In 2011, ASMBS joint Task force determined that the most commonly used end-point in bariatric studies was percentage excess weight loss (%EWL). “Excess weight” being the difference between the patient’s weight and the average weight of a standard individual with body mass index (BMI) of 25 kg/m². The weight loss achieved after bariatric intervention is calculated as a percentage of pre-intervention excess weight, this is the %EWL (16).

Of all the available intragastric balloons, the BioEnteric Intragastric Balloon has been the most widely used since 1995 in well over 20 countries worldwide, particularly in Europe, South America, and Asia (35). Probably because of this widespread use it has the highest number of publications than any other intragastric device. The indications for BIB use may be summarized as the following: (1) preoperatory weight loss in a patient candidate to bariatric surgery with high anesthesiological risk, (2) temporary weight loss treatment in a patient with body mass index (BMI) in the range of bariatric surgery (>35) who refuse surgery or has possible low compliance to surgery or in case of very long waiting list, and (3) temporary weight loss treatment for a patient with no indications to surgery in the context of an integrate medical approach to obesity (BMI < 35).

To be able to clearly advise a patient on weather or not an intragastric balloon will be helpful in their situation, we must first evaluate all the possibilities. Are intragastric balloons better than lifestyle modifications of diet and exercise alone for weight loss?

A study by Genco et al. (41) compared in a retrospective manner 130 patients with BIB placement with a 130 patients who underwent structured diet therapy with simple behavioral modifications for 6 months. A caloric restricted diet of 1000–1200 cal/day using an approximate macronutrient distribution, comparable to the “Mediterranean diet ,” including 25 % protein (at least 60 g/day), 20–25 % lipids, and 50–55 % carbohydrates. In the BIB group, patients received just generic counseling for eating behavior. In both groups considered weight loss parameters (kilograms, percentage of excess weight loss [%EWL], body mass index [BMI], percentage of excess BMI loss [%EBL]) at 6 and 24 months from baseline and comorbidities at baseline and after 24 months.

At 6 months time, BIB was removed significantly better results in terms of weight loss in kilograms 16.7 ± 4.7 vs. 6.6 ± 2.6; p < 0.01, BMI 35.4 ± 11.2 vs. 38.9 ± 12.1; p < 0.01, %EBL 38.5 ± 16.1 vs. 18.6 ± 14.3; p < 0.01, and %EWL 33.9 ± 18 vs. 24.3 ± 17.0; p < 0.01 were documented in patients treated by intragastric balloon as compared to diet-treated patients. All these parameter findings were statistically significant.

At 24 months from baseline, patients treated with intragastric balloon have tended to regain weight, whereas diet-treated patients have already regained most of lost weight. But we can state that in the short-to-medium term, BIB is significantly superior to diet in terms of weight loss.

The BIB has been compared with surgical treatment , specifically the sleeve gastrectomy, in two nonrandomized studies. At 6 months, one study showed no difference in mean weight loss, although the surgical procedure was shown to be superior at the 12-month follow-up (42). The second study of superobese patients (BMI > 50) found that sleeve gastrectomy patients lost significantly more weight at 6 months (45.5 kg vs 22.3 kg) as compared to the intragastric balloon (43).

So we now have the data to prove that intragastric balloons are not comparable to a surgical intervention for weight loss, but are statistically better at promoting weight loss when compared to diet and exercise alone.

In the largest reported retrospective study using intragastric balloon, 2515 patients were analyzed (44). The aim of the study was the evaluation of the efficacy of the BIB in a large population, specifically in terms of weight loss and its influence on comorbidities. Data were retrospectively recruited from May 2000 to September 2004, 2515 patients from the database of the Italian Collaborative Study Group for Lap-Band and BIB (GILB). Patients were discharged with diet counseling (~1000 kcal) and medical therapy for the post procedure symptoms. The BIB was removed after 6 months. Endoscopic positioning and removal were both performed under conscious or unconscious sedation. Technical success was achieved in 99 % of cases, and the authors reported five cases of gastric perforation (0.19 %), of which two were fatal, it was noted that previous gastric surgery is a contraindication to BIB placement.

