Health Care

Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says

Intragastric Weight Loss Balloons Linked to 5 Deaths, FDA Says”

The FDA sent a letter to healthcare providers warning of reports of seven deaths with liquid-filled intragastric balloon systems used to treat obesity. 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.

In five cases, the cause of death was unclear, but all occurred within a month or less of balloon placement, the agency said. Four of the deaths occurred after patients used the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one took place after a patient used the ReShape Integrated Dual Balloon System, which is made by ReShape Medical Inc.

The process involves placing one or two uninflated balloons using an endoscope that goes through a patient's mouth into the stomach.

Shares sold off nearly 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons. The object of the balloon is to reduce how much a person can eat by filling the stomach with the balloon, NBC News noted.

According to Apollo Endo-Surgery, there has been one additional death of a person who received its device.

The FDA has not determined the root cause or incidence rate of patient death. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017. "Patients must be monitored closely during the entire term of treatment in order 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", added CMO Dr. Christopher Gostout. ReShape is committed to supporting the continued safe and effective use of the dual balloon and is proactively communicating with physicians about this FDA update. 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.



Like this

Latest


11 August 2017
Bill Hader plays Anthony 'The Mooch' Scaramucci on SNL Weekend Update
Instead of saying " Steve Bannon was trying to "s" his own 'c, '" Scaramucci insisted that he "didn't say he tried - he did". You got a little bump of me, I made you feel excited, and I was out of your system too quick.

11 August 2017
Anonymous app Sarahah goes viral amid bullying concerns
In the past, we have seen apps such as Yik Yak , Whisper, Connected2, and Secret that are identical to that of the Sarahah app . The company believes that getting this honest feedback will help your friendship by finding areas for improvement.

11 August 2017
Swiss franc consolidates after rallying hard on North Korea tensions
Department of Defense is monitoring this situation very closely and is maintaining a condition of readiness, daily", he said. It has since been used in Syria and the wake of the Ukraine-Russia crisis.

11 August 2017
Duluth FD: Father, Daughter Pulled From Lake Superior
Duluth police reported shortly after 5 p.m. that a search was underway for two missing swimmers near the beach house. The fire department issued a rip current warning earlier in the day, and Park Point Beach was closed.

11 August 2017
Analysts Set The Middleby Corporation (MIDD) PT at $141.60
Several large investors have recently modified their holdings of MIDD. 60 funds opened positions while 109 raised stakes. The stock of Middleby Corp (NASDAQ:MIDD) has "Neutral" rating given on Thursday, December 15 by Macquarie Research.

11 August 2017
Ezekiel Elliott Will Be Suspended
The woman, Tiffany Thompson, also had accused Elliott of pushing her against a wall during a February 2016 incident in Florida. According to NFL Media's Ian Rapoport , a ruling on whether Elliott will be suspended could come as early as Friday.

11 August 2017
Game of Thrones Fans Spotted Something Creepy in Season 7 Episode
Martin wrote that the spirit of Catelyn comes back to life as an undead character called Lady Stoneheart. She wants revenge on the Freys for the Red Wedding, a role Arya has pretty much filled in Season 7.

11 August 2017
Nally believes the Affordable Care Act should be repealed
Large numbers of these Americans needed it desperately, so of course the costs are going up, and insurance companies are balking. For those who do qualify for subsidies, the government would have to increase the amount of each subsidy to match the premium .

11 August 2017
'Hamilton' stage musical launches an official app
The official " Hamilton " app launches August 11, with the app-based lottery available in Chicago starting August 29. The app's stickers and emojis feature fan art and show lyrics, and will be continually upgraded with new offerings.

11 August 2017
Guliyev wins 200m with Van Niekerk second & Makwala sixth
I feel like I have let the nation down today. "I will always pray to not face this again", Makwala said. He ran under the targeted time and then finished second in the semi-final to earn a place in the final.



Recommended