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Ethicon Media Monitoring 10/27/16
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Bride needed pain relief injections to walk down the aisle after controversial incontinence surgery left her with an egg-sized blood clot
Oct 26, 2016 | Daily Mail
By Kelly Strange
Kim Vallis had suffered a leaky bladder since the birth of her son, Haydon, six years earlier. She was offered what she thought would be a quick and easy solution to the embarrassment of stress incontinence when she was 27. -
Boston Scientific sales growth exceeds expectations as profits rise
Oct 26, 2016 | Star Tribune
By Joe Carlson
...The company expects to pay sizable sums to the IRS for disputed taxes and to women who say they were injured by the company’s pelvic mesh devices, but executives don’t expect to have to borrow money next year to cover those costs, Chief Financial Officer Dan Brennan said Wednesday. -
Boston Scientific Remains Disciplined Buyer in Light of Large-scale Industry Consolidation
Oct 26, 2016 | The Street
By Sarah Pringle
Having steered clear of megadeals ever since its highly controversial purchase more than a decade ago of Guidant Corp., Boston Scientific Corp. (BSX) is likely to stick to tuck-in transactions for the foreseeable future-that is, unless the medical device developer were to find itself the target of M&A.
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Oct 26, 2016 | Daily Mail
By Kelly Strange
Kim Vallis has troubles with a leaky bladder after having her son Haydon, 6
She was 27 when she decided to have transvaginal tape treatment
Involves transvaginal tape being implanted under the bladder for support
Procedure left her in 'agony' and struggling to walk before being removed
Is now taking legal action and wants procedure stopping in England
Kim Vallis had suffered a leaky bladder since the birth of her son, Haydon, six years earlier.
She was offered what she thought would be a quick and easy solution to the embarrassment of stress incontinence when she was 27.
She had a treatment called transvaginal tape (TVT) - a mesh implanted under the bladder like a hammock to treat incontinence by supporting the internal organs.
But she says the controversial procedure - which has already been blacklisted in Scotland - left her in agony and she is now taking legal action against the hospital involved.
TVT tape is now known to have a devastating design fault — a tendency to break up in the body, causing small fragments to cut their way into surrounding tissue.
Mrs Vallis, from Gloucestershire, said coughing or sneezing would result in embarrassing leaks, to the point it was preventing her from doing everyday things with her son.
Using incontinence pads made her feel 'like an old woman' so when her consultant told her TVT would be a quick and easy answer she was happy to go ahead.
The 30-year-old now bitterly regrets her decision to go under the knife and says the operation almost destroyed her health.
'I ended up in agony for months and the pain nearly ruined my wedding day and my sex life,' she said.
But after the operation in January 2014 she awoke in agony.
The pain failed to ease and she struggled to pick up her son. She walked with a limp and a lump also appeared in her groin.
Partner Tony Vallis, 37, who the teaching assistant met a few months later, was understanding but she was in too much pain to have sex.
'I was madly in love with the man but sex was impossible. It was agony,' she said.
Still hoping things would get better the couple decided to marry in August 2015.
But as the big day approached Mrs Vallis begged doctors to investigate.
She went back into hospital where further surgery revealed a 4cm piece of mesh had looped over, causing the lump and pain.
It was removed, but her pain got worse and she could not walk or drive. She then had more surgery to remove an egg-sized blood clot in her groin.
'People told me I should cancel the wedding but I refused. I said I would use a wheelchair if I had to,' she said.
In the end, to allow her some sort of normality on the big day, a doctor injected painkillers so she could walk pain-free down the aisle. But a honeymoon was out of the question.
Mrs Vallis then discovered she was pregnant – but miscarried after 10 weeks.
'Nobody could tell me if it was the mesh but I felt there was no question. My body was a wreck because of it.'
She turned to her family for help and together they raised enough money so she could have the mesh removed privately.
After the procedure she was told by her specialist that it had been inserted incorrectly.
She claims to be one of hundreds of British women who say TVT surgery left them suffering chronic pain, repeat infections, nerve damage and poor urine flow.
Such is the controversy surrounding the mesh that NHS England has undertaken a working group review and several hospitals have stopped using it.
