Study: NCT00905645

Adverse event: Asymmetry
Serious: no
Organ System: Surgical and medical procedures
Frequency: 19 affected / 1116 at risk

Adverse event: Capsular Contracture(Baker Grade II)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 132 affected / 1116 at risk

Adverse event: Capsular Contracture (Baker Grade III/IV)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 120 affected / 1116 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 26 affected / 1116 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 1116 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 54 affected / 1116 at risk

Adverse event: Explantation with or without replacement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 151 affected / 1116 at risk

Adverse event: Asymmetry
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 363 at risk

Adverse event: Capsular Contracture(Baker Grade II)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 41 affected / 363 at risk

Adverse event: Capsular Contracture (Baker Grade III/IV)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 363 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 15 affected / 363 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 363 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 363 at risk

Adverse event: Explantation with or without replacement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 79 affected / 363 at risk

Adverse event: Asymmetry
Serious: no
Organ System: Surgical and medical procedures
Frequency: 22 affected / 225 at risk

Adverse event: Capsular Contracture(Baker Grade II)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 225 at risk

Adverse event: Capsular Contracture (Baker Grade III/IV)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 225 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 225 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 225 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 225 at risk

Adverse event: Explantation with or without replacement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 73 affected / 225 at risk

Adverse event: Asymmetry
Serious: no
Organ System: Surgical and medical procedures
Frequency: 11 affected / 84 at risk

Adverse event: Capsular Contracture(Baker Grade II)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 84 at risk

Adverse event: Capsular Contracture (Baker Grade III/IV)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 84 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 84 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Explantation with or without replacement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 36 affected / 84 at risk