Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT00690339
First received: June 2, 2008
Last updated: October 6, 2014
Last verified: December 2013
Results First Received: December 17, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Breast Augmentation
Breast Reconstruction
Revision of Augmentation or Reconstruction
Intervention: Device: Style 410 Silicone-Filled Breast Implants

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Augmentation

Augmentation

Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery

Reconstruction

Reconstruction

Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery

Revision-augmentation

Revision-augmentation

Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery

Revision-reconstruction

Revision-reconstruction

Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery


Participant Flow:   Overall Study
    Augmentation     Reconstruction     Revision-augmentation     Revision-reconstruction  
STARTED     492     225     156     68  
COMPLETED     375     144     99     43  
NOT COMPLETED     117     81     57     25  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Augmentation

Augmentation

Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery

Reconstruction

Reconstruction

Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery

Revision-augmentation

Revision-augmentation

Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery

Revision-reconstruction

Revision-reconstruction

Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery

Total Total of all reporting groups

Baseline Measures
    Augmentation     Reconstruction     Revision-augmentation     Revision-reconstruction     Total  
Number of Participants  
[units: participants]
  492     225     156     68     941  
Age  
[units: subjects]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     492     218     156     65     931  
>=65 years     0     7     0     3     10  
Gender  
[units: subjects]
         
Female     492     225     156     68     941  
Male     0     0     0     0     0  



  Outcome Measures
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1.  Primary:   Local Complications   [ Time Frame: 10 years ]

2.  Secondary:   Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.   [ Time Frame: 10 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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