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Obesity is a major global health issue with serious consequences, including death. The intragastric balloon (IGB) is a bariatric surgery option but is limited to 6–12 months due to risks such as deflation, migration, and, rarely, intestinal obstruction. These complications are difficult to diagnose and manage. A 46-year-old woman with an intragastric balloon for ten months experienced gastric distension, excessive salivation, and nausea, leading to hospitalization. Abdominal radiography and a CT scan revealed a small bowel obstruction caused by the balloon, located 40 cm before the ileocecal junction. A laparotomy was performed to explore the surgical site further. An ileotomy was conducted to remove the balloon during the surgery. The patient was discharged in stable condition after five days. Complete small bowel obstruction due to intragastric balloon migration in bariatric surgery is very rare. Initial symptoms include mid-gut dilation, nausea, and vomiting. A CT scan is the best method to locate and identify the cause of intragastric balloon migration. Laparoscopy can be challenging in acute obstruction cases due to limited space, increasing the risk of iatrogenic bowel injury. Therefore, laparotomy with a semi-circular ileotomy is a safe treatment option. Ileal obstruction due to intragastric balloon migration is a rare but serious complication of bariatric surgery, which requiring immediate surgical intervention. The use of a semi-circular ileotomy during laparotomy has proven to be an effective and safe treatment option for complete obstruction. • Intragastric balloons (IGB) are used in bariatric therapy but limited due to risks like deflation, migration, and intestinal blockage. • Laparotomy with semicircular ileotomy is a safe surgical option for complete small bowel obstruction caused by IGB migration. • Prompt and appropriate surgical intervention is essential to prevent life-threatening complications from ileal obstruction due to IGB. [ABSTRACT FROM AUTHOR]

Intragastric balloons (IGBs) are minimally invasive devices used for managing obesity. Despite their relative safety and patient tolerance, there have been reports of adverse events associated with IGBs. Gastric perforation is a rare but feared complication that mostly occurs as an early event after transitional interventions, such as insertion or removal procedures. This case report describes a combined endoscopic and laparoscopic approach to a rare case of late gastric perforation secondary to an IGB whose removal was long overdue. [ABSTRACT FROM AUTHOR]

• Intra-gastric balloon treatment led to brain structural improvements. • They are consistent with pattern observed in bariatric patients. • Structural recovery observed in regions earlier related to diabetes and hypertension. • These changes are related to normalziation of in brain myo-inositol, a marker of neuroinflammation, We simultaneously performed structural MRI, 1H magnetic resonance spectroscopy, and whole-body hydration status assessment to evaluate brain changes in patients with morbid obesity treated with intra-gastric balloon (IGB) for six months. We asked, if changes in myo-inositol ratios (marker of neuroinflammation) are related to brain volume increases accompanying IGB-induced weight loss. Twenty five patients with morbid obesity (OB , 43.9 ± 11.8 years, BMI = 49.1 ± 7.2, 12 females, 9 without co-morbid conditions) were treated with IGB for six months. They underwent magnetic resonance imaging at 3T one month before IGB insertion, three months after insertion (N = 19), and one month after IGB removal (N = 14). Insertion of IGB lead to 8.9% and 12.3% weight reduction over the first three months and over the entire treatment, respectively. Over the entire treatment, total gray matter volume increased by 2.0% (p = 0.009). These changes were mostly pronounced in the left precuneus and in the right frontal pole (>1.9%, p < 0.009). The increases in cortical volume in the right hemisphere and the left posterior cingulate cortical thickness over the entire treatment were significantly related to decreases in myo-inositol ratios measured over the first three months of the treatment (r < −0.740, p < 0.006). IGB treatment lead to brain structural improvements consistent with earlier studies of bariatric patients without co-morbid conditions. Our results also pointed to improvements in brain regions, where atrophy in other studies was related to type 2 diabetes and hypertension. The correlations point to neuroinflammation as one of the potential processes behind brain volume reductions in patients with morbid obesity. [ABSTRACT FROM AUTHOR]

• Gastric perforation caused by intragastric balloon represents a rare but life-threatening complication. • There is a lack of information about perforation in the same day of surgery. • An endoscopic and laparoscopic approach with a gastric wedge resection was performed. IGB (Intragastric Balloon) is acknowledged to be a safe and secure device, whose outcomes in terms of weight loss are widely discussed. Bariatric community has soon noted tolerance and benefit of this tool, considered a first and easy step before bariatric surgery. Nevertheless, some authors have described a series of complications that, although rare, could be life threatening and hard to manage, as a gastric perforation. We reported a case of a 55-year-old obese woman, undergone placement of IGB device heisting in a gastric perforation. In the same day of surgery, we performed an emergency, applying a combined endoscopic and laparoscopic approach, to remove the balloon and to close perforation by a gastric resection. Discussion. Short term outcome was satisfactory, and the patient had a successful further follow up and weight loss. IGB is a valuable tool among bariatric procedure, nevertheless the surgeon has to consider the possible and life-threatening complications and to provide a multidisciplinary equip to face this occurrence. [ABSTRACT FROM AUTHOR]

