title: Adjustable silicone gastric banding adverse events reported to the Food and Drug Administration.
abstract: 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.
authors.affiliation: 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. syb@cdrh.fda.gov
authors.forename: S Lori
authors.initials: SL
authors.lastname: Brown
authors.forename: Marie H
authors.initials: MH
authors.lastname: Reid
authors.forename: Hesha Jani
authors.initials: HJ
authors.lastname: Duggirala
mesh_terms: D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000009:adverse effects* / Q000379:methods*; D006801:Humans; D008297:Male; D009767:Obesity, Morbid / Q000175:diagnosis / Q000601:surgery*; D011183:Postoperative Complications; D011358:Product Surveillance, Postmarketing; D012086:Reoperation; D018570:Risk Assessment; D012828:Silicones; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D012828:Silicones