floor - very often they end up moving the thigh muscles or buttocks,' he says.Every time I sneezed or laughed, I'd have an accident. I used to love running and doing yoga, but it became impossible
A pelvic floor exercise is a squeeze and a lift at the base of pelvis - and you should feel a lift up inside. To locate the right muscles, sit on a chair with your knees slightly apart, and squeeze and lift the muscles in your pelvis as if trying to stop urine flow.
Ideally, all women should be doing pelvic floor muscle exercises every day, says Teresa Cook. Try to squeeze the muscles ten to 15 times in a row.
Women with stress incontinence should be referred to a specialist women's health physiotherapist to ensure they're doing the exercises correctly. 'The longer muscles are left not working or are working incorrectly, perhaps if someone is doing the exercises wrong - for instance, bearing down rather than lifting up - it could be making the problems worse,' she says.
'That said, it's not uncommon for me to see women who've had problems for 30-odd years who never sought help. And, while it depends on the level of damage, there's no reason we can't resolve the problem.'
Lifestyle changes can also help. Smoking can weaken your pelvic floor as nicotine interferes with the work of oestrogen.
'Extra weight also adds strain to the muscles, and there may also be changes within the muscles themselves, as fat can be laid down within them, meaning they don't work as well,' she explains.
When more conservative methods have failed, surgery may be suggested. This can involve inserting a piece of plastic mesh to support the urethra, known as a tension-free vaginal tape (TVT) procedure, or an operation to lift up the neck of the bladder to stop leaks.+3
She now uses a new device worn outside the body that uses electrical stimulation to strengthen the pelvic floor muscles. It's called the Femifree
However, the use of TVT tape is controversial; as Good Health has reported, thousands of women have been left with problems as a result of the procedure, leading to pain and infection, worsened incontinence and even the end of their sex lives.
This is either because the tape was incorrectly inserted or the mesh itself has broken up in the body.
It was not until Jack was two that a thoroughly demoralised Stephanie was referred to a physiotherapist, who told her that her muscles were so weak that trying to strengthen her pelvic floor herself wouldn't be enough - she'd need to do 1,000 contractions to achieve the equivalent effect of two contractions for a woman with a normal pelvic floor.
She was told surgery was an option, or she could try 'biofeedback', where she'd be monitored using a special probe as she did her pelvic floor exercises to help her improve her contraction strength.
Her specialist physio also mentioned another option, a new device worn outside the body that uses electrical stimulation to strengthen the pelvic floor muscles. Called the Femifree, it looks a bit like a thick pair of cycling shorts, but has no waistband or gusset, and is connected to a remote, which controls the electrical pulses. It can be bought online for £249.
The idea is that the electrical impulse is transmitted to the muscles, which are strengthened in response to the stimulation. 'It's not painful to use - it feels a bit like pins and needles,' says Stephanie.
It's meant to be used for at least 12 weeks, for half an hour every day, for five days a week, with two days off. The strength of the stimulation is controlled by the user and can be increased over time.
'I started to see an improvement after four weeks,' says Stephanie. 'After a couple of months, the wetting had completely stopped.'
Findings from a trial of 20 women, sponsored by the manufacturers, presented at the annual meeting of the International Urogynecological Association in 2013, found that 79 per cent of women who used it for 12 weeks had good pelvic floor contraction compared to 6 per cent at the start of the trial.
However, not all the experts are convinced. 'The evidence just isn't there,' says Dr Slack. 'But it does at least make people more aware of their pelvic floor.'
Katie Mann, a specialist women's health physiotherapist and spokesperson for the Chartered Society of Physiotherapy, is concerned that such devices 'only move the muscles, they don't strengthen'.
'There are also concerns for women using this sort of device who've had an abnormal smear result, as stimulation may have an effect on cell division.'
Cancer occurs when cells divide in an uncontrolled fashion.
But Stephanie is adamant the Femifree worked for her and she has been using it again following the birth of her second baby, George, in March.
'My problems were much worse after having George. I actually started having leaks while I was pregnant this time. I'm still not quite myself but I'm confident I'll get back there again,' she says.
Read more: http://www.dailymail.co.uk/health/article-3252635/Can-electric-pants-help-stop-embarrassing-leaks-Device-uses-electrical-stimulation-strengthen-pelvic-floor-muscles.html#ixzz3n6S6zOnJ
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