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Ethicon Media Monitoring 5/22/2017
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Probe to examine possible conflicts of interest in troubled mesh implant inquiry
May 21, 2017 | The Sunday Post
By Marion Scott & Alistair Grant
HEALTH secretary Shona Robison has ordered an independent review of Scotland’s troubled mesh implant inquiry – amid fears that some members of the team had previous links to firms which make the devices. -
Alison Britton to report on Scottish government’s review of transvaginal mesh implants
May 19, 2017 | Scottish Legal News
Health Secretary Shona Robison has commissioned Glasgow Caledonian University’s (GCU) Professor Alison Britton to examine and report on the Scottish government’s Independent Review into Transvaginal mesh implants. -
Gruesome tales from a dysfunctional health care system
May 19, 2017 | The Washington Post
By Juliet Eilperin
... While this might sound reasonable in theory, it means different versions of a vaginal mesh taken off the market in 2002 continued to sell, even though the original one had caused a significant number of internal injuries. -
Canadian Concerns Over Surgical Mesh Recalls and Usage on the Rise
May 21, 2017 | Legal Scoops
Dr. John Morrison, Canada’s Hernia Society president, has expressed concerns over the growing number of hernia meshes in the country. The president stresses concern that the surgical abdominal mesh is being used in almost all hernia repairs with many products not receiving proper clinical trials or research before entering the market. -
Prolapse And Her Sex Life
May 21, 2017 | The Cleaner
... Now it is this surgical mesh that you have heard bad news about. When this treatment was invented - quite a while ago, it seemed like a great idea. People often referred to it as 'the hammock', because it seemed like placing it between the front vaginal wall and the bladder would be a comfortable way of holding everything up.
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Probe to examine possible conflicts of interest in troubled mesh implant inquiry
May 21, 2017 | The Sunday Post
By Marion Scott & Alistair Grant
HEALTH secretary Shona Robison has ordered an independent review of Scotland’s troubled mesh implant inquiry – amid fears that some members of the team had previous links to firms which make the devices.
The Scottish Government set up the inquiry after hundreds of women given the implants to treat bladder problems were left with life-changing injuries.
But mesh campaigners were dissatisfied with its report, which decided against banning most types of mesh implant.
Three inquiry members resigned just before the report’s publication, claiming some recommendations had been removed.
Now The Sunday Post can reveal that all four clinical experts on the 20-strong inquiry, plus three other members, had links to firms which made the mesh implants.
There is no suggestion that any of these people has done anything wrong, and many surgeons work closely with companies developing new medical techniques.
But campaigners and politicians say all their links with mesh firms should have been made clear.
Last week, campaigners took their complaints to Holyrood’s Public Petitions Committee.
Miss Robison told the committee she has now asked Glasgow Caledonian University Professor Alison Britton to “produce a report on how the independent review process was undertaken”.
It will look at the selection of review committee members and any conflicts of interest.
Members were only required to declare outside interests going back 12 months.
Former health secretary Alex Neil – who ordered the original inquiry – welcomed the review, saying: “The whole issue of conflicts and declaration of interest is an area I will expect Professor Britton to look closely at. I was adamant nobody with any mesh interest should be appointed.
“I feel people have gone behind my back and appointed those who clearly did have previous interests.
“I want to know who knew about those interests, and why those taking part were only asked to go back just one year when clearly that did not give a true picture.”
Mr Neil will call every member of the review group to Parliament to explain their links.
Among the campaigners at Holyrood this week was mesh survivor Elaine Holmes, who earlier this year resigned from the review.
She said: “Vital evidence was ignored by the review which hasn’t taken account of so many significant issues and safety warnings, we fear it will leave more women at risk.”
One member, Karen Guerrero, lead urogynaecologist for NHS Glasgow, had organised training programmes for gynaecologists which were sponsored by mesh firm Boston Scientific.
Surgeon Paul Hilton took part in some of the earliest trials of mesh implants. He is also an independent expert witness for the NHS in a forthcoming mesh damages case.
NHS Lothian consultant Voula Granitsiotis took part in mesh trials while Ayrshire and Arran’s Wael Agur had links to Boston Scientific, Ethicon and CR Bard.
Professor Cathryn Glazener, researcher to the inquiry, was also involved in a number of multi- million-pound trials funded by an NHS research body.
Patient representative Isobel Montgomery was involved in two mesh trials.
Urogynaecologist Ash Monga, who sat on the review to represent professional bodies, was involved in a mesh research project which did not go ahead. He said: “All the mesh problems started to appear so they abandoned it.”
He added he had complied with all the committee’s requirements on declaring interests.
Mr Agur, who resigned from the review before publication of the report, added: “All my competing interests were declared to the Scottish Government.”
