Intragastric Balloons – Summary and Publications:
Attempts at gastric restriction and mechanical satiety by use of a gastric balloon or bag have been present in
bariatric literature dating back to the 1980. At least four balloons which have been trialed are currently obsolete.
The Garren-Edwards bubble made by American Edwards Laboratories of Irvine, California is obsolete. This was
used for a short period of time between 1985 and 1988. This was a polyurethane cylinder. Success rates were
limited and the safety issues resulted in this being pulled from the market. Three other balloons are also obsolete
and are no longer used. These balloons are the following:
1) The silicone rubber acid resistant balloon made by Dow Corning in Midland, Michigan and is no longer
used.
2) The Wilson Cook balloon from Winston-Salem, North Carolina again is obsolete and no longer in use.
3) The Tremco balloon from Cleveland, Ohio is again obsolete and no longer used.
There are several balloons in use today. At least four of the balloons are saline balloons. These balloons are the
following:
1) The BioEnteric Intragastric Balloon, or “BIB” (trademark), also known as the Orbera (trademark.)
2) The Silimed Intragastric Balloon or “BIS” is a saline balloon.
3) The Spatz(trademark) Adjustable Balloon System
4) ReShape Intragastric balloon
In addition, there is the Helioscopie, Heliosphere Bag System which is an air based bag or balloon. The balloons
can be briefly summarized in the following manner. First of all, despite multiple trials, primarily on the BioEnterics
Intragastric Balloon, there is no FDA approved balloon system thus far in the United States. Current trials are
ongoing. Multiple trials within the United States and in other parts of the world have been performed. The
balloons have been used as primary bariatric procedures as well as pre-bariatric procedures with some success. In
other parts of the world, the safety and efficacy have been better than the United States trials. When evaluating
the gastric balloons, it appears that when used appropriately for the right indications, less than six months at a
time under supervision and with appropriate volumes, that the balloons can be safe and provide some, although
somewhat limited efficacy(15-50lbs.). They may be better used for obese but not morbidly obese patients or
possibly as pre-bariatric procedures. The barriers to use of balloons in the United States are its limited efficacy in
comparison to diet and placebo and the concerns for life-threatening complications such as obstruction and
perforation which have been observed in some studies.
Balloons/Bags
Bioenterics Intragastric Balloon (BIB / Orbera)
Saline filled, 6 months
Allergan
www.allergan.com
www.allergan.com/contact
Silimed Intragastric Balloon (BIS /SGB)
Saline filled silicone balloon, 6 month
Silimed
www.silimed.com
www.silimedproductos.com
Spatz Adjustable Balloon System
Saline filled, Anchored, 12 month
Spatz Medical
www.spatzmedical.com
www.spatzmedical.com/contactus
Heliosphere Bag System
Air filled, 6 month
Helioscopie SA
www.helioscopie.fr/en
www.helioscopie.fr/en/contactus
ReShape Intragastric Balloon
Saline Filled, Dual Balloon, 6 month
ReShape Medical, Inc.
www.reshapemedical.com
www.reshapemedical.com/contact/
Summary:
As of now--NO FDA approval
Multiple Trials with multiple balloons/bags ongoing
Efficacy in terms of weight loss and co-morbidities uncertain
Role/Indications Uncertain
Safety Uncertain
Submitted April 2012