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Ethicon Media Monitoring 1/23/2019
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Vaginal mesh has caused health problems in many women, even as some surgeons vouch for its safety and efficacy
Jan 22, 2019 | Washington Post (In SFGate)
By Susan Berger
Regina Stepherson needed surgery for rectocele, a prolapse of the wall between the rectum and the vagina. Her surgeons said that her bladder also needed to be lifted and did so with vaginal mesh, a surgical mesh used to reinforce the bladder. -
Video: Woman crowdfunding to have vaginal mesh removed
Jan 22, 2019 | BBC News
Victoria Adams says she has been left in constant pain and feeling suicidal as a result of a vaginal mesh operation. -
New NHS mesh centres cannot guarantee surgeons are competent enough to remove mesh implants
Jan 22, 2019 | Cambs Times
By Kath Sansom
A total of 25 centres have been set up across the UK to deal with hundreds of women suffering pain, loss of sex life and infections. -
Botched surgeries lead to two-decade fight with ACC
Jan 23, 2019 | Stuff.co.nz
By Cate Broughton
A woman's bowel has been left so disfigured in multiple botched surgeries she struggles to use a colostomy bag and spends hours in her bathroom every day. -
J&J Sees Slowing 2019 Growth in a Warning to Health-Care Sector
Jan 22, 2019 | Bloomberg
By Riley Griffin
Johnson & Johnson, the world’s largest maker of health-care products, said it expects growth to slow or halt this year, a warning as the rest of health-care sector prepares to give 2019 guidance in the coming weeks.
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Jan 22, 2019 | Washington Post (In SFGate)
By Susan Berger
Regina Stepherson needed surgery for rectocele, a prolapse of the wall between the rectum and the vagina. Her surgeons said that her bladder also needed to be lifted and did so with vaginal mesh, a surgical mesh used to reinforce the bladder.
Following the surgery in 2010, Stepherson, then 48, said she suffered debilitating symptoms for two years. An active woman who rode horses, Stepherson had constant pain, trouble walking, fevers off and on, weight loss, nausea and lethargy after the surgery. She spent days sitting on the couch, she said.
In August 2012, Stepherson and her daughter saw an ad relating to vaginal mesh that mentioned 10 symptoms and said that if you had them, to call a lawyer.
"My daughter said, 'Oh Mom - you have every one of those,' " Stepherson, of Tyler, Texas, recalled.
Vaginal mesh, used to repair and improve weakened pelvic tissues, is implanted in the vaginal wall. Initially, in 1998, it was thought to be a safe and easy solution for women suffering from stress urinary incontinence.
But over time, complications were reported, including chronic inflammation, and mesh that shrinks and becomes encased in scar tissue, causing pain, infection and protrusion through the vaginal wall.
Katrina Spradley, then 49, was about to have a hysterectomy in April 2008. She said that she told her physician that she also had urinary issues - every time she would laugh, cough or sneeze, she would leak urine. It happened so often that she wore sanitary pads. A urologist determined that implanting vaginal mesh at the same time as the hysterectomy would repair her bladder problem, she said.
Spradley, of Dawson, Georgia, also had endometriosis, a condition resulting from the appearance of endometrial tissue outside the uterus that most commonly causes pain (painful periods, heavy bleeding, pain with sexual intercourse). She thought that was the reason she began having stomach cramps after the surgery, she said, and physicians told her nothing was wrong.
In 2011, a urine test she took for her truck-driving license showed blood. Later, while having sex with her husband, his penis got scratched. It took a visit to a physician with her husband to detail his discomfort to find mesh eroding through Spradley's vagina, she said.
Chrissy Brajcic, a Canadian who struggled for four years with persistent infections following a mesh implant, became the face of mesh victims with a Facebook page. Brajcic died in December 2017 from sepsis at 42.
About 3 million to 4 million women worldwide have had mesh implanted to treat urinary incontinence and prolapse, said Shlomo Raz, professor of urology and pelvic reconstruction at UCLA school of medicine. About 5 percent - or 150,000 to 200,000 - of those have complications, he said.
"But when you have complications, it's hard to treat," Raz said.
Among the complications: chronic pelvic pain, erosion of mesh into the vagina, incontinence, obstruction, pain in the groin, hip and leg, and pain during intercourse. Raz also believes, based on his experience, that 20 to 30 percent of the complications are what he calls "lupus-type," causing runny nose, muscle pain, fogginess and lethargy. He bases this on the fact that, after removal, the patients are cured of these complications.