• 5-Year-old Intra-gastric Balloon. • Gastric perforation. • Acute abdomen. • Bariatric surgery. Insertion of an Intra gastric Balloon (IGB) has widely been used as a minimally invasive procedure for the treatment of obesity. Gastric balloons are usually inserted for a period of six months only. They have a high safety profile and one of their rare, reported, serious complications include gastric or esophageal perforation, which are usually early and require immediate operative management. We report a 26-year-old lady who presented to the ED with signs and symptoms of acute abdomen and five-year history of endoscopic placement of Intra-gastric Balloon. Emergent endoscopic removal of the balloon revealed a large pressure ulcer at gastric incisura with central necrosis. Laparoscopy confirmed gastric perforation along lesser curvature with extensive soilage of peritoneal cavity. Extensive irrigation and drainage and Graham omental patch repair were carried out laparoscopically, and the perforation sealed satisfactorily. She recovered well from surgery and within days she was tolerating a diet. Broad spectrum IV antibiotics were given for 10 days. Gastric perforation is a rare complication reported in 0.1% of patients undergoing IGB insertion. It can ensue as early as days after placement or late at weeks to months. In our review of literature, we found the maximum time frame in which a patient presented with an IGB induced gastric perforation was at 22 months. This makes our case unique as the patient was able to tolerate it for 5 years (60 months) before presenting to the emergency with this sinister complication. Very late Gastric perforations in patients with IGB placement are rare. An upper gastrointestinal endoscopy should be arranged as soon as possible to remove the balloon and assess the stomach visualize the perforation followed by a laparoscopic approach to repair the defect if expertise is available. [ABSTRACT FROM AUTHOR]

• Intra-Gastric Balloon use as non-operative strategy for bariatric patients. • Rise of adverse life-threatening outcomes of Intra-Gastric Balloon. • Pancreatitis could be secondary to pancreas compression by the Intra-Gastric Balloon. • Need for the recognition of balloon pancreatitis as a complication of Intra-Gastric Balloon insertion. Obesity is a complex multifactorial disease that affects populations worldwide. In Kuwait, the prevalence of obesity is a major public health problem. Intra-Gastric Balloon (IGB) is commonly used as a non-operative strategy among bariatric patients. However, with the increasing use of IGB, life-threatening adverse outcomes are widely reported. A case series five patients presenting with pancreatitis from IGB in Kuwait is reported to better investigate the emerging complications of IGB. Three types of IGB were inserted, these include the Orbera Intragastric Balloon System, Orbera365 Intragastric Balloon System, and the Spatz Adjustable Gastric. The clinical course of balloon pancreatitis is described. The case series examined existing case reports of IGB associated pancreatitis in the literature, in addition to the investigated clinical outcomes. Patients presented with mild pancreatitis, and removal of balloon resulted in significant improvement in symptoms. Pathogenesis of balloon pancreatitis could be secondary to the pancreas compression by the IGB. Despite the rarity of balloon pancreatitis, it needs to be recognized as a complication of IGB insertion. Further research is needed to better understand the implications of the balloon size, shape, volume and location of balloon insertion in order to prevent this fatal complication. [ABSTRACT FROM AUTHOR]

Intragastric balloon (IGB) insertion leads to dietary restriction; however, its neurohormonal actions were also described. Resting metabolic rate (RMR) adjusted for body mass (RMR/mass) seems to increase after bariatric interventions, whereas it generally decreases after caloric restriction–based therapies. However, no studies have evaluated the changes in body composition and RMR over IGB treatment. To evaluate the relationships between changes in body composition, RMR, RMR/mass, and RMR adjusted for fat-free mass (FFM) (RMR/FFM) over IGB treatment lasting 6 months. Single-center observational study. Twenty-one morbidly obese patients treated with IGB (143 ± 20 kg, body mass index [BMI] = 49.5 ± 7.3, 98% ± 29% percent excess weight, 43.6 ± 12.6 yr) were enrolled. Changes in body composition, RMR, RMR/mass, and RMR/FFM were evaluated between 1 month before IGB insertion (time point 1 [TP1]) and 3 months thereafter (TP2). Fourteen patients were also assessed 1 month after IGB removal (TP3). There was a 9.5% reduction in weight, a 9.4% reduction in BMI, and 19.1% decrease in percent excess weight at TP2 (n = 21; P <.001); a further 6.5% reduction in weight and BMI and a 13.1% drop in percent excess weight (n = 14, P <.001) at TP3. They were accompanied by a 5.4% reduction in FFM between TP1 and TP2 (n = 21, P <.001). Compared with pretreatment values, at TP2 RMR was 12.5% lower (P <.001) but did not change thereafter. RMR/mass increased 12.4% between TP2 and TP3 (n = 14, P =.02) but on average did not change between TP1 and TP3. The results in the smaller cohort (n = 14) between TP1 and TP2 were consistent with results obtained for the entire cohort. Similar findings were obtained for RMR/FFM. The larger increases in RMR/mass between TP1 and TP3 were associated with more weight loss, larger drop in BMI, and more loss of excess weight (r < −.55, P <.03). This is the first study to evaluate the relationship between changes in body composition and RMR over IGB treatment. IGB therapy leads to both fat and fat-free mass reductions and RMR decreases. More weight reduction is associated with larger increases in RMR/mass. • Intragastric balloon (IGB) leads to body weight, BMI, excess weight reductions over the entire treatment. • IGB leads to reductions in resting metabolic rate over the first three months of the treatment. However RMR adjusted for body mass increased significantly over the remaining period of treatment. • Only over the first three months of treatment fat-free mass loss was recorded. • The larger increase in RMR adjusted for body mass over the treatment was associated with more weight loss, larger drop in BMI, and more loss of excess weight. [ABSTRACT FROM AUTHOR]

