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The need for transparency of clinical evidence for medical devices in Europe

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Pathologist explains how mesh distorts, twists in J&J pelvic mesh trial Kubota SAN DIEGO – In a trial to determine if Johnson & Johnson injured women by selling pelvic mesh devices the company allegedly knew were dangerous for profit, a pathologist on Thursday said the mesh can distort once it’s implanted and such devices can also migrate in the body. “Polypropylene is not inert; the mesh is migrating, moving through the tissue and can become exposed,” said Dr. Infographic: Beyond Fake News – 10 Types of Misleading News – Sixteen Languages The work needed to effectively filter information in our media-saturated environment takes time and skill. A study showed that the more content we consume, the more our ability to make decisions about its veracity becomes impaired. With 80% of Europeans now regularly going online, it is vital for the sustainable and effective functioning of democracy for citizens to be able to curate their media diets with a healthy critical eye. Our Beyond Fake News infographic identifies the 10 types of potentially misleading news. It was created to be used in class with real-world examples to spark classroom debate and reflection on the ways that media is constructed.

Programme - WorldConference Monday 15 april 2019 09:30 – 09:45 Opening speeches by the Presidents With: Pr Jean-Jacques Eledjam, President of the French Red Cross; Dr Francesco Rocca, President of the International Federation of Red Cross and Red Crescent Societies (IFRC) 09:45 – 10:30 Round table “From war to climate: 100 years of humanitarian action” 10:30 – 11:00 Opening addresses: by political, artistic or corporate representatives

Hidden home truths about children's homes By ELVIS ONDIEKIMore by this Author By KAREN MBUYA MURIUKIMore by this Author The festive season is approaching and, in a few weeks, many Kenyans are expected to throng children’s homes with lavish donations as has been the tradition. Bales of foodstuff, bundles of clothes, loads of toiletries and tonnes of motivational words and prayers will accompany the visits as Kenyans actualise their desire to celebrate with the less fortunate. Ethicon complaint reviewer says in J&J trial that patients felt vaginal mesh instructions fell short of explaining risks Chen SAN DIEGO – In a trial to determine if Johnson & Johnson officials sold vaginal mesh implant kits to doctors to make profits knowing the devices were harming women, a complaint reviewer on Wednesday said some sling patients had felt misled about the risks. “I saw there were (complaint) patterns,” said Dr. Meng Chen, a San Francisco doctor and former medical director for surveillance safety at Ethicon, a J&J subsidiary that made the vaginal mesh that is the subject of the suit. The trial in the San Diego Superior Court is being streamed live courtesy of Courtroom View Network.

Fact check: Do more people die in Australia than Sweden due to poorly heated homes? - Fact Check Updated The claim Liberal MP Craig Kelly has claimed that poorly heated homes cause more deaths in Australia than in Sweden, despite our milder winters. In an interview with Sky News, Mr Kelly said: "Our rates of excess mortality are twice that of places like Sweden simply because we don't have adequate heating in our homes." RMIT ABC Fact Check takes a look at whether cold homes kill more people in Australia than in Sweden. The verdict No hugs, no one to talk to: how Ugandan orphanages are harming a generation At a Catholic orphanage for children aged seven and under near Kampala, a noisy tangle of children moves around the complex. It takes a moment to notice that the children aren’t actually speaking, or even attempting to form words. Instead, they’re shrieking and squawking; they scream at each other as they squabble over toys, cling like burrs to the legs of any passing adult and stare mutely when they’re spoken to. This is common – children who grow up in the orphanage have few chances for conversations with harried staff, and are rarely read stories.

State attorneys argue J&J missed adequate label warnings in pelvic mesh trial Hinoul SAN DIEGO – In a trial to decide if Johnson & Johnson sold pelvic mesh implants allegedly knowing they could harm women, state attorneys on Wednesday attempted to get a top company official to admit that risk warnings on the products had been lacking. Jinsook Ohta, the attorney with the state's attorney general's office, asked if the words “life-long erosion” and possible “re-occurrence” were cited in the warnings of potential risk. “Re-occurrence and life-long (complications) are not cited,” said Dr.

Bushfires, heatwaves and early deaths: the climate is changing before our eyes When I wrote The Weather Makers, I laid out the state of climate science as it was understood in 2005. The book received much acclaim, but it was also criticised by climate-change sceptics as extremist and alarmist. Since the book was published, the Intergovernmental Panel on Climate Change (IPCC) has completed two major summaries, in the form of its fourth and fifth assessment reports, and thousands of scientific publications have added to our understanding of how Earth’s climate system responds to carbon pollution. As a result, many details of climate science have been clarified. Not only are the scientific projections of major trends more certain than ever, but today many of us also have firsthand experience of living in a strongly shifted climate.

Why the institutionalisation of children must end: key facts Translate This About Hundreds of thousands of children are still growing up in institutions in Europe today[1]. This includes children with disabilities, children without parental care, children in the child protection system, migrant, unaccompanied and separated children[2]. Although institutions are often funded by public money – intended for the public good – their environment is utterly inappropriate for children’s emotional, physical, intellectual and social development[3]. The very existence of institutions for children encourages families to place children into care, and so draws funding away from services that could support children living within families and communities[4].

Climate Change and Human Well-Being Although climate change is mainly caused in industrialized nations, the impact of climate change has spread across the globe, among developing countries and the world’s most vulnerable populations. While the public health effects of environmental degradation and the resulting natural disasters are well-known, less is understood about their mental health impact and psychosocial well-being, and what types of interventions may best minimize the damage. Climate Change and Human Well-Being identifies the psychological responses and mental health impacts that accompany gradual environmental change and extreme weather events, and explains how climate change exacerbates existing inequities.

Time Orphanages, as we all know from Charles Dickens, studies of kids from former Eastern Bloc countries and the musical Annie, are bad for children. Except, as a few studies are now beginning to find, when they’re not. The latest study looked at children from five not-so-wealthy countries in Asia and sub-Saharan Africa over the course of three years and found that being in an institution did not necessarily make them much worse off. Whether or not orphanages are a viable solution for children with no homes is no small issue. According to the most recent figures from UNICEF, there were more than 132 million orphans in sub-Saharan Africa, Asia, Latin America and the Caribbean in 2005. That’s a scary number — more than the entire population of Britain and Italy combined — and figuring out the best way to look after that many vulnerable beings is a problem of significant complexity.

Morrisey sues Johnson & Johnson over marketing of surgical mesh CHARLESTON – West Virginia Attorney General Patrick Morrisey's office has filed suit against Johnson & Johnson and subsidiaries alleging the companies engaged in unlawful, unfair and deceptive marketing practices associated with their surgical mesh devices. “Misrepresenting any product’s safety is unlawful and can have dire effects on consumers,” Morrisey said in a Sept. 18 press conference at the state Capitol. “When medical products are marketed in an improper manner, it can put consumers’ health at risk.” The lawsuit, filed Sept. 18 in Monongalia Circuit Court, claims Johnson & Johnson and Ethicon misrepresented the effectiveness, properties, risks and safety history of the surgical mesh products in marketing and educational materials provided to patients and doctors, in personal meetings and in published medical articles. Morrisey's office alleges informational and marketing materials for the companies’ surgical mesh devices consistently omitted or concealed complications.

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