The surgery was suspended in Scotland by the Scottish government two years ago where 400 lawsuits are ongoing.
And in the USA and Canada around 100,000 lawsuits have been filed by TVT victims who have permanent disabilities.
However, it is still routinely offered to women in England and Wales suffering incontinence and pelvic organ prolapse – where the womb presses against the bladder – and there are no plans to stop the 13,000 operations taking place each year.
Mrs Vallis and others are now campaigning for England to follow Scotland's example.
Sohier Elneil, a consultant urogynaecologist and uroneurologist at University College Hospital, London, believes TVT has been hugely overused.
Before the tape was introduced patients were offered physiotherapy.
If that failed the next step could be a Burch colposuspension, a surgical procedure that involves lifting the front wall of the vagina and stitching it to the pubic bone. However, the procedure is more specialised than TVT.
'The scale of the (TVT) problem is not really acknowledged, but the complexity is, so much so that professional bodies are now coming together to try and standardise the care patients access,' says Miss Elneil.
Mrs Vallis now belongs to a support group called Sling The Mesh, which is campaigning for a ban and a national register of complications.
It was started by journalist Kath Samson after she had the surgery in March last year.
She had the mesh removed in September 2015 and says she is one of the 'lucky ones' who returned to full health.
'The problem is that the operation is considered a success on the basis that it does stop incontinence,' she said.
'What those statistics don't take into account is the fact it can destroy every other area of your life.'
Corinna Lincoln, a solicitor at Taylor & Emmet in Sheffield, said the number of women affected is worrying.
'In many instances other options were not explored properly with patients and women were not informed clearly that once implanted, the mesh is intended to be permanent,' she said.
'Removing it is extremely difficult and can result in even more harm and damage.
'As a result there are concerns women were not aware of the risks and were not able to make an informed decision.'
However, Natalia Price, the consultant gynaecologist and urogynaecologist who removed Mrs Vallis's mesh, stands by TVT as a treatment.
She argues it remains the 'gold standard' operation for treating stress incontinence.
'Complications can occur but the majority of patients get stress incontinence cured and experience no adverse outcomes,' she said.
Miss Price adds that mesh surgery to treat prolapse has a higher complication rate because the surgery involves a larger mesh, but says despite that, the surgery still offers considerable benefits.
She acknowledges she has seen an increase in women coming forward with concerns but believes some media reports about TVT have been misleading - and was unable to confirm if Mrs Vallis's had been inserted incorrectly because of the ongoing legal case.
'It is very important that women receive evidence-based unbiased information on the risks and benefits. They can then make a fully informed decision,' she said.
While Mrs Vallis can now walk, drive, and enjoy intimacy with her husband again, she remains angry, has formally complained to the hospital and is taking legal action.
'Women like me have been to hell and back because of the TVT mesh,' she said.
'Scottish women are now safe so why is it still available elsewhere in the UK? We won't stop until all women are safe and it is banned.'
http://www.dailymail.co.uk/health/article-3836629/Bride-needed-pain-relief-injections-walk-aisle-controversial-incontinence-surgery-left-egg-sized-blood-clot.html
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Boston Scientific sales growth exceeds expectations as profits rise
Oct 26, 2016 | Star Tribune
By Joe Carlson
Boston Scientific Corp., a medical device maker with major operations in Minnesota, saw profits rise 13 percent in the third quarter as sales grew at all of its divisions.
Overall sales rose 11 percent — the third consecutive quarter of growth exceeding 8 percent. Executives said in an earnings call Wednesday that they expect mid-single-digit percentage growth in revenue next year as well.
Although Boston Scientific stock dropped 35 cents to $22.09 Wednesday, stock analysts said the company’s positive financial news stood in contrast to what other med-tech companies have reported so far in third-quarter results.
“Certainly some [companies] that have gone before you [in the quarter] were starting to make investors nervous. So, congrats on a great quarter,” Bank of America analyst Bob Hopkins said, according to a transcript of the earnings call.
Boston Scientific executives believe the company is well-positioned to continue growth, but hurdles remain.
