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 4,2020

The Union health ministry on Friday revised the dosage of anti-viral drug remdesivir to be administered to coronavirus patients in the moderate stage of illness from the earlier six days to five days as it issued an updated 'Clinical Management Protocols for COVID-19'.

The drug, administered in the form of injection, should be given at a dose of 200 mg on day one followed by 100 mg daily for four days (total five days), the new treatment protocols stated.

The Health Ministry on June 13 had allowed the use of remdesivir for restricted emergency use in moderate cases under "investigational therapies".

"Under emergency use authorisation, remdesivir may be considered for patients in moderate stage requiring oxygen support," the document stated.

It is not recommended for those with severe renal impairment and high level of liver enzymes, pregnant and lactating women, and those below 12 years, it said.

The ministry also okayed off-label application of tocilizumab, a drug that modifies the immune system or its functioning, and convalescent plasma for treating COVID-19 patients in the moderate stage of illness as "investigational therapies".

It also recommended hydroxychloroquine for patients during the early course of the disease and not for critically-ill patients.

On June 27, the ministry had included an inexpensive, widely used steroid dexamethasone in treatment protocols for COVID-19 patients in the moderate to severe stages of their illness among other therapeutic measures.

The ministry advised use of dexamethasone, which is already used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects, as an alternative choice to methylprednisolone for managing moderate to severe cases of coronavirus infection.

India's COVID-19 cases soared by over 20,000 in a day for the first time taking the country's total tally to 6,25,544 on Friday while the death toll climbed to 18,213 with 379 new fatalities, according to the Union Health Ministry data updated at 8 am.

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Agencies
June 20,2020

At a time when the country is yet to recover from the shock of losing 20 Indian soldiers in a violent clash with the Chinese People's Liberation Army (PLA) troops in Ladakh's Galwan Valley, another shocker has come to light with news coming of a malware hitting the Indian Railways network and snooping its data for foreign countries, including train movements, sources in the intelligence agencies said on Friday.

Meanwhile, Railways Board Chairman V K Yadav said that the national transporter keeps on receiving malware security threats and the engineers in the railways keep on taking all precautions and keeps on updating the firewalls to prevent data theft.

The news comes a day after the Dedicated Freight Corridor Corporation Limited (DFCCIL) decided to terminate the 417-km signalling project worth Rs 471 crore with Chinese firm Beijing National Railway Research and Design Institute of Signal and Communication Group Company Limited (BNRRDISC) due to non-performance.

According to intelligence agency sources, the system of the Railways has been hit by the APT 36 Malware campaign. The source said that the intel agencies have also alerted the Railway Board to instantly disconnect the system with the Internet and change the password immediately.

The source said the APT 36 Malware is connected to Pakistan, which is a close ally of China. The source further said that following the red flag from the intel agencies, the system of a senior Principal Executive Director of the Railways, working in its vigilance department, has been taken for cleaning the malware threat.

As per the source, through the APT 36 Malware campaign, data stored in the Indian Railways systems were being stolen and stored in foreign locations, including the movement of the trains.

He further claimed that the APT 36 Malware also tried to take defence movement data. 

The source said the APT 36 Malware effect was reported from at least four systems of the Indian Railways.

Responding to queries, the Railways Board Chairman said: "Whether it is our systems or the IRCTC, we continuously update it with firewalls, and it is an ongoing process as we get the updates." 

Yadav said that our system is updated time to time. "We get malware threat on a regular basis. And we look at it continuously," he said. 

When pressed further about the malware threat in four railways systems, he said: "It has not come to our notice that some information has been leaked. Our systems are secure and our engineers keep on working on it."

According to intel sources, besides Railways, there was also malware threat in the defence, central police organisations, education and healthcare sectors, the source said.

In view of the threat, the intel agencies have asked the departments concerned to change the passwords of emails and online services from secure computers, format the hard-disk of the affected computers after taking back-up and re-install the operating systems and other softwares.

Sources in the Railways had said on Thursday that DFFCIL, which is looking after the work of the Dedicated Freight Corridor Project, has decided to terminate the tender with BNRRDISC.

A source in the Railway Ministry said that it has informed the Railway Board and the World Bank to take the final decision in the matter.

The source said the project was awarded to the Chinese firm in 2016 for signalling and telecommunication work on the 417-km Kanpur-Deen Dayal Upadhyaya section of the Eastern Dedicated Freight Corridor (EDFC). 

The source disclosed that the contract was awarded to the Beijing National Railway Research and Design Institute in June 2016. The source further said that even after four years, the progress in the project was only 20%. The issues that led to the termination of the project are reluctance by the company to furnish technical documents, as per the contract agreement, such as logic design of electronic interlocking.

The source further said that other issues like non-availability of their engineers and authorised personnel on site were a serious constraint. Even physical work could not progress as they have no tie-up with local agencies. 

The 3,373-km DFC, a flagship project of the Railways, aims to augment rail transport capacity to meet the growing requirement of movement of goods by segregating freight from passenger traffic.

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Agencies
June 20,2020

The World Health Organisation has warned that the COVID-19 pandemic is entering a "new and dangerous" phase. Thursday saw the most cases in a single day reported to the WHO.

Tedros Adhanom Ghebreyesus said the day had seen 150,000 new cases with half of those coming from the Americas and large numbers also from the Middle East and South Asia, the BBC reported.

He said the virus was still spreading fast and the pandemic accelerating.

He acknowledged people might be fed up with self-isolating and countries were eager to open their economies but he said that now was a time for extreme vigilance.

Maria van Kerkhove, technical lead of the WHO's COVID-19 response, told a press conference the pandemic is "accelerating in many parts of the world".

"While we have seen countries have some success in suppressing transmission and bringing transition down to a low level, every country must remain ready," she said.

Mike Ryan, the head of the WHO's Health Emergencies Programme, said that some countries had managed to flatten the peak of infections without bringing them down to a very low level.

"You can see a situation in some countries where they could get a second peak now, because the disease has not been brought under control," he said.

"The disease will then go away and reduce to a low level, and they could then get a second wave again in the autumn or later in the year."

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