Table 26 - Adverse events VSB incidence incidence Adverse Events VSB Fisch Fraysse Labassi Mosnier Luetje Sterkers n Total n of n cases when across all reported 2001 2001 2005 2008 2010 2003 studies subjects 2006 reported studies taste disturbances 6 6 3 7 4 239 1,86 26 10,9 middle ear effusion 0 1 95 0,00 0 0,00 pain 3 1 2 120 0,29 4 3,33 vertigo / dizziness 0 1 95 0,00 0 0,00 tinnitus 1 2 1 3 162 0,29 4 2,47 facial palsy 0 1 2 3 1172 0,50 7 0,60 limited benefit 3 1 95 0,21 3 3,16 headaches 2 0 2 115 0,14 2 1,74 revision surgery 1 16 12 4 3 5 1278 2,72 38 2,97 skin flap problems 9 9 2 1177 1,29 18 1,53 implant failure 27 7 2 1177 1,93 27 2,29 aural fullnes 21 1 77 1,50 21 27,3 complications 8 4 54 55 4 10 12 7 1398 10,52 147 10,5 TOTAL EVENTS 47 25 1100 77 34 20 95 1398
Table 26 - Adverse events VSB Adverse Events VSB reported Fisch 2001 Fraysse 2001 Labassi 2005 Mosnier 2008 Luetje 2010 2006 Sterkers 2003 n studies Total n of subjects n cases incidence when reported incidence across all studies taste disturbances 6 6 3 7 4 239 26 10,9 1,86 middle ear effusion 0 1 95 0 0,00 0,00 pain 3 1 2 120 4 3,33 0,29 vertigo / dizziness 0 1 95 0 0,00 0,00 tinnitus 1 2 1 3 162 4 2,47 0,29 facial palsy 0 1 2 3 1172 7 0,60 0,50 limited benefit 3 1 95 3 3,16 0,21 headaches 2 0 2 115 2 1,74 0,14 revision surgery 1 16 12 4 3 5 1278 38 2,97 2,72 skin flap problems 9 9 2 1177 18 1,53 1,29 implant failure 27 7 2 1177 27 2,29 1,93 aural fullnes 21 1 77 21 27,3 1,50 complications 8 4 54 55 4 10 12 7 1398 147 10,5 10,52 TOTAL EVENTS 47 25 1100 77 34 20 95 1398
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