Five people who had a balloon system put into their stomach to treat obesity have died since 2016, the FDA warned Thursday. 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. Studies have suggested that fluid is superior to air for distending gastric balloons. Inflated balloons reduce the operative volume capacity of the stomach. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way. Four of the deaths occurred after patients used the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one took place after a patient used the ReShape Integrated Dual Balloon System, which is made by ReShape Medical Inc.
Apollo said in a press release that the deaths of the patients using their weight-loss balloon were not necessarily caused by their products. In three reports, the patients died in as little as one to three days later.
The FDA said it is not clear whether the deaths were caused by the devices - which were approved in 2015 - or the surgical process.
All deaths happened within a month of the procedure, the FDA said in a letter earlier this week to health-care providers.
Disney To Remove All Content Off Netflix!
If Disney's direct-to-consumer platforms are successful, Greenfield anticipates that will accelerate ESPN's demise. Disney now uses BAMTech to stream the content, which it now owns a third of but plans to buy a majority stake in.
It says it has not received any communications or indications from physicians or hospitals that the deaths were due to ORBERA, adding that the FDA's letter did not indicate the deaths were related to the device. Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.
Apollo Endo-Surgery said in a press conference they are responsible for one death in the U.S., one in Great Britain, one in Mexico, and two in Brazil.
The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag.
"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the US clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website. 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 comments follow reports that the North has mastered a technology needed to strike the United States with a nuclear missile. Unit labor costs had been expected to climb by 1.2% compared to the 2.2% jump that had been reported for the previous quarter.
Paramedics arrived on scene shortly afterwards and were able to save the officer's life despite the serious nature of his wounds. He told WJCL TV that he has nightmares about that day, but that he still hopes to return to work sometime early next year.
He said that the problem of Encephalitis- inflammation of the brain- has been in Uttar Pradesh since 1978. BSP and Samajwadi Party also announced that they will send delegation to take stalk of the situation.
While the 162,000 Guamanians on the island rely primarily on tourism, the US military is also essential to the island's economy. A THAAD battery includes a truck-mounted launcher, tracking radar, interceptor missiles and an integrated fire control system.
The juveniles are charged with child endangerment and assault and battery by means of a risky weapon, that being the refrigerator. She says she was showering and left the baby with her and a 14-year-old friend for about a half hour. "Kids do stupid things".
Austin-Travis County Emergency Medical Services officials said at the time that the woman was treated at a hospital. Police released video of the crash August 10. "I was pivoting in that little administration conveyance zone".
The GSA owns the lease to the Old Post Office, the building which was later developed into the Trump International Hotel. The only divisions of the hotel that didn't churn a profit were retail, parking, and the Spa by Ivanka Trump.
The Watch tab and a number of shows will start arriving on some US users' mobile, desktop, and Facebook's TV apps today. Facebook has limited the number of content creators who can take advantage of the program during a testing phase.
But we've been checking around with various agencies, the White House, and they just don't quite know yet. The president could ask HHS Secretary Price to declare an emergency under the Public Health Service Act .
More locally-heavy downpours tonight could do the same: some get wet, others get left without much rain at all. The National Weather Service says to expect isolated morning showers with scattered storms around midday.
Deportivo La Coruna , who sold Perez to Arsenal for £17m only a year ago, are keen to bring the 28-year-old back to La Liga. We know what we need (in the transfer market) and we will try to do this until the end of the window.
Premier League updates from Goodison Park
Stoke could complete the signing of Bruno Martins Indi before the game but it will not be done in time for him to feature. Everton will hope to get off to a good start at home as they seek to finally qualify for the Champions League.
Kim Jong Un doesn't need to strike Guam - he's already won
The escalating threats between the USA and North Korea have thrown the tiny US territory of Guam into the headlines. Guam officially became a USA territory in 1950 and was put under the administration of the Department of the Navy .
Russian military spy jet flies over DC, New Jersey
S. locations, including Trump National Golf Club in Bedminster, where President Donald Trump is now in residence. Open Skies allows for unarmed aerial surveillance flights over the entire territory of a participating country.
Venezuelan wants to meet Trump
The Maduro regime is under increasing economic and diplomatic pressure as the political crisis in Venezuela gets worse. Trump recently imposed sanctions on Maduro , accusing him of undermining democracy.
Bus driver shortage raises ire of Dallas school trustees
But once drivers are on Veterans Parkway, which has a grass median, they must stop only for a bus going in their direction. Wait for OK to cross - Wait until the bus driver gives the OK sign or thumbs up to cross the street or get on the bus.
With no Wednesday victor , Powerball jackpot grows
Annuity is paid out as one immediate sum, followed by 29 annual payments, each 5 percent bigger than the previous one. If no one matched all five numbers plus the Mega Ball in tonight's drawing, the jackpot will continue to increase.
Jordan Matthews Traded to the Bills
The Buffalo Bills and Los Angeles Rams have completed a trade that sends wide receiver Sammy Watkins to Southern California. In exchange for Darby, the Bills will receive wide receiver Jordan Matthews and the Eagles' 2018 third round pick.