Mr Hilton stressed his independence, saying that he had received research funding from two companies between 1998 and 2003, but had no contact with any such firm since 2003.
Miss Granitsiotis declined to comment but a spokesman for NHS Lothian said: “All working group members were requested to declare relevant interests and to state whether they were personal or non-personal interests.”
Prof Glazener and Dr Guerrero both declined to comment.
Mrs Montgomery, from Aberdeen, said the trials she had been involved with were “completely unbiased.” She added: “I am an ordinary member of the public, with no industrial or business interests, and have taken on this work on a purely altruistic basis with the aim of improving the treatment of women in the future.”
NHS Greater Glasgow and Clyde said: “The patients have the opportunity to fully discuss the risks and benefits of treatment options with their consultant before they are listed for surgery.”
Boston Scientific said: “Boston Scientific takes seriously its obligation to help train physicians on the proper use of our products.
“Any monetary or in-kind contributions offered by Boston Scientific for these educational sessions follow our strict internal guidelines and external legal requirements.”
A Scottish Government spokeswoman said: “All members of the review were asked to complete a declaration of interests form at the time the group was set up and the lists for remaining members of the group were updated in 2016 and again prior to publication to add interests not previous declared.”
Review chair Tracey Gillies told MSPs that leading the review had been “almost mission impossible from the beginning.”
https://www.sundaypost.com/fp/probe-to-examine-possible-conflicts-of-interest-in-troubled-mesh-implant-inquiry/
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Alison Britton to report on Scottish government’s review of transvaginal mesh implants
May 19, 2017 | Scottish Legal News
Health Secretary Shona Robison has commissioned Glasgow Caledonian University’s (GCU) Professor Alison Britton to examine and report on the Scottish government’s Independent Review into Transvaginal mesh implants.
The final Independent Review was published this year in March 2017. The review assessed the evidence relating to the surgical procedure of transvaginal mesh implants, when in 2014, former Health Secretary Alex Neil called for the suspension of the procedure, and an independent review group was set up to look at the safety issues.
Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
Professor Britton said: “It is an honour to be asked by the Cabinet Secretary to examine and report on the Independent Review. I am aware of the challenges that lie ahead.”
Professor Britton will consider how the independent review process was undertaken and look to lessons learned for the future, including a review of the selection of committee members; potential conflicts of interest; and the management of external influences.
Following this, she is expected to draft guidance for the chairs and members of all independent inquiries to ensure that full understanding of the roles and terms of reference and to support those who give their time and expertise.
Professor Britton is a specialist in public healthcare, clinical negligence, mental health law and professional ethics. In recent years, her interests have focused upon the practical application and the role of law in matters of public health. She is currently working with the General Medical Council to review their guidelines on consent.
https://www.scottishlegal.com/2017/05/19/alison-britton-to-report-on-scottish-governments-review-of-transvaginal-mesh-implants/#
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Gruesome tales from a dysfunctional health care system
May 19, 2017 | The Washington Post
By Juliet Eilperin
Juliet Eilperin is The Washington Post’s senior national affairs correspondent and author of “Fight Club Politics: How Partisanship Is Poisoning the House of Representatives” and “Demon Fish: Travels Through the Hidden World of Sharks.”
Covering the current health-care debate in Washington, I hear politicians every day (and read them on Twitter) describing our current system as a disaster. Health and Human Services Secretary Tom Price informed a key House Appropriations panel recently that the Affordable Care Act is making health “unaffordable for so many Americans.” President Trump has predicted that the federal insurance exchanges the ACA has created will both “explode” and “implode” (in which order, I’m still unclear). Having just passed the American Health Care Act through the House, congressional leaders and administration officials have promised that the legislation will return the country to “patient-centered care” and lower the costs of premiums for Americans in some states who have seen them spike, once it’s eventually signed into law.
But with just one exception — Trump’s call for lower prescription drug prices — almost no one inside the Beltway is coming up with plausible ideas to cut the cost of health care. Luckily, Elisabeth Rosenthal, a longtime health-care journalist and former emergency room physician, has tackled this question in her new book, “An American Sickness: How Healthcare Became Big Business and How You Can Take It Back.” Reading it is a sobering experience, one that shows what’s really at stake when it comes to our sprawling, costly and illogical health-care system.
Other authors have taken on this territory before: David Goldhill’s 2013 book, “Catastrophic Care: How American Health Care Killed My Father — and How We Can Fix It,” provided a persuasive case for applying free-market principles and greater transparency to the health-care industry. But Rosenthal — who practiced medicine before entering journalism and now serves as editor in chief of Kaiser Health News — combines her reportorial and medical skills to provide an authoritative account of the distorted financial incentives that drive medical care in the United States. As a result, she has produced a fairly grim tale of how patients — and at times, insurers — are getting ripped off, sometimes with devastating consequences. In short, this is the antithesis of a feel-good book.