"If you remove mesh, and lupus-type symptoms disappear, the mesh is responsible," Raz said.
Michael Thomas Margolis, assistant clinical professor at UCLA, has removed more than 600 mesh slings in patients since 1998. He has served as an expert witness on polypropylene mesh in lawsuits for plaintiffs and most recently for lawsuits filed by the states of Washington and California.
"I have never implanted through a woman's vagina a polypropylene mesh or sling system ever, because of the complications," Margolis said. "I had concerns when they first came out - but my concerns were the tip of the iceberg."
Once the damage is done, it cannot be corrected, Margolis said.
The American Urogynecologic Society (AUGS) and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) support the use of polypropylene slings for stress incontinence. Their joint statement says that "Polypropylene material is safe and effective as a surgical implant."
Raz and Margolis disagreed. Raz, who said that many of the AUGS physicians who wrote the positive position statement were his fellows, said: "I don't agree based on my experience. I found that in the long run, we have created a monster, planting mesh in young women - some of them you can never cure."
Margolis said that many of the authors of the AUGS and SUFU joint position statement "receive substantial money from mesh manufacturers." He also said: "I have been a giant thorn in AUGS's side. They should at least acknowledge their financial conflict of interest."
According to the AUGS board of directors website, some of the directors do have financial interests in companies that make mesh.
Dionysios Veronikis, director of female pelvic medicine and reconstructive surgery at Mercy Hospital St. Louis, who has removed 250 to 300 mesh slings a year, said that problems result when a mesh is not implanted properly. He also said that women need to see a surgeon who does many of these surgeries. Their patients have fewer complications, Veronikis claimed.
He also said that "some of the [mesh] products have helped many women."
"The slings I do, although synthetic, have helped many women," he said. "I put the sling in differently. I don't follow the instructions that are outlined because I have a unique skill set that allows me to make the operation fit the patient. I don't make the patient fit the operation. That is the flaw. There is no one size fits all, and not every woman wears a size 7 shoe."
Two years ago, Roxann Bentz was 67 and had a cystocele (prolapsed bladder) and some urinary incontinence. The Bucks County, Pa., woman researched physicians to repair the problem. Bentz, a registered nurse, was aware of poor outcomes and found a surgeon who specialized in the procedure. "I knew he had done many of these," she said.
Bentz, an active woman who enjoys biking and canoeing, said the recovery was fine, and she has had no problems since the surgery.
Raz, who said he has removed 1,800 mesh implants in the past six years, said vaginal bacteria creates a potential for chronic mesh infection and pain in some patients, and mesh should not be used in the vagina.
"We took patients with pelvic pain and mesh complications and those without pain. We removed four segments. All of those with pelvic pain were positive for live bacteria in the mesh," Raz said. "Those without pain had no DNA positive for bacteria in mesh."
More than 100,000 lawsuits have been filed against makers of mesh, according to ConsumerSafety.org, making it "one of the largest mass torts in history."
In October 2016, a judge upheld a $14.3 million jury award for three women who were injured by a Boston Scientific mesh device, and in 2015, Boston Scientific announced a settlement of $457 million for 6,000 mesh lawsuits.
Kate Haranis, a spokeswoman for Boston Scientific, said the company stands behind its products and noted that "Nearly one million women have been successfully treated with Boston Scientific Urogynecologic mesh and our pelvic floor therapies are supported by more than 60 clinical publications."
Lawsuits have been filed by the states of Washington, California, Kentucky and Mississippi against mesh maker Johnson & Johnson and its subsidiary, Ethicon, saying that product marketing should have provided more detail about the risks. They accuse the company of deceiving physicians and patients, and say the mesh has destroyed the quality of life for some of them, according to the Associated Press.
In response, 63 surgeons in Washington wrote a letter in December to state Attorney General Robert Ferguson denying that they were misled, and expressing the concern that the lawsuit would "eliminate the mid urethral mesh sling as a treatment option for women in Washington." This, they said, would have a negative impact because the sling is standard surgical treatment for stress urinary incontinence.
Jeffrey L. Clemons and two other physicians who signed the letter disclosed they had been retained by the defense, but that they were not being paid nor receiving any assistance.
Ethicon called the lawsuit filed by Kentucky "unjustified" and said "the company plans to vigorously defend itself against the allegations."
