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Ethicon Media Monitoring 11/20/2018
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What you should know about the reversal of transvaginal mesh surgery
Nov 19, 2018 | Health24
By Marelize Wilke
Transvaginal mesh is often offered as a solution for women who suffer from urinary incontinence. This procedure entails the implanting of mesh made from synthetic propylene to fix pelvic floor prolapse and stress urinary incontinence. -
The mesh implant scandal has highlighted how doctors must properly listen to women, says a male patient safety expert
Nov 19, 2018 | Cambs Times
By Kath Sansom
Women suffer from more illnesses throughout their lifetime than men, yet doctors often do not give proper time or serious attention to them, leaving some suffering for years, he said. -
FDA-Approved Medical Devices: Least Burdensome for Whom?
Nov 19, 2018 | The Legal Examiner
By Jane Akre
It is the jargon used by the U.S. Food and Drug Administration (FDA) to guide how it regulates medical devices. -
J&J Fights $4.7B Verdict Finding Talc Caused Ovarian Cancer
Nov 19, 2018 | Bloomberg Law
By Julie Steinberg
Johnson & Johnson will ask a Missouri court Wednesday to undo or at least cut a $4.69 billion verdict awarded to 22 women who blame their ovarian cancer on asbestos in its talc products. -
Kelp harvesting bid sparks plea from Sir David Attenborough
Nov 19, 2018 | The Herald
By Maureen Sugden
But one Scots company wants to harvest 30,000 tonnes of kelp off the west coast in a bid that has sparked controversy, amid concern for the preservation of these intricate systems, with Sir David Attenborough now stepping in to voice his concerns.
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What you should know about the reversal of transvaginal mesh surgery
Nov 19, 2018 | Health24
By Marelize Wilke
Transvaginal mesh is often offered as a solution for women who suffer from urinary incontinence. This procedure entails the implanting of mesh made from synthetic propylene to fix pelvic floor prolapse and stress urinary incontinence.
Although the procedure sounds non-invasive and simple on paper, the statistics tell an entirely different story. During the past couple of years, the transvaginal mesh procedure has come under the spotlight – and several lawsuits have been filed.
Common complaints were that it caused severe pain and discomfort, didn’t stop urinary incontinence despite being a costly procedure, and that it causes damage to the nerves around the bladder and the urethra.
Severe side effects
Other frequently reported side effects include infection, bleeding, pain during intercourse and the exposure of the mesh through the vagina. Vaginal scarring was also reported by the FDA.
Because of the severity of these side effects, many patients who underwent transvaginal mesh implants wish to reverse the surgery. Luckily, a procedure named transvaginal mesh excision makes this possible.
According to The Guardian, thousands of women who underwent the surgery have had their transvaginal mesh implants removed. According to the publication, this means that one in 15 women who opted for transvaginal mesh implants will eventually opt to reverse the procedure.
A recent study published online in Journal of the American Medical Association stated that at least 3.3% of mesh surgery will be reversed after at least nine years. The study examined 95 057 women who had mesh inserted to treat stress urinary incontinence.
What does the procedure entail?
According to the UCLA School of Medicine, transvaginal mesh removal is a complicated, technical surgical procedure that requires a highly skilled surgeon.
In some cases, additional surgery may also be needed to correct the original prolapse or any other serious complications caused by the mesh.
What makes this procedure difficult?
Transvaginal mesh is considered a permanent implant and often results in tissue growing around the mesh, which means that it can only partially be removed. Removing the mesh without damaging the surrounding tissue and organs is difficult.
According to Dr Prenevin Gordin, a Cape Town-based urologist and Health24’s incontinence expert, the mesh is divided rather than entirely removed. He also says that the insertion of mesh, which is also called a “sling”, should be carefully considered and that your doctor should inform you of all the possible risks and side effects.
Is the removal safe?
A previous study cited on Health24 in 2014 mentioned that the removal of a transvaginal mesh implant might not necessarily improve side effects caused by the implant. According to study authors, it is not always clear whether the symptoms are definitely caused by the mesh implant and that removal of the implant will improve the situation.
That being said, the overall outcome of the study was positive – the study followed 123 women who underwent mesh removal surgery. Out of the 123 subjects, 67% experienced improvement in pain and side effects.
Another study published in 2017 in the Journal of Urology looked retrospectively at clinical cases of transvaginal mesh removal over a period of eight years. Albeit a small sample size, the results were better and the outcome was that the removal of vaginal mesh is safe and that it can eliminate symptoms.
How should you be treating your incontinence?
The first port of call would be to consult your doctor who might refer you to a urologist. Although you might feel embarrassed at first, you should know that incontinence can be successfully treated or managed, even without surgical intervention.
