Study: NCT00812097

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 572 at risk

Adverse event: Asymmetry
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 4 affected / 572 at risk

Adverse event: Baker III Capsular Contracture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 18 affected / 572 at risk

Adverse event: Baker IV Capsular Contracture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 1 affected / 572 at risk

Adverse event: Breast Sensation Changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 21 affected / 572 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 30 affected / 572 at risk

Adverse event: Palpability-Implant
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 6 affected / 572 at risk

Adverse event: Patient Dissatisfied With Aesthetic Appearance Of Breast
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 7 affected / 572 at risk

Adverse event: Position Dissatisfaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 12 affected / 572 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 26 affected / 572 at risk

Adverse event: Skin wrinkling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 15 affected / 572 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 190 at risk

Adverse event: Asymmetry
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 19 affected / 190 at risk

Adverse event: Baker III Capsular Contracture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 19 affected / 190 at risk

Adverse event: Baker IV Capsular Contracture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 4 affected / 190 at risk

Adverse event: Breast Sensation Changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 2 affected / 190 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 5 affected / 190 at risk

Adverse event: Palpability-Implant
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 2 affected / 190 at risk

Adverse event: Position Dissatisfaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 4 affected / 190 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 4 affected / 190 at risk

Adverse event: Recurrent Breast Cancer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 10 affected / 190 at risk

Adverse event: Skin wrinkling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 9 affected / 190 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 124 at risk

Adverse event: Asymmetry
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 4 affected / 124 at risk

Adverse event: Baker III Capsular Contracture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 10 affected / 124 at risk

Adverse event: Baker IV Capsular Contracture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 1 affected / 124 at risk

Adverse event: Palpability-Implant
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 2 affected / 124 at risk

Adverse event: Patient Dissatisfied With Aesthetic Appearance Of Breast
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 4 affected / 124 at risk

Adverse event: Position Dissatisfaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 5 affected / 124 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 2 affected / 124 at risk

Adverse event: Skin wrinkling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 8 affected / 124 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: Asymmetry
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 3 affected / 69 at risk

Adverse event: Baker III Capsular Contracture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 11 affected / 69 at risk

Adverse event: Baker IV Capsular Contracture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 5 affected / 69 at risk

Adverse event: Breast Sensation Changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 4 affected / 69 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 6 affected / 69 at risk

Adverse event: Palpability-Implant
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 5 affected / 69 at risk

Adverse event: Patient Dissatisfied With Aesthetic Appearance Of Breast
Serious: no
Organ System: Surgical and medical procedures
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 5 affected / 69 at risk

Adverse event: Position Dissatisfaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 5 affected / 69 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 10 affected / 69 at risk

Adverse event: Skin wrinkling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Frequency: 8 affected / 69 at risk