Intragastric balloon (IGB) placement can provide a mean percent total weight loss (%TWL) of 10.2% at 6-month follow-up. We aimed to evaluate 30-day outcomes and safety of patients undergoing IGB placement. Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. The 2016 to 2017 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program was queried for adult patients who underwent primary IGB placement. Demographic characteristics and preoperative risk factors were collected. Postoperative outcomes included %TWL, percent excess weight loss, and complications rates and causes. Subset analysis was done for outcomes comparison between surgeons or gastroenterologists performing the procedure. Statistical analysis was performed using SPSS 25.0. A total of 1221 patients were included. The majority was female (81.9%), Caucasian (81.2%), with a mean age of 48 ± 11.3 years and a mean preoperative body mass index of 34.9 ± 11.2 kg/m2. Of patients, 98.8% were discharged within 24 hours of the procedure. Two patients were admitted to the intensive care unit, and 7.2% received postoperative treatment for dehydration. Reoperation and readmission rates were 1.1% and 7.2%, respectively, mainly due to nausea, vomiting, and poor nutritional status (n = 22). The intervention rate was 6.2%. Patients in this cohort achieved a mean %TWL of 6.2% (standard deviation, 5.52%) and mean TWL of 6.8 kg within 30 days postoperatively (n = 147; 24–30 d). Our data show patients met approximately 50% of their target weight loss 30 days after IGB placement. Nausea, vomiting, and poor nutrition status were the most common complications within 30 days of the procedure. Long-term follow-up is necessary to determine if these patients are able to sustain their weight loss and for how long. • This is an analysis of the 2016-2017 MBSAQIP® data • Patients reached 50% of target weight loss 30-days after IGB placement • Weight loss in the first 30-days after procedure is most likely due to dehydration [ABSTRACT FROM AUTHOR]

Intragastric balloon (IGB) is approved for weight reduction in obesity patients who have a body mass index (BMI) of 30 to 40 kg/m2. The effectiveness of IGB in various degrees of obesity is not well established. We aimed to study the effect and safety of IGB in different groups of obese patients. A retrospective study was performed. All patients who underwent placement of the ReShape™ gastric balloon and completed a 6-month follow-up were included. There were 35 gastric balloons in 34 patients who had a baseline body weight of 106.5 ± 23.5 kg and a BMI of 37.1 ± 5.5 kg/m2. After IGB removal, total body weight was reduced 6.8 ± 7.3% (P < 0.001) and the BMI reduction was 2.7 ± 2.9 kg/m2 (P < 0.001). Subgroup analysis showed that patients with BMI >40 kg/m2 also had significant reduction of total body weight and BMI. The diastolic blood pressure was reduced by 4.7 ± 12.3 mm Hg (P = 0.03) after balloon removal. The most common complication was nausea in 22.9%. One patient had balloon migration leading to small bowel obstruction. One patient had a bleeding gastric ulcer. In summary, IGBs are an effective method to assist in weight loss in patients with various degrees of obesity, even with a BMI >40 kg/m2, with minor adverse effects. [ABSTRACT FROM AUTHOR]

The historical concept that obesity protects against bone fractures has been questioned. Weight loss appears to reduce bone mineral density (BMD); however, the results in young adults are inconsistent, and data on the effects of weight loss on bone microstructure are limited. This study aimed to evaluate the impact of weight loss using an intragastric balloon (IGB) on bone density and microstructure. Forty obese patients with metabolic syndrome (mean age 35.1 ± 7.3 yr) used an IGB continuously for 6 mo. Laboratory tests, areal BMD, and body composition measurements via dual-energy X-ray absorptiometry, and volumetric BMD and bone microstructure measurements via high-resolution peripheral quantitative computed tomography were conducted before IGB placement and after IGB removal. The mean weight loss was 11.5%. After 6 mo, there were significant increases in vitamin D and carboxyterminal telopeptide of type 1 collagen levels. After IGB use, areal BMD increased in the spine but decreased in the total femur and the 33% radius. Cortical BMD increased in the distal radius but tended to decrease in the distal tibia. The observed trabecular bone loss in the distal tibia contributed to the decline in the total volumetric BMD at this site. There was a negative correlation between the changes in leptin levels and the measures of trabecular quality in the tibia on high-resolutionperipheral quantitative computed tomography. Weight loss may negatively impact bone microstructure in young patients, especially for weight-bearing bones, in which obesity has a more prominent effect. [ABSTRACT FROM AUTHOR]

• Endoscopic Bariatric Therapies are a new class of obesity treatment options including devices that require endoscopy for placement or removal, including intragastric balloons that are space-occupying devices in the stomach. • Randomized controlled trials with intragastric balloons have demonstrated significantly more weight loss with the intragastric balloons plus lifestyle therapy compared with lifestyle therapy alone. • This manuscript describes safety and effectiveness data collected from a swallowable gas-filled intragastric balloon in the first year of availability in the United States collected in a registry made available to all treating physicians. Obesity is the most common chronic disease in the United States today. Additional therapies are needed to improve obesity treatment. A swallowable, gas-filled intragastric balloon system was approved for the treatment of obesity by Food and Drug Administration in September 2016 and commercialization started January 2017. A registry was made available to physicians to capture evidence of safety and effectiveness with use. United States private clinics, surgery centers, and hospitals. This study is a retrospective analysis of a prospective registry of patients with body mass index (BMI) ≥25 kg/m2 that initiated therapy in the first year. Data on demographics, procedural timing, weight loss, adverse events, and device deficiencies were captured. The final analysis comprised 1343 patients across 108 treating physicians (mean age 45.7 ± 10.8 yr, 78.6% female, baseline BMI of 35.4 ± 5.4 kg/m2). Nonserious and serious adverse events were reported in 14.2% and.15% of patients, respectively. There were 7 balloon deflations, none caused obstruction. Weight loss in the indicated use (BMI 30–40 kg/m2) was 9.7 ± 6.1 kg and 10.0 ± 6.1% total body weight loss (TBWL). Weight loss in other BMI categories was 8.2 ± 5.6 kg or 10.3 ± 7.0% total body weight loss for BMI 25 to 29.9 kg/m2 and 11.6 ± 7.8 kg or percent total body weight loss 9.3 ± 6.0 for BMI >40 kg/m2. This swallowable gas-filled intragastric balloon system is safe and effective at inducing weight loss and offers physicians another tool for patients whose obesity has been resistant to noninvasive treatments. [ABSTRACT FROM AUTHOR]

