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Journal of Long-Term Effects of Medical Implants

Publicou 4 edições por ano

ISSN Imprimir: 1050-6934

ISSN On-line: 1940-4379

SJR: 0.184 SNIP: 0.485 CiteScore™:: 1.1 H-Index: 39

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Adjustable Silicone Gastric Banding Adverse Events Reported to the Food and Drug Administration

Volume 13, Edição 6, 2003, 10 pages
DOI: 10.1615/JLongTermEffMedImplants.v13.i6.70
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RESUMO

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.

CITADO POR
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  2. Tucker Olga, Sucandy Iswanto, Szomstein Samuel, Rosenthal Raul J., Revisional surgery after failed laparoscopic adjustable gastric banding, Surgery for Obesity and Related Diseases, 4, 6, 2008. Crossref

  3. Torab Fawaz C., Hefny Ashraf F., Taha Mazen, Abou-Rebyeh Hassan, Abu-Zidan Fikri M., Delayed life-threatening upper gastrointestinal bleeding as a complication of laparoscopic adjustable gastric banding: Case report and review of the literature, Asian Journal of Surgery, 35, 3, 2012. Crossref

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  5. Ponce Moderator: Jaime, Gagner Participants: Michel, O'Brien Paul, Laparoscopic Gastric Stapling Procedures as a Replacement to Gastric Banding in the 21st Century?, Bariatric Surgical Practice and Patient Care, 9, 1, 2014. Crossref

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