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. The five people died with a month of getting the balloons inserted into their bodies, and three of them died within just three days.
The company has not received product-liability claims as a result of any of the deaths, it said.
The full statement from the FDA follows below.
Nawaz Sharif fields wife in 'Waterloo'
Nawaz asked the people, "I don't expect you to reinstate me, but I want you to support me for the betterment of this country". He asked Pakistan Muslim League-Nawaz (PML-N) workers need not to worry, and added that they were progressing.
"At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices", the FDA wrote.
Also, as part of ongoing studies of these devices ordered by the FDA, the agency will measure their safety and effectiveness.
Scaramucci to guest on Colbert's 'Late Show' next week
Trump's first communications director Sean Spicer resigned after it was announced The Mooch was being brought into the White House.
The FDA will keep the public informed as significant new information becomes available.
Shares sold off nearly 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons. Since issuing this letter, both companies have revised their product labeling to address these risks. "Patients must be monitored closely during the entire term of treatment to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms".
A typical stomach has a gastric volume of 900 ml, and the inflated balloon occupies a volume around 700 ml.
The products and procedures are approved by the FDA. Use of the device may have unwanted side effects. This can be done in an outpatient setting under sedation.
Bears Mike Glennon to remain starter following opener — John Fox
Trubisky's first and only touchdown pass came with 16 seconds left in the first half to cap a six-play, 50-yard drive. The next two drives were stalled after wide receiver Jordan Taylor failed to find the first down marker.
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. Thus, the space for food is reduced, tending to a loss of weight. After a maximum of up to six months, the device is removed using endoscopy again.
- Nagasaki commemorates 72nd anniversary of A-bombing
- Video shows babysitters putting baby in refrigerator
- Tesla: Self-Driving Semi-Trucks On The Way
- JP: Rain chances remain high with slightly drier weekend ahead
- Auto plunges seven floors from parking garage into alley below
- South Africa's Opposition Party Seeks Early Elections Over Corruption
- Man kills himself after shooting officer in Brooklyn, authorities say
- Glen Campbell, Country Legend, Dies at 81
- Canadian Pastor freed by North Korea
- Korea to halt all provocations, says door for dialogue still open