Endo International settled 22,000 mesh lawsuits in 2017 for $775 million and said its president and chief executive, Paul Campanelli, called it "a very important milestone for Endo to have reached agreements to resolve virtually all known U.S. mesh product liability claims."
In 2008, according to the Food and Drug Administration, "the number of adverse events reported to the FDA for surgical mesh devices to repair POP [pelvic organ prolapse] and SUI [stress urinary incontinence] for the previous 3-year-period (2005-2007) was 'over 1000.' " The agency said the complications included mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems.
From 2008 to 2010, the FDA received 2,874 reports of complications associated with surgical mesh. The FDA's literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication.
According to a study published last year, all surgical meshes in the United States were cleared by the FDA's 510(k) process, "in which devices simply require proof of 'substantial equivalence' to predicate devices, without the need for clinical trials." The study also said that "recalled meshes associated with adverse effects may, indirectly, continue to serve as predicates for new devices raising concerns over the safety of the 510(k) route." The authors conclude that improvements for regulation are "urgently required."
An FDA spokeswoman said that the agency is making improvements. The agency reclassified surgical mesh in 2016 for transvaginal pelvic organ prolapse (POP) repair from Class II (which includes moderate-risk devices) to Class III (which includes high-risk devices). "FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device, and these devices present a potential unreasonable risk of illness or injury," the final order reads.
In addition, the agency is, "issuing postmarket surveillance orders to 34 manufacturers who had cleared 510(k)s for transvaginal repair of pelvic organ prolapse," the spokeswoman said. As a result of the FDA's actions, she said, "all manufacturers ceased marketing of surgical mesh intended for transvaginal repair of posterior compartment prolapse (rectocele). Only three surgical mesh products intended for transvaginal repair of anterior compartment prolapse (cystocele) remain legally marketed."
The FDA is also planning an advisory meeting on Feb. 12 to share evidence and expert opinion about the safety and effectiveness of transvaginal mesh.
Margolis said removing mesh that has scarred into place is like trying to remove bubble gum from hair or rebar from concrete.
"I have seen women with their vaginas essentially mutilated. So scarred and disformed as a result of the chronic inflammation and scarring from the mesh as to be left with a nonfunctional vagina or dysfunctional bladder and urethra," Margolis said. "When tissue, the vagina, bladder or bowel is damaged enough, no surgeon can fix the tissue past a certain point - and I see that with great regularity, even after mesh was implanted years before."
If women are concerned about complications because of a mesh, what should they do if they are plagued by stress incontinence or prolapse?
There are nonsurgical options, such as Kegel exercise and pessaries, that can help with stress incontinence, Margolis said.
Raz and Margolis prefer slings made from organic, biologic material such as tissue or tendons from their own patients.
Margolis also said that the Burch procedure, a surgical procedure in which the neck of the bladder is suspended from nearby ligaments with suture is excellent, but noted that it, too, can fail.
Vaginal mesh is no longer being used in Australia, Ireland and Scotland. In July, the United Kingdom instituted a temporary ban while long-term damage is assessed.
https://www.sfgate.com/news/article/Vaginal-mesh-has-caused-health-problems-in-many-13551930.php
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Video: Woman crowdfunding to have vaginal mesh removed
Jan 22, 2019 | BBC News
Victoria Adams says she has been left in constant pain and feeling suicidal as a result of a vaginal mesh operation.
The NHS has curbed the procedure over safety concerns after it was found some women were left in agony.
Ms Adams, from Standlake in Oxfordshire, is now crowdfunding to have it removed, after the NHS refused to do it.
For full video: https://www.bbc.com/news/av/uk-england-oxfordshire-46947574/woman-crowdfunding-to-have-vaginal-mesh-removed
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New NHS mesh centres cannot guarantee surgeons are competent enough to remove mesh implants
Jan 22, 2019 | Cambs Times
By Kath Sansom
A total of 25 centres have been set up across the UK to deal with hundreds of women suffering pain, loss of sex life and infections.
However, the same surgeon society calling for women to seek help, admits that being on the special list “does not endorse competency”.
All it means is they comply with “correct personnel and agreement to correct processes.”
Campaigners say it is a harsh blow to women.
Jackie Harvey, of Sling The Mesh Northern Ireland, said: “If they cannot guarantee competency then what is the point? Mesh removal is not a walk in the park, it is a highly skilled and high risk procedure.
“You cannot announce specialist centres then quietly add they might not be any good. This pays lip service to women who have been left to suffer by surgeons, who deny their pain is anything to do with their mesh implant.