Abstract Background Obesity represents one of the common medical disorders that carries a high risk of morbidity and mortality. Insertion of intragastric balloon is one of the recently introduced lines of treatment of obesity. It allows patients to sense abdominal fullness and reduce their food intake. However, gastric ulceration may be a serious adverse effect that may be associated with intragastric balloon insertion. Aim To assess the role of silent helicobacter pylori infection in intragastric balloon-induced ulcers and to explore the possible methods for amelioration of this effect. Methods Thirty patients were divided into 2 equal groups; one of them received triple therapy for helicobacter pylori eradication and the other group received placebo treatment. Then, they underwent intragastric balloon insertion. After removal of the balloon, gastroscopy was performed to evaluate the gastric mucosal lesions, if present. Results There was significant decrease in the incidence of gastric erosions and ulcerations in the group that received triple therapy for helicobacter pylori eradication compared to the group that received placebo treatment. Conclusion Eradication of silent helicobacter pylori infection may represent a promising hope to decrease the incidence and improve symptoms of gastric erosions and ulceration that may be associated with intragastric balloon insertion. [ABSTRACT FROM AUTHOR]

Abstract Background Obesity is a significant health problem and additional therapies are needed to improve obesity treatment. Objective Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss. Setting Fifteen academic and private practice centers in the United States. Methods This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group. Results Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only.4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P =.0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P <.0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P <.0001), respectively. The responder rate in the treatment group was 66.7% (P <.0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks. Conclusions Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks. [ABSTRACT FROM AUTHOR]

We describe two cases of increased pancreatic enzyme levels after intragastric balloon (IGB) placement possibly related to extrinsic pancreatic duct compression, followed by a short review of the literature. Case 1 is the first, to our knowledge, of a patient with asymptomatic increase of pancreatic enzymes due to pancreatic duct compression, with unknown clinical significance. We hypothesize that this finding maybe can be relatively common in IGB users and almost certainly an important risk factor for the development of acute pancreatitis (AP). On the other hand, case 2 reports an AP that occurred one day after IGB placement, presented with nausea and vomiting, making AP a differential diagnosis of initial IGB intolerance. [ABSTRACT FROM AUTHOR]

Objectives: This systematic review and meta-analysis was performed to examine the rates of nausea and vomiting along with other common side effects reported from different subtypes of intragastric balloons (IGBs) placed in obese adults.Methods: The online databases of Pubmed, Cochrane Database, and Web of Science were searched to include studies conducted from 09/31/2012 to 09/31/2017 in English using keywords to identify articles relevant to this study. Two independent reviewers performed a full text review to ensure quality of studies and report rates of primary end point of interest: nausea and vomiting post IGB placement.Results: Ten studies fulfilled the inclusion criteria. The treatment group's sample size comprised of 688 patients and adverse events' sample size comprised of 938 patients. We evaluated rates of nausea and vomiting of four subtypes of IGB systems: Elipse, Obalon, ORBERA, and ReShape and calculated meta-analytic rates based on adverse events' sample size. Total 564 patients reported experiencing nausea which provided a meta-analytic rate of 63.33% (95% CI 61.49%-65.16%), and 507 patients reported experiencing vomiting which resulted in a meta-analytic rate of 55.29% (95% CI 53.59%-56.99%). The ORBERA balloon system had the highest rates of nausea and vomiting compared to other balloon systems.Conclusions: Based on the findings from previous studies scrutinizing side effects of different types of IGB offered on the market, it has been concluded that nausea and vomiting are very common side effects post gastric balloon placement. [ABSTRACT FROM AUTHOR]

Highlights • A propensity-matched analysis was performed on the MBSAQIP database • Safety of intragastric balloon (IGB) was compared to laparoscopic bariatric surgery • IGB had twice the adverse event rate due to quadruple the nonoperative reintervention rate Abstract Background Laparoscopic bariatric surgery (LBS) is effective for severe obesity but is invasive and costly. Intragastric balloons (IGBs) are increasingly popular as an alternative to LBS with modest short-term weight loss. However, IGBs are associated with complications and a comparison of the safety of IGB to LBS is warranted. Objectives The objective of this study was to compare the safety profile of IGB with LBS through analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. Setting The MBSAQIP collects data from 791 bariatric surgery centers in the United States and Canada. Methods A propensity-matched analysis was performed between IGB and LBS. Multivariable logistic regression analysis was performed to determine if IGBs were independently associated with adverse outcomes. Results A total of 145,408 patients were included, of which 144,627 (99.5%) underwent LBS and 781 (0.5%) underwent IGB therapy. With one-to-one propensity score matching, 684 pairs of IGB and LBS patients were selected. Multivariable logistic regression found that IGB (odds ratio 1.97, confidence interval 1.10–3.52, P =.023) was independently predictive of 30-day adverse outcomes. This was due to a significantly higher nonoperative reintervention rate in the IGB cohort (4.2% versus 1.0%, P <.001) from early balloon removal (2.8%). Conclusions In this propensity-matched analysis, IGBs were associated with a higher adverse event rate than LBS, due to a 4-times higher nonoperative reintervention rate. The utility of IGB as a primary weight loss intervention should be reconsidered due to its poor safety profile compared with LBS. [ABSTRACT FROM AUTHOR]

Obesity is considered the most common nutritional disorder in Western countries and is related to multiple morbidity and mortality. There are different options for obesity treatment, including diet, behavioral therapy, medications, and surgery. If patients do not meet the criteria for bariatric surgery, intragastric balloons may be used to achieve weight reduction. Currently, the intragastric balloon is one of the most common bariatric procedures in obese patients in Europe. Gastric perforation associated with intragastric balloon is a rare but dangerous complication. We report a case of a 42-year-old female patient who presented to the emergency department with acute abdomen. Chest x-ray in an erect posture indicated free gas under the diaphragm. She had undergone placement of an intragastric adjustable balloon device 13 months earlier and was overdue for removal of the balloon. In the emergency theater, a large perforated ulcer was found in the posterior wall of the stomach, which was repaired laparoscopically. Her postoperative course was uneventful. We also review the literature on intragastric balloon–induced gastric perforation. Our case is a very rare report of late gastric perforation after adjustable intragastric balloon placement. We recommend regular follow-up and removal in proper time after insertion of the gastric balloon. [ABSTRACT FROM AUTHOR]

