vegassports-odds.com
vegassports-odds.com December 16, 2017


FDA Reports That 5 People Have Died After Weight Loss Balloon Treatments

12 August 2017, 12:56 | Winifred Adams

Aurora Colorado. John Moore

Aurora Colorado. John Moore

All 5 patients died within 1 month of receiving the weight-loss balloon.

The FDA said that five deaths have been linked to intragastric balloons albeit it remains unclear if the fatalities were caused by the device itself or the surgery.

Gastric balloons are among the varied devices on the market to treat severe obesity.

Four of the reported deaths involved the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one other death involved the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc., the FDA said in a press release.

The FDA said that they also received two other reports of fatal cases in the same period which were associated with potential complications linked to balloon treatment.

Sammy Watkins traded to NFC team
The 2011 South Fort Myers high school graduate went to Clemson University where he broke records and entered the draft in 2014. The team announced they dealt wide receiver Sammy Watkins to the Los Angeles Rams in exchange for cornerback E.J.

30 kids die at UP hospital in 48 hrs
A high-level magisterial probe has been ordered into the incident . "The report will be out in the next 24 hours", he said . Ironically, the tragedy struck the hospital two days after the Chief Minister reviewed BRD Medical College's functioning.

Toronto Blue Jays vs. New York Yankees
In Oakland, Nelson Cruz homered twice, Kyle Seager also went deep off Jharel Cotton (5-9) and Seattle completed a two-game sweep. Gibbons said RHP Chris Rowley will be promoted from Triple-A Buffalo to start against Pittsburgh on Saturday.

"All five reports indicate that patient deaths occurred within a month or less of balloon placement", the FDA said in a statement cited by NBC. In three reports, the patients died in as little as one to three days later.

"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. No product liability lawsuits have been filed against it, the Austin, Texas-based company said, claiming an incident rate since the beginning of 2006 of less than 0.01%.

An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States. 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. "In our physician training, we are diligent to emphasize the factors that support the safe and effective use of ORBERA and we will continue to do so". Pancreatitis and balloon over-inflation were not listed as potential side effects until February 2017, so doctors might not be aware of the risk.

APEN shares closed down -23.3% at $4.34 apiece yesterday.



Other News

Trending Now

China quake toll rises to 24
Jiuzhaigou, or Jiuzhai Valley, is a national park known for spectacular waterfalls and karst formations. More than 70,000 people have been evacuated from quake-hit towns and villages, state media reported.

Guam residents confident in US military
The 163,000 residents that make up Guam's population, which includes 6,000 USA service members, are considered US citizens. South Korean President Moon Jae-In has also urged limits on Seoul's missiles to be loosened in a conversation with Trump.

Bill Hader takes on Anthony Scaramucci on Weekend Update
He then takes some questions, including commenting on his remarks to the New Yorker about Steve Bannon trying to "S his own C". Here's to hoping the world avoids nuclear destruction, and that Hader's priceless impersonation comes back this fall .

Guardiola unmoved by Manchester City favourite tag
We are here to win the games and titles. "The big fail now takes one week in football". Asked about extra pressure, he added: "It's the same pressure as I had last season".