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Ethicon Media Monitoring 10/27/2017
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Dr. Bendavid Hernia Researcher Tells Parliament Adverse Events Are Underreported
Oct 26, 2017 | Mesh Medical Device Newsdesk
Dr. Robert Bendavid, of Shouldice Hospital in Toronto, researches hernia repair with polypropylene mesh and studies both mesh and non-mesh repairs and the adverse outcomes. -
New Health Minister Wants Answers on Slow Surgical Mesh Injuries Response
Oct 27, 2017 | Stuff.co.nz
By Cate Broughton
New Minister of Health David Clark wants an explanation on the slow progress on surgical mesh injury prevention. -
Boston Scientific's 3Q Sales, Earnings Grow Despite Puerto Rico Plant Shutdown
Oct 26, 2017 | Minneapolis Star Tribune
By Joe Carlson
Boston Scientific said its profit grew nearly 15 percent in the July-to-September quarter, despite pressure on its implantable heart devices business. -
Why French Women Don’t Suffer From Incontinence (And How to Prevent Post-Baby Leakage)
Oct 26, 2017 | Organic Authority
By Sara Novak
It’s a running joke amongst many women, you laugh too hard, sneeze unexpectedly, or go for a run and you may spring a leak post-baby birth.
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Dr. Bendavid Hernia Researcher Tells Parliament Adverse Events Are Underreported
Oct 26, 2017 | Mesh Medical Device Newsdesk
Dr. Robert Bendavid, of Shouldice Hospital in Toronto, researches hernia repair with polypropylene mesh and studies both mesh and non-mesh repairs and the adverse outcomes.
Because he is so involved in offering research that challenges the established medical societies, he flew to London to participate in Parliamentary debate initiated by the Sling the Mesh Campaign.
During the Parliamentary debate, it is clear that MP (Member of Parliament) Emma Hardy led the way. She says her mail box has been filled with statements from people all around the UK such as:
“Please help me I feel desperate. Who can I turn to to get relief from the terrible irritation and pain I am experiencing. My husband is very worried about my health mentally and bodily, because I keep telling him the quality of my life is dreadful.”
The government of England has rejected a ban on surgical mesh unlike Scotland that has suspended the use of pelvic mesh since 2014. While an estimated 8,000 women in England have experienced mesh complications, no one is keeping tabs on the actual number of complications. Many women are told instead that their symptoms are due to “getting old.”
Like the U.S., there is no active post-approval registry. Adverse events or complications are also not reported by surgeons as Dr. Bendavid enforced in his address to Parliament.
Here is a transcript from the event is recorded in the Hansart here.
Dr. Bendavid tells MND what is needed next.
“As to my trip in London, it was simply to listen to the presentations and debate led by Emma Hardy who passionately defended the women who were victimized by various surgeries (TVT, TVT-O, POP). She did it eminently well. She had the support of many of the MPs present if not all (it was not easy understanding them all!).
“The last to speak was Jackie Doyle Price, who is the undersecretary of Health but also a Minister of Social Affairs, I understand. She stated that “there was not enough evidence to suspend the mesh” and that hopefully, by Christmas, there should be a report.
“The second session was one led by Owen Smith (MP for Ireland and who smart as a whip and very likable) and Emma Hardy. I spoke and so did Carl Heneghan (Oxford and in charge of Evidence Based Medicine) and a stunning lady who was a urogynaecolological surgeon, Dr Suzy Elneill, who spoke eminently well and drove the message clearly home.
“The message I brought is that not all complications are being reported. A registry has to be mandatory otherwise there would be no collaboration.
“On that subject, the very same Dr David Urbach published a paper proving how little cooperation can be expected from practicing surgeons and why!
“Also, follow-ups are deceiving since complications reported are too soon and we do know that for procidentia* in women, 50% of the problems may occur by 4 years and 8-10 years would be a far better period to assess all patients.
“In hernia surgery, the invasion and erosion which needs explanation of the mesh and vas deferens is usually after 7-13 years. So that if a young man of 18 is to have a bilateral inguinal hernia repair with mesh (as recommended by the EHS “World Guidelines” … by the time he is 30, marries … he may never have a family if he were to plan on one.”
https://www.meshmedicaldevicenewsdesk.com/dr-bendavid-hernia-researcher-tells-parliament-adverse-events-underreported/
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New Health Minister Wants Answers on Slow Surgical Mesh Injuries Response
Oct 27, 2017 | Stuff.co.nz
By Cate Broughton
New Minister of Health David Clark wants an explanation on the slow progress on surgical mesh injury prevention.