Introduction Intra-Gastric Balloon (IGB) is increasingly used as a non-operative management strategy in bariatric patients. However, as IGB use has become more prevalent, new potentially life-threatening adverse effects have emerged. We report a case of IGB-related acute pancreatitis from a tertiary referral hospital. A literature review of electronic databases was conducted to identify other cases Presentation of case A 20-year-old female presented to the emergency department with acute onset of epigastric pain on day-1 post-insertion of an IGB (Orbera ® ). The diagnosis of acute pancreatitis was made on the basis of the clinical picture, with radiological and serological confirmation. Complete resolution of symptoms promptly followed endoscopic removal of the balloon. Discussion We examine all prior reported cases of IGB associated pancreatitis in the literature, as well as the impact of the particular balloon subtypes. Mass effect of the device on the pancreas or dislodgement of the rigid catheter into the second part of the duodenum appear to be the underlying cause in all cases. While there were no deaths reported, major sequelae have been noted, including presence of mucosal ischemia and failure to retrieve the balloon endoscopically, necessitating laparotomy. Conclusion Although the incidence of IGB-induced pancreatitis is still rare, this complication which must be highlighted as a potentially serious adverse outcome. [ABSTRACT FROM AUTHOR]

Background Intragastric balloons (IGBs) are a minimally invasive option for obesity treatment, acting as a space-occupying device and leading to weight loss through increased satiety. This device has been growing in popularity owing to its safety profile and good weight loss results. However, there are no published guidelines that standardize the technical aspects of the procedure. Objectives To create a practical guideline for intragastric balloon usage. Setting Private and Academic Settings, Brazil. Methods A consensus meeting was held in São Paulo, Brazil, in June 2016, bringing together 39 Brazilian endoscopists with extensive experience in IGBs from all regions of the country. Topics on patient selection, indications, contraindications, multidisciplinary follow-up, technique, and adverse events were discussed in the form of questions. After electronic voting, a consensus was defined when there was ≥70% agreement. Experts were also requested to provide data on their experience with IGBs. Results The selected experts discussed and reached a consensus on 76 questions, mainly concerning specific indications and contraindications for the procedure; technical details, such as patient preparation, minimum balloon-filling volume, techniques for implant and explant; patient follow-up and recommended medication for the adaptation period; and adverse event management. The overall Brazilian expert data encompassed 41,863 IGBs, with a mean percentage total weight loss of 18.4% ± 2.9%. The adverse event rate after the adaptation period was 2.5%, the most common being hyperinflation (.9%) and spontaneous deflation (.8%) of the device. The early removal rate due to intolerance was 2.2%. Conclusions The present consensus represents practical recommendations for performing IGB procedures and reflects Brazil’s significant experience with this device. The experience of over 40,000 cases shows that the device leads to satisfactory weight loss with a low rate of adverse events. [ABSTRACT FROM AUTHOR]

Introduction The Elipse™ intragastric balloon (IGB) for weight loss is a swallowable capsule that is filled with 550 mL of fluid and resides in the stomach for four months before being excreted from the gastrointestinal tract. Although initial data showed that use of this device is safe and free from serious complications, we report for the first time the successful management of an Elipse™ IGB-related adverse event. Presentation of case A 41-year-old woman presented to our emergency department following two days of abdominal pain, vomiting, and constipation. Her medical history included four caesarean sections and insertion of the Elipse™ IGB 16 weeks prior to presentation. The patient was vitally stable at presentation and abdominal examination revealed a mildly distended abdomen. Plain X-ray revealed a small bowel obstruction (SBO), and a double contrast computed tomography scan showed a dilated small bowel with mild free fluid proximal to a transition zone at the distal jejunum. Laparoscopic enterotomy was performed just proximal to the obstruction site, and the balloon was visualized and extracted after it had been incised and emptied. The enterotomy incision was closed with an intracorporeal continuous absorbable suture. The patient’s recovery was uneventful and she was discharged on postoperative day 4. Discussion We discuss the possible etiologies of SBO following Elipse™ IGB insertion, and present a brief literature review regarding surgical and nonsurgical management options for such cases. Conclusion Although initial data showed the Elipse™ IGB to be safe, complications can occur and be managed successfully. [ABSTRACT FROM AUTHOR]

Background The Elipse Balloon is a swallowable gastric balloon for weight loss that can be deployed without the use of endoscopy or anesthesia. This study aims to report on 12-month safety and efficacy outcomes. Setting Private hospital, Athens, Greece. Methods This was a prospective, nonrandomized open trial. Twelve patients between 18 and 64 years of age with a body mass index (BMI) of 27.0 to 40.0 kg/m 2 were enrolled. The Elipse capsule is swallowed with water and its location in the stomach is confirmed by x-ray. All patients received diet and exercise counseling only during the therapy period (0–4 mo). Eight months later they were seen in clinic to assess 12-month outcomes. Results There were 7 (58.3%) females and 5 (41.7%) males. The mean age was 41 years, mean BMI was 35.9 kg/m 2 , mean weight was 103.5±15.8 kg, and mean waist circumference was 117.6±14.9 cm. All patients swallowed the balloon. Eleven (91.7%) balloons were filled and were included in subsequent analysis. All balloons were excreted safely, and no serious adverse events were reported. Accommodative symptoms were not severe and of very short duration. Mean excess weight loss percentage and total weight loss percentage were 50.2% and 14.6% at balloon excretion and 17.6% and 5.9% at 12 months, respectively. There was a statistically significant improvement in patients’ weight, BMI, body fat, waist circumference, diastolic blood pressure, HbA1C, cholesterol, thyroid stimulating hormone, aspartate transaminase, and alanine transaminase at balloon excretion. Quality of life was significantly improved at excretion and 12 months. Conclusions This study is the first to demonstrate 12-month efficacy and performance outcomes of the Elipse Balloon. [ABSTRACT FROM AUTHOR]

