Study: NCT00388947

Adverse event: Adhesion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1543 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1543 at risk

Adverse event: Dehiscence at vaginal suture line before healing occurs
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1543 at risk

Adverse event: Extrusion
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 1543 at risk

Adverse event: Granuloma formation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1543 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1543 at risk

Adverse event: Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Notes: includes denovo and recurrent incontinence
Frequency: 6 affected / 1543 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1543 at risk

Adverse event: Other Genitourinary
Serious: yes
Organ System: General disorders
Notes: 1)Coumadin medicated patient received too much anticoagulation therapy resulting in bleeding 2)small separation of anterior mesh from vaginal mucosa
Frequency: 2 affected / 1543 at risk

Adverse event: Pain - dyspareunia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1543 at risk

Adverse event: Pain - excluding dyspareunia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1543 at risk

Adverse event: Perforation - bladder
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1543 at risk

Adverse event: Prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: includes denovo and recurrent
Frequency: 14 affected / 1543 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1543 at risk

Adverse event: Urinary urge, frequency, or hesistancy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1543 at risk

Adverse event: Wound separation <3 months post-op
Serious: yes
Organ System: General disorders
Notes: Wound separation events less than 3 months post-procedure including mesh exposure events
Frequency: 3 affected / 1543 at risk

Adverse event: extrusion
Serious: no
Organ System: General disorders
Notes: mesh exposure through vaginal mucosa
Frequency: 30 affected / 1543 at risk

Adverse event: granuloma formation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 1543 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 1543 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: Includes both denovo and worsening incontinence
Frequency: 12 affected / 1543 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 1543 at risk

Adverse event: other events below threshold
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Incongruous events that are individually below the threshold
Frequency: 28 affected / 1543 at risk

Adverse event: pain (excluding dyspareunia)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 1543 at risk

Adverse event: Prolapse
Serious: no
Organ System: Reproductive system and breast disorders
Notes: includes denovo and recurrent prolapse
Frequency: 40 affected / 1543 at risk