Brown S Lori, Reid Marie H, Duggirala Hesha Jani
Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiologic Health, Food and Drug Administration, 1350 Piccard Dr., HFZ-541 Rockville MD 20850, USA.
J Long Term Eff Med Implants. 2003;13(6):509-17. doi: 10.1615/jlongtermeffmedimplants.v13.i6.70.
A silicone adjustable gastric banding system was approved by the Food and Drug Administration (FDA) in June, 2001. The purpose of this report is to review and characterize the reports on silicone adjustable gastric banding systems received by the FDA through August 8, 2002. We also review medical literature on adverse events with silicone adjustable gastric banding systems. Manufacturers of regulated medical devices, such as adjustable silicone gastric bands, are required to report adverse events, including deaths and serious injuries, to the FDA. We reviewed all such reports received by the FDA through August 8, 2002, for adjustable silicone gastric bands and summarize the data by type of adverse event, reported device problems, and reported patient problems. The FDA received 556 reports of adverse events related to the use of adjustable silicone gastric bands. Two of these reports were for deaths, one during surgery and the other as a result of an erosion of the gastric band into the stomach 9 weeks after implantation. Forty-four reports were for injuries including band erosions, slippage, and infection. The most common type of report (499) was for device malfunction, and of these, 485 (97.2%) described a leak at or near the port. Of the 485 leaks reported as malfunctions, 99.4% were treated surgically. The majority of reports were related to disconnection, breakage, and leakage at or near the access port. Physicians and potential patients should be aware of these problems and recognize the possibility that additional surgery(ies) may be required for leaking access port/connections. The loose connection may cause pain and the device no longer performs as intended when there is a leak.
一种硅胶可调节胃束带系统于2001年6月获得美国食品药品监督管理局（FDA）批准。本报告的目的是回顾并描述FDA截至2002年8月8日收到的关于硅胶可调节胃束带系统的报告。我们还回顾了关于硅胶可调节胃束带系统不良事件的医学文献。受监管的医疗器械制造商，如可调节硅胶胃束带，必须向FDA报告不良事件，包括死亡和重伤。我们回顾了FDA截至2002年8月8日收到的所有关于可调节硅胶胃束带的此类报告，并按不良事件类型、报告的器械问题和报告的患者问题对数据进行了总结。FDA收到了556份与使用可调节硅胶胃束带相关的不良事件报告。其中两份报告涉及死亡，一例在手术期间，另一例是由于胃束带在植入9周后侵蚀到胃中。44份报告涉及损伤，包括束带侵蚀、移位和感染。最常见的报告类型（499份）是器械故障，其中485份（97.2%）描述了端口处或其附近的泄漏。在报告为故障的485例泄漏中，99.4%通过手术治疗。大多数报告与接入端口处或其附近的断开、破损和泄漏有关。医生和潜在患者应了解这些问题，并认识到可能需要进行额外手术来处理泄漏的接入端口/连接。连接松动可能会引起疼痛，当出现泄漏时，器械将无法按预期运行。