The company expects to pay sizable sums to the IRS for disputed taxes and to women who say they were injured by the company’s pelvic mesh devices, but executives don’t expect to have to borrow money next year to cover those costs, Chief Financial Officer Dan Brennan said Wednesday.
Boston Scientific also doesn’t expect to get Food and Drug Administration approval to sell an MRI-safe implantable defibrillator until next year, but officials expect sales to recover quickly, as they did in Europe once MRI-safe approval was secured there. “We believe the same performance we are seeing in Europe ... portends what we will see in the U.S.,” said Dr. Ken Stein, chief medical officer of the cardiac-rhythm management (CRM) division.
In response to analysts’ questions, CEO Mike Mahoney said Boston Scientific has not seen a boost in defibrillators sales this month after competitor St. Jude Medical revealed that a small percentage of its 350,000 implanted defibrillators have batteries that may lose power with little warning. But neither has it seen sales decline over fears of similar problems, he said.
Boston Scientific makes its own defibrillator batteries at a factory in Arden Hills. St. Jude buys its batteries from an unnamed third party.
Boston Scientific’s adjusted net income grew to $368 million on surprisingly strong revenue of more than $2.1 billion for the three months ended Sept. 30.
The revenue total came in 1 percent higher than Wall Street analysts had forecast, and higher than the company’s own guidance of up to 10 percent revenue growth for the three-month period.
Earnings per share were in line with expectations, at 27 cents per share, which was three cents higher than the same quarter last year.
The fastest-growing part of the company was the medical-surgical group, which grew 15 percent on sales of medical devices and supplies for endoscopy, urology and neuromodulation. The group of products for minimally invasive vascular procedures grew 13 percent. CRM device sales were up 4 percent.
The company raised guidance for its full-year results. Boston Scientific is now projecting full-year revenue of up to $8.38 billion, which would be a 12 percent operational growth, and adjusted earnings of between $1.09 and $1.11 per share.
For the fourth quarter, the company is expecting sales of up to $2.19 billion and adjusted earnings of 27 cents to 29 cents per share.
http://www.startribune.com/boston-scientific-profits-rise-13-percent-beating-forecasts/398662481/
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Boston Scientific Remains Disciplined Buyer in Light of Large-scale Industry Consolidation
Oct 26, 2016 | The Street
By Sarah Pringle
Having steered clear of megadeals ever since its highly controversial purchase more than a decade ago of Guidant Corp., Boston Scientific Corp. (BSX) is likely to stick to tuck-in transactions for the foreseeable future-that is, unless the medical device developer were to find itself the target of M&A.
As peers, including Abbott Laboratories (ABT) , Medtronic Inc. (MDT) and Johnson & Johnson (JNJ) , continued to fork out several billions of dollars for large acquisitions, Marlborough, Mass.-based Boston tended to pick up smaller companies that it could fold into its infrastructure and leverage cross-selling opportunities, as it touches virtually all of the gastrointestinal (GI) treatment market.
Company followers suspect that Boston's management team still hasn't built quite the appetite for transformative M&A, which is partly because it's not really the company's modus operandi and partly because the company has been working to de-lever its balance sheet and overcome litigation.
"There are companies that believe scale and breadth are important," Raj Denjoy of Jefferies LLC said. "The idea is that if you can offer a whole suite of products, you can offer unique solutions for customers. Then there are other companies-Boston, [Zimmer Biomet Holdings Inc. (ZBH) ] to an extent-that believe if you stick to your knitting, you can still do quite well, and so far Boston has demonstrated that. The jury is still out in terms of what strategy is going to prove most successful."
CEO and chairman Mike Mahoney doesn't seem to believe that adding another vertical would really help them, added Needham & Co.'s Mike Matson: "I think we'll see more of the same," he agreed.
Boston, which reports its third-quarter results Wednesday morning, has seen a reacceleration of top-line growth in recent months, fueled by areas outside of cardiology, including urology, endoscopy and women's health. Shares are up about 22.7% year to date and have appreciated 35.24% over the last 12 months.