"I will want to be briefed on it, but I've said in the past I can't understand why there hasn't been a [surgical mesh] registry formed and if there is a good reason I haven't heard it, so I would like to hear from the ministry," he said.
At a meeting of health agencies and the advocacy group Mesh Down Under last week, the ministry committed to a cost-benefit analysis for a pelvic surgical mesh registry within the next three to six months, director of protection, regulation and assurance Dr Stewart Jessamine said.
The registry would exclude mesh hernia repair surgeries.
"It's possible other mesh surgeries could be considered subsequently," Jessamine said.
In the three years since a parliamentary Health Select Committee (HSC) launched an inquiry into surgical mesh injuries, ACC treatment injury claims have increased by 82 per cent, according to a ACC review published on October 18.
The review said ACC had spent $13 million on 810 claims for surgical mesh injuries lodged between July 2005 and June 2017.
Claims had increased over the 12-year period from six in 2005-06 to 150 in 2016-17.
People injured by mesh procedures suffer infection, damaged nerves and chronic sharp pain, which can result from erosion or displacement of the mesh.
Other effects include loss of feeling in the groin, legs and abdomen; inability to work; sexual dysfunction; depression; anxiety and opioid addiction.
A mesh registry was among eight recommendations made by the HSC in 2016 to better monitor use of mesh and prevent injuries.
No action was taken to investigate a registry as it was to be part of the overhaul the therapeutic goods legislation due to begin later this year.
The ACC review found just over half of all mesh ACC claims (53 per cent) were for gynaecological procedures and 36 per cent were for hernia repair surgeries, with the remainder for urology, plastic and burns and other.
Most mesh injury claims were from women (76 per cent).
Mesh Down Under membership had grown to 472 injured people since it first petitioned the Government for an inquiry in 2014.
At last week's meeting the parties also agreed to the co-design of patient information leaflets by the Royal Australasian College of Surgeons and Mesh Down Under, ministry involvement in the distribution of new information to patients and support for mesh injury research.
Jessamine said all parties "recognised the harm done to a number of women as a result of the use of surgical mesh and a commitment from all involved to work together to improve patient outcomes".
The ministry also committed to establishing a working group to progress the HSC's recommendations.
Mesh Down Under spokeswoman Charlotte Korte said the group was thrilled the Government and medical colleges had agreed to take action on the issue, but wanted the registry to include all mesh procedures.
"We think it is really fantastic that the ministry are doing the cost-benefit analysis on a register because it means it is being treated with urgency and separate from the therapeutics goods legislation, which is a great step forward."
Christchurch man John Pritchard, who has suffered from excruciating pain after a hernia procedure in June last year, said he was pleased the meeting had gone ahead.
He wanted Clark to ensure patients were properly informed about the potential risks and for a registry to be set up urgently.
"I didn't even know I had mesh in me until I had all this pain."
https://www.stuff.co.nz/national/health/98259214/New-Health-Minister-wants-answers-on-slow-surgical-mesh-injuries-response
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Boston Scientific's 3Q Sales, Earnings Grow Despite Puerto Rico Plant Shutdown
Oct 26, 2017 | Minneapolis Star Tribune
By Joe Carlson
Boston Scientific said its profit grew nearly 15 percent in the July-to-September quarter, despite pressure on its implantable heart devices business.
Three major hurricanes in the third quarter, including one that temporarily halted manufacturing in Puerto Rico, didn’t stop medical device maker Boston Scientific Corp. from increasing sales a tad more than Wall Street had expected.
Hurricanes Harvey and Irma triggered widespread flooding and evacuations in Houston and parts of Florida during the quarter, depressing medical-procedure volumes in those areas, while Hurricane Maria inundated medical-device factories across Puerto Rico, cutting off grid power and making it difficult for many employees to even report for work. A fourth storm, Hurricane Ophelia, had a small impact on operations in Ireland when it hit on Oct 16.
