Trial Outcomes & Findings for Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants (NCT NCT01785069)
NCT ID: NCT01785069
Last Updated: 2020-06-25
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
355 participants
Primary outcome timeframe
3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Results posted on
2020-06-25
Participant Flow
Participant milestones
| Measure |
Augmentation
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
107
|
76
|
104
|
68
|
|
Overall Study
COMPLETED
|
95
|
64
|
91
|
54
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
13
|
14
|
Reasons for withdrawal
| Measure |
Augmentation
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Overall Study
Implanted with nonstudy device
|
1
|
2
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
2
|
0
|
|
Overall Study
Subject choice
|
2
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
4
|
1
|
|
Overall Study
Reason not Specified
|
1
|
2
|
1
|
4
|
|
Overall Study
Not evaluable
|
7
|
4
|
5
|
8
|
Baseline Characteristics
Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
Baseline characteristics by cohort
| Measure |
Augmentation
n=100 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=72 Participants
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=99 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=60 Participants
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.1 years
n=5 Participants
|
48.3 years
n=7 Participants
|
51.8 years
n=5 Participants
|
54.7 years
n=4 Participants
|
46.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
331 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)Population: 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.
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.
Outcome measures
| Measure |
Augmentation
n=100 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=66 Participants
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=95 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=49 Participants
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Percentage of Participants According to Investigator Satisfaction With Implants
|
99.0 percentage of participants
|
97.0 percentage of participants
|
100.0 percentage of participants
|
95.9 percentage of participants
|
PRIMARY outcome
Timeframe: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)Population: 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.
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.
Outcome measures
| Measure |
Augmentation
n=99 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=66 Participants
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=95 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=49 Participants
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Percentage of Participants According to Participant Satisfaction With Implants
|
99.0 percentage of participants
|
95.5 percentage of participants
|
94.9 percentage of participants
|
91.8 percentage of participants
|
SECONDARY outcome
Timeframe: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)Population: 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.
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).
Outcome measures
| Measure |
Augmentation
n=100 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=72 Participants
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=99 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=60 Participants
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Percentage of Participants With Local Complications
Any complication
|
9.05 percentage of participants
Interval 4.81 to 16.66
|
15.71 percentage of participants
Interval 9.03 to 26.58
|
15.28 percentage of participants
Interval 9.34 to 24.43
|
3.77 percentage of participants
Interval 0.95 to 14.33
|
|
Percentage of Participants With Local Complications
Asymmetry
|
1.00 percentage of participants
Interval 0.14 to 6.89
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
3.03 percentage of participants
Interval 0.99 to 9.1
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Local Complications
Breast pain
|
2.00 percentage of participants
Interval 0.5 to 7.76
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
1.01 percentage of participants
Interval 0.14 to 6.95
|
2.00 percentage of participants
Interval 0.28 to 13.36
|
|
Percentage of Participants With Local Complications
Capsular contracture
|
3.05 percentage of participants
Interval 0.99 to 9.17
|
3.12 percentage of participants
Interval 0.78 to 12.01
|
4.40 percentage of participants
Interval 1.67 to 11.34
|
3.67 percentage of participants
Interval 0.93 to 13.99
|
|
Percentage of Participants With Local Complications
Delayed wound healing
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
1.39 percentage of participants
Interval 0.2 to 9.45
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Local Complications
Fluid accumulation/seroma
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
1.39 percentage of participants
Interval 0.2 to 9.45
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Local Complications
Implant malposition
|
3.00 percentage of participants
Interval 0.98 to 9.01
|
4.17 percentage of participants
Interval 1.36 to 12.36
|
4.04 percentage of participants
Interval 1.54 to 10.41
|
1.67 percentage of participants
Interval 0.24 to 11.25
|
|
Percentage of Participants With Local Complications
Implant palpability/visibility
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
1.39 percentage of participants
Interval 0.2 to 9.45
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Local Complications
Implant rupture
|
3.09 percentage of participants
Interval 1.01 to 9.29
|
12.64 percentage of participants
Interval 5.12 to 29.38
|
2.16 percentage of participants
Interval 0.55 to 8.38
|
5.91 percentage of participants
Interval 1.91 to 16.94
|
|
Percentage of Participants With Local Complications
Infection
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
1.39 percentage of participants
Interval 0.2 to 9.45
|
2.02 percentage of participants
Interval 0.51 to 7.84
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Local Complications
Ptosis
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
1.39 percentage of participants
Interval 0.2 to 9.45
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Local Complications
Redness
|
1.00 percentage of participants
Interval 0.14 to 6.89
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
2.02 percentage of participants
Interval 0.51 to 7.84
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Local Complications
Swelling
|
1.05 percentage of participants
Interval 0.15 to 7.24
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Local Complications
Wrinkling/rippling
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
2.78 percentage of participants
Interval 0.7 to 10.65
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
1.67 percentage of participants
Interval 0.24 to 11.25
|
|
Percentage of Participants With Local Complications
Other complications
|
1.00 percentage of participants
Interval 0.14 to 6.89
|
2.78 percentage of participants
Interval 0.7 to 10.65
|
2.12 percentage of participants
Interval 0.53 to 8.22
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)Population: 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.
Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
Outcome measures
| Measure |
Augmentation
n=100 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=72 Participants
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=99 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=60 Participants
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Percentage of Participants With Reoperations
|
9.07 percentage of participants
Interval 4.82 to 16.71
|
25.64 percentage of participants
Interval 16.44 to 38.66
|
39.84 percentage of participants
Interval 30.88 to 50.3
|
39.01 percentage of participants
Interval 27.81 to 52.78
|
SECONDARY outcome
Timeframe: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)Population: 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.
Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement
Outcome measures
| Measure |
Augmentation
n=100 Participants
Women who had breast augmentation with NATRELLE® 410 implants.
|
Revision-Augmentation
n=72 Participants
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=99 Participants
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=60 Participants
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Percentage of Participants With Implant Removal With or Without Replacement
|
1.05 percentage of participants
Interval 0.15 to 7.24
|
12.42 percentage of participants
Interval 4.43 to 32.13
|
2.35 percentage of participants
Interval 0.59 to 9.08
|
6.13 percentage of participants
Interval 1.98 to 18.16
|
Adverse Events
Augmentation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reconstruction
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Revision-Augmentation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Revision-Reconstruction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Augmentation
n=100 participants at risk
Women who had breast augmentation with NATRELLE® 410 implants.
|
Reconstruction
n=72 participants at risk
Women who had breast reconstruction with NATRELLE® 410 implants.
|
Revision-Augmentation
n=99 participants at risk
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
|
Revision-Reconstruction
n=60 participants at risk
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/100 • 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
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.
|
1.4%
1/72 • 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
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.
|
0.00%
0/99 • 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
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.
|
0.00%
0/60 • 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
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.
|
|
Infections and infestations
Bacterial pneumonia
|
0.00%
0/100 • 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
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.
|
1.4%
1/72 • 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
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.
|
0.00%
0/99 • 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
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.
|
0.00%
0/60 • 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER