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Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00689871
First received: June 2, 2008
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
Results First Received: December 19, 2011  
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: Natrelle(TM) 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
Enrollment: January 6, 1999-June 30, 2000 at multiple US sites

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
Primary Augmentation All women implanted for an indication of primary breast augmentation
Primary Reconstruction All women implanted for an indication of primary breast reconstruction
Revision-augmentation All women implanted for revision of a breast augmentation
Revision-reconstruction All women implanted for revision of a breast reconstruction

Participant Flow:   Overall Study
    Primary Augmentation     Primary Reconstruction     Revision-augmentation     Revision-reconstruction  
STARTED     455 [1]   98 [2]   147 [3]   15 [4]
COMPLETED     280 [5]   46 [5]   74 [6]   8 [7]
NOT COMPLETED     175     52     73     7  
Lost to Follow-up                 123                 13                 37                 1  
Explanted of All Study Devices                 36                 25                 29                 3  
Withdrawal by Subject                 13                 3                 4                 1  
Death                 1                 10                 2                 2  
Physician Decision                 2                 1                 1                 0  
[1] 908 Implants
[2] 127 Implants
[3] 288 Implants
[4] 25 Implants
[5] 35 Patients discontinued
[6] 28 Patients discontinued
[7] 4 Patients discontinued



  Baseline Characteristics
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Reporting Groups
  Description
Primary Augmentation All women implanted for an indication of primary breast augmentation
Primary Reconstruction All women implanted for an indication of primary breast reconstruction
Revision-augmentation All women implanted for revision of a breast augmentation
Revision-reconstruction All women implanted for revision of a breast reconstruction
Total Total of all reporting groups

Baseline Measures
    Primary Augmentation     Primary Reconstruction     Revision-augmentation     Revision-reconstruction     Total  
Number of Participants  
[units: participants]
 		  455     98     147     15     715  
Age, Customized  
[units: participants]
 		         
<=40 years     319     10     61     0     390  
Between 40 and 60 years     136     73     84     9     302  
>=60 years     0     15     2     6     23  
Gender  
[units: participants]
 		         
Female     455     98     147     15     715  
Male     0     0     0     0     0  



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

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


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Primary Augmentation All women implanted for an indication of primary breast augmentation
Primary Reconstruction All women implanted for an indication of primary breast reconstruction
Revision-augmentation All women implanted for revision of a breast augmentation
Revision-reconstruction All women implanted for revision of a breast reconstruction

Other Adverse Events
    Primary Augmentation     Primary Reconstruction     Revision-augmentation     Revision-reconstruction  
Total, other (not including serious) adverse events          
# participants affected / at risk     0/455     0/98     0/147     0/15  



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
The Revision-reconstruction arm only had 15 patients enrolled, which makes the data for that arm difficult to interpret.  


Results Point of Contact:  
Name/Title: Medical Monitor
Organization: Allergan Medical
phone: (805) 961-5000
e-mail: devicetrials@allergan.com


No publications provided


Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00689871     History of Changes
Other Study ID Numbers: 020056
Study First Received: June 2, 2008
Results First Received: December 19, 2011
Last Updated: February 13, 2012
Health Authority: United States: Food and Drug Administration