FDA reports at least 5 deaths from gastric balloons. A link to a CNN article.

Momepro

Just saw this today and decided to share. Not so much because I want to scare anyone, but because it can be hard to find out side effects and issues when the companies PR people are so good at flooding Google with positive reviews and articles.

5 deaths reported while using weight loss balloon treatment, FDA says
http://www.cnn.com/2017/08/11/health/fda-weight-loss-balloon-alert/index.html

mph323

Momepro wrote: »

Just saw this today and decided to share. Not so much because I want to scare anyone, but because it can be hard to find out side effects and issues when the companies PR people are so good at flooding Google with positive reviews and articles.

5 deaths reported while using weight loss balloon treatment, FDA says
http://www.cnn.com/2017/08/11/health/fda-weight-loss-balloon-alert/index.html

Interesting and certainly thought-provoking, but this article doesn't really add new information though. The deaths are still being investigated for cause, and the percentage falls within the self-reported mortality guidelines. The cause could be related to the device, the patient's own ore-existing conditions, the skill of the Dr. doing the surgery or a number of other factors. From the article

The company said it "received no product liability-related claims in connection with these five cases" and noted that the incidence rate "remains less than 0.01%," which is in line with what it reports in the directions for use of the device. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017.

"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," the company said.

Note that I'm not expressing any opinion regarding whether or not people should go the WLS route, just commenting on the article.

Old_Cat_Lady

No deaths from Aspire Assist.

nutmegoreo

I know this is off topic, but I got a chuckle from self-reported mortality. I'm pretty sure that once I'm dead, I won't be reporting anything. Of course, I am chatty, so maybe I will.

RuNaRoUnDaFiEld

That doesn't seem high to me. Any procedure carries risk.

mph323

nutmegoreo wrote: »

I know this is off topic, but I got a chuckle from self-reported mortality. I'm pretty sure that once I'm dead, I won't be reporting anything. Of course, I am chatty, so maybe I will.

Oh geez I missed that! Wouldn't that be awesome!

*It should have said "...the manufacturer's self-reported mortality guidelines..."

edited to fix quote

nutmegoreo

mph323 wrote: »

nutmegoreo wrote: »

I know this is off topic, but I got a chuckle from self-reported mortality. I'm pretty sure that once I'm dead, I won't be reporting anything. Of course, I am chatty, so maybe I will.

Oh geez I missed that! Wouldn't that be awesome!

*It should have said "...the manufacturer's self-reported mortality guidelines...

edited to fix quote

It was highly amusing! :bigsmile:

Momepro

RuNaRoUnDaFiEld wrote: »

That doesn't seem high to me. Any procedure carries risk.

Absolutely true. This is a reminder that no matter how well hyped or popular something is, looking for the negatives are even more important for making an informed decision. This was just a post to help consumers find where they can look for the negatives.

NorthCascades

Is five deaths a lot or a little? A few people drown in their bath tubs every year just in my state. How often are these performed?

mph323

NorthCascades wrote: »

Is five deaths a lot or a little? A few people drown in their bath tubs every year just in my state. How often are these performed?

The 5 deaths are less than 0.01% of the total procedures performed. Between 2006 and 2017 there have been 21 deaths reported.

Blankcanvas89

mph323 wrote: »

Momepro wrote: »

Just saw this today and decided to share. Not so much because I want to scare anyone, but because it can be hard to find out side effects and issues when the companies PR people are so good at flooding Google with positive reviews and articles.

5 deaths reported while using weight loss balloon treatment, FDA says
http://www.cnn.com/2017/08/11/health/fda-weight-loss-balloon-alert/index.html

Interesting and certainly thought-provoking, but this article doesn't really add new information though. The deaths are still being investigated for cause, and the percentage falls within the self-reported mortality guidelines. The cause could be related to the device, the patient's own ore-existing conditions, the skill of the Dr. doing the surgery or a number of other factors. From the article

The company said it "received no product liability-related claims in connection with these five cases" and noted that the incidence rate "remains less than 0.01%," which is in line with what it reports in the directions for use of the device. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017.

"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," the company said.

Note that I'm not expressing any opinion regarding whether or not people should go the WLS route, just commenting on the article.

Spoke to the doc about this.He said, due to absolute transparency reports, anyone who dies while having this, needs to be reported, whether the death is related to the device or not.If an Orbera patient dies in a car crash, for instance, it needs to be recorded as a death during usage of balloon. Out of the 5 deaths, one was in US, and that person had cardiac issues.

crackpotbaby

I am all for informed consent. It's a legal and ethical requirement here in Australia. Everyone should know the risk vs benefit of any medical intervention, particularly invasive procedures or devices. Including mortality and morbidity data.

..............

My immediate thought with this post is the comparative, how many people died from obesity related causes during this same time period?

CSARdiver

FYI - you can review all the adverse events experienced with any registered medical device using the MAUDE dbase:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

You can do the same with pharmaceutical products, but you need to request the search parameters and the FDA provides the results.

cynthiab74

These records don't indicate cause of death.....just that a gastric balloon was in place at time of death.

CSARdiver

cynthiab74 wrote: »

These records don't indicate cause of death.....just that a gastric balloon was in place at time of death.

Pharmacovigilance systems rarely delve into causation as this is entirely subjective and typically eliminated from studies. This is true for the majority of warnings and indication on pharmaceutical/medical device labeling.

emily_howard925

I had the balloon placed August 9th (3 weeks ago) and am down 17.6lbs. I had zero nausea and haven't throw up at all BUT that is not the typical experience. Most are extremely sick the first few days. The mental challenges have been the hardest for me. I had to be on a liquid diet 3 days prior to placement and a week after placement. Then I moved to pureed, soft, and am now almost to a normal diet. Going weeks without eating solid food is difficult but I have survived.

Start weight 207 5'6"