Monday, 11 December, 2017

People are dying after getting these weight-loss implants

The intragastric balloon is placed inside the human's stomach to create a sensation of fullness. Image credit Hedden Plastic Surgery Youtube Channel Apollo Endosurgery Provides Update and Clarity to FDA Letter to Health Care Providers Related to Potential Risks of Intragastric Balloons
Jerome Frank | 13 August, 2017, 01:10

The weight loss system, which the FDA first issued a safety warning for in February, involves the inflation of balloons in patients' stomachs via a micro-catheter.

The FDA issued an update to alert healthcare providers of 5 deaths that occurred since 2016 in patients with liquid-filled stomach balloons. In addition to saline, the balloon that is made from silicone may contain some radio-opaque material as a radiographic marker and a dye such as methylene blue to alert the patient when the balloon would leak.[1] Studies have suggested that fluid is superior to air for distending gastric balloons.[2] Inflated balloons reduce the operative volume capacity of the stomach. The balloons are left in the stomach for up to six months with the idea being they leave less room for food. The agency said two more death reports it received happened within the same time frame and are potentially related to complications from the balloon treatment.

But three of the five patients died within three days of their supposedly low-risk operation.

"At this time, we do not know the root cause or incidence per rate of patient death", the FDA said, adding that it is working with the companies that manufacture the devices.

Image credit Dr Dirk
Image credit Dr Dirk

Four of the cases involve Apollo Endo Surgery's Orbera Intragastric Balloon System while one involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System. Four of those deaths involved the Orbera Intragastric Balloon System, and one involved the ReShape Integrated Dual Balloon System, the FDA says. The other two died within a month.

"Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously", said Apollo Endosurgery CEO Todd Newton in a statement. The agency recommends that doctors closely monitor patients who are using these devices.

Last year America expended $2.5 billion on commercial weight-loss balloons. The company confirmed that only 21 devices from 277,000 distributed all over the world had been linked to deaths between January 1, 2006, and March 31, 2017.

'The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity'.

Recommended

  • Billy Big Rigger! 'Platooning' Self-Driving E-Trucks Next on Tesla's List

    Billy Big Rigger! 'Platooning' Self-Driving E-Trucks Next on Tesla's List

    Reuters revealed the information after viewing an email exchange between Tesla and the Nevada Department of Motor Vehicles. The electric-car maker also reportedly met with the California DMV to discuss "efforts with autonomous trucks".
    Glasses cam shows moment SC  police officer shot in neck

    Glasses cam shows moment SC police officer shot in neck

    Orr, 29, has been jailed for 35 years after being found guilty of attempted murder and possessing a weapon in a violent crime. An officer wearing camera glasses captured video of the moment he was shot four times at close-range by a robbery suspect.
    Canadian officials back in North Korea to discuss imprisoned pastor

    Canadian officials back in North Korea to discuss imprisoned pastor

    President Donald Trump on Tuesday warned the country would be met with "fire and fury" if it threatens the United Sates. Security Council imposed new sanctions on North Korea at the weekend over its continued missile tests, and U.S.
  • Yemen: African migrants thrown into the sea

    Yemen: African migrants thrown into the sea

    According to survivors' testimonies, the smuggler pushed them to the sea after he saw men he perceived as "authority types". According to IOM figures, 55,000 African asylum seekers have travelled from Somalia to Yemen since the start of this year.

    Stephen Colbert books Anthony Scaramucci for Monday's 'Late Show'

    The former Wall Street financier was sacked days after launching an expletive-laden attack against senior White House staff. Scaramucci played a pivotal role in the ouster of former chief-of-staff Reince Priebus, who was replaced on July 28 by Gen.
    Ex-Liverpool striker Saunders can see Benitez quitting Newcastle

    Ex-Liverpool striker Saunders can see Benitez quitting Newcastle

    Benitez is keen to see more new arrivals, though he and managing director Lee Charnley are under pressure to move on a number of players. "I can read our fans saying "we will sign a £25m striker".
  • Deposed Pakistani PM calls for 'revolution' in talk to crowd

    Deposed Pakistani PM calls for 'revolution' in talk to crowd

    In a statement in Lahore on Saturday, he said we will continue our journey started under the leadership of Muhammad Nawaz Sharif. Nawaz Sharif embarked on an on-the-road rally on Wednesday from Islamabad , heading to his hometown of Lahore .
    AIADMK factions likely to come together before Aug 15

    AIADMK factions likely to come together before Aug 15

    According to sources, the two factions of the ruling AIADMK party have given their nods to a possible merger between the two. Sources said that the decision was a step forward towards the reunion of the two warring factions of the AIADMK.