Yet it is illuminating, because Rosenthal does plenty of digging to explain the puzzling outcomes that patients and those who care for them often encounter. How does the American Medical Association determine the value of specific services that are entered as codes in a given bill? The AMA convenes the Relative Value Scale Update Committee three times a year, where representatives from different specialties argue over how much they’re worth. One former committee member, a dermatologist, tells her it’s like having “26 sharks in a tank with nothing to eat but each other.” Why did the reimbursement rate for immunological tests done by pathologists drop? Rosenthal offers one theory: “Pathologists tend to be quiet, antisocial types and have never been very good at forming alliances or lobbying.” Why doesn’t the Food and Drug Administration have more tools to ensure that drug development is cost effective? Because Congress was in a rush to respond to the thalidomide tragedy in the early 1960s, when the babies of some women who took the morning-sickness drug were left with permanent birth defects.
Plenty of Americans are familiar with the idea that pharmaceutical drugs are vastly more expensive in the United States than in other nations and that drugmakers spend enormous sums on advertising their wares while keeping generic versions of these same medicines off the market. But few probably know that many medical devices get scant scrutiny from the FDA because they fit into the “Class 2” category of devices, which are “substantially similar” to ones on the market and used for a similar purpose. While this might sound reasonable in theory, it means different versions of a vaginal mesh taken off the market in 2002 continued to sell, even though the original one had caused a significant number of internal injuries.
Throughout the book, Rosenthal intersperses human stories that demonstrate what happens when the medical profession fails us. Wanda Wickizer was a healthy 50-year-old until she had “a random explosion deep within her skull” on Christmas in 2013; since she was uninsured, her physical injuries were accompanied by hundreds of thousands of dollars in bills. At one point, a hospital official suggested seizing her home as a way to help erase the debt. A 36-year-old diabetic in Memphis, Catherine Hayley, noted that the insulin pump she wears on the waistband of her jeans is “made of plastic and runs on triple-A batteries, but it’s the most expensive thing I own, aside from my house.”
While Rosenthal does her best to squeeze in a few jokes (mostly lighthearted references at pathologists’ expense), the subject matter makes for dense reading at times. This is a thorough book, but it’s hard to envision a casual reader picking it up and whiling away the weekend with it. And on occasion her obvious immersion in the medical field slows the writing down a bit, as when she decries the disappearance of two anti-nausea generic drugs. “Not having prochlorperazine available in an emergency room is like not having acetaminophen (Tylenol) in a drugstore.” I couldn’t help wondering why the book’s editor hadn’t just struck “acetaminophen” and left “Tylenol” in its place.
Still, Rosenthal does include a set of very practical tips at the end of the book for ensuring that individual patients lower their bills and obtain the treatment they need. This sort of “news you can use” served as a pick-me-up after the parade of horribles that preceded it. She provides smart questions consumers can ask not just their doctors, but also hospitals and insurers. She even strikes a rebellious tone by suggesting that readers consider importing “long-term medicines whose efficacy can be clearly measured” since that’s an easy way to cut costs. “Importing drugs for personal use is technically illegal,” she notes blithely, “but intercepting small packages of medicine is impossible from a practical standpoint — and the U.S. government has for a long time intentionally turned a blind eye to the practice.”
There are several policy prescriptions at the end, too, but even Rosenthal acknowledges that most of them aren’t going to be adopted anytime soon. And that’s the irony of this book: At a time when the national health debate is largely centered on how to manage insurance rules for about 15 percent of Americans, Rosenthal has made a powerful case for everything else that’s wrong in the way that we treat illness in this country. Maybe every lawmaker and administration official should pick up a copy of “An American Sickness.” Then, at last, the serious debate could begin.
https://www.washingtonpost.com/opinions/gruesome-tales-from-a-dysfunctional-health-care-system/2017/05/19/589e7f92-1fb2-11e7-ad74-3a742a6e93a7_story.html?utm_term=.74069ddef01c
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Canadian Concerns Over Surgical Mesh Recalls and Usage on the Rise
May 21, 2017 | Legal Scoops
Dr. John Morrison, Canada’s Hernia Society president, has expressed concerns over the growing number of hernia meshes in the country. The president stresses concern that the surgical abdominal mesh is being used in almost all hernia repairs with many products not receiving proper clinical trials or research before entering the market.
Canadian patients have filed a mass tort lawsuit against Johnson & Johnson, the maker of the recalled Physiomesh product.
Reports from CTV News, find that some patients had to have surgery to determine the cause of unexplained pain only to find that the hernia mesh procedure failed with the one patient having the mesh rolled up inside the torso.
