Study: NCT00325039

Adverse event: Mesh exposure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 298 at risk

Adverse event: Mesh erosion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 298 at risk

Adverse event: Urethral perforation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 298 at risk

Adverse event: Bladder perforation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 15 affected / 298 at risk

Adverse event: Vaginal epithelial perforation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 298 at risk

Adverse event: Recurrent cystitis, leading to diagnostic cystoscopy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 298 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Neurological symptom
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Voiding dysfunction requiring surgery, use of catheter or both
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 298 at risk

Adverse event: Mesh exposure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 298 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 298 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 298 at risk

Adverse event: Vascular or hematologic
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 298 at risk

Adverse event: Neurologic symptom of numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 298 at risk

Adverse event: Neurologic symptom of weakness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 298 at risk

Adverse event: Voiding dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 298 at risk

Adverse event: Self-reported pain 6 or more weeks after procedure
Serious: no
Organ System: General disorders
Frequency: 7 affected / 298 at risk

Adverse event: Persistent urge incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 36 affected / 298 at risk

Adverse event: Excessive granulation tissue
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 298 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 298 at risk

Adverse event: Candida infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 298 at risk

Adverse event: Wound edge separation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 298 at risk

Adverse event: Minor wound
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 298 at risk

Adverse event: Decreased bladder sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 298 at risk

Adverse event: Mesh exposure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 299 at risk

Adverse event: Mesh erosion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 299 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 299 at risk

Adverse event: Excessive granulation tissue
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 299 at risk

Adverse event: Vaginal epithelial perforation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 13 affected / 299 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 299 at risk

Adverse event: Urothelial abrasion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 299 at risk

Adverse event: Mesh exposure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 299 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 299 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 299 at risk

Adverse event: Vascular or hematologic
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 299 at risk

Adverse event: Neurologic symptom of numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 299 at risk

Adverse event: Neurologic symptom of weakness
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 299 at risk

Adverse event: Voiding dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 299 at risk

Adverse event: Self-reported pain 6 or more weeks after procedure
Serious: no
Organ System: General disorders
Frequency: 6 affected / 299 at risk

Adverse event: New urge incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 299 at risk

Adverse event: Persistent urge incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 30 affected / 299 at risk

Adverse event: Excessive granulation tissue
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 299 at risk

Adverse event: Medication reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 299 at risk

Adverse event: Skin irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 299 at risk

Adverse event: Sac in pelvis (seroma)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 299 at risk

Adverse event: Bilateral leg pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 299 at risk