Preoperative comorbidities were diagnosed 56.4 % of patients, 44.3 % of these comorbidities resolved, 44.8 % improved requiring less pharmacological dosage or shift to other therapies, and 10.9 % were unchanged. After 6 months %EWL was 33.9 ± 18.7 and BMI loss was 4.9 ± 12.7 kg/m², this along with the concomitant improvement in hypertension and diabetes values achieved significant correction in blood pressure and glycemic control.

In Brazil, Sallet et al. (45) conducted a study from November 2000 to February 2004, where 483 overweight and obese patients were treated with the BIB^®. Of these 483 patients only 323 completed a 6-month follow-up, and 85 of them completed a 1-year follow-up. A multidisciplinary program involving clinical, psychiatric, physical training, and dietary approaches was part of the required guidelines for every patient.

At the 6-month follow-up subjects measurements were compared to their baseline values, and statistically significant reductions were observed in weight (15.2 ± 10.5 kg), percent excess weight loss (48.3 ± 28.1), and BMI (−5.3 ± 3.4 kg/m²) (p < 0.000). There results are similar to other studies of the BioEnteric Intragastric Balloon (40). At the 1-year follow-up, 85 patients had maintained more than 90 % of their BMI reduction.

In a meta-analysis done by Imaz et al. (46) a Methods Systematic literature review of Medline, Embase, and other information sources from inception to March 2006 was done to perform the evidence-based systematic review of the published literature, afterwards the quality of the selected studies was assessed, 15 articles were pooled (3608 patients). Meta-analysis of weighted mean difference was made using the inverse variance method.

The estimates for weight lost at balloon removal for BIB^® were the following: 14.7 kg, 12.2 % of initial total body weight, 5.7 kg/m² in BMI, and 32.1 % of excess weight. Efficacy at balloon removal was estimated with a meta-analysis of two randomized controlled trials (75 patients) that compared intragastric balloon versus placebo, the results indicated the balloon group lost more weight than the placebo group. These differences in weight lost were 6.7 kg, 1.5 % of initial weight, 3.2 kg/m², and 17.6 % of excess weight.

This meta-analysis did make note of the scant data available after balloon removal.

So what happens to these post BIB patients 6 months or a year after the balloon is removed? Is this short time period sufficient to change patients’ lifestyle, modify their eating habits and exercise practices to maintain the weight reduction achieved with the BIB after its removal?

In a study published in 2005, Herve et al. (47) tried to answer just that. Hundred patients who received a BIB were included in a prospective study and followed for 1 year after BIB removal. The patients assisted to monthly post-implantation follow-up visits during which they were seen by the surgeon, dietitian, and if necessary, the psychologist.

The results upon BIB^® removal were mean weight loss for the group of 12.0 kg. Mean percent excess weight loss (%EWL) was 39.8 %. A year after removal of the BIB^® the documented mean weight loss was 8.6 kg and mean %EWL was 26.8 % for the group as a whole.

The results 1 year after removal of the BIB were found to be encouraging, specially considering it is a temporary non-surgical and non-pharmaceutical treatment for obesity that is totally reversible and repeatable. The authors recommend it for patients who have previously failed traditional methods of weight reduction. They do note that careful patient follow-up is of primary importance in avoiding complications and supporting efficacy of the treatment because concurrent behavior modification is essential for durable weight loss.

A second 1 year post BIB a randomized, double-blind trial of balloon or sham treatment of 3 months’ duration consisting of 43 patients. A preset weight-loss goal was set and if the patients (sham- and balloon-treated groups) achieved this weight they were given an additional 9 months of balloon treatment. The patients were continued to be followed for a second year post balloon (48).

The mean body mass index at enrollment was 43.3 kg/m² were enrolled. Five patients did not meet the preset weight-loss goal and were considered nonresponders 11.6 %. Three patients were unable to tolerate the balloon 7.0 %, at the time of the endoscopy severe esophagitis was diagnosed.

In the intention-to-treat analysis, sham- and balloon-treated groups had overall weight loss of 20 kg (16.1 %) and 16.7 kg (13.4 %) after 6 months in the sham/balloon and in the balloon/balloon treated groups which was not shown to be statistically significant. After 1-year of balloon treatment, a mean weight loss of 21.3 kg (17.1 %) was achieved in all patients, 12.6 kg (9.9 %) was maintained at the end of the second balloon-free year. Forty-seven percent of patients sustained a greater than 10 % weight loss, with considerably reduced comorbidity. In those 33 patients who completed the study per protocol, the weight loss at 1 year was of 25.6 kg (EBW 20.5 %) and 14.6 kg (EBW 11.4 %) after 2 years; 55 % maintained a weight loss of greater than 10 %.