The three storms during the quarter that ended Sept. 30 decreased sales by less than $20 million for Boston Scientific, which employs thousands in Minnesota. The plant in Puerto Rico is back online and operating at about 90 percent capacity with generator power.
“We didn’t really want to overplay the weather card,” CEO Mike Mahoney told stock analysts Thursday in a quarterly earnings call.
Competitor Medtronic has said publicly that the storms may cut revenue by as much as $250 million in the quarter.
Asked whether Boston Scientific would benefit from other companies’ setbacks, Mahoney said, “I think our team has done a really good job of limiting supply outages and having terrific contingency plans and backup plans to minimize those impacts that you’re maybe seeing a little bit stronger from other companies.”
Meanwhile, executives said Boston Scientific continues to make progress on its backlog of legal liabilities, which have been a billion-dollar-plus overhang on the stock and company cash flow for the past several years.
Chief Financial Officer Daniel Brennan said Thursday the company has settlement agreements in place, or is in final-stage negotiations, to resolve 44,000 of the 48,500 known and potential lawsuits facing Boston Scientific over patient injuries blamed on its pelvic-mesh products. Industrywide, well over 100,000 such lawsuits have been filed against mesh manufacturers.
Brennan said Boston Scientific continues to build its legal reserves with the expectation of resolving the majority of its mesh claims in 2018. The legal reserve stood at $1.6 billion as of Sept. 30, he said.
Various legal settlements have required so much cash that they have consumed the majority of Boston Scientific’s free cash flow for several years running. Executives hope that with the mesh litigation resolved, and a sizable payment to the IRS for disputed back taxes in the works, they can begin to devote more of their cash to stock repurchases and mergers-and-acquisitions (M&A).
“M&A and returning cash to shareholders are our two most favored uses of cash. I think we’ve balanced that well over the last four or five years, while at the same time settling a lot of legacy litigation liabilities,” Brennan told investors. Earlier this year, “we talked about 90 percent-plus of our cash over the next three years being able to go toward M&A and share repurchase, where it’s been kind of the reverse of that over the last three or four years.”
At the same time, Boston Scientific is confident it can grow its U.S. cash flow with new products that are already selling well in Europe.
Mahoney said sales grew 9 percent in Europe in the most recent quarter, propelled by sales of products like the Acurate Neo minimally invasive aortic heart valve replacement device, the Eluvia drug-eluting stent system for blocked arteries in the legs, and the Vercise Gevia deep-brain stimulation system to treat Parkinson’s, dystonia and essential tremor. None of those devices is yet approved in the U.S.
“One of the reasons we have confidence in our continued growth profile is because many of those products that we’re selling in Europe today that are doing well are not yet approved in the U.S., and they will be approved in the U.S. over the next coming years,” Mahoney said in a phone interview Thursday.
On Thursday, the company reported adjusted net income of 31 cents per share for the third quarter, in line with expectations. Its $2.2 billion in revenue was slightly above Wall Street estimates and represented growth of about 6 percent over the same quarter last year.
Looking ahead, the Massachusetts-headquartered company increased its full-year sales guidance to a range between $8.99 billion and $9.02 billion, representing an expectation for 7 percent operational growth for the year. The company also tightened its expected full-year earnings range to between $1.24 and $1.27 per share, raising the bottom end of the range by a penny.
Boston Scientific shares closed at $28.82, down 2.7 percent for the day.
http://www.startribune.com/boston-scientific-s-3q-sales-earnings-grow-despite-puerto-rico-plant-shutdown/453304833/
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Why French Women Don’t Suffer From Incontinence (And How to Prevent Post-Baby Leakage)
Oct 26, 2017 | Organic Authority
By Sara Novak
It’s a running joke amongst many women, you laugh too hard, sneeze unexpectedly, or go for a run and you may spring a leak post-baby birth. Once you open up the flood gates, it’s hard to close them back up again. But for many women it’s not funny. It’s a real problem that leaves them feeling embarrassed and isolated. However, if you look at women in France, you’ll find that incontinence post-baby or at any point is far from an inevitability, in fact, it’s highly preventable.What is Incontinence?
