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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
May 26,2020

Tedros Adhanom Ghebreyesus, the World Health Organisation's (WHO) Director-General, said that a clinical trial of hydroxychloroquine (HCQ) on COVID-19 patients has come to "a temporary pause", while the safety data of the the anti-malaria drug was being reviewed.

According to the WHO chief, The Lancet medical journal on May 22 had published an observational study on HCQ and chloroquine and its effects on COVID-19 patients that have been hospitalized, reports Xinhua news agency.

The authors of the study reported that among patients receiving the drug, when used alone or with a macrolide, they estimated a higher mortality rate.

"The Executive Group of the Solidarity Trial, representing 10 of the participating countries, met on Saturday (May 23) and has agreed to review a comprehensive analysis and critical appraisal of all evidence available globally," Tedros said in a virtual press conference on Monday.

The review will consider data collected so far in the Solidarity Trial and in particular robust randomized available data, to adequately evaluate the potential benefits and harms from this drug, he said.

"The Executive Group has implemented a temporary pause of the HCQ arm within the Solidarity Trial while the safety data is reviewed by the Data Safety Monitoring Board. The other arms of the trial are continuing," Tedros added.

WHO initiated the Solidarity Trial, a plan to evaluate the safety and efficacy of four drugs and drug combinations against COVID-19 more than two months ago, which include HCQ.

According to the WHO, over 400 hospitals in 35 countries are actively recruiting patients and nearly 3,500 patients have been enrolled from 17 countries under the Solidarity Trial.

Tedros added that the safety concern over the drug related only to the use of HCQ and chloroquine in COVID-19, and "these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria".

"WHO will provide further updates as we know more," he added.

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Agencies
August 2,2020

Washington, Aug 2: Children under the age of five have between 10 to 100 times greater levels of genetic material of the coronavirus in their noses compared to older children and adults, a study in JAMA Pediatrics said Thursday.

Its authors wrote this meant that young children might be important drivers of Covid-19 transmission within communities -- a suggestion at odds with the current prevailing narrative.

The paper comes as the administration of US President Donald Trump is pushing hard for schools and daycare to reopen in order to kickstart the economy.

Between March 23 and April 27, researchers carried out nasal swab tests on 145 Chicago patients with mild to moderate illness within one week of symptom onset.

The patients were divided into three groups: 46 children younger than five-years-old, 51 children aged five to 17 years, and 48 adults aged 18 to 65 years.

The team, led by Dr Taylor Heald-Sargent of the Ann & Robert H. Lurie Children's Hospital, observed, "a 10-fold to 100-fold greater amount of SARS-CoV-2 in the upper respiratory tract of young children."

15 countries with the highest number of cases, deaths due to the Covid-19 pandemic

The authors added that a recent lab study had demonstrated that the more viral genetic material was present, the more infectious virus could be grown.

It has also previously been shown that children with high viral loads of the respiratory syncytial virus (RSV) are more likely to spread the disease.

"Thus, young children can potentially be important drivers of SARS-CoV-2 spread in the general population," the authors wrote.

"Behavioral habits of young children and close quarters in school and daycare settings raise concern for SARS-CoV-2 amplification in this population as public health restrictions are eased," they concluded.

The new findings are at odds with the current view among health authorities that young children -- who, it has been well established, are far less likely to fall seriously ill from the virus -- don't spread it much to others either.

However, there has been fairly little research on the topic so far.

One recent study in South Korea found children aged 10 to 19 transmitted Covid-19 within households as much as adults, but children under nine transmitted the virus at lower rates.

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Agencies
July 2,2020

London, Jul 2: The World Health Organisation says smoking is linked to a higher risk of severe illness and death from the coronavirus in hospitalised patients, although it was unable to specify exactly how much greater those risks might be.

In a scientific brief published this week, the U.N. health agency reviewed 34 published studies on the association between smoking and Covid-19, including the probability of infection, hospitalisation, severity of disease and death.

WHO noted that smokers represent up to 18% of hospitalised coronavirus patients and that there appeared to be a significant link between whether or not patients smoked and the severity of disease they suffered, the type of hospital interventions required and patients' risk of dying.

In April, French researchers released a small study suggesting smokers were at less risk of catching Covid-19 and planned to test nicotine patches on patients and health workers — but their findings were questioned by many scientists at the time who cited the lack of definitive data.

WHO says "the available evidence suggests that smoking is associated with increased severity of disease and death in hospitalized Covid-19 patients. It recommends that smokers quit.

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