Five people have died since 2016 from complications relating to non-surgical balloon systems placed in their stomachs as obesity treatments.
Back in February, the FDA issued a similar warning to keep an eye on complications from these procedures including the balloons spontaneously overinflating, which can fill the patient's stomach with fluid, or acute pancreatitis.
In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution. In the other death, there was an esophageal perforation with the ReShape Integrated Dual Balloon System.
Three died one to three days after the balloon placement.
"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. It has not received any product liability claims in connection with the five deaths.
A fourth patient died from a stomach hole and a fifth from a tear in the esophagus.
The FDA warned that someone who has already had gastrointestinal surgery or who is "unwilling or unable to participate in a medically-supervised diet and behavior modification program" should not try either of the devices.
This is less than 0.01 percent of the more than 277,000 Orbera balloons distributed during that time period, their statement said.
При любом использовании материалов сайта и дочерних проектов, гиперссылка на обязательна. «» 2007 - 2017 Copyright. Автоматизированное извлечение информации сайта запрещено.
It had earlier warned such losses might balloon to almost ￥1 trillion, and had given similar figures for the earnings. While agreeing generally with the financial results of Toshiba , the sign off from PwC did come with a caveat.
The eggs at the centre of the scandal have mainly come from the Netherlands , followed by Belgium and Germany. The insecticide Fipronil , found in the eggs, can be harmful to humans if consumed in large doses.
"Democrats have given Congress fairly low ratings throughout 2017, ranging from 10% to 19%", the pollster noted. The health law is more popular than ever with 52 percent of respondents saying they hold a favorable view of it.
There are also shows that give viewers a window to real-life events as they happen, like Major League Baseball games. In a nutshell, Shows are videos grouped by episode or theme, in contrast to your run of the mill one-off cat videos.
"Choosing his wife over his brother will deepen the crisis of credibility for Nawaz Sharif ", said Mosharraf Zaidi, a columnist. He has also planned to deliver speeches at important places where even bigger crowds of supporters are expected to turn up.
AFP Assistant Commissioner Neil Gaughan said the groups had long-been involved in the importation of illicit substances. The ABC understands Michael and Fadi Ibrahim were arrested in Dubai early on Tuesday.
India's economy is at risk of slowing down in the current fiscal year, the government said in a mid-year economic survey Friday. Industry bodies CII, FICCI and Assocham also hailed steps taken by the government to resolve the "twin balance sheet" problem.
He said he would act against any partyman, including the chief minister, if they went against the interests of the party. Jayakumar expressed confidence over the merger of EPS, OPS factions of the AIADMK and said he hopes it happens soon.
Cooke said the show would be slightly better in the predawn hours of August 12, but that there'd be a decent show both nights. Those hoping to catch a glimpse of the Perseid meteor shower at its peak Friday night might want to stay indoors.
Trump at the Helm - God Help Us
After days and days of build-up North Korea and the United States have now bluntly threatened each other with nuclear catastrophe. Chances are, he doesn't want to live in one.
Hamid Ansari signs off as Vice-President
Majority appreciated his constant endeavour to stick to the rules and not allowing any legislation to be passed during din. Finance Minister Arun Jaitley said that Hamid Ansari has contributed to the quality of debate with his wisdom.
LDS Church excommunicates general authority
Lee in 1989 for "apostasy and other conduct unbecoming a member of the church", the Daily Herald reported. In 1985, he earned a master's degree in political philosophy and a juris doctorate degree from BYU.
MN teen competes for $1M in World of Dance finale
Eva took the stage first in the second round, and it was a huge comeback because her choreography was lacking in her first dance. Les Twins dominated the first round, scoring a 93, while Swing and Igo scored a 91.7 and 91, respectively.
UCLA QB Josh Rosen on being a student athlete
The interview was published yesterday on B/R's College Football section and had a controversial quote featured from Rosen himself. They don't realize that they're getting screwed until it's too late. "I want to create my own business", he said.