According to the National Association for Incontinence, 25 million Americans suffer from incontinence at some point in their lives and nearly 75 percent of them are women. Incontinence is the term used to describe involuntary or accidental loss of urine from the bladder. It ranges in severity from a little leak to a complete loss of bladder control. Stress incontinence is the form of incontinence that’s common amongst many women post-pregnancy and childbirth when the pelvic floor muscles that support the urethra are weakened. This can cause leaking during activities that push down on this part of the body.
“During childbirth, the increase in gestational weight gain puts additional pressure on your entire pelvic floor. The muscles and ligaments in your pelvic floor are weakened and damaged, making it more difficult to hold your bladder,” says Laura Arndt, a certified strength and conditioning coach that recently started Matriarc, an app focused on pregnancy and postpartum health. “Relaxin is a hormone in your body that increases elasticity of your ligaments and joints to aid in delivery and this also causes issues. During delivery, there may be additional damage and strain to the muscles in your pelvic floor. This can later lead to Pelvic Organ Prolapse which effects urinary and rectal incontinence.”Why Don’t French Women Suffer From Incontinence?
One of the main reasons that French women don’t suffer from incontinence is because post baby, French women are prescribed 20 post baby “pelvic floor re-education” sessions. The sessions consist of a probe being inserted into a women’s undercarriage after which she is instructed to squeeze on the probe with her pelvic floor muscles to test the strength of the pelvic floor. Then, the doctor sets what amounts to a dildo with electrodes in it to a level necessary to work the pelvic floor muscles into a tizzy. Women even play video games with their vaginas, one writer wrote about her favorite of the games which she calls “cooter Pac-Man“. But embarrassing video games aside, after a few sessions, most women don’t have to worry whether a sneezing spell will cause an unexpected leak from below.
The difference in the U.S. versus France is that in the U.S. we view occasional leakage as a given post-baby and as the number of vaginal births increases, the worse the problem becomes. Add in an episiotomy and all bets are off. But it doesn’t have to be this way. For starters, says Gail Page, co-founder of Consortia Health, which specializes in treating incontinence, we need to open up a dialogue on the subject.
“People don’t want to talk about it,” says Page. “But incontinence is associated with isolation, depression, and reduced intimacy with partners. It can even cause marital problems.”
Page helped open a state-of-the-art facility in Austin, Texas, that she says is even better than what the French are currently doing. Consortia Health offers pelvic floor screening surveys, incontinence testing, and pelvic floor muscle training.What to Do About Incontinence
Beyond contacting Consortia Health or another healthcare provider that specializes in treating incontinence, there are a number of other steps that you can take that according to Arndt, can do a lot to prevent incontinence post pregnancy.1. Stay active during pregnancy and avoid too much weight gain.
In 2015, Yale School of Medicine published research that found that women who gained too much weight during pregnancy or weren’t active were more likely to experience weakening of their pelvic floor.2. Make time to strengthen your pelvic floor.
In France, new moms make time for their pelvic floors because of the treatment regimen that nearly all moms go through. But in the U.S. it’s not seen as important. This shouldn’t be the case. If you make time for your pelvic floor post-pregnancy, you won’t have to deal with leakage later. According to Arndt, strengthening of your core and pelvic floor immediately postpartum and continuing for life can greatly reduce your risk of “mommy bladder”. “Your transverse abdominals (lower abs), hips, lower back, and pelvic muscles strength all play a role in your body’s ability to control your bladder,” she says. She recommends kegels, pelvic tilts, bridges, dead bug crunch, supermans, and bird dogs for a couple minutes each day because they can play a huge role in prevention of incontinence.3. Don’t do exercises post-pregnancy that could damage your pelvic floor.
Arndt warns against exercises that increase abdominal pressure in the first six months to a year postpartum. Recti Diastasis, or abdominal separation, is common in many pregnancies, but in order for it to heal properly, women need to avoid exercises like crunches, planks, and heavy lifting that can increase abdominal pressure and make diastases worse. “If Diastasis doesn’t heal, your core muscles will remain weak and difficult to strengthen,” says Arndt. “This puts pressure on your lower back and pelvic muscles, causing pain, muscle weakness, strain, and increasing incontinence.”
http://www.organicauthority.com/why-french-women-dont-suffer-from-incontinence-and-how-to-prevent-post-baby-leakage/
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