    Federal Bureau of Investigation conducted raid at Paul Manafort's home

    According to the Post , documents seized during the raid were the same that Manafort had already turned over to Congress. Investigators were looking for tax documents and foreign banking records, the New York Times reported .
  • Snapchat's owner publishes its latest chapter of troubling financial results

    Snapchat's owner publishes its latest chapter of troubling financial results

    Investors have been anxious about the volatility of the stock, with a post-IPO ban on employees selling shares expiring on Monday. A measure of revenue that Snapchat generates from each user was flat compared with the figure in the fourth quarter of 2016.
    Giant Rooster Inflated Behind The White House

    Giant Rooster Inflated Behind The White House

    According to The Hill , the inflatable chicken is modeled after a statue unveiled as the mascot for a Chinese mall in December. In April, the large bird appeared at marches across the USA as demonstrators called on Trump to release his tax returns.
    2 teen babysitters arrested after video shows them putting baby in refrigerator

    2 teen babysitters arrested after video shows them putting baby in refrigerator

    The incident happened after the baby's mother asked her niece and a friend to watch her daughter while she took a shower. The pair appeared in juvenile court in Salem and were released into the custody of their parents.

Arsenal score two late goals to open season with victory over Leicester Arsenal score two late goals to open season with victory over Leicester Harry Maguire , another debutant, headed the ball back in for his new team-mate who beat Granit Xhaka to head home easily . But Leicester , which so astonishingly won the league in 2016, couldn't hold on for its first win at Arsenal since 1973.

Drivers cheat death when auto plunges seven stories onto SUV Drivers cheat death when auto  plunges seven stories onto SUV Seconds later, and as the driver on the ground level is backing up, the auto on the seventh floor comes crashing down. A man drove through the barrier cables which wrapped around his tires, suspending his auto from the ninth floor.

Money the primary reason for axing the Force Money the primary reason for axing the Force The Rugby Union Players' Association condemned the axing of the Force, which removes Super Rugby from Australia's far-flung west.

Rajya Sabha bids farewell to Vice President Hamid Ansari Rajya Sabha bids farewell to Vice President Hamid Ansari Either way, if Ansari is right or wrong every body India has the freedom to speak for themselves. "That's my impression. Responding to questions on triple talaq, Ansari said it is a social aberration, not a religious requirement.

Facebook Watch Is Looking To Launch New Types Of Shows Facebook Watch Is Looking To Launch New Types Of Shows The company has said that Watch will be available on laptop, desktop, mobile as well as in most o the provider's TV apps. If you like any show, you can just follow the show, and latest episodes will then appear in your Watchlist .

Russian spy plane passes over Trump's vacation spot Russian spy plane passes over Trump's vacation spot According to the Open Skies Treaty of 2002, 32 countries are aloud to fly, unarmed over the participating countries territories. According to the treaty guidelines، USA airmen are aboard the Russian jet observing when an Open Skies flight occurs.

Bears rookie QB Mitch Trubisky impresses in National Football League preseason debut Bears rookie QB Mitch Trubisky impresses in National Football League  preseason debut Should Trubisky falter, Sanchez will likely take over traditional backup duties while still offering plenty of aid to the rookie. His pocket presence was there from the start, and he got rid of the ball quickly and accurately, even while on the move.

Country Music Legend Glen Campbell Has Died at Age 81 Country Music Legend Glen Campbell Has Died at Age 81 Campbell received a Grammy Lifetime Achievement Award in 2012. "I miss you already", commented soberly Miley Cyrus. After having accompanied Frank Sinatra , Elvis Presley or the Beach Boys , the guitarist prodigy went solo in 1963.

Fired Google Employee James Damore Podcast Interview: In His Own Words Fired Google Employee James Damore Podcast Interview: In His Own Words Google regularly holds town hall meetings but this one is expected to be a little different in light of the recent memo post. The person behind the memo - James Damore - has already been fired by Google Bloomberg claims.

700000 'contaminated' eggs sold to United Kingdom from Dutch farms 700000 'contaminated' eggs sold to United Kingdom  from Dutch farms Some 180 farms - which produce millions of eggs a week - have been temporarily shut down while further tests are carried out. A Food Standards Agency spokesman said today: 'Investigations into the Fipronil incident in Europe continue.

Spieth, chasing the career grand slam, finishes strong to open PGA Championship Spieth, chasing the career grand slam, finishes strong to open PGA Championship Murray, a home-state hopeful who struck the opening shot at the year's last major tournament, birdied 3 of the last 6 holes. Denmark's Thorbjorn Olesen capped off his day with a 27-foot putt to take a one-stroke lead at the PGA Championship .

Canada says diplomat also suffered hearing loss in Cuba Canada says diplomat also suffered hearing loss in Cuba Cuban officials have denied directing actions against the diplomats and have launched their own investigation into the allegations.

Consumer Reports removes recommendation for Microsoft's Surface Consumer Reports removes recommendation for Microsoft's Surface The publication gauges reliability by surveying its subscribers about the products they use and own. Of course, a Microsoft representative provided Consumer Reports with a public statement via email.

South African Opposition Says Zuma No-Confidence Vote Means ANC Party 'Death' South African Opposition Says Zuma No-Confidence Vote Means ANC Party 'Death' ANC supporters march ahead of the vote of no confidence against President Jacob Zuma in Cape Town, South Africa, August 8, 2017 . Ramaphosa's main rival Nkosazana Dlamini-Zuma, Zuma's former wife, would not be eligible as she is not a lawmaker at present.

Sharad says he is with Grand Alliance Sharad says he is with Grand Alliance On Thursday, Sharad told reporters that he would undertake a yatra (journey) across the state to speak to the voters. Sharad Yadav arrived in Patna on Thursday and will remain in Bihar for the next three days.