In this study the conclusion was that for patients with treatment-resistant obesity , the intragastric balloon appeared to be safe, an independent benefit of balloon treatment beyond diet, exercise, and behavioral therapy with balloon treatment for 1 year resulted in substantial weight loss, the greater part of which was maintained during the balloon-free second year.

More recently, Angrisani et al. (49) observed the almost total regain of excess weight 1 year after BIB removal in 82 patients who had refused any other kind of treatment—surgical, pharmacological, or dietetic. On the other hand, Sallet et al. (45) observed 90 % weight loss maintenance in a subset of 85 (from the total of 323) patients at 1-year follow-up. Weight loss was noted to be significantly higher in BIB-treated patients both at 6 and 18 months follow-up. Additionally, the dropout rate was significantly lower in BIB-treated patients (1 % vs. 18 %, p < 0.001).

Seeing that the data is unclear at 1 year post BIB removal and stabilization of weight is uncertain, Kotzampassi et al. (50) published a study on 500 enrolled patients, who were followed post 6 months of BIB^® induced weight reduction for up to 5 years. All patients were contacted for follow-up at 6, 12, and 24 months post-removal and then yearly thereafter. Twenty-sex patients had to be excluded because of treatment protocol interruption, thus remaining 474, of these at the time of BIB^® removal 79 were excluded because of %EWL less than 20 %; thus remaining 395 patients had weight loss of 23.91 ± 9.08 kg, BMI reduction of 8.34 ± 3.14 kg/m², and percent EWL of 42.34 ± 19.07. At 6 months and 12 months, 387 (98 %) and 352 (89 %) presented with percent EWL of 42.73 ± 18.87 and 27.71 ± 13.40, respectively. At 12 and 24 months, 187 (53 %) and 96 (27 %) of 352 continued to have percent EWL of >20. Finally, 195 of 474 completed the 60-month follow-up 23 % retained the percent EWL at >20. It was observed that those who in general lost 80 % of the total weight during the first 3 months of treatment succeeded in maintaining a percent EWL of >20 long term after. Speaking in percentages of EWL > 20, we can state from this publication that from the total of 500 obese subjects, EWL > 20 % was achieved in 83 % at the time of removal, in 53 % at the time of the 12-month follow-up, in 27 % at the time of the 24-month follow-up, and in 23 % at the time of the 60-month follow-up.

In search of improving the weight loss outcomes of the patients undergoing BIB^® placement, various studies have introduced the notion of sequential IGB placements.

In 2010, a study by Dumonceau et al. (51) aimed at assessing the potential benefits of repeating IGB therapy , with a prospective non-randomized multicenter trial. Hundred and eighteen consecutive patients with a BMI 34 kg/m² were included. Nineteen patients (16 %) underwent repeat IGB placement as requested by them, 8 to prolong the first treatment and 11 after a IGB free trial.

Higher weight loss 3 months after first IB insertion independently predicted repeat therapy (p = 0.008). Median weight loss in subjects who had repeat therapy was lower with second vs. first IGB 9.0 kg vs. 14.6 kg; 30.4 % vs. 49.3 % excess weight loss; this achieved statistical significance p = 0.003. Compared to subjects with single treatment, those with repeat treatment had greater weight loss at first IGB extraction 14.6 kg vs. 11.0 kg; 49.3 % vs 30.7 % EWL and 1 year later 12.0 kg vs 6.0 kg but the difference became less than 2 kg starting at 3 years.

At final follow-up at 4.9 years approximately, the whole subject population had lost a median of 2.0 kg or 6.2 % EW and identical proportions of subjects with single/repeat treatment had ≥10 % baseline weight loss (26 %) or bariatric surgery (32 %) which was delayed in subjects with repeat vs those with single IB therapy.