Consult your doctor immediately in the following cases when:Home treatments and lifestyle changes don't make a difference.There is blood in your urine.Your incontinence gets significantly worse in a short amount of time, especially after a surgical procedure or medication.You experience any additional physical weakness, which can signify a stroke.
https://www.health24.com/Medical/Incontinence/News/what-you-should-know-about-the-reversal-of-transvaginal-mesh-surgery-20181113
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Nov 19, 2018 | Cambs Times
By Kath Sansom
Women suffer from more illnesses throughout their lifetime than men, yet doctors often do not give proper time or serious attention to them, leaving some suffering for years, he said.
Bruce Hugman, communications specialist for Uppsala Monitoring Centre in Sweden, says in addition, the risk of treatments are often not properly communicated to women.
Mr Hugman, part of a global organisation dedicated to improving patient safety, said: “Doctors must listen, give time and pay serious attention to women.
“Healthcare systems, institutions and priorities are designed and managed largely by men; many women are subject to the arbitrary rule of male authority.
“Successful health care for women can happen only when patient’s own personal health stories are deeply appreciated and risk of any treatment or operation are properly communicated.
“Chronic pelvic pain has long been neglected, even disparaged; the vaginal mesh implant disaster took years to be taken seriously, clandestine abortions represent a huge threat.
“Although women live longer than men almost everywhere, they suffer from more illnesses and disabilities throughout their lives.
“Reproductive health, cancer, heart disease, chronic pain, depression, visual impairment, osteoarthritis, dementia and other diseases of old age, are major issues.
“In coronary heart disease, women receive less effective treatment and have poorer outcomes than men.
“In conditions unique to women such as pregnancy and menopause, there are vast disparities in access, treatment and outcomes within nations and across the world.
“Many of the treatments for women are complex, problematic or risky. Screening for breast cancer, medication for epilepsy and other procedures and conditions in pregnancy, menopausal hormone therapy, contraception among them.
“Recruitment of women in clinical trials, neglect of issues of importance to women in research (such as endometriosis and menopause); differential and discriminatory treatment (excess opioid prescription for pain), oppressive male behaviour and neglect of compassionate care, all exhibit systemic bias, a real danger for women.
“Data and information are often not disaggregated by sex.
“Millions of women have little or no access to healthcare or are inhibited or prevented from accessing it.
“Women in ethnic and sexual minorities, even within affluent societies, endure higher risks of pregnancy related complications and deaths than white women, rural women, higher risks than urban women.”
Bruce said three major changes are needed;
• Women need easy access to the best information, ideally access to local, well informed health workers, preferably women.
• Researchers and health workers, must act on the belief that the needs, preferences and priorities of women are important and quite different from those of men.
• Women’s health and welfare, their potential for self-management, the risk of treatment regret, are intimately influenced by political, social, economic, systemic, spiritual and psychological operators that are additional, major risk factors that require recognition.
Mr Hugman said: “Without knowledge and wisdom in the richness, complexity and risks of women’s lives, even good data is a poor servant, and the statistical benefits and harms of medicines unreliable guides.
“The authentic narratives of women’s lives are the essential foundation for good risk communication and good health care.
“Doctors must listen, give time and pay serious attention to them.”
http://www.cambstimes.co.uk/news/mesh-health-women-1-5786170
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FDA-Approved Medical Devices: Least Burdensome for Whom?
Nov 19, 2018 | The Legal Examiner
By Jane Akre
It is the jargon used by the U.S. Food and Drug Administration (FDA) to guide how it regulates medical devices. It sounds like what Americans expect of their federal agency—that an FDA clearance means only the safest devices make it to market.
But look at little closer.
Least burdensome is regulatory language that imposes the least burden on industry, not on you! The 510(k) requires device makers to register their device and notify the FDA they intend to market it in 90 days. It’s different from a drug clearance which generally involves Premarket Notification (PMA) and years of testing and clinical trials. There is no such imposition on device makers. The company must only name a “predicate device” theirs resembles and exchange paperwork with the FDA’s Center for Devices and Radiological Health (CDRH), which oversees medical devices.
In other words, the FDA gently guides industry through the clearance process to assure it will get on the super highway to marketing in the least burdensome way possible.
In 2005, the average cost for a 510(K) review was about $4,000, compared to a PMA fee of about $200,000, according to the Government Accountability Office (GAO). A 510(k) will generally happen within 90 days as compared to up to 295 days for a PMA submission. In a 2011 review of medical device recalls by the consumer group, the National Research Center for Women & Families, more than two-thirds of the faulty devices that had caused death or serious harm went through the 510(k) clearance process. Hernia mesh is among them which also includes metal-on-metal hips and transvaginal mesh.
In other words, permanently implanted medical devices can make it to market in 90 days in the easiest clearance possible. More than 90% of medical devices make it to market through the 510(k). The FDA currently does not even have the power to require a medical device maker to fix a defective device. Instead, it relies on the manufacturer to conduct a voluntary recall. That leaves the door opened for industry to reintroduce the device at a later time.