Bariatric surgery remains the gold standard for therapy of the morbidly obese patient. However, these procedures are not without risk. Risk factors for adverse events and readmission after bariatric surgery are well studied. Included in these risk factors are preoperative weight, liver size, and medical comorbidities that can be improved with modest weight loss before bariatric surgery and other major abdominal procedures. This article reviews intragastric space-occupying devices, endoluminal gastric volume reduction procedures, gastric content aspiration therapy, and endoluminal duodenal exclusion as possible choices to “bridge” the high-risk patient to bariatric surgery and as a possible alternative to bariatric surgery. The current state of the literature is robust for the intragastric balloon, supporting both primary and preoperative indications. The limited literature support for gastric volume reduction, gastric content aspiration, and endoluminal barrier therapy is reviewed. [ABSTRACT FROM AUTHOR]

Summary Obesity represents a global hazard that predisposes to many serious health problems. Various solutions have been proposed to overcome obesity ranging from dietary balance to bariatric surgery. Intragastric balloons are a widely used measure to decrease weight, although they are advocated as safe devices, some major complications have been reported. We report a case of acute pancreatitis after insertion of a gastric balloon for weight reduction. Abdominal pain associated with nausea and vomiting maybe due to acute pancreatitis caused by compression of the pancreas by the balloon. It is advisable that physicians recognise these complications early to avoid serious and severe end-results. [ABSTRACT FROM AUTHOR]

The prevalence of obesity has steadily increased throughout recent decades, and along with it, the costs of caring for the associated comorbid conditions has increased as well. Traditional bariatric surgical procedures generally are safe and effective, but patient acceptance, the risk of minor and sometimes serious complications, costs, and insurance coverage have limited the application of these techniques to the treatment of a minority of patients. Endoluminal techniques represent newer approaches to weight loss that can be used independently or in concert with traditional medical and surgical treatments for obesity, with varying degrees of success. It is anticipated that less invasiveness will increase the appeal across a broader representation of patients, perhaps increasing the number of obese patients who choose an intervention over medical management and possibly resulting in a greater total loss of excess body weight across a population; this may reduce costs involved in treating the complications of weight-related comorbidities. Acceptance of endoluminal bariatric procedures and devices will hinge on proving safety, efficacy, and value. [ABSTRACT FROM AUTHOR]

Background Obesity has become a worldwide epidemic, and many methods are currently used to reduce obesity. This systematic review shows the effectiveness of the intragastric balloon (IGB) method compared to the sham/diet (s/d) method. Objective To demonstrate the effectiveness of the IGB method compared to the s/d method. Setting Hospital das Clinicas da Universidade de São Paulo, Brazil, Public Hospital. Methods After searching MEDLINE, Embase, Cochrane, Lilacs, Scopus, and CINAHL, only enrolled randomized control trials comparing IGB/diet with s/d were analyzed. For qualitative analysis, 12 studies were selected, and 9 of these were acceptable for quantitative analysis. Results The IGB/diet is more effective than s/d when comparing body mass index (BMI) loss with a mean difference of 1.1 kg/m 2 by the Student’s t test and 1.41 kg/m 2 by the meta-analysis, with significant differences in both. It is also more effective in weight loss (WL), with a mean difference of 2 kg by the Student’s t test and 3.55 kg by the meta-analysis. In the qualitative analysis of % excess WL (%EWL), the mean %EWL is 14.0% in favor of the IGB group compared to the s/d group by the Student’s t test; however, no significant difference was found between these groups by quantitative analysis. Conclusion Based on randomized control trial data alone, IGB>400 mL is more effective than sham/diet in achieving BMI loss, WL, and %EWL. [ABSTRACT FROM AUTHOR]

Background Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake. Objective: To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone. Setting: Academic and community practice, United States. Methods Participants (n = 326) with body mass index (BMI) 30–40 kg/m 2 were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment. Results Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT , P = .004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT , P <.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%). Conclusion The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile. [ABSTRACT FROM AUTHOR]

Obesity has become a global health crisis and is now considered a pandemic. Intragastric balloons (IGB) can aid obese patients achieve a better effect of weight loss than medications while being noninvasive compared to surgical therapy. We report a case of a 42-yr-old female with difficulty in losing weight even after three attempts of IGB and several diet programs. At the time of presentation, the patients BMI was 46.2 kg/m2. The patient experienced no gastrointestinal symptoms or stomach complaints and was found to have morbid obesity with hypertension and glucose intolerance. Laparoscopic sleeve gastrectomy (LSG) was suggested for the patient. While performing LSG in association with a gastroscope, an unexpected old and deflated gastric balloon was found residing inside the stomach cavity. The rest of the surgery had no difficulty after the old gastric balloon was removed. The patients BMI post-LSG after 18 months was noticed to be 26.6 kg/m2. We recommend performing gastroscopy prior to LSG for every patient with a previous gastric balloon insertion, especially if they had it more than once, to avoid potential complications during surgery. • Intragastric balloons (IGB) can aid obese patients achieve a better effect of weight loss than medications. • A patient (Female, 42-yr-old) failed to reduce weight after three attempts of IGB. • Hence, advised for laparoscopic sleeve gastrectomy. • Gastroscopy was done to remove the old deflated IGB that was found inside the stomach cavity. • We recommend gastroscopy prior to LSG for patients with a previous gastric balloon insertion to avoid potential complications during surgery [ABSTRACT FROM AUTHOR]

