Table 2:
Focus Group Ranking of AEs
| Preoperative Group Ranking of AEs | |||
|---|---|---|---|
| Very Severe | Moderately to Somewhat Severe |
Not Severe | |
| N = 26 | • Infection • Surgery failure* • Death • Recovery: Lack of mobility* • Multiple surgeries* • Causing more problems* • Nicking something • Anesthesia Related |
• Catheter: unable to void • Pain • Sexual function • Unwelcome surprises: discovering another disease • Recovery time • Blood clots |
• Mesh related complications • Financial |
| AEs Added After Physician Generated AE List Reviewed | |||
| • Everything on list • Sepsis |
• Inability to jump/exercise |
• No additions | |
| Immediate Post-Operative Group Ranking of AEs | |||
| Very Severe |
Moderately to Somewhat Severe |
Not Severe | |
| N = 27 | • Incontinence* • Infection • Death • Pain at surgical site • Blood loss/blood transfusion • Constipation* • Nicked bladder • Anesthesia during surgery • Recurrence of problem* • Mesh complication • Scar tissue at surgical site causing pain • Sexual function* • Dehydration during/after surgery |
• Pain • Financial recovery • Numbness in limbs • Unpleasant smell • Limited mobility • Stitches • Sexual function • Weight gain • Double voiding |
• Blood clots • Weight loss |
| AEs Added After Physician Generated AE List Reviewed | |||
| • Up more than 2 times per night to urinate* • Mesh pain |
• No additions | • Spraying of urine • Painful intercourse |
|
| Long Term Post-Operative Group Ranking of AEs | |||
| Very Severe |
Moderately to Somewhat Severe |
Not Severe | |
| N = 28 | • Sexual Function* • Repeat Surgery* • Surgery failure* • Chronic pain • Death • Lifelong treatment*: Stool softener, Catheterization • Continue incontinence* • Pulmonary edema • MI/CHF • Mesh complication • Anal incontinence* • Burn after surgery • Catheter • Recovery time* • ICU admission • Stiches too tight • Constipation* |
• UTI • Pain • Recovery with limited mobility • Neurologic injury |
• Bleeding during surgery • Blood clots • Mesh complications |
| AEs Added After Physician Generated AE List Reviewed | |||
| • No additions | • No additions | • No additions | |
*
These adverse events marked to signify those that are further discussed in the Results section and represent a significant departure from adverse events that would be typically considered as “very severe” by surgeons