Health Canada finds that 12 hernia mesh products have been recalled since 2000 in Canada’s market. Patients suffered from infections and perforations with three deaths and 185 reports of serious injury as a result of the hernia mesh products.
Dr. Morrison states that in some cases, the hernia mesh isn’t required but is still used. His practice includes the removal of mesh products which have shifted inside of the patient’s body and often pierce their organs.
Mesh products have been found to erode in the body and move into other organs of the body, too.
Morrison states that as much as 20% of people that have hernia mesh procedures are left in chronic pain afterwards. He suggests that patients that have pain for longer than three months should find a hernia surgeon that will correct the issue.
He foresees the issue only getting worse as more and more patients are being treated using the surgical mesh procedures despite the massive recalls and warnings against the products.
Thousands of Canadians have hernia surgery each year with a growing number of complaints as a result of surgical mesh complications. Morrison suggests that people undergoing hernia surgery ask their doctors if surgical mesh will be used and research their options for the type of hernia they’re diagnosed with.
The class-action lawsuit against Johnson & Johnson, the mesh is made by the company’s subsidiary Ethicon, alleges that the company’s surgical mesh caused higher than average reoperation and recurrence rates in the patients that had surgery to implant the mesh product.
The group behind the lawsuit believes that the product is linked to their chronic health and pain problems. Plaintiffs allege that the surgical mesh had a design defect that causes the mesh to migrate, tear or contract while in the body.
http://www.legalscoops.com/canadian-concerns-surgical-mesh-recalls-usage-rise/
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May 21, 2017 | The Cleaner
Q Doc, could my sex life be affected by a prolapse?
I am a married woman with four children, and recently sex has become very difficult. My husband has trouble entering me even though his erections are always good.
Sometimes we can't manage at all, so we are reduced to giving him a hand-job. He does not mind, but he said that he feels that there is an 'obstruction' in my vagina, so he has urged me to go to the doctor.
She examined me, and told me that I had this thing called a prolapse. She said it is very common. I think she mentioned that it has something to do with childbirth, and I am going back to her next week to find out about treatment.
I am a little worried, because I heard something about a treatment being dangerous. But what is prolapse, Doc? And will I be able to have sex again?
ASorry to hear about your problem. As your doctor says, prolapse is very, very common, particularly among women who have had children.
The word means a 'falling downwards' of the internal organs. Because the vagina is an opening in the lower part of the body, there is a tendency for internal structures to fall down through it! These structures include the womb and bladder.
In young women, there are a lot of natural supports (like ligaments) which prevent everything from falling down. But childbirth does weaken these supports. The more children you have, the weaker the supports are likely to get. I note that you have had four children, so the support of your womb and bladder may have taken a bit of a battering!
Now what are the symptoms of prolapse? These vary, but if the womb is coming down through the vagina, you may well feel a swelling progressing downward. This bulge may make intercourse impossible.
Furthermore, if the bladder is starting to come down through the vagina, you'll very likely get urinary problems, like difficulty in urinating and perhaps incontinence.
So, a prolapse can be a great trial to a woman. What can be done about it? Well there are various possible treatments:
- Pelvic exercises. These build up the supports of the womb. In mild cases, they can be very helpful. Any midwife can teach you how to do them.
- A 'ring pessary.' This is a kind of solid 'prop' which a gynecologist fits into the vagina. Mainly for older women, it has to be changed every few months.
- Hysterectomy. This is complete removal of the womb. In some women, that is a good solution, but it's not for everybody.
- A 'repair' operation. This term is applied to various surgical procedures, in which the surgeon/gynaecologist 'darns up' the tissues, so as to make them all strong again.
- Surgical mesh. This is a rectangle of polypropylene which the gynecologist inserts under the bulging bladder, so as to try and support everything.
Now it is this surgical mesh that you have heard bad news about. When this treatment was invented - quite a while ago, it seemed like a great idea. People often referred to it as 'the hammock', because it seemed like placing it between the front vaginal wall and the bladder would be a comfortable way of holding everything up.
But unfortunately, things have not turned out so well. It turns out that the female body is not too keen on polypropylene, which is the kind of plastic used in packaging, and in drink bottles. Sometimes, the material cuts into the tissues and causes pain and swelling. The edge of the mesh sometimes pokes into the vagina, making intercourse very difficult and even painful. Some male partners have actually been injured by the sharp edge of the mesh!
As a result, thousands of American women are trying to sue their surgeons, or the makers of the mesh. This is a sorry state of affairs.
So now that you are aware of some of the options that are open to you, you can choose your course of action. I strongly advise you not to choose the mesh (also known as 'the tape').
http://jamaica-gleaner.com/article/outlook/20170521/dear-doc-my-wife-puts-viagra-my-food
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