The FDA said in one treatment, there was a gastric perforation with the Orbera Intragastric Balloon System. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way.
The FDA said it's working with both companies, Apollo Endo-Surgery and ReShape Medical Inc., to understand the deaths and "to monitor the potential complications of acute pancreatitis and spontaneous over-inflation".
According to Apollo Endo-Surgery, there has been one additional death of a person who received its device.
"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. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017. The exact causes in three of the deaths remained unknown.
"Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously", said Apollo Endosurgery CEO Todd Newton in a statement.
Most of the adverse events involve Obera, which uses saline to fill a single stomach balloon, as opposed to the ReShape system that uses 2 balloons filled with saline and a blue due.
The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring.
Netflix, Inc. (NASDAQ:NFLX) Lifted to "Buy" at BidaskClub
The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available through this hyperlink . Following the completion of the sale, the director now owns 8,012 shares in the company, valued at approximately $1,264,373.72.
ISIS Laundered Money into US Using eBay
He denied planning an attack on the country himself but admitted that the money was sent to fund operations like "terror attacks". The network was run by senior Islamic State official Sitful Sujan who was killed in a US -led airstrike in December of 2015.
Bills trade Sammy Watkins and Ronald Darby in massive shakeup
Earlier this offseason, the Bills declined the fifth-year option on Watkins' contract, making him a free agent after this season. The 2011 South Fort Myers high school graduate went to Clemson University where he broke records and entered the draft in 2014.
No Man's Sky Atlas Rises update released today
Hello Games has released a new update for No Man's Sky that makes some major changes to the experience that launched past year . Earlier this week, we heard that No Man's Sky would be getting a big free expansion this week called " Atlas Rises ".