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Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01785069
Recruitment Status : Terminated (There was no indication that long-term follow-up would differ between any of the studies that have evaluated devices within the 410 Style Matrix.)
First Posted : February 6, 2013
Results First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Augmentation
Breast Reconstruction
Breast Implant Revision
Intervention Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
Enrollment 355
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
Hide Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had revision of a previous breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Period Title: Overall Study
Started 107 76 104 68
Completed 95 64 91 54
Not Completed 12 12 13 14
Reason Not Completed
Implanted with nonstudy device             1             2             1             0
Death             0             0             2             0
Subject choice             2             2             0             1
Lost to Follow-up             1             2             4             1
Reason not Specified             1             2             1             4
Not evaluable             7             4             5             8
Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction Total
Hide Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had revision of a previous breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants. Total of all reporting groups
Overall Number of Baseline Participants 100 72 99 60 331
Hide Baseline Analysis Population Description
Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and magnetic resonance imaging (MRI) within the window.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 100 participants 72 participants 99 participants 60 participants 331 participants
35.1
(19.0 to 60.0)
48.3
(26.0 to 68.0)
51.8
(28.0 to 69.0)
54.7
(25.0 to 71.0)
46.5
(19.0 to 71.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 72 participants 99 participants 60 participants 331 participants
Female
100
 100.0%
72
 100.0%
99
 100.0%
60
 100.0%
331
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants According to Investigator Satisfaction With Implants
Hide Description The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied,3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Time Frame 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Evaluable population, all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window, with data available for analysis.
Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
Hide Arm/Group Description:
Women who had breast augmentation with NATRELLE® 410 implants.
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
Women who had breast reconstruction with NATRELLE® 410 implants.
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Overall Number of Participants Analyzed 100 66 95 49
Measure Type: Number
Unit of Measure: percentage of participants
99.0 97.0 100.0 95.9
2.Primary Outcome
Title Percentage of Participants According to Participant Satisfaction With Implants
Hide Description The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Time Frame 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Evaluable population, all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window, with data available for analysis.
Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
Hide Arm/Group Description:
Women who had breast augmentation with NATRELLE® 410 implants.
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
Women who had breast reconstruction with NATRELLE® 410 implants.
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Overall Number of Participants Analyzed 99 66 95 49
Measure Type: Number
Unit of Measure: percentage of participants
99.0 95.5 94.9 91.8
3.Secondary Outcome
Title Percentage of Participants With Local Complications
Hide Description Kaplan-Meier risk rates (estimation of the percentage of participants) of developing local complications is presented. Local complications collected in the study were: Asymmetry, Breast Pain, Capsular contracture, Delayed wound healing, Fluid accumulation/seroma, Implant malposition, Implant palpability/visibility. Implant rupture, Infection, Ptosis, Redness, Swelling, Wrinkling/rippling and Other complications (calcifications on mammogram, thing of mastectomy flap, deformity and nipple stretching).
Time Frame 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window.
Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
Hide Arm/Group Description:
Women who had breast augmentation with NATRELLE® 410 implants.
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
Women who had breast reconstruction with NATRELLE® 410 implants.
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Overall Number of Participants Analyzed 100 72 99 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Any complication
9.05
(4.81 to 16.66)
15.71
(9.03 to 26.58)
15.28
(9.34 to 24.43)
3.77
(0.95 to 14.33)
Asymmetry
1.00
(0.14 to 6.89)
0.00
(0.00 to 0.00)
3.03
(0.99 to 9.10)
0.00
(0.00 to 0.00)
Breast pain
2.00
(0.50 to 7.76)
0.00
(0.00 to 0.00)
1.01
(0.14 to 6.95)
2.00
(0.28 to 13.36)
Capsular contracture
3.05
(0.99 to 9.17)
3.12
(0.78 to 12.01)
4.40
(1.67 to 11.34)
3.67
(0.93 to 13.99)
Delayed wound healing
0.00
(0.00 to 0.00)
1.39
(0.20 to 9.45)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
Fluid accumulation/seroma
0.00
(0.00 to 0.00)
1.39
(0.20 to 9.45)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
Implant malposition
3.00
(0.98 to 9.01)
4.17
(1.36 to 12.36)
4.04
(1.54 to 10.41)
1.67
(0.24 to 11.25)
Implant palpability/visibility
0.00
(0.00 to 0.00)
1.39
(0.20 to 9.45)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
Implant rupture
3.09
(1.01 to 9.29)
12.64
(5.12 to 29.38)
2.16
(0.55 to 8.38)
5.91
(1.91 to 16.94)
Infection
0.00
(0.00 to 0.00)
1.39
(0.20 to 9.45)
2.02
(0.51 to 7.84)
0.00
(0.00 to 0.00)
Ptosis
0.00
(0.00 to 0.00)
1.39
(0.20 to 9.45)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
Redness
1.00
(0.14 to 6.89)
0.00
(0.00 to 0.00)
2.02
(0.51 to 7.84)
0.00
(0.00 to 0.00)
Swelling
1.05
(0.15 to 7.24)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
Wrinkling/rippling
0.00
(0.00 to 0.00)
2.78
(0.70 to 10.65)
0.00
(0.00 to 0.00)
1.67
(0.24 to 11.25)
Other complications
1.00
(0.14 to 6.89)
2.78
(0.70 to 10.65)
2.12
(0.53 to 8.22)
0.00
(0.00 to 0.00)
4.Secondary Outcome
Title Percentage of Participants With Reoperations
Hide Description Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
Time Frame 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window.
Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
Hide Arm/Group Description:
Women who had breast augmentation with NATRELLE® 410 implants.
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
Women who had breast reconstruction with NATRELLE® 410 implants.
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Overall Number of Participants Analyzed 100 72 99 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.07
(4.82 to 16.71)
25.64
(16.44 to 38.66)
39.84
(30.88 to 50.30)
39.01
(27.81 to 52.78)
5.Secondary Outcome
Title Percentage of Participants With Implant Removal With or Without Replacement
Hide Description Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement
Time Frame 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window.
Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
Hide Arm/Group Description:
Women who had breast augmentation with NATRELLE® 410 implants.
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
Women who had breast reconstruction with NATRELLE® 410 implants.
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Overall Number of Participants Analyzed 100 72 99 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.05
(0.15 to 7.24)
12.42
(4.43 to 32.13)
2.35
(0.59 to 9.08)
6.13
(1.98 to 18.16)
Time Frame 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Adverse Event Reporting Description Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
 
Arm/Group Title Augmentation Reconstruction Revision-Augmentation Revision-Reconstruction
Hide Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of a previous breast augmentation with NATRELLE® 410 implants. Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
All-Cause Mortality
Augmentation Reconstruction Revision-Augmentation Revision-Reconstruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Augmentation Reconstruction Revision-Augmentation Revision-Reconstruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   2/72 (2.78%)   0/99 (0.00%)   0/60 (0.00%) 
Infections and infestations         
Bacterial pneumonia *  0/100 (0.00%)  1/72 (1.39%)  0/99 (0.00%)  0/60 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism * [1]  0/100 (0.00%)  1/72 (1.39%)  0/99 (0.00%)  0/60 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Following knee surgery
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Augmentation Reconstruction Revision-Augmentation Revision-Reconstruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
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.
A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01785069    
Other Study ID Numbers: 410XL-001
First Submitted: January 14, 2013
First Posted: February 6, 2013
Results First Submitted: May 13, 2020
Results First Posted: June 25, 2020
Last Update Posted: June 25, 2020