In three of the cases the FDA said it does not yet know the root cause or incidence rate of patient death, nor can it "definitively attribute the deaths to the devices or the insertion procedures for these devices".
The five people died within a month or less of having the balloons inserted.
Since the FDA's OK, there have been five reported deaths in patients who received the ORBERA intragastric balloon in four countries, one in the U.S. The company reported all five cases under its Global Product Surveillance program.
Deaths in all five patients occurred within one month of balloon placement with three occurring as early as 1-3 days after placement. The remaining two deaths could be related to "potential complications associated with balloon treatment", - one was a stomach perforation and the other was a perforation in the esophagus, according to the FDA.
Guam 'well-equipped' to handle North Korean threat: governor
Andersen Air Force Base hosts a Navy helicopter squadron and Air Force bombers that rotate to Guam from the US mainland. It did so to compensate for US forces diverted from other bases in the Asia-Pacific region to fight in the Middle East.
Apollo Endo-Surgery said, per NBC News, that worldwide sales of gastric balloons were estimated to total about $120 million in 2015, driven by broad use in Brazil, Mexico and Europe, and the death reports came from all around the world, and did not necessarily include US patients. "Patients must be monitored closely during the entire term of treatment in order to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms", added CMO Dr. Christopher Gostout.
In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety". 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.
APEN shares closed down -23.3% at $4.34 apiece yesterday.
Manitowoc Company, Inc. (The) (MTW) Upgraded at TheStreet
Since January 1, 0001, it had 0 insider purchases, and 3 insider sales for $1.53 million activity. 108,510 Amkor Technology, Inc. In terms of Buy, Sell or Hold recommendations, Manitowoc Company (NYSE:MTW) has analysts' mean recommendation of 2.6.
Panthers Down Texans In Opener With Many Locals In Action
Panthers cornerback Captain Munnerlyn, another Gamecock, praised the play of Watson but said he was glad to see Byrd step up. WHAT BROWN DOES FOR YOU: The Texans clearly missed left tackle Duane Brown, whose contract situation remains unresolved.
Disney dropping Netflix, eyes own streaming service
But the big news in the release wasn't about earnings, it was that Disney was going to remove its movies from Netflix , Inc. Sky already has a multi-year deal with Disney for its major film releases like Frozen, which does not appear on Netflix .
Applebee's to close up to 135 locations
TheStreet lowered shares of DineEquity from a "b-" rating to a "c" rating in a research note on Monday, March 20th. ILLEGAL ACTIVITY NOTICE: This piece was posted by Chaffey Breeze and is the sole property of of Chaffey Breeze.
Are total solar eclipses possible on other planets?
He is pointing the passage from Bible that states,"The Stars of Heaven and their constellations will not show their light. The video was put up as a response to questions from students who were scared of the end of the world.