Weight Loss Intragastric Balloons Linked To Five Deaths

Five Die While Using Obesity Devices, FDA Says

Five Die While Using Obesity Devices, FDA Says

Obesity balloons were being used in five post-surgical deaths that all occurred within a month of the device being implanted, the U.S. Food and Drug Administration said in a safety alert.

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. Pancreatitis and balloon over-inflation were not listed as potential side effects until February 2017, so doctors might not be aware of the risk.

"In three reports, death occurred as soon as one to three days after balloon placement".

The FDA said in one treatment, there was a gastric perforation with the Orbera Intragastric Balloon System. The balloon is inserted via an endoscope down the esophagus to the stomach. The balloons are then inflated with saline to the size of a grapefruit and are left there for six months, leaving the person with a "full" feeling.

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.

Shares sold off nearly 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons.

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.

'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'. 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.

In an August 10 letter to health care providers, the FDA says all five reports indicate that the deaths occurred within a month or less of balloon placement.

Recommended News

  • Newborn baby found covered in ants in a bush in Houston, Texas

    Newborn baby found covered in ants in a bush in Houston, Texas

    Authorities said they found evidence that the baby was born inside the apartment and then taken outside and placed on the ground. Neighbors questioned why the mother had left the baby outside the apartments when there is a hospital less than a block away.
    Alvaro Morata needs more time - Antonio Conte

    Alvaro Morata needs more time - Antonio Conte

    Morata's position in the starting line-up is even more crucial in the continued absence of out-of-favour compatriot Diego Costa . Conte kept his counsel on Chelsea's transfer business, with the summer window open until August 31.
    Sega releases Sonic Mania opening animation video

    Sega releases Sonic Mania opening animation video

    The previously announced Collector's Edition of Sonic Mania can be pre-ordered here for a limited time. We got to see a small portion of this a few months back , so it's nice to see the full thing.
  • Former Liberty Co. star McMillan tears ACL in National Football League  debut

    Former Liberty Co. star McMillan tears ACL in National Football League debut

    McMillan, a second-round pick from Ohio State, had been all the Dolphins hoped for as he prepared to enter the league. Dolphins linebackers Lawrence Timmons and Kiko Alonso remain a strong pairing at the top of the depth chart.
    Middlesbrough sign Chelsea midfielder Lewis Baker on season-long loan

    Middlesbrough sign Chelsea midfielder Lewis Baker on season-long loan

    The 26-year-old joined Middlesbrough for £12m from the Italian side but now is on the verge of returning to Atalanta . De Roon made 33 appearances last season in the Premier League , scoring four goals as they were relegated.
    Kenya elections: No need to kill for power - Mahama

    Kenya elections: No need to kill for power - Mahama

    His running-mate, Kalonzo Musyoka, added obliquely, "There may come a time when we need to call you into action". Police killed one person when they opened fire on protesters in Kisii County, a regional police commander said.
  • Valley natives visiting from Guam reflect on North Korea threat

    Valley natives visiting from Guam reflect on North Korea threat

    He said they are coordinating with the Guam Homeland Security/Office of Civil Defense and the U.S. Life on Guam is also deeply tied the military bases and the service members stationed at them.
    Oxygen supply disruption: 30 children die in India hospital

    Oxygen supply disruption: 30 children die in India hospital

    The negligence has raised a question over the prevailing infrastructure in the state-run hospitals in Uttar Pradesh . The 23 deaths comprised of 14 in the neonatal ward, three in the AES ward and six in the general ward.
    Summit Midstream Partners, (SMLP) Earning Somewhat Positive Press Coverage, Study Finds

    Summit Midstream Partners, (SMLP) Earning Somewhat Positive Press Coverage, Study Finds

    Alphamark Advsrs Limited Liability Com has 0.01% invested in Magellan Midstream Partners, L.P. (NYSE:MMP) for 354 shares. Similar to ROE, ROIC measures how effectively company management is using invested capital to generate company income.
  • Coutinho Hands In Transfer Request At Liverpool

    The German club confirmed they met Barca representatives but the offer did not meet their valuation of the France global . This time, Fenway and Klopp have both invested personal capital in facing Couthino and Barcelona down.
    Asia stocks, dollar extend slide as US, North Korea tensions intensify

    Asia stocks, dollar extend slide as US, North Korea tensions intensify

    Shanghai's main index also tumbled 1.6 percent to 3,208.54 while Australia's S&P/ASX 200 dropped 1.2 percent to 5,693.10. Crude futures meanwhile extended losses on fears of slowing demand and lingering concerns over global oversupply.
    Iran accuses Trump of 'bad faith' on nuclear deal

    Iran accuses Trump of 'bad faith' on nuclear deal

    Trump had described it as "the worst deal ever" and accused Tehran of continuing to back extremist groups in the Middle East. Trump for his golf course in Bedminster (New Jersey), promising "very heavy" if this was the case.

We are pleased to provide this opportunity to share information, experiences and observations about what's in the news.
Some of the comments may be reprinted elsewhere in the site or in the newspaper.
Thank you for taking the time to offer your thoughts.