One of the devices is a balloon that can be placed in the stomach and filled with saline water, the Orbera balloon made by Apollo Endo-Surgery. It stays in the stomach for up to six months, while the patient also follows a diet and exercises regularly.
In each case, the person who received the weight loss balloon died within a month or less of having the balloon placed. Three of them died within the first three days, the administration said.
The agency says they don't know the root cause or the incidence rate of death with these devices, nor have they confirmed that the balloon systems definitely caused the deaths. The other is a dual balloon system made by ReShape.
Four of the patients were implanted with Apollo Endosurgery's Orbera balloon, while the fifth was implanted with ReShape Medical's Integrated Dual Balloon System.
Google Hosts Town Hall to Discuss Diversity in Its Ranks
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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.
The FDA's adverse report system is very broad and is not created to immediately prove a device or drug caused a complication.
According to NBC News, Apollo says it reported the deaths to the FDA itself.
"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the USA clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website.
The (intra) gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding.
The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag. 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.
Zuma had survived six previous attempts to unseat him in parliament, but this was the first to be held by secret ballot. Across the country, there were huge marches and protests as the elected leaders debated the issue of Zuma's removal.
French government spokesman Christophe Castaner said the Paris prosecutor's office has opened a counterterrorism investigation. Operation Sentinelle guards major Parisian sites from terrorist attacks, such as the recent knife scare at the Eiffel Tower .
After more than two months since it dropped in theaters, " Wonder Woman " continues to be a wonder and make box office history. The special features include interviews with filmmakers, featurettes, and extended scenes .
She also shared her story about life with Glen and life as a caregiver during a visit to Knoxville in September 2016. A college friend, I realized, also liked those songs. "Love and peace to his family", with the hashtag #endalz.
Disney dropped 5.2 percent as it reported flat third-quarter revenues due in part to weakness in its cable subscription business. The technology-focused Nasdaq Composite Index (NYSEARCA:QQQ) reversed course to finish down 0.2% at 6,370.46.
He is working towards a degree in multi-platform journalism with a minor in history at nearby University of Maryland. A US official told ABC News that Russians often fly Open Skies missions over key locations.
The company - named as Chickfriend by local media - allegedly used fipronil at poultry farms, prosecutors in the Netherlands said. Aldi said it was "purely precautionary" and added that those sold in its United Kingdom outlets are produced in Britain .
System notifications will now be surfaced via the Quick Menu, so you don't need to head back to your home screen to see them. Expect 5.00 sometime in the near future alongside an overhauled PlayStation App that isn't quite as useless as it now is.
The NLRB guarantees workers the right to engage in "concerted activities" for "mutual aid or protection," according to CNBC . Pichai said parts of the 3,300-word manifesto crossed the line by "advancing harmful gender stereotypes" in the workplace.
Snapchat results show growth in users and revenue
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Canadian diplomat in Cuba also suffered hearing loss
Trump said he was keeping the US embassy in Havana "in the hope that our countries can forge a much stronger and better path". State Department spokeswoman Heather Nauert appeared to be taken off guard at a briefing with the press pool on Wednesday.
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Video shows babysitters putting baby in refrigerator
The baby was not injured in the incident and is home safe with its family. "I don't want anyone near my child anymore", she said. The girls attempted to explain away their actions by saying they were merely reaching for a bottle to feed the crying baby.