FacebookInstagramTwitterContact

 

Citizenship Certificate Presentation Ceremony           >>           Seven Teens With Alleged 'Extremist Ideology' Arrested In Sydney Raids           >>           Seven Teens With Alleged 'Extremist Ideology' Arrested In Sydney Raids           >>           Launching of A.I. Diabetic Retinopathy Screening Services           >>           Honey: An Amazing Superfood With Many Health Benefits           >>           Exploring The Benefits Of FASTING For Treating COVID-19 And Vaccine Injuries           >>           Milan Wants To Ban Gelato, Pizza And Other Italian Favourites (Sort Of)           >>           Skai Jackson Reveals Where She Stands With Her Jessie Costars Today           >>           Billie Eilish Details When She Realized She Wanted Her “Face In A Vagina”           >>           Messages of Condolences           >>          

 

SHARE THIS ARTICLE




REACH US


GENERAL INQUIRY

[email protected]

 

ADVERTISING

[email protected]

 

PRESS RELEASE

[email protected]

 

HOTLINE

+673 222-0178 [Office Hour]

+673 223-6740 [Fax]

 



Upcoming Events





Prayer Times


The prayer times for Brunei-Muara and Temburong districts. For Tutong add 1 minute and for Belait add 3 minutes.


Imsak

: 05:01 AM

Subuh

: 05:11 AM

Syuruk

: 06:29 AM

Doha

: 06:51 AM

Zohor

: 12:32 PM

Asar

: 03:44 PM

Maghrib

: 06:32 PM

Isyak

: 07:42 PM

 



The Business Directory


 

 



Health


  Home > Health


FDA Admits Five Patients Now KILLED By Anti-Obesity Surgical Balloon Surgery


 


 August 19th, 2017  |  09:22 AM  |   1200 views

NATURALNEWS.COM

 

The Food and Drug Administration (FDA) reported that at least five patients have died soon after being fitted with anti-obesity gastric balloons.

 

“All five reports indicate that patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement. 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 Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment,” an FDA statement said.

 

The FDA-approved, liquid-filled balloons were designed to induce weight loss by surgically inserting them into the stomach, thus coaxing the body into feeling fuller and prompting lower food intake among users.

 

Four of the patients used Apollo Endo Surgery’s Orbera balloon. The saline-filled device was approved in 2015 and was touted to help obese patients shed more than three times the weight lost through diet and exercise. According to the company, there have been more than 220,000 cases of successful implants across 80 countries.

 

On the other hand, the fifth patient was found to have used ReShape Medical Inc.’s ReShape Integrated Dual Balloon System. The device, approved in June 15, was inserted into a patient’s stomach through the mouth in order to avoid surgical scarring.

The FDA remains uncertain whether the devices or the required surgery to implant them caused the deaths, but issued a warning that physicians should closely monitor patients who receive the gastric balloons. The federal agency also cautioned that the devices should not be used by patients who already had gastrointestinal surgery and those who were unwilling or unable to undergo a medically-supervised diet and behavior modification program.

 

Device maker responds to recent reports

 

In response to the recent reports, Apollo has released a company statement indicating that the deaths were not necessarily caused by their device.

 

“The FDA’s letter to health care providers does not indicate that the patient deaths were related to the Orbera device or the insertion procedures. 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,” an Apollo statement read.

 

Apollo also noted that it did not receive liability claims as a result of any of the deaths. Likewise, the company noted that while 21 patients using the Orbera device died between January 2006 to March 2017, the rate was a minuscule 0.01 percent of the more than 277,000 units distributed during the said period.

 

According to Apollo’s CEO Todd Newton, many of the patients who used the weight-loss devices also had other preexisting conditions associated with excess weight. “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,” Newton said.

 

The FDA said it will examine two other deaths associated with the gastric balloons in question. Apollo subsequently countered, stating that on the first case, the Brazilian patient’s cause of death was ruled out as heart attack. The company also noted that on the second case, non-device related gastric perforation lead to complications and eventual death in yet another Brazilian patient.

 


 

Source:
courtesy of NATURALNEWS

by Russel Davis

 

If you have any stories or news that you would like to share with the global online community, please feel free to share it with us by contacting us directly at [email protected]

 

Related News


Lahad Datu Murder: Remand Of 13 Students Extende

 2024-03-30 07:57:54

Seven Teens With Alleged 'Extremist Ideology' Arrested In Sydney Raids

 2024-04-25 10:57:21

Boycotts Aren't The Only Way To Hold Companies Accountable

 2024-04-25 01:24:19