Silicone breast implants up risk of stillbirth, cancer

Agencies
September 18, 2018

Houston, Sept 18: Silicone breast implants may increase the likelihood of stillbirth by over four times, and put women at higher risk of developing cancer and several rare disorders, a study warns.

The elevated risks included three conditions classified as autoimmune or rheumatologic disorders: Sjogren's syndrome, with a risk about eight times higher than in the general population; scleroderma, a seven-fold increase in risk; and rheumatoid arthritis, about a six-fold increase in risk.

"We are reporting an analysis of the largest prospective study to date on silicone breast implant safety," said Mark W Clemens, from the University of Texas in the US.

"This data gives women important safety information about silicone breast implants to have real expectations and to help them choose what is right for them," said Clemens.

In 2006, the US Food and Drug Administration approved silicone gel-filled implants from two manufacturers, stipulating that the manufacturers conduct large postapproval studies (LPAS) to monitor long-term health and safety outcomes.

"Despite abundant data collection, and open public access, the LPAS database had not yet been analysed and reported," said Clemens.

The researchers analysed data on nearly 100,000 patients enrolled in the LPAS between 2007 and 2009-10. More than 80,000 patients received silicone implants; the rest received implants filled with sterile saline solution.

Seventy-two per cent of the patients underwent primary breast augmentation, 15 per cent had revision augmentation, 10 per cent had primary breast reconstruction, and three per cent had revision reconstruction procedures.

The large size of the database enabled researchers to assess the risk of rare adverse outcomes.

Women receiving silicone implants were at increased risk of several rare harms compared to the general population.

Silicone implants were also associated with a 4.5-fold increase in the risk of stillbirth, but no significant increase in the risk of miscarriage.

Risk of melanoma, a serious type of skin cancer, was nearly four times higher in women with silicone implants. There was no significant association with the risk of suicide, which had been suggested by a previous study.

The database included just one case of breast implant-associated anaplastic large cell lymphoma -- a rare but serious type of cancer previously linked to breast implants.

Compared to saline-filled implants, silicone implants were also linked to a higher risk of some surgical complications. These included capsular contracture (scarring around the implant), which occurred at a rate of 5.0 per cent with silicone implants versus 2.8 per cent with saline-filled implants.

Capsular contracture occurred in 7.2 per cent of primary breast augmentation procedures and was the most common reason for reoperation in this group.

While certain rare harms appeared to be more common in women with silicone implants, absolute rates of these adverse outcomes were low.

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Agencies
July 15,2020

The first COVID-19 vaccine tested in the US revved up people's immune systems just the way scientists had hoped, researchers reported Tuesday -- as the shots are poised to begin key final testing.

No matter how you slice this, this is good news, Dr. Anthony Fauci, the U.S. government's top infectious disease expert, told The Associated Press.

The experimental vaccine, developed by Fauci's colleagues at the National Institutes of Health and Moderna Inc., will start its most important step around July 27: A 30,000-person study to prove if the shots really are strong enough to protect against the coronavirus.

But Tuesday, researchers reported anxiously awaited findings from the first 45 volunteers who rolled up their sleeves back in March. Sure enough, the vaccine provided a hoped-for immune boost.

Those early volunteers developed what are called neutralizing antibodies in their bloodstream -- molecules key to blocking infection -- at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine.

This is an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection, said Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, who led the study.

There's no guarantee but the government hopes to have results around the end of the year -- record-setting speed for developing a vaccine.

The vaccine requires two doses, a month apart.

There were no serious side effects. But more than half the study participants reported flu-like reactions to the shots that aren't uncommon with other vaccines -- fatigue, headache, chills, fever and pain at the injection site. For three participants given the highest dose, those reactions were more severe; that dose isn't being pursued.

Some of those reactions are similar to coronavirus symptoms but they're temporary, lasting about a day and occur right after vaccination, researchers noted.

Small price to pay for protection against COVID, said Dr. William Schaffner of Vanderbilt University Medical Center, a vaccine expert who wasn't involved with the study.

He called the early results a good first step, and is optimistic that final testing could deliver answers about whether it's really safe and effective by the beginning of next year.

It would be wonderful. But that assumes everything's working right on schedule, Schaffner cautioned.

Moderna's share price jumped nearly 15 percent in trading after US markets closed. Shares of the company, based in Cambridge, Massachusetts, have nearly quadrupled this year.

Tuesday's results only included younger adults. The first-step testing later was expanded to include dozens of older adults, the age group most at risk from COVID-19.

Those results aren't public yet but regulators are evaluating them. Fauci said final testing will include older adults, as well as people with chronic health conditions that make them more vulnerable to the virus and Black and Latino populations likewise affected.

