>>
Product Design Features
| - | Constructed of a high quality silicone elastomer, making it resistant to gastric acidity and sharp pieces of food. | | - | Saline-fluid filled | | - | Spherical shape and smooth surface, provides a low potential for causing ulcers and obstructions. | | - | Radiopaque marker to allow proper follow-up of the device. | | - | Adjustable in volume from 400cc to 500cc to accommodate varying anatomy. | >>
Balloon Placement
The upper gastrointestinal tract is visualized immediately prior to insertion of the balloon. The diagnostic endoscopy is performed to define anatomy and to exclude concomitant disease which could preclude the safe and effective use of the device. If the stomach is healthy the balloon is introduced into the stomach under general anesthesia and direct visualization to ensure proper placement and to prevent any complications that could occur related to balloon inflation. When the balloon is well within the stomach, it is filled with approximately 500cc of saline fluid. The procedure lasts approximately ten minutes and is performed on an out-patient basis. >>
Balloon Removal
At the end of treatment, the fluid in the balloon is removed under direct visualization to empty the balloon. This may take up to 20 minutes. A grasper is then used to gently pull the balloon out of the stomach. >>
Indications For Use
The BioEnterics Intragastric Balloon System is a non-surgical, non-pharmaceutical, alternative for the treatment of obesity. It is indicated for temporary use in: | - | Subjects between the age of 18-60. | | - | Subjects with a BMI >=35 who are candidates for surgery but need to lose weight in order to reduce surgical risk. However, this is a matter of dispute among surgeons. | | - | Subjects with a BMI 30-39 who have significant health risks related to their obesity | | - | Subjects with a history of demonstrated failure in maintaining weight loss with non-surgical weight loss methods | | - | No congenital or acquired anomalies of the GI tract, such as large hiatal hernia, atresias or stenosis, esophageal and or gastric varices, etc. | | - | Not currently pregnant and no intention of becoming pregnant in the next 12 months following BIB placement | | - | No addiction to alcohol or drugs | | - | No previous bariatric surgery, intestinal obstruction, or adhesive peritonitis | | - | No history of chronic or current use of high doses of NSAID and or aspirin | >> Contraindications | - | A Body Mass Index (BMI) < 30 | | - | Subjects with inflammatory disease of the GI tract including esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease. | | - | Subjects with potential upper gastrointestinal bleeding such as esophageal or gastric varices. | | - | Subjects with congenital or acquired abnormalities of the G.I. tract such as atresias or stenoses | | - | Subjects mentally retarded, emotionally unstable, or exhibits psychological characteristics which makes the subject a poor candidate | | - | Subjects who are alcoholics or drug addicts | | - | Subjects whose age or poor general health would preclude surgery should a complication occur | | - | Presence of large hiatal hernia | | - | Subjects that have had previous open abdominal surgery or bowel surgery | >>
Potential Complications and Management
| Complication | Treatment/Management | | Severe nausea | Motilium or Primperan. | | Dehydration | Minimum 1liter of NaCl 0.9% IV during admission. At discharge, provide patient information on liquid intake and diet. In case of severe dehydration, clinical rehydration may be required. | | Balloon Deflation | According to manufacturers guidelines, maximum placement of balloon is six months. Methylene blue is used for premature detection of balloon deflation. The methylene blue will be eliminated through the urine if the balloon deflates. The patient should contact their physician. If the patient is not sure the balloon is still in place, a plain abdominal X-ray can be performed. | | Obstruction | This is a rare complication that is mainly due to former adhesions to the bowel because of an operation in the lower part of the abdomen. The manufacturer recommends removing the balloon within a six month period. | >> Outcomes
The main action or mechanism of the balloon consists in partially filling the stomach, thus inducing satiety or restricting food intake.
The use of the intragastric balloon in the treatment and management of morbid obesity is not a panacea; correct patient selection and respect of the dietetic and behavioral program are key factors in obtaining successful results.
The main effect of the balloon is supposed to last about two months. During this period there is a limitation of appetite, that decreases afterwards. Strict attention must be paid to the nutritional follow-up. Long-term outcome should result in a substantial weight-loss of about 15 kilos. Extreme weight-losses of 0 to 80 kg have been obtained. In Italy, three centres have treated 264 patients with good results in morbid obese patients (with a BMI above 40 kg/m2). An study led in the Netherlands on more than 500 patients is also encouraging. After the removal of the balloon or its spontaneous evacuation, weight-regain is possible. There is thus a relative long-term ineffectiveness, which explains that this device is not reimbursed in most countries. In some cases, weight-loss is not sufficient, or is impossible to stabilize because the patient has not changed his former eating-habits.
Long-term results are not currently available in order to assess the efficiency of the balloon, and more prospective studies are mandatory. Hence, it should be understood that this procedure is meant to incite a modification in eating-habits, and that it is pointless if there is no diet support. In no way it can be regarded as an ultimate solution for obesity. >>
ADVICE AFTER BALLOON PLACEMENT
| - | Eat slowly and quietly, masticate food properly. | | - | Divide food intake into small amounts, use small plates. | | - | Stop eating if you feel acid reflux or swelling. | | - | Have three meals and three collations a day. | | - | Avoid snacking. | | - | Drink at least one and a half litres of water a day. | | - | Do not drink and eat at the same time. It can be useful to have a glass of water half an hour before the meal and one or two glasses after the meal. This will wash the balloon, which prevents rotten-egg-smelling regurgitations due to the stagnation of food around the balloon. | | - | Avoid drinks with too much gas. Strong tea and coffee are also not advised. | | - | Do not smoke before eating. | | - | Do not have supper too late in the evening. | | - | Wait at least two hours before going to bed. | | - | Some pain may occur when lying asleep, or when leaning on the side. | | - | Do more exercise, walk at least fifteen minutes each day. | |