Abstract: Background: The intragastric balloon has been reported to be a safe and effective tool for temporary weight loss. The aim of this study is the evaluation of the possible predictive role of intragastric balloon when used before laparoscopic adjustable gastric banding. Methods: A longitudinal multicenter study was conducted in patients with body mass index (BMI)>35 kg/m2 who underwent gastric banding with the BioEnterics Intragastric Balloon (BIB). After balloon removal (6 mo), patients were allocated into 2 group according to their percentage of excess weight loss (%EWL): group>25 (%EWL>25%) and group<25 (%EWL<25%). Patients from both group underwent laparoscopic adjustable gastric banding (LAGB) 1–3 months after BIB removal. The LAP-BAND AP band was placed in all patients via pars flaccida. Weight loss parameters were considered in both groups. Results: From January 2005 to December 2009, 1357 patients were enrolled in this study. Mean BMI at time of BIB positioning was 44.9±8.4 (range 29–82.5). After 6 months, at time of removal, mean BMI was 39.4±7.3. According to the cutoff, patients were allocated into group A (n = 699) and group B (n = 658). At this time the mean BMI was 36.4±6.4 and 42.7±6.9 (P = .001) in groups A and B, respectively. At 1-year follow-up from LAGB, mean BMI was 35.8±6.5 and 40.0±7.4 (P<.001) in groups A and B, respectively. This significant difference was confirmed at 3- and 5-year follow-ups. A similar pattern was observed with the %EWL. Conclusion: Satisfactory results with BIB are predictive of a positive outcome of LASB at 1, 3, and 5 years after the procedure, and poor results do not inevitably indicate a negative outcome for gastric banding. [Copyright &y& Elsevier]

Abstract: Background: Morbid obesity is an increasing health problem. Dietary intervention often fails in the medium to long term, and surgery is the gold standard. Intragastric balloon is a valuable treatment in the short–term, and multiple balloon treatment has been shown to be effective in the medium term. The aim of this study was to investigate the efficacy of multiple balloon treatment in the long-term (6 years) in terms of weight loss, influence on co-morbidities, and quality of life in patients refusing surgery. Methods: Eighty-three patients with body mass index (BMI)>40, good candidates for surgery but refusing it, were enrolled in a clinical treatment protocol involving multiple intragastric balloon placement. After removing the first balloon, a second balloon was placed when the patients had regained≥50% of the weight loss achieved with previous balloon. Weight, co-morbidities parameters, and quality of life test were recorded during a follow-up of 72 months. Results: All patients experienced a second balloon placement; 22.2% had a third device placed and 1 patient had a fourth device placed. At 76 months follow-up, mean BMI was 37.6 kg/m2 (P<.001); weight cycling periods were observed. Significant difference was recorded in the presence of co-morbidities at baseline (80% of the patients) and follow-up (30%) (P = .02). Quality of life test in the follow-up indicated better scores than those at baseline (P<. .001). Conclusion: Despite the weight cycling, in patients refusing surgery, multiple intragastric balloon is the recommended treatment, allowing the patients to achieve a good weight loss, better control of co-morbidities, and better quality of life than at baseline. [Copyright &y& Elsevier]

Intragastric balloon (IGB) placement for the treatment of obesity is presented as a non-invasive and safe technique leading to significant weight loss. We report a case of an IGB migration that led to small bowel occlusion. Radiological analysis confirmed impaction at 250 cm from the angle of Treitz. Enterotomy was necessary to treat the occlusion. [ABSTRACT FROM AUTHOR]

Abstract: Background: Intragastric balloons are designed to occupy space within the stomach and induce satiety. The present study evaluated the safety and efficacy of an intragastric dual balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. Methods: After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (TG) or control group (CG) in a 2:1 ratio. Three sites randomized a total of 30 patients to the TG (n = 21) or CG (n = 9). Patients randomized to the TG underwent endoscopic placement of the dual balloon. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48-week study duration. Results: Our patient population included 26 women and 4 men aged 26–59 years. At 24 weeks, the mean excess weight loss in the TG and CG was 31.8% ± 21.3% and 18.3% ± 20.9%, respectively (P = .1371). At 48 weeks, 24 weeks after device removal, the TG maintained 64% of their weight loss. No deaths, unanticipated adverse effects, early removals, balloon deflations, or balloon migrations occurred. In the TG, 4 patients were readmitted for severe nausea, 1 had asymptomatic gastritis at balloon removal, and 1 patient experienced transient hypoxia during device removal. Conclusion: In the present small study, the dual balloon proved easy to use, was associated with a trend toward greater weight loss than the CG, and demonstrated a good safety profile. [Copyright &y& Elsevier]

Background: There is a strong association between obesity and infertility, and weight loss can increase fecundity in obese women. In an attempt to determine the effect of bariatric surgery on obesity-related infertility, we reviewed the fertility outcomes after intragastric balloon placement, adjustable gastric banding, sleeve gastrectomy, and gastric bypass in childbearing women with a diagnosis of infertility at a university hospital in Italy. Methods: This was a retrospective study of 110 obese infertile women. We evaluated the effectiveness of bariatric surgery in improving fertility, assessing the influence of age, surgical technique, co-morbidities (hypertension and diabetes), weight loss, and body mass index before and after surgery. Results: Of these 110 women who had tried unsuccessfully to become pregnant before weight loss, 69 became pregnant afterward. The pregnancies proceeded without complications and ended with a live birth. Only the weight loss (odds ratio 20.2, P = .001) and the achieved body mass index (P = .001) after surgery were the predictors of pregnancy. Conclusion: Bariatric surgery might be effective in young infertile obese women who wish to become pregnant. Weight loss appears to be independent from the surgical technique in determining the increase in the pregnancy rate as well as the body mass index achieved at pregnancy. [ABSTRACT FROM AUTHOR]

