Spatz 3 Adjustable Intragastric Balloon: Long-Term Safety Concerns

Daniel, Fady; Fadel, Carla Abou; Houmani, Zaher; Salti, Nader

doi:10.1007/s11695-015-1897-y

Cited by 27 publications

(11 citation statements)

References 4 publications

(4 reference statements)

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“…In the United States, the FDA has approved four IGB systems, including Orbera and Obalon systems until now. The Spatz3 adjustable IGB system, a new type of IGB, was developed as a system that enables 1‐year implantation and adjustment of the filling volume after balloon placement; however, the safety remains controversial 22 . A recent paper showed that the adjustable IGB system achieved a good response (>25%EWL or > 10%TWL) in over 88% of patients 13 .…”

Section: Discussionmentioning

confidence: 99%

Endoscopic intragastric balloon therapy for 15 years in Japan: Results of nationwide surveys

Ohta

Maékawa

Imazu³

et al. 2020

Asian J Endoscop Surgery

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Introduction Endoscopic intragastric balloon (IGB) placement has been performed in Japan since 2004. The nationwide surveys were repeatedly carried out to confirm the effectiveness and safety of IGB in Japan. We herein present the accumulated results. Methods Twenty‐six Japanese endoscopists personally imported products of the BioEnterics Intragastric Balloon (BIB)/Orbera system after completing the training courses in Japan. Mail surveys were posted to them every 2 years from 2010. This study included the accumulated data of the six surveys, and excluded data from non‐Japanese patients and the Orbera365 data. Results Between 2004 and 2019, 399 obese Japanese patients underwent IGB treatment using the BIB/Orbera system. The incidence rates of early removal of IGB within 1 week and complications due to IGB were 4.8% and 6.1%, respectively. The average percent excess weight loss (%EWL) and percent total weight loss (%TWL) at IGB removal were 46.6% and 11.5%, and successful weight loss, defined as %EWL ≥ 25% or %TWL ≥ 10%, was achieved in 65.6% or 54.5% of the patients, respectively. Multivariate analyses revealed that older age and larger saline filling volume were independent predictors of successful weight loss. At 1 year after IGB removal, successful weight loss defined by the %EWL and %TWL was maintained in 44.7% and 34.1% of the patients, respectively. Conclusion IGB therapy using the BIB/Orbera system has been safely and effectively performed in Japan. The successful weight loss may be associated with older age and larger saline filling volume.

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Section: Discussionmentioning

confidence: 99%

Endoscopic intragastric balloon therapy for 15 years in Japan: Results of nationwide surveys

Ohta

Maékawa

Imazu³

et al. 2020

Asian J Endoscop Surgery

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“…In their case-control study, they compared the weight loss outcome, weight maintenance after removal, and short- and medium-term complications and found that there were no differences in these parameters observed between the two balloons [ 29 ]. However, long-term safety issues of severe complications and high mortality have been reported [ 30 ]. Further studies are needed to address the safety concerns.…”

Section: Spatz Balloonmentioning

confidence: 99%

Various Intragastric Balloons Under Clinical Investigation

Choi

2018

Clin Endosc

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Obesity is a chronic disease with an exponentially increasing incidence rate, and its negative effects are well documented in numerous studies. As a result, the importance of bariatric therapy cannot be overemphasized, and many bariatric treatment methods with varying mechanisms have been developed. Of the available treatment methods, intragastric balloons, introduced in the 1980s, have been shown to be a safe and effective treatment modality; various intragastric balloon products have been developed and are currently being widely used in clinical settings. However, the disadvantages of intragastric balloons, such as unclear long-term weight loss benefits and complications experienced during insertion and removal, preclude their wider use. In this review, we discuss different intragastric balloon products, focusing on those under clinical investigation, and suggest future research directions.

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“…Three subjects did require surgical extraction of the device, with 1 of those having migration into the duodenum. Although this case series did not find any gastric complications, 2 cases of late gastric perforation have been reported, occurring 6 months after balloon placement and needing surgical intervention 37 . Unfortunately, 1 of the patients died intraoperatively.…”

Section: Adjustable Igb Systemmentioning

confidence: 55%

Novel Nonsurgical Endoscopic Approaches for the Treatment of Obesity

2017

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Globally, obesity is a leading cause of preventable death and is associated with >60 comorbid medical conditions, including 10 types of cancer that are strongly associated with body mass index. There are a number of traditional obesity treatments-for example, lifestyle management (eg, decreased caloric intake and increased expenditure), pharmacotherapy, and bariatric surgery. Recently, endoscopic approaches have emerged as a viable alternative for weight loss. Endoscopically placed intragastric balloons were introduced in the early 1980s for the treatment of medically complicated obesity but, unfortunately, had high rates of complications, such as premature deflation leading to obstruction. Despite these shortcomings, these devices have experienced a renewal, with a second generation of improved devices being approved for clinical use in 2015. In addition to the intragastric balloons, there are a number of other endoscopic approaches to weight loss that are either Food and Drug Administration approved or undergoing evaluation (aspiration therapy, duodenal jejunal bypass sleeve). The current review examines the literature available and discusses the practical clinical considerations involved.

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Spatz 3 Adjustable Intragastric Balloon: Long-Term Safety Concerns

Cited by 27 publications

References 4 publications

Endoscopic intragastric balloon therapy for 15 years in Japan: Results of nationwide surveys

Endoscopic intragastric balloon therapy for 15 years in Japan: Results of nationwide surveys

Various Intragastric Balloons Under Clinical Investigation

Novel Nonsurgical Endoscopic Approaches for the Treatment of Obesity

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