Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says


Placed in the stomach orally in a minimally invasive endoscopic procedure, they're created to be filled with fluid and stay in the stomach for six months.

Four of the patients were using the Orbera Intragastric Balloon System, made by Apollo Endo Surgery.

In an August 10 letter to health care providers, the FDA says all five reports indicate that the deaths occurred within a month or less of balloon placement.

Real-life wedding crashers gave the newlyweds a very memorable card
Michael Tufo and his now-wife Karen Fox Tufo were in for an interesting surprise on their wedding night . These newlyweds are looking for a couple that crashed their wedding and became the life of the party.

The FDA issued a safety alert warning health care providers that since 2016, five patients who were treated with liquid-filled intragastric balloons for obesity died unexpectedly.

The FDA has also received two other reports of deaths since 2016 related to potential balloon treatment problems: one case where a person got stomach hole, with the Orbera Intragastric Balloon System, and one who got an esophagus hole, with the ReShape Integrated Dual Balloon System. Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure. Then saline is used to fill the balloons. The object of the balloon is to reduce how much a person can eat by filling the stomach with the balloon, NBC News noted. The agency recommends that doctors closely monitor patients who are using these devices. It has not received any product liability claims in connection with the five deaths.

'While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device'.

Man City players happy with three at the back, says Kompany
I'm rarely optimistic about City but this time , I'll go on record and say we're going to win the league. City start their Premier League campaign at Brighton and Hove Albion on Saturday.

In the product's package insert, there have been 21 deaths in ORBERA patients in the period from January 1, 2006 through March 31, 2017, out of more than 277K devices distributed during the same period, an incident rate below 0.01%.

In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety". The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.

'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'.

Analyst Research and Ratings: Etsy, Inc. (ETSY), Cenovus Energy Inc. (CVE)
As of the end of the quarter Teachers Advisors, LLC had disposed of a total of 1,306,271 shares trimming its position 18.8%. Cenovus Energy Inc. on 6/29/2017 reported its EPS as $-0.22 with the analysts projecting the EPS of the stock as $-0.06.

Related news:

Hot News

isis-killer-beheading-video-story-top Dodgers rally against Zack Greinke, hand Diamondbacks another loss
Aug 11, 2017 - 19:07
And if you were to ask right fielder Yasiel Puig, he'd tell you it really doesn't matter who they square off with in October. Stewart has not pitched since his start in Atlanta last Wednesday and was scheduled to start for the OKC Dodgers on Friday.

isis-killer-beheading-video-story-top Luann de Lesseps heads to Switzerland after filing for divorce
Aug 11, 2017 - 19:06
Perhaps she just needed some time away to deal with her emotions and to get back to who she was prior to getting married. Being single is not that bad, and it's certainly better than hitching your wagon to someone you don't know very well.

isis-killer-beheading-video-story-top Southwest Airline employee personally delivers cancer patient's lost luggage
Aug 11, 2017 - 18:55
But when you're battling stage four colon cancer , this mix-up has the potential to be more than just an annoyance. The airline also sent Hurt a "swag bag" filled with travel necessities like a phone charger and earbuds.

isis-killer-beheading-video-story-top Man rushes stage at Britney Spears concert
Aug 11, 2017 - 18:46
In a video, Spears does not notice at first that a man is getting slammed to the floor by security guards behind her on stage. As the security men deal with the crazed fan , the town bodyguards decide not to take any risks and escort the star off stage.

Research Ratings: Bed Bath & Beyond Inc. (BBBY), The Gap, Inc. (GPS)
Aug 11, 2017 - 18:43
Tiaa Cref Management Ltd Com holds 0.02% in Martin Marietta Materials, Inc. (NASDAQ:BBBY) for 26,149 shares. (NASDAQ:AMZN). Out of 2 Wall Street analysts rating Realogy, 0 give it "Buy", 1 "Sell" rating , while 1 recommend "Hold".

Experts proposition on the searing stocks: Oclaro, Inc. (OCLR), TrueCar, Inc. (TRUE)
Aug 11, 2017 - 18:40
In related news, insider Thomas Gordon Beck Mason sold 32,352 shares of Oclaro stock in a transaction dated Tuesday, May 16th. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which is available at the SEC website .

isis-killer-beheading-video-story-top Research Analysts' Weekly Ratings Changes for Energy Transfer Equity, LP (ETE)
Aug 11, 2017 - 18:40
It increased, as 46 investors sold AMP shares while 229 reduced holdings. 58 funds opened positions while 108 raised stakes. The stock of Energy Transfer Partners LP (NYSE:ETP) is a huge mover today! It has underperformed by 113.21% the S&P500.

isis-killer-beheading-video-story-top Stock Jumping Abnormally High: Plains GP Holdings, LP (PAGP)
Aug 11, 2017 - 18:39
BidaskClub downgraded Plains All American Pipeline, L.P. from a "hold" rating to a "sell" rating in a research note on Thursday. The average volume for Plains All American Pipeline, L.P. (NYSE:PAA) has been 2.9 million shares per day over the past 30 days.

isis-killer-beheading-video-story-top Antonio Conte says Matic's sale to Manchester a 'gross loss' for Chelsea
Aug 11, 2017 - 18:33
And it's something that motivates me and makes me work harder every day. "I know that double the people are watching me now". Chelsea manager Antonio Conte has insisted that the club are "trying to do their best" to bring in more players this summer.

isis-killer-beheading-video-story-top Gray makes second Yankees start vs. Blue Jays
Aug 11, 2017 - 18:27
He's pitched better in recent starts but still has nothing to show for it, having still not won a decision since May 27. Not exactly an encouraging way to go into a weekend series with the American League East-leading Red Sox in the Bronx.

isis-killer-beheading-video-story-top Cam Newton will not play in preseason opener
Aug 11, 2017 - 18:26
Despite believing to have initially suffered the injury late previous year , the former Tiger made it through the entire 2016 season.

How Many Tata Motors Limited (ADR) (NYSE:TTM)'s Analysts Are Bearish?
Aug 11, 2017 - 18:24
Sumitomo Life Insurance Company decreased Tata Mtrs Ltd Sponsored Adr ( TTM ) stake by 60.95% reported in 2016Q4 SEC filing. BB&T Corp purchased a new position in shares of Tata Motors during the first quarter valued at approximately $209,000.

isis-killer-beheading-video-story-top Cowboys running back Ezekiel Elliott expected to be suspended
Aug 11, 2017 - 18:22
And in July, he was involved in an altercation at a Dallas nightclub during which a DJ's nose was broken. No charges were brought in that case, as well.

isis-killer-beheading-video-story-top Wife of ousted Pakistani PM Nawaz Sharif to seek his parliament seat
Aug 11, 2017 - 18:13
As per media reports, Law Minister of the Province said the convoy was heading slowly and an enquiry was ordered into the matter. He said that representatives from the PML-N were already at the boy's house to offer their condolences.

isis-killer-beheading-video-story-top Near-fatal crash as auto narrowly avoids train
Aug 11, 2017 - 18:09
A auto was almost smashed to pieces by a speeding train after making a risky pass at a level crossing recently. The 48-year-old driver was fined 500 zlotys (£105) following the accident in Koszalin, Poland.