Intragastric Balloon System – FDA Issues Safety Alert

News » Intragastric Balloon System - FDA Issues Safety Alert
intragastric balloon system safety alert

In the United States, an estimated 160 million Americans are overweight or obese, according to the Institute for Health Metrics and Evaluation. The statistics are not only overwhelming but an indication that obesity is a massive, worldwide problem. Weight loss surgery is an extreme option, but for many, it helps to not only lose weight but to solve many health ailments. There are different types of weight loss surgeries, and each has its advantages and disadvantages.

In recent years, a new method, the intragastric balloon system, has risen in popularity. Developed by two prominent companies, Apollo Endo-Surgery and ReShape Medical, the new method involves a minimally invasive method of treating obesity with liquid filled intragastric balloon systems. The intragastric balloon system is essentially a balloon of liquid that fills a portion of the stomach to make the individual feel fuller faster, and as a result, eat less. It provides an alternative to an invasive and extensive weight loss surgery. Unfortunately, the balloon system has had deadly side effects. Five people died as a result of complications from the balloon system in 2016.

According to the Food & Drug Administration (FDA), there were four reported deaths involving the Orbera Intragastric Balloon System (Apollo Endo-Surgery), and one report involving the ReShape Integrated Dual Balloon System (ReShape Medical). Each of the five deaths occurred within a month or less after the balloon was placed inside the stomach. The deaths caused the FDA to issue a safety alert warning consumers of the potential dangers of this weight loss method. Additionally, Apollo Endo-Surgery and ReShape Medical are working with the FDA to conduct post-approval studies to evaluate the safety of the products. It is still unclear whether there is a definite link between the products and deaths. If you or someone you know has suffered from an adverse effect as a result of the intragastric balloon system please report your experience to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Commissioner, Office of the. “Reporting Serious Problems to FDA.” U S Food and Drug Administration Home Page, Office of the Commissioner, www.fda.gov/Safety/MedWatch/HowToReport/ucm2007306.htm.

Commissioner, Office of the. “Safety Alerts for Human Medical Products – Liquid-Filled Intragastric Balloon Systems: Letter to Healthcare Providers – Potential Risks.” U S Food and Drug Administration Home Page, Office of the Commissioner, www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570916.htm.

Mukherjee, Sy. “5 Patients Died After Obesity-Fighting Stomach Balloon Procedures. The FDA Wants to Know Why.” Fortune, 11 Aug. 2017, fortune.com/2017/08/11/fda-obesity-gastric-balloon-deaths/.

Share

Related Posts

FDA Approval Process | What is the FDA Drug Approval Process?

June 23, 2020
Learn More

June 23, 2020

FDA Approval Process | What is the FDA Drug Approval Process?

Black Box Warning – The Strongest Consumer Warning FDA Can Issue

September 8, 2017
Learn More

September 8, 2017

Black Box Warning – The Strongest Consumer Warning FDA Can Issue

Should I Report A Drug Injury or Drug Side Effect?

May 17, 2017
Learn More

May 17, 2017

Should I Report A Drug Injury or Drug Side Effect?

FAERS: A Questionable Drug Safety Reporting System

February 19, 2015
Learn More

February 19, 2015

FAERS: A Questionable Drug Safety Reporting System

FDA Approval Process Called Into Question for Unsafe Practices

August 2, 2011
Learn More

August 2, 2011

FDA Approval Process Called Into Question for Unsafe Practices

CLIENT REVIEWS

quotation
Tom Lewis

TorHoerman Law was responsible for handling a medical case for our family. I was extremely impressed with their professionalism and ability to react quickly. They also did a nice job keeping us updated with the case throughout the process. This was the first time experiencing a situation like this and Tor Hoerman law did an excellent job from start to finish.

quotation
Jordan Terry

TorHoerman Law is an extraordinary law firm – a firm that truly makes the client’s best interests the primary concern. Their team of personal injury lawyers are experienced, personable, and well versed in a range of litigation areas. They are supported by a dedicated team of staff that are as equally friendly and helpful. I would recommend TorHoerman Law for any personal injury litigation needs.

quotation
Dave Woodley

All of my questions were answered quickly and in a way I could understand. Steve and the entire staff were friendly and professional.

quotation
Jordan Butler

I highly recommend this law firm! The attorneys and staff at THL worked hard, communicated every step of the process, kept me well informed at all times, and exceeded all expectations! The staff is kind, considerate, professional, and very experienced. Look no further, call now!

quotation
Maddy Moeller

Top-notch, hardworking attorneys!

quotation
Karen Hersman

A wonderful and professional legal team. They helped me when I needed expert legal representation! Thank you TorHoerman Law!

THANK YOU FOR YOUR MESSAGE

One of our associates will follow up with you shortly