The Institute of Medicine, in its 2011 report, (read it here) called the 510(k) clearance “fatally flawed” and suggested it be abolished but leave it to lobbyists to weigh in. AdvaMed (Advanced Medical Technology Association) concluded changes weren’t needed and the reports of injuries were overblown, even though more than half of all device recalls (51%) from 2005 to 2010 were cleared through the 510(k).
The FDA appears to be more of a lap dog than a fearless watchdog most Americans rely on to keep them safe.
https://herniamesh.legalexaminer.com/health/medical-devices-implants/fda-approved-medical-devices-least-burdensome-for-whom/
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J&J Fights $4.7B Verdict Finding Talc Caused Ovarian Cancer
Nov 19, 2018 | Bloomberg Law
By Julie Steinberg
Johnson & Johnson will ask a Missouri court Wednesday to undo or at least cut a $4.69 billion verdict awarded to 22 women who blame their ovarian cancer on asbestos in its talc products.
The verdict, which the company calls “excessive and unconstitutional,” includes $4.14 billion in punitive damages and $550 million in compensatories against J&J and its Johnson & Johnson Consumer Inc. unit.
It came in the first suit to go to trial in Missouri alleging asbestos-exposure from the companies’ talcum powders. Earlier Missouri talc trials, two of which yielded $110 million and $70 million verdicts and which also are currently on appeal, haven’t involved allegations of asbestos contamination.
Other states also have seen trials linking talc to mesothelioma, a signature asbestos-related disease. Trials in South Carolina and California resulted in a mistrial and a verdict in favor of J&J this past week.
J&J and its subsidiary are expected to tell the Missouri Circuit Court in St. Louis City Nov. 21 that combining the women’s claims into one trial was improper and unfair. Each family should have its own new trial, J&J says in a filing with the court.
The women, or their representatives, meanwhile, will counter that they each proved the companies’ talcum powders caused their ovarian cancers, illnesses that are especially deadly because they are hard to detect early.
And the plaintiffs will contend J&J’s “highly reprehensible” conduct in knowing their products contained asbestos, and selling the powders anyway, make their case the “rare” situation that justifies such sizable punitive damages.
J&J and its subsidiary “knew there was asbestos in what they marketed as `baby’ powder, but they deliberately targeted mothers and women in general with advertising misrepresenting the safety of their talc products,” the women say in their own filing to the appeals court.
Too Many Differences, J&J SaysThe trial improperly lumped together too many plaintiffs with differing risk factors and stages of cancer, including some who had died, the companies say.
The grouping gave the jury the “false impression” the powder must have been responsible because powder use and ovarian cancer were all that the women had in common.
The verdict itself demonstrates how each plaintiff’s claim bolstered that of the others, J&J says in its court filings.
The jury deliberated for less than 20 minutes per plaintiff before awarding the same $25 million in compensatory damages to each family.
At the very least, the court should order a new trial on damages or slash the awards, J&J argues. The compensatory award should be no more than $3 million per plaintiff.
Also, per U.S. Supreme Court guidelines, only a roughly even ratio between punitive and compensatory awards would “remotely pass muster here, even if compensatory awards were substantially reduced,” the companies say.
Women Say Case ClosedBut the 22 women, or their representatives, counter that ample evidence shows the powders contained asbestos and are linked to their cancers.
The “vast majority of evidence” concerns the companies’ conduct and whether their talc products generally could have caused their illnesses, the plaintiffs say.
Plaintiff-specific proof took up only one week of the six-week trial trial.
The women also dispute J&J’s “unfair spillover” argument.
They cite an Eleventh Circuit opinion, Eghnayem v. Boston Scientific Corp., that upheld combining the cases of four pelvic mesh plaintiffs into one trial.
As for the award’s size, the women say the compensatory award in this case aligns with a New Jersey jury’s $37 million award in another talc-asbestos case, that one over mesothelioma.
And the punitive award should survive scrutiny under both federal due process principles and under Missouri law, the plaintiffs say.
The jury awarded $990 million in punitive damages against the subsidiary, and $3.15 billion against J&J, the plaintiffs argue.
That makes a 1:1.8 ratio of compensatory to punitive damages for the Johnson & Johnson Consumer Inc. unit, and a ratio of 1:5.72 for the parent company.
“Numerous courts have approved ratios much greater based on less egregious conduct,” they say.
J&J faces about 600 women in total in legal proceedings in St. Louis linking its talc products to ovarian cancer, according to a filing in the federal multidistrict talc litigation. Some of those cases specifically allege asbestos-exposure, others don’t.
The bulk of the ovarian cancer litigation, however, is in the U.S. District Court for the District of New Jersey with some 9,000 cases there.