Nearly two dozen possible COVID-19 vaccines are in various stages of testing around the world. Candidates from China and Britain's Oxford University also are entering final testing stages.

The 30,000-person study will mark the world's largest study of a potential COVID-19 vaccine so far. And the NIH-developed shot isn't the only one set for such massive U.S. testing, crucial to spot rare side effects. The government plans similar large studies of the Oxford candidate and another by Johnson & Johnson; separately, Pfizer Inc. is planning its own huge study.

Already, people can start signing up to volunteer for the different studies.

People think this is a race for one winner. Me, I'm cheering every one of them on, said Fauci, who directs NIH's National Institute of Allergy and Infectious Diseases.

We need multiple vaccines. We need vaccines for the world, not only for our own country. Around the world, governments are investing in stockpiles of hundreds of millions of doses of the different candidates, in hopes of speedily starting inoculations if any are proven to work.

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Agencies
June 30,2020

Between 30-40 per cent of deaths from studies in intensive care units from different countries are people with diabetes, said Paul Zimmet, Professor of Diabetes, Monash University, Australia.

Zimmet, who is President International Diabetes Federation, added that the actual mechanism as to why COVID-19 may cause diabetes is as yet unknown, however, several possibilities exist. "COVID-19 is a very destructive and cunning virus and causes terrible damage to tissues including the lungs and pancreas," said Zimmet. Below are excerpts from an exclusive chat with IANS.

Why do you say Diabetes is dynamite if a person has been infected with COVID-19?

There have been many deaths in many countries, e.g. Italy, China, the UK and US among people with diabetes after infection with COVID-19 (SARS-Cov-2).

The mortality tends to be mainly in older Type 2 diabetics. Between 30-40 per cent of deaths from studies in intensive care units from different countries are people with diabetes. This outcome and other complications from the virus, particularly pneumonia, are more likely in people with diabetes which is poorly controlled with high blood sugars (poor metabolic control).

Diabetes is often associated with other chronic conditions, including obesity, hypertension and heart disease compounding the risk. These latter conditions all convey higher risk to COVID-19 infections.

ACE-2, which binds to SARS-Cov-2 and allows the virus to enter human cells is also located in organs and tissues involved in glucose metabolism. Is there solid evidence that virus after entering tissues may cause multiple and complex impairment of glucose metabolism?

The actual mechanism as to why COVID-19 may cause diabetes is as yet unknown.

However, several possibilities exist. Firstly, COVID-19 is a very destructive and cunning virus and causes terrible damage to tissues, including the lungs and pancreas.

A new study just published showed that in miniature lab-grown pancreas, and other cells such as liver, made using human stem cells, COVID-19 caused destruction of the pancreas beta cells that produce insulin.

It is possible that the virus causes disruption of the cells by disrupting cellular metabolism. This is possibly the way it brings about new-onset diabetes. ACE-2 exists in high concentration in the lung as this also explains the terrible lung side effects of COVID-19 infections.

Can COVID-19 lead to a new mechanism of diabetes? Probably a new form of diabetes or a new form of disease?

The COVID-19 virus has only been with us for about 5 months and there is a huge amount that we still must learn about its cunning and devastating ways. The purpose of the Global COVIDIAB Diabetes Registry, a joint initiative of Monash University in Australia, and King’s College London is to gain a much better understanding of how common is the appearance of COVID-19 related diabetes, what form does it take be it type 1 or type 2 or a new form, and how common are the complications that we already know e.g. diabetic keto-acidosis, hyperosmolar coma and high insulin requirements are causing high rates of ill health and mortality worldwide. The knowledge gained will aid our understanding for developing strategies to prevent and treat this terrible virus that has caused destruction globally.

Diabetes is one of the most prevalent chronic diseases in India. According to a recent study, sugar levels of diabetic persons increased by 20 per cent during nationwide lockdown in India to contain COVID-19 outbreak. Even after lockdown was lifted, many people are confined within their home. Do you think lack of physical activity will create more problems for diabetics?

My own major research has been on studying populations with high rates of diabetes, including ethnic Indian communities including India, Mauritius, and Fiji so I am very well aware of this. It is now well established that along with diabetes, that associated poor metabolic control of their diabetes places these people at the highest risk for COVID infection and its devastating complications and the associated morbidity and mortality. And these communities have high prevalence of heart disease as well.

Lockdown not only has deleterious effects on metabolic control of the diabetes through reduced opportunities for exercise to be protective serious consequences of SARS-CoV-2 infection, lockdown usually results in disruption of the regular medical care and the regular monitoring of metabolic control. This may also be partly due to the stress and poor compliance, or inability to afford their medications such as insulin. It may also be compounded by inability to access the care during the pandemic. Nevertheless, we now know that poor metabolic control heightens their risk as described above.