Boston's latest deal came in late September, when it agreed to spend about $210 million for EndoChoice Holdings Inc. (GI) to expand its endoscopy franchise. The company's last billion-dollar-plus deal was its $1.6 billion purchase of the urology portfolio of Endo International plc's (ENDP) , under American Medical Systems. That included its men's health and prostate health businesses and was completed in August 2015.
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Those are just a drop it the bucket compared to Abbott, which is working to complete two pending deals--St. Jude Medical Inc. (STJ) and Alere Inc. (ALR) --worth nearly $40 billion combined. Medtronic, meanwhile, completed its $49.9 billion takeout of rival Covidien plc in January 2015.
The last time Boston did a deal close to that size, it didn't bode well for the company. In fact, Boston's current management team is arguably still feeling a little bit of a hangover from the actions taken several years ago by their predecessors.
Boston spent about $26 billion in April 2006 to trump Johnson & Johnson in the bidding war for troubled cardiac-device company Guidant. The transaction, which Fortune magazine and others called the second-worst deal in history (behind the $164.7 billion fusion of AOL and Time Warner (TWX) ), left Boston with a massive debt load, plus plenty of other problems. The target faced litigation and government investigations around failing cardiac devices that led to more than 50,000 product recalls or warnings around safety.
While it's paid down much of that debt in the years since, Boston still had about $5.4 billion in total debt as of June 2016. The company total debt-to-Ebitda ratio was just shy of 3 times at the time, as opposed to about 3.6 times as of December 2015.
Besides working to deleverage in the years since Guidant, Boston has also had to deal with other issues, including ligation related to its pelvic mesh business as well as a tax dispute with the Internal Revenue Service, said senior credit officer Diana Lee of Moody's Investors Service Inc., noting that it continues to make progress on both disputes.
"The point is, the company is trying to clean up some of these issues, which would certainly help provide it with greater flexibility, including for other investments and M&A," she noted. "It just comes down to the magnitude."
Matson expects Boston will likely limit itself to acquisitions valued below $1 billion and added that a transformative transaction involving Boston would more likely be one in which it was the target of a takeover."
"If there's a large deal, it's more likely them getting bought," Matson said.
This article was originally published by The Deal, a sister publication of TheStreet that offers sophisticated insight and analysis on all types of deals, from inception to integration. Click here for a free trial.
The most logical buyer of Boston Scientific would be Johnson & Johnson, given that it has largely gotten out of cardiovascular, said Matson. He sees it as a great fit given that the latter's device business has been a drag for them while Boston has been steadily growing.
While Johnson & Johnson is among the few companies that would even have the capacity to swallow Boston-with a current market cap of about $31 billion-Jefferies' Danhoy noted that it's "impossible to define what they'd want to do."
Indeed, the healthcare conglomerate also includes pharmaceutical and consumer segments. Despite an ability to act, it depends on its commitment to the medtech space.
Interestingly, Boston's Mahoney previously served as worldwide chairman of medical devices and diagnostics and worldwide group chairman of the DePuy orthopedics and neurosciences businesses at Johnson & Johnson from April 2007 through October 2011.
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Theoretically speaking, if Boston did want to do something transformative it could look to Edwards Lifesciences Corp. (EW) , which specializes in artificial heart valves and hemodynamic monitoring, suggested Venkat Rajon of Frost & Sullivan Inc. The two minimally overlap from a product standpoint and Edwards is first in market with its transcatheter heart valve, which Rajon noted has significant advantages to traditional valves. Boston is still developing a similar product, leaving Edwards and Medtronic as the two main providers.
Rajon added that what he'd really like to see Boston do is make a disruptive play that captures the growing evolution toward the internet of medical things, perhaps by pursuing an opportunity in information technology, consumer health, artificial intelligence or robotics.
"We have this wealth of data," Rajon said. "But how do we find out what's actionable? This 'insights as a service' type of model is where we're seeing healthcare try to make a pivot towards."
Representatives of Boston did not return a request for comment, while representatives of J&J and Edwards declined to comment.
https://www.thestreet.com/story/13866862/2/boston-scientific-remains-disciplined-buyer-in-light-of-large-scale-industry-consolidation.html
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