Intragastric Balloon Treatment for Obesity: FDA Safety Updates

被引：21

作者：

Tate, Chinara M. ^{[1
]}

Geliebter, Allan ^{[1
,2
]}

机构：

[1] Icahn Sch Med Mt Sinai, Mt Sinai St Lukes, Dept Psychiat, New York, NY 10029 USA

[2] Touro Coll & Univ Syst, Dept Psychol, New York, NY USA

来源：

ADVANCES IN THERAPY | 2018年 / 35卷 / 01期

关键词：

Bariatric surgery; Endoscopy; Gastric capacity; Gastric distension; Obesity; Obesity treatment; Qsymia; Weight loss;

D O I：

10.1007/s12325-017-0647-z

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Over the past year, the FDA has issued two letters to healthcare providers alerting them to adverse events associated with ORBERA and ReShape intragastric balloons (IGBs), including several deaths. Both IGB devices were FDA-approved for use in the US in the summer of 2015. Although the adverse events cited in the two letters occurred following FDA approval, there was already evidence prior to FDA approval that the safety and efficacy of ReShape and ORBERA were highly questionable. Since January 1, 2006, ORBERA and Reshape IGB have been implicated in 33 deaths. Given the cited evidence, we recommend FDA withdrawal of these two devices.

引用

页码：1 / 4

页数：4