“We know of so-called specialist centres that continue to deny mesh is a problem, others where they say they cannot help and simply refer women on. This is not good enough.”
Surgeons in Northern Ireland in particular, insist they have transferable skills to automatically perform mesh removals, Jackie added.
“You can’t just have a go. We need accredited mesh removal programmes so women trust that these surgeons know what they are doing.”
The burden to the NHS of mesh injured women is becoming increasingly apparent after surgeon Suzy Elneil at UCLH in London was forced to close her doors to new referrals, quoting waiting times of up to 18 months.
Three three other removal surgeons women trust - Hashim Hashim in Bristol, Karen Ward in Manchester and Natalia Price in Oxford - have waiting lists of more than a year.
A spokesman for RCOG said: “It is absolutely vital that women with mesh-related complications receive prompt and comprehensive support and care from a multi-disciplinary team of professionals in a specialist unit.
“Women can either self-refer or be referred by their GP to any one of the specialist centres across the country identified by the British Society of Urogynaecology based on compliance with set criteria.
“NHS England is currently producing a specification for mesh removal centres which will be commissioned to provide care for women with mesh complications through a network.
“RCOG remains committed to ensuring the highest standards of training and care among obstetricians and gynaecologists (O&Gs). Consultants who work in specialist units must have the necessary skills required to operate in the affected areas of women with mesh related complications.
“RCOG provides the GMC approved curriculum for sub speciality training in urogynaecology which addresses mesh complications.
“The RCOG continues to work with key partners to meet the conditions set out by the Independent Medicines and Medical Devices Safety Review to ensure the safety of treatments – including mesh – for women with stress urinary incontinence and vaginal prolapse.”
https://www.cambstimes.co.uk/news/sling-the-mesh-rcog-bsug-1-5862362
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Botched surgeries lead to two-decade fight with ACC
Jan 23, 2019 | Stuff.co.nz
By Cate Broughton
A woman's bowel has been left so disfigured in multiple botched surgeries she struggles to use a colostomy bag and spends hours in her bathroom every day.
But the 60-year-old says the emotional trauma and financial harm she's been left with after 16 years of dealing with ACC has been worse.
"It's all the mistakes, having to fight them all the time."
The woman has suffered pain, trauma and humiliation following reconstructive surgeries with mesh for a pelvic organ prolapse in 2001 and 2002, and undergone 13 further corrective procedures.
ACC initially declined a claim for a treatment injury following the 2001 procedure but then agreed to accept it one day before a review hearing in November 2001.
Weekly compensation payments did not begin until early 2003 though.
By then she had been forced to sell her house, unable to afford mortgage payments on a sickness benefit.
Advocate Meagan McKee-Trail, who began helping the woman in 2014, said ACC had failed in their duty of care to her client on numerous occasions.
Failures included not providing supplies of colostomy bags, stopping weekly compensation 15 times without explanation, a bungled bathroom re-fit and leaving the woman with a substandard mobile home that has already cost her $6000 in repairs.
She has suffered severe depression and anxiety.
ACC spokesman Nick Maslin said ACC had done nothing wrong.
"We are working closely with [her] to meet her injury-related needs quickly and effectively."
The woman chose to speak out about her experience of ACC in the hope it would spur a change.
"There are so many changes that are needed to make it a fair system."
In 2001 life was going well, and she was working as a landscaper and had bought her first house.
Following a pelvic organ prolapse – when the uterus, rectum or bladder push down into the vagina due to weakened muscles and tissue – she had surgical treatment that was covered by ACC as a work injury.
In the following year her pelvic floor prolapsed again and a mesh procedure in 2002 resulted in major complications.
Over time, the mesh wrapped around her bowel and severe constipation disabled the colon muscles.
In 2014, McKee-Trail helped the 60-year-old with an application for a vehicle with a toilet and shower so she could visit family in other parts of New Zealand.
But the second-hand mobile home ACC approved did not meet its own standards and was considered of "below average condition" in a pre-purchase AA report.
Plumbing for the toilet and shower do not work and the woman has to use bottles of water instead.
Maslin said ACC was "not obliged to replace [her] current vehicle".
"We were clear about the van's limitations and discussed with her what we were responsible for."
Several times compensation payments have been stopped without explanation resulting in huge financial stress.
"I'm terrified. I live on the minimum wage ... you live day to day in fear of them making mistakes."
