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France is first to ban breast implants linked to rare cancer

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France has banned several types of textured breast implants that have been linked to a rare form of cancer. The ban, which covers macro-textured and polyurethane implants, took effect. It was announced this week by France’s National Agency for Safety of Medicines and Health Products, or ANSM, in a letter to manufacturers.


The implants, characterized by a textured, Velcrolike surface that adheres to the breast tissue, are suspected of being linked to anaplastic large-cell lymphoma, a rare form of cancer. Since 2011, 59 cases have been recorded in France, according to the ANSM, and most women affected by the disease had textured breast implants. Although the safety agency did not find a causal link between the cancer and the implants, it said it was imposing the ban as a “precautionary measure.”


In December, Allergan, one of the makers of textured implants, halted European sales after its certification expired. The French safety agency had asked for additional data on the implants, but the company said it could not provide it before the expiration date. At the time, the ANSM said it had not “identified any immediate risk for the health of women carrying the implants concerned,” and it did not mention the unusual cancer.

 


France’s decision this week has set off a chain reaction in regulators across continents, with Canada and the Netherlands announcing similar plans to suspend the sale of textured breast implants. In the United States, the Food and Drug Administration held public hearings on the subject on March 25 and 26. It said it would announce a decision “in the coming weeks.”
The prohibition followed a series of media investigations last year, coordinated by the International Consortium of Investigative Journalists, that found poorly designed breast implants had led to health issues for patients globally. In the ANSM letter this week, which the French newspaper Le Monde published on its website, Dr Christelle Ratignier-Carbonneil, deputy director-general of the agency, asked manufacturers to remove their implants from the market, “in view of the rare but serious danger that their implantation is likely to constitute.”


Nearly 500,000 women have breast implants in France. In 2018, macro-textured and polyurethane implants represented 27 per cent of sales, according to the ANSM. Over the past five years, some 70,000 women are thought to have received the implants, which do not slip out of place or rotate, unlike smooth ones. They are also less likely than smooth ones to cause thick scarring around the implant, which is common and requires more surgery.


Joëlle Manighetti, a French activist who started a blog on breast implants after suffering from faulty ones, praised the decision as going “beyond our recommendations.”


“I now hope that there will be a serious follow-up of the other breast implants still on the market,” she said.


Breast implants came under scrutiny in France in the last decade, in a landmark case involving the company Poly Implant Prothèse, which was accused of selling hundreds of thousands of defective implants in 65 countries.


After a trial that involved more than 7,000 defendants, the company’s founder, Jean-Claude Mas, and four former employees were found guilty of aggravated fraud in 2012. Mas, who died Thursday at age 79, was later sentenced to four years in prison.


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Health

Cutting 300 calories in healthy adults known to improve heart health

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If you think you don’t need to cut calories just because you have a few extra pounds or are healthy, then take note! Even in healthy adults cutting around 300 calories a day significantly improved already good levels of cholesterol, blood pressure, blood sugar, and other markers, suggests a study. The study was published in the journal ‘The Lancet Diabetes & Endocrinology’.

The trial, part of an ongoing project with the National Institutes of Health continues to build on the researchers’ hypothesis that it’s not just weight loss that leads to these improvements, but some more complex metabolic change triggered by eating fewer calories than what’s expended.

“There’s something about caloric restriction, some mechanism we don’t yet understand that results in these improvements. We have collected blood, muscle and other samples from these participants and will continue to explore what this metabolic signal or magic molecule might be,” said William E. Kraus, the study’s lead author.

 

For the first month of the trial, participants ate three meals a day that would cut one-fourth of their daily calories to help train them on the new diet. Participants were asked to maintain the 25 per cent calorie reduction for two years. Their ability to do that varied, with the average calorie reduction for all participants being about 12 per cent. Still, they were able to sustain a 10 per cent drop in their weight, 71 per cent of which was fat, the study found.

There were numerous improvements in markers that measure the risk of metabolic disease. After two years, participants also showed a reduction in a biomarker that indicates chronic inflammation which has also been linked to heart disease, cancer, and cognitive decline.

“This shows that even a modification that is not as severe as what we used in this study could reduce the burden of diabetes and cardiovascular disease. People can do this fairly easily by simply watching their little indiscretions here and there, or maybe reducing the amount of them, like not snacking after dinner,” said Kraus.

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Health

Just 20-minute ‘nature pill’ can lower your stress

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Taking just 20 minutes out of your day to stroll or sit near nature will significantly lower your stress hormone levels, a new study suggests.

Healthcare practitioners can use this finding to prescribe ‘nature pills’ to have a real measurable effect, according to researchers from the University of Michigan.

“We know that spending time in nature reduces stress, but until now it was unclear how much is enough, how often to do it, or even what kind of nature experience will benefit us,” said lead author MaryCarol Hunter from the varsity.

 

For the study, published in the journal Frontiers in Psychology, the research team involved 36 participants. Over an eight-week period, they were asked to take a ‘nature pill’ for at least 10 minutes, three times a week.

Levels of cortisol — a stress hormone — were measured from saliva samples taken before and after taking the ‘nature pill’, once every two weeks.

The data revealed that just a 20 minute nature experience was enough to significantly reduce cortisol levels.

And if you take in a little more nature experience – 20 to 30 minutes sitting or walking – cortisol levels dropped at their greatest rate, the researchers said.

“Our study shows that for the greatest payoff, in terms of efficiently lowering levels of the stress hormone cortisol, you should spend 20 to 30 minutes sitting or walking in a place that provides you with a sense of nature,” Hunter noted.

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Health

Exercise can help in containing arthritis

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A new study has found that degradation of cartilage due to osteoarthritis could be prevented with the help of exercise. The study, published in the journal Osteoarthritis and Cartilage, demonstrates the benefits of exercise on the tissues that form our joints.

The researchers have shown for the first time how mechanical forces experienced by cells in joints during exercise prevent cartilage degradation by suppressing the action of inflammatory molecules that cause osteoarthritis. During exercise, the cartilage in joints such as the hip and knee is squashed.

This mechanical distortion is detected by the living cells in the cartilage, which then block the action of inflammatory molecules associated with conditions such as arthritis. The researchers showed that this anti-inflammatory effect of physical activity is caused by activation of a particular protein, called HDAC6, which triggers changes in the proteins that form primary cilia.

 

Pharmaceutical drugs that blocked HDAC6 activation prevented the anti-inflammatory effects of physical activity, while other drug treatments were able to mimic the benefits of exercise. Changes in length of the primary cilia, which are only a few 1000th of a millimetre, provided a biomarker of the level of inflammation.

Cilia got longer during inflammation, but treatments that prevented this elongation successfully prevented inflammation. Su Fu, a PhD student at Queen Mary University of London and study author, said: “We have known for some time that healthy exercise is good for you. Now we know the process through which exercise prevents cartilage degradation.”

Professor Martin Knight, lead researcher of the study added, “These findings may also explain the anti-inflammatory effects of normal blood flow in arteries, which is important for preventing arterial diseases such as atherosclerosis and aneurysm.” The researchers hope that these findings will help in the search for treatments for arthritis. The researchers suggest the results may lead to a whole new therapeutic approach known as “mechanomedicine” in which drugs simulate the effect of mechanical forces to prevent the damaging effects of inflammation and treat conditions such as arthritis.

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