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Introduction Intragastric balloons are a non-surgical treatment method for obesity. Presentation of case We report a 28 year old Kuwaiti women presented with vomiting and epigastric pain two years following insertion of a intra gastric balloon. The women was diagnosed as a case of intestinal obstruction secondary to intragastric balloon migration. Discussion Most intragastric balloons, should be removed in 6 months, to prevent complications. In our case, failure to follow up and remove the intragastric balloons in time led to bowel obstruction secondary to balloon migration. Conclusion We report a rare complication of the BioEnterics intragastric balloon. Adherence to manufacturer and physician recommendations may prevent serious complications of intra gastric balloon insertion. [ABSTRACT FROM AUTHOR]

Abstract: Background: Super-obese patients with many co-morbidities present a challenge in bariatric surgery because of the high perioperative morbidity and mortality. The BioEnterics intragastric balloon (BIB) is an endoscopic device used preoperatively to induce weight loss to reduce the risk of surgery for morbid obesity. Methods: From November 2003 to April 2006, the BIB was endoscopically placed in 26 high-risk super-obese patients with a mean body mass index of 65.3 ± 9.8 kg/m2 and severe co-morbidities (mean 4.33 ± 1.12, range 3–7). The BIB was endoscopically removed 6 months later, at which time the patients were evaluated in terms of weight loss and improvement of co-morbid conditions. Results: BIB placement was uneventful in all patients. The major side effect related to the procedure was occasional vomiting during the first 2 days (65%). One patient died (3.8%) of cardiac arrest after aspiration on the first postinsertion day as a direct result of BIB placement. The mean weight loss was 28.5 ± 19.6 kg, and clinical re-evaluation revealed significant improvement in patient co-morbidity status (mean 2.23 ± .7, range 1–3; P = .024). Twenty patients underwent a primary bariatric surgical procedure the day after BIB removal; 2 patients were rejected for surgery because of inadequate weight loss. Conclusions: BIB placement can be considered an effective first-stage treatment of high-risk super-obese patients in need of surgical intervention. Although not without risk, it is generally a simple procedure leading to satisfactory weight loss, improvement in co-morbidities, and consequent reduction of the perioperative mortality and morbidity rates associated with surgery. [Copyright &y& Elsevier]

Background Today a variety of bariatric surgical procedures is available and, currently, it is difficult to identify the most effective option based on patient characteristics and comorbidities. Aim of this retrospective study is to evaluate the efficacy of four different techniques; Intragastric Balloon (IB), Laparoscopic Adjustable Gastric Banding (LAGB), Laparoscopic Sleeve Gastrectomy (LSG) and Laparoscopic Mini Gastric Bypass (LMGB), performed in our unit along ten years. Patients and methods Starting from January 2005, 520 patients, 206 men (39.6%) and 314 women (60.4%) were treated at our institution. Among patients candidate to bariatric surgery 145 underwent IB, 120 underwent LAGB, 175 underwent LSG and 80 underwent LMGB. Follow up rate was 93.1% for IB at 6 months; 74.1% and 48% for LAGB at 36 and 60 months respectively; 72.8% and 58.1% for LSG at 36 and 60 months respectively; and 84.2% for LMGB at 36 months. Results The period 2005–2014 has been considered. Mortality was 1/520 patients (0.19%). The excess weight loss rate (EWL%) has been 32.8 for IB at six months, 53.7 for LAGB and 68.1 for LSG, at 60 months respectively and 79.5 for LMGB at 36 months. Early major postoperative complications requiring surgery were 0.6% for IB and 1.1% for LSG whereas late major postoperative complications were 1.2% for IB, 4.1% for LAGB and 0.5% for LSG. Diabetes resolution rate was 0 for LAGB, 76.9% for LSG and 80% for LMGB at 36 months. Conclusions If more invasive procedures as LSG or LMGB may entail higher operative and peroperative risks, conversely, in skilled hands their efficacy remains undisputed, especially in the long term, presenting a very low rate of major complications. In general, the efficacy of a bariatric surgery unit seems improved by the capability to offer both different primary procedures and re-do surgery. [ABSTRACT FROM AUTHOR]

Abstract: Obesity in Prader–Willi syndrome (PWS) is progressive, severe and resistant to dietary, pharmacological and behavioural treatment. A reduction in body weight is mandatory to reduce the risk of cardiorespiratory and metabolic complications. The aim of the present study was to assess the risks and benefits of the BioEnterics Intragastric Balloon (BIB) for the treatment of morbid obesity in patients with PWS. Twenty-one BIBs were positioned in 12 patients with PWS (4 male and 8 female) aged from 8.1 to 30.1 years, and were removed after 8 ± (SD) 1.4 (range 5–10) months. Auxological, clinical and nutritional evaluations were performed every 2 months. Variations in body composition were analysed by dual-energy X-ray absorptiometry (DEXA). One patient (aged 28.5 years and with a body mass index [BMI] of 59.3 kg/m2) died 22 days after BIB positioning because of gastric perforation. In another individual (26.2 years, BMI 57.6 kg/m2), the BIB was surgically removed after 25 days because of symptoms suggesting gastric perforation (which was not confirmed). The remaining 10 patients showed a significant decrease of BMI (p = 0.005) and of fat tissue as measured by DEXA (p = 0.012). No significant modifications in bone mineral density occurred, but a slight loss in lean body mass (p = 0.036) was documented. In five patients, BIB treatment was repeated more than once. This study shows that when non-invasive pharmacological therapies fail, BIB may be effective to control body weight in PWS patients with morbid obesity, particularly when treatment is started in early childhood. However, careful clinical follow-up and close collaboration with parents are crucial to avoid severe complications, which can be caused by persisting unrestrained food intake. [Copyright &y& Elsevier]