The woman's bathroom was renovated in 2015, after a request to ACC in 2014 as the toilet was separated from the bathroom by a long hallway and had no sink.
Major defects in the work resulted in a rotting shower floor and difficulty flushing the toilet.
Despite raising concerns about the mistakes with her case manager, ACC failed to act on them, McKee-Trail said.
"She became more and more suicidal. We're lucky she's still here."
Work to fix the mistakes only started in July 2018.
Maslin said the delays were due to "variations in the build" and the client "was always involved in the build process and we kept her fully informed throughout".
A lump sum payment for her permanent disability took two years to calculate and the final amount of $23,000 was nearly half the $40,000 originally promised.
Maslin said an ex-gratia payment of $5000 was paid "due to the issues around this calculation".
In 2016 the woman requested counselling for stress caused by ACC's mishandling of her case, which doctors found had resulted in "mental disorders and chronic depression".
ACC's decision was upheld at a review as she did not meet the criteria for cover for a mental injury under the Act, which states it must be caused by a physical injury, a result of sexual abuse or workplace trauma.
https://www.stuff.co.nz/national/health/109835004/botched-surgeries-lead-to-two-decade-fight-with-acc
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J&J Sees Slowing 2019 Growth in a Warning to Health-Care Sector
Jan 22, 2019 | Bloomberg
By Riley Griffin
Johnson & Johnson, the world’s largest maker of health-care products, said it expects growth to slow or halt this year, a warning as the rest of health-care sector prepares to give 2019 guidance in the coming weeks.
The company’s shares fell 1.8 percent Tuesday morning after saying that revenue this year will grow somewhere between 0 and 1 percent -- potentially worse when the strong dollar is factored in. While the company often tops the targets it sets for itself, the 2019 goal pales in comparison to its projections a year ago for sales growth of almost 2 percent.
“We still have more work to do and we are committed to continuing to build upon this momentum and return to above-market growth in 2020,” Chief Executive Officer Alex Gorsky said during a conference call with analysts.
J&J has consumer, medical-device and pharmaceutical units that would be large health-care companies in their own right. It’s the first of the major medical-device and drug companies to report earnings, and offers investors a hint about how the rest of the industry may fare.
The Standard & Poor’s industry subindex of drug, biotech and medical device companies, was down 0.9 percent, in line with the broader S&P 500.
Two major trends that could hurt other companies are likely to pressure J&J this year.
Almost half of J&J’s fourth-quarter revenue growth came from abroad, where its operations grew 5.1 percent, compared to 1.5 percent in the U.S. But foreign exchange fluctuations trimmed out all but 0.4 percentage points of those gains.
In the U.S., the company is feeling the ongoing effects of the drug cost debate, which is being led by the Trump administration and Democrats who now control the House of Representatives.
“We share the administration’s goals of reducing health-care costs while improving the quality and efficiency of care,” said Gorsky. Net prices for its drugs -- which make up about half of J&J’s business -- fell 6 percent to 8 percent in 2018, according to the company.
“Pricing pressure is expected to persist and a stronger U.S. dollar will likely result in a negative impact on reported results in 2019,” Chief Financial Officer Joseph Wolk said on the call.
The company is also facing competition to some of its biggest drug products. Zytiga, a prostate cancer drug, now faces cheaper generic rivals. The company also expects more competition to Remicade, its top-selling drug product, from so-called biosimilar copies.
Gorsky said the company will look for deals to expand its drug portfolio.Legal Costs
J&J is also dealing with thousands of lawsuits in which plaintiffs have claimed they were harmed by the company’s artificial hips and vaginal reconstructive mesh, or given cancer by its talc-based baby powder.
The company reported $1.29 billion in litigation expenses before taxes in the fourth quarter, more than twice what it spent a year before.
“The significant majority of these reported expenses reflect the company’s efforts to resolve some of the older cases in our medical device business,” said Ernie Knewitz, a spokesman for the company. In December, Bloomberg reported that J&J had agreed to pay an average of about $125,000 per case to resolve about a third of 10,000 pending suits against the company over defective hip replacements.
The company also faces more than 20 trials this year focused on claims it hid the alleged cancer risk posed by its talc-based baby powder.
The company has said it will continue to defend the safety of its talc products. Talc litigation made up about 10 percent of the company’s legal costs in 2018.
https://www.bloomberg.com/news/articles/2019-01-22/j-j-predicts-slower-growth-in-2019-in-warning-to-health-sector
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