The FDA has not identified a root cause for the patient deaths and can not "definitively attribute the deaths to the devices or the insertion procedures for these devices", according to an agency notice. Placed in the stomach orally in a minimally invasive endoscopic procedure, they're created to be filled with fluid and stay in the stomach for six months.
Federal officials are warning health providers about weight loss balloon devices after five people died unexpectedly shortly after being treated with them.
The FDA says it doesn't know if the devices or the surgery to implant them is to blame but issued an alert to doctors to closely monitor patients who get them.
We're buying three more players - Guardiola
Now many pundits' favourites for this season's Premier League title, Manchester City's transfer business has been eye-catching. The excitement and anticipation of the Man City game has been marred by injury to Beram Kayal in the final warm-up match.
The FDA said the deaths occurred from 2016 to present. Intragastric balloons are created to treat obesity by taking up room in the stomach, making patients feel full. These are spontaneous overinflation, with liquid or gas, of the devices and acute pancreatitis. Apollo's Orbera intragastric balloon system is composed of a single balloon which is filled with saline, while ReShape's integrated dual balloon system uses 2 balloons filled with saline and methylene blue dye. 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%.
The other two deaths occurred within a month or less of having the procedure.
'While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device'.
"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. Patients with questions about this FDA update should contact their physicians directly".
SoundCloud Set To Secure Financial Future
If accepted, then the new investment - $169.5 million at a $150 million pre-money enterprise valuation - also closes tomorrow. Leading the potential funders for the new round are Raine Group and Temasek , as we had previously reported.
Yankees ride stacked bullpen, timely hits past Blue Jays
In the fourth inning the Jays added a third run on a Steve Pearce base hit, a sacrifice and a run-scoring single by Kevin Pillar . Marco Estrada will get the ball for the series finale and is 4-7 with a 5.12 ERA and 134 strikeouts this season.
No Man's Sky may finally be getting multiplayer
This includes a communicator, which can be used to advance mission steps, or even to hail pirates before they attack. You'll now see other players who are exploring the same world as you represented in-game as floating orbs.
Sells 343 Shares of Netflix, Inc. (NASDAQ:NFLX)
July 17 investment analysts at Nomura left the company rating at "Buy" but raised the price expectation to $175.00 from $130.00. The business had revenue of $2.79 billion during the quarter, compared to the consensus estimate of $2.76 billion.
FTSE 100 slides for a second day
On the currency markets , the pound fell 0.2% against the dollar to $1.2976 and slipped 0.05% against the euro at 1.1055 euros. In oil, the price of Brent crude sunk by 0.5% to 51.65 U.S. dollars a barrel amid concerns about over supply in the market .