The Holland Law Firm, The Lanier Law Firm, and Gray Ritter & Graham, PC represent the plaintiffs.
HeplerBroom LLC; Orrick, Herrington & Sutcliffe LLP; and Shook, Hardy & Bacon LLP represent J&J.
The case is Ingham v. Johnson & Johnson, Mo. Cir. Ct., 1522-CC10417-01, hearing 11/21/18.
https://news.bloomberglaw.com/product-liability-and-toxics-law/j-j-fights-47b-verdict-finding-talc-caused-ovarian-cancer
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Kelp harvesting bid sparks plea from Sir David Attenborough
Nov 19, 2018 | The Herald
By Maureen Sugden
But one Scots company wants to harvest 30,000 tonnes of kelp off the west coast in a bid that has sparked controversy, amid concern for the preservation of these intricate systems, with Sir David Attenborough now stepping in to voice his concerns.
It comes as Ayr-based Marine Biopolymers (MBL) claims Scotlandcould lose out on a £300 million industry if MSPs vote to ban the industrial harvesting of kelp in its waters.
The firm wants to harvest the kelp using a revolutionary process it has developed to create a product that could be used to make “invisible armour” or slow release cancer drugs.
The nanocellulose it produces from the seaweed is the “best in the world”, it claims, and could have a whole host of possible applications – including an alternative to the vaginal mesh implants that have left some women in crippling pain.
But MBL says this hi-tech new industry will be halted if MSPs pass new legislation that bans dredging for kelp.
After more than 14,000 people signed a petition against such dredging, Green MSP Mark Ruskell successfully amended the Scottish Crown Estate Bill to ban the removal of entire kelp plants.
Veteran naturalist Sir David Attenborough has also lent his voice to the cause, speaking to Fauna & Flora International (FFI), of which he is vice-president, saying: “Charles Darwin was one of the first people to recognise just how important kelp forests are for our oceans, comparing them in diversity to rainforests.
“These kelp forests, which can be found right here, around the coast of the British Isles, not only form an important part of the food chain, but also act as a vital habitat for a wide array of species.
“Their thick foliage offers food and safety from predators, and provides a nursery ground where juvenile fish can mature in safety.
“Look closely among the intricate stems and fronds of kelp, and you will find a range of fascinating sea life, from invertebrates such as sea stars, anemones and limpets, to mammals such as sea otters.
“Many of the fish species, such as cod, that are so important to us economically and culturally are also found here.
“For these reasons and many more – carbon storage being just one – it is imperative we protect our kelp forests.”
But MBL co-founder David Mackie insisted its plans to harvest the seaweed laminaria hyperborea are “entirely sustainable”, saying there is an estimated 20 million tonnes of it in Scotland’s waters.
The kelp, which he described as “the daddy of the seaweeds in Scottish waters”, grows up to 8ft long, with the plants attaching themselves to rocky surfaces.
He said: “People say we intend to dredge. Well you can’t dredge a rocky bottom, so we’re not doing that.”
As MBL developed its processes to remove alginate from the seaweed, it found marine cellulose was also produced.
Dr Mark Dorris, a senior research fellow and lecturer in material science at Edinburgh’s Napier University, has been working with that to create new bioplastic materials, the starting point of which are fibres that are 1,000th of the width of a human hair.
Wood pulp is already used to produce nanocellulose, but Dr Dorris said when kelp is used the end result is “better than any nanocellulose in the world”.
This raw product can be turned into bioplastics to be used in food packaging
for products such as sandwiches and ready meals, but work has also been taking place with the Ministry of Defence to develop a “transparent armour” that could be used for helmet visors and body shields by police and the armed services.The nanocellulose could also be used to develop slow release drugs for treating colon cancer, as well as to help conserve fragile, historic documents and artefacts.
Dr Dorris said: “There’s loads of applications for this, medical implants, meshes. This stuff, because it is made from seaweed, is biocompatible, the wood cellulose isn’t.”
But Mr Mackie said he fears plans to develop such products could be halted if MSPs vote through the legislation as it currently stands on Wednesday.
He said: “We worked long and hard to develop our process, basically we have turned the whole alginate processing upside down, to get to what is unique, nobody else does it.
“We’ve got this brilliant raw material, we do a wee bit of magic with it.
“This is the thing I am most proud of that we have done, and when I see what these guys can do it is just incredible.”
For Sir David, though, his concerns for kelp remain.
He said: “It is perfectly possible to harvest them sustainably by removing their fronds while leaving the rest of the plant intact.
“But dredging – or indeed any kind of harvesting that removes the whole plant – is a wholly short-sighted measure that risks the wholesale devastation of our kelp beds.
“I urge decision makers to take the necessary action to protect these vital, and globally important, habitats.”
https://www.heraldscotland.com/news/17232152.kelp-harvesting-bid-sparks-plea-from-sir-david-attenborough/
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