In Spain, Lopez-Nava et al. [52] evaluated a population of 714 consecutively placed BIB^® which were removed after 6 months, between June 1, 2005 and May 31, 2007. These patients were discharged post BIB^® with drug therapy and 1000 kcal diet. Of the initial patient population 112 patients underwent a second consecutive balloon positioning, a month after the removal of the first BIB during which they received medical therapy, the second BIB^® was also removed at 6 months. Consequently patients were followed up in a weekly basis. After 6 months of BIB mean %EWL was 41.6 ± 21.8, mean BMI loss was 6.5 ± 12.7. After the second balloon removal, mean BMI was 30.3 ± 7.2, mean %EWL was 31.5 ± 23.2; mean BMI loss was 2.5 ± 18.2. After 24 months of follow-up, 22 (%) patients regained the pre-BIB weight, 61 (%) regained the 45–50 % of their pre-BIB weight, and 45 remain at the weight level after BIB removal ±2 kg. Considering the current experience, the support for this sequential approach should be in patients who require a continuous weight loss, even if not significant, to avoid the patients regain weight while waiting for definitive bariatric surgery.

The consideration in obtaining satisfactory basic results in terms of resolution of comorbidities is relevant, taking into account that the risk of death from cardiovascular disease, cancer, diabetes and other diseases increases throughout the range of moderate and severe overweight to obesity.

In this Spanish series (52), the improvement or resolution of preoperative comorbidities was obtained in 140/162 (86.4 %) patients. Many prior studies have confirmed the importance of these results demonstrating the benefit of 10 kg weight loss in terms of comorbidities (diabetes, blood pressure, lipids, etc.) and the related mortality (53)–(55).

The conclusion of these authors is that a second balloon can be positioned without difficulties, achieving good results after 12 months of treatment (52).

Both prior studies have shown that although patients who underwent a second balloon insertion had greater initial weight loss, there was no statistically significant difference in %EWL at 3-year follow-up [51, 52]. Furthermore, the placement of a second balloon was linked with a trend towards greater procedure- and device-related complications (52).

A prospective study by Forlano et al. (56) analyzed the metabolic benefits of intragastric balloon placement in 130 patients with mean BMI of 43.1 kg/m² who were maintained on a 1000–1200-kcal diet for 6 months after balloon placement. Hepatic steatosis was followed by ultrasound, and the frequency of sonographically detected advanced hepatic steatosis declined from 52 % at baseline to 4 % at the end of the 6 months. Comparable improvements were noted a well in blood glucose and triglyceride levels, these corrections indicators of medical disease highlights the multifaceted role of intragastric balloon in patients with “metabolic syndrome.”

A prospective study from November 2003 to April 2006 in the high risk superobese population examining the role of IGB as a bridge therapy prior to bariatric surgery (57). The BioEnterics intragastric balloon (BIB) was endoscopically placed in 26 high risk superobese patients preoperatively to induce weight loss to reduce the risk of surgery associated with morbid obesity. These patients had a mean body mass index of 65.3 ± 9.8 kg/m² and severe comorbidities. After 6 months the BIB^® was endoscopically removed. The mean weight loss was 28.5 ± 19.6 kg, and clinical reevaluation revealed significant improvement in patient comorbidity status permitting bariatric surgery and reducing the perioperative morbidity and mortality rates associated with the superobese during bariatric surgical procedures. Post BIB^® 20 patients underwent a primary bariatric surgical procedure the day after BIB removal; 2 patients were rejected for surgery because of inadequate weight loss. This study proves that BIB placement can be considered an effective first-stage treatment of high-risk superobese patients in need of surgical intervention.

These same findings were also corroborated by Zerrweck et al. (58) with a case control study between 2004 and 2009, where the records of 60 consecutive super-superobese patients (BMI 66.6 ± 3.4 kg/m²), 23 cases with preoperative BIB^® and 37 controls with no Balloon. The end point of significant adverse events was defined as the presence of at least one of the following conditions: conversion to open laparotomy, intensive care unit stay for more than 2 days, and overall hospital stay superior to 2 weeks. In the 23 cases IGB group, the intragastric balloon was maintained during 155 ± 62 days and induced a loss of 5.5 ± 1.3 kg/m². This weight loss manifested with clinical changes documented at the time of LGBP, and was associated with a decrease in systolic blood pressure and gamma-glutamyl transpeptidase level (p < 0.05 vs. baseline). Operative time was lower in the IGB group 146 ± 47 min vs. 201 ± 81 min in controls; p < 0.01 achieving statistical significance. Significant adverse events were also found to occur less frequently after LGBP in the BIB^® group (2 vs. 13 in controls; p < 0.05).