Study: NCT00565136

Adverse event: Low Back Pain/Disk Herniation
Serious: yes
Organ System: Nervous system disorders
Notes: Severe low back pain into legs. Admitted into hospital - MRI completed and indicated L2 - L3 disk herniated. Surgery for L2-L3 disk herniation. Related to procedure but not device. Onset = 3 days post implant.
Frequency: 1 affected / 29 at risk

Adverse event: Blood Clot in Lungs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject states that she had "2 blood clots in her lungs" that caused her to be hospitalized. Not related to device or procedure. Onset = 541 post implant.
Frequency: 1 affected / 29 at risk

Adverse event: Right Leg Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Ruled out deep vein thrombosis. Hospital admit 5/9/09 and discharges 5/13/09. Treated with vancomycin and rocephin. Not related to device/procedure. Onset = 334 days post implant.
Frequency: 1 affected / 29 at risk

Adverse event: Costochondoritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient was admitted to medical center for right wall chest pain. Negative for pulmonary embolism, electrocardiogram = normal sinus rhythm. Not related to device or procedure. Onset = 136 days post implant,
Frequency: 1 affected / 29 at risk

Adverse event: Carpel Tunnel
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient had carpel tunnel requiring surgical release. Not related to device or procedure. Onset = 733 days from implant.
Frequency: 1 affected / 29 at risk

Adverse event: Urinary Incontinence (De Novo)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 29 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 29 at risk

Adverse event: Dyspareunia (De Novo)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 29 at risk

Adverse event: Worsening Fecal Incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Infection (other than urinary tract infection)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 29 at risk

Adverse event: Abnormal Uterine Bleeding (De Novo)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: Worsening Vaginal Prolapse
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 29 at risk

Adverse event: Worsening Urinary Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Worsening Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 29 at risk

Adverse event: Erosion (non-TOPAS Mesh Device)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vaginal Prolapse (De Novo)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: Persistent Vaginal Discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: Excessive Internal Fibrosis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Other (unclassified)
Serious: no
Organ System: Investigations
Frequency: 13 affected / 29 at risk