You have said diabetes is itself a pandemic just like Covid-19, and the two pandemics could be clashing. How could governments address this problem?

These are “The Times of COVID-19”. Most nations of the world were totally unprepared for a pandemic of this magnitude. They underestimated its potential impact and the destructive nature of the viral infection. This should prompt all countries to upgrade their guidelines to take into account the lessons learnt on infection control including training of staff specialising in infectious diseases and improved public education and taking their communities into their confidence about the terrible nature of COVID-19. The risks of COVID-19 infection need a much higher priority in the general community, particularly for people with chronic conditions such as diabetes, obesity, and cardiac conditions.

Governments are faced with chronic diseases (NCDs) like diabetes and communicable diseases (CDs) like viral and enteric diseases and TB. In general WHO gives the highest priority to communicable diseases and much less attention and funding to chronic diseases like diabetes (I was an adviser to WHO for many years (about 30) on diabetes and obesity and it was very frustrating to deal with this situation).

This attitude to diabetes, for example, has a flow down effect so that diabetes funding in countries by governments, rich and poor, suffered and was insufficient.

So now we have a COVID-19 pandemic and who are those at highest risk, yes people with diabetes and other NCDs, it is very important that now the two, Diabetes and COVID-19 are clashing face-to-face. This is a major issue that WHO and national governments have to face with equal priority’

Stressed people suffering from diabetes run a greater risk of poor blood glucose levels, what do you suggest to these people?

As mentioned in the answer above, stress is an important factor in upsetting the blood sugar (metabolic) control of diabetes. Additive to this is poor compliance with medications and diet. These and potential associated comorbidities due to other chronic conditions are part of the dynamic dynamite mixture.

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Agencies
April 28,2020

As the world grapples with the impact of the novel coronavirus, daily interaction with the outside world --- public and retail spaces, restaurants, educational institutions, and even with each other has been and will continue to be reoriented prioritising personal hygiene and public health.

The sensibilities are building towards and leading to major changes in how the country's food service industry is expected to operate.

Based on a recent consumer survey by restaurant tech platform, Dineout, Indian diners are now ranking safety assurances and premier hygiene as top factors when it comes to choosing a restaurant to dine in.

The survey by Dineout conducted across 20 cities revealed that in a post-COVID-19 era, 81 per cent diners will prefer digital menus at restaurants, while 77 per cent of people will continue to want to dine out.

The survey found that 23 per cent people would prefer continuing with delivery/takeaway and online payment becomes the most preferred option with 60 per cent votes.
 
Diner's response to Contactless Dining:

 

Over 96 per cent demand better waitlist management
 
81 per cent consumers would rather scan a QR on their phone to place an order instead of handling physical menus or tablet-based digital menus.
 
After a dining experience, 60 per cent prefer seamless wallet-based digital payments over cash/cards 85 per cent would choose a digital valet over waiting in possibly contaminated public spaces and 84 per cent would prefer offering digital feedback over physical feedback collection.

 

What do people want to eat?
 
The report also revealed that most of India has been craving Pizza since the lockdown, except in Chennai, Hyderabad and Kolkata where their popular and indigenous Biryani recipes reign supreme. 
 
Which restaurants are diners waiting to go to?
 
77 per cent respondents claimed that they are waiting to dine out with friends and family once the lockdown is lifted.
 
Big Chill, Barbeque Nation and Social emerged as favourites in Delhi, while Mumbaikars picked Global Fusion, Poptates and Asia Kitchen. Bangaloreans miss going to pubs like Toit, Vapour and Barbeque Nation.
 
Aminia, Arsalan and Momo I Am emerge as the top picks in Kolkata.
 
Contrary to popular belief, Delhitties picked vegetarian over non-vegetarian food.
 
Bangaloreans and Lucknowis would rather have their drinks over food.
 
Besides the new parameters for restaurant selection, the factors deciding consumer delight have also seen a major overhaul as hygiene takes precedence. Consumers would prefer that the total number of reservations in a certain period be limited with the option to pre-select the seating, ample amounts of sanitisers at tables along with UV sanitised utensils whenever possible.
 
Hygiene ratings with detailed hygiene information, regular hygiene checks & usage of mask and disposable gloves by waiters are likely to be the new standard, with diners expecting service personnel to sanitise tables & chairs after every use.
 
Dineout recently unveiled the �contactless dining suite' to help restaurants survive and thrive in a post-COVID-19 world. The brand will also provide PPE Safety Kits to Restaurants to help ensure hygiene measures and is facilitating COVID free certification for restaurants through a licensed lab to ensure all microbiological tests are in place before restaurants restart post the lockdown.

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