Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration
العنوان: | Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration |
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المؤلفون: | Jonathan A. Schoen, J. H. Clarke, Thomas N. Robinson, M. D. Walsh |
المصدر: | Surgical endoscopy. 19(12) |
سنة النشر: | 2005 |
مصطلحات موضوعية: | medicine.medical_specialty, business.industry, United States Food and Drug Administration, medicine.medical_treatment, Surgical Mesh, medicine.disease, Hernia repair, United States, Surgery, Food and drug administration, Surgical mesh, Anesthesia, Seroma, Product Surveillance, Postmarketing, Medicine, Humans, Hernia, Adverse effect, business, Complication, Abdominal surgery |
الوصف: | Mesh material affects complications following hernia repair. Medical device reports on the use of surgical mesh for hernia repair were reviewed from the Food and Drug Administration’s (FDA) Manufacturer User Facility Device Experience Database from January 1996 to September 2004. We analyzed 252 adverse event reports related to the use of surgical mesh for hernia repair. Adverse events included infection (42%, 107 reports), mechanical failure (18%, 46), pain (9%, 23), reaction (8%, 20), intestinal complications (7%, 18), adhesions (6%, 14), seroma (4%, 9), erosion (2%, 6), and other (4%, 9). Compared to all other mesh types, Sepra/polypropylene mesh had more mechanical failures (80 vs 14%, p < 0.05), biomaterial mesh had more reactions (57 vs 7%, p < 0.05), polytetrafluoroethylene (PTFE)/polypropylene mesh had more intestinal complications (14 vs 7%, p < 0.05), and PTFE mesh tended to have more infections (75 vs 41% all other, p = 0.07). Death occurred in 2% (5). We conclude that specific mesh materials are related to specific complications. |
تدمد: | 1432-2218 |
URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2e8bc97ff9eea5ae24259082d3110360 https://pubmed.ncbi.nlm.nih.gov/16211441 |
حقوق: | CLOSED |
رقم الأكسشن: | edsair.doi.dedup.....2e8bc97ff9eea5ae24259082d3110360 |
قاعدة البيانات: | OpenAIRE |
تدمد: | 14322218 |
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