Trial Outcomes & Findings for NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study (NCT NCT01853605)

Results Overview

Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3811 participants

Primary outcome timeframe

5 years

Results posted on

2015-08-11

Participant Flow

The study was discontinued following product approval.

Participant milestones

Participant milestones
Measure	Augmentation Women undergoing breast augmentation.	Revision-Augmentation Women undergoing revision of previous breast augmentation.	Reconstruction Women undergoing breast reconstruction.	Revision-Reconstruction Women undergoing revision of previous breast reconstruction.
Overall Study STARTED	1939	693	751	428
Overall Study COMPLETED	1939	693	751	428
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Augmentation n=1939 Participants Women undergoing breast augmentation.	Revision-Augmentation n=693 Participants Women undergoing revision of previous breast augmentation.	Reconstruction n=751 Participants Women undergoing breast reconstruction.	Revision-Reconstruction n=428 Participants Women undergoing revision of previous breast reconstruction.	Total n=3811 Participants Total of all reporting groups
Age, Continuous	36.0 Years STANDARD_DEVIATION 8.65 • n=5 Participants	46.2 Years STANDARD_DEVIATION 9.96 • n=7 Participants	49.8 Years STANDARD_DEVIATION 10.03 • n=5 Participants	53.5 Years STANDARD_DEVIATION 9.11 • n=4 Participants	42.5 Years STANDARD_DEVIATION 11.52 • n=21 Participants
Sex: Female, Male Female	1939 Participants n=5 Participants	693 Participants n=7 Participants	751 Participants n=5 Participants	428 Participants n=4 Participants	3811 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: 5 years

Population: Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.

Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.

Outcome measures

Outcome measures
Measure	Augmentation n=1929 Participants Women undergoing breast augmentation.	Revision-Augmentation n=688 Participants Women undergoing revision of previous breast augmentation.	Reconstruction n=740 Participants Women undergoing breast reconstruction.	Revision-Reconstruction n=419 Participants Women undergoing revision of previous breast reconstruction.
Subject Satisfaction With Breast Implants on a 5-Point Scale Definitely Satisfied	1772 Subjects	559 Subjects	542 Subjects	295 Subjects
Subject Satisfaction With Breast Implants on a 5-Point Scale Somewhat Satisfied	119 Subjects	87 Subjects	145 Subjects	89 Subjects

PRIMARY outcome

Timeframe: 5 years

Population: Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.

Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.

Outcome measures

Outcome measures
Measure	Augmentation n=1922 Participants Women undergoing breast augmentation.	Revision-Augmentation n=689 Participants Women undergoing revision of previous breast augmentation.	Reconstruction n=745 Participants Women undergoing breast reconstruction.	Revision-Reconstruction n=418 Participants Women undergoing revision of previous breast reconstruction.
Investigator Satisfaction With Breast Implants on a 5-Point Scale Definitely Satisfied	1798 Subjects	560 Subjects	564 Subjects	310 Subjects
Investigator Satisfaction With Breast Implants on a 5-Point Scale Somewhat Satisfied	97 Subjects	83 Subjects	141 Subjects	83 Subjects

PRIMARY outcome

Timeframe: 5 years

Population: Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants who completed the 5 year follow-up visit.

Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.

Outcome measures

Outcome measures
Measure	Augmentation n=1939 Participants Women undergoing breast augmentation.	Revision-Augmentation n=693 Participants Women undergoing revision of previous breast augmentation.	Reconstruction n=751 Participants Women undergoing breast reconstruction.	Revision-Reconstruction n=428 Participants Women undergoing revision of previous breast reconstruction.
Local Complications Capsular Contracture	3.27 Percentage of Subjects Interval 2.56 to 4.16	6.33 Percentage of Subjects Interval 4.74 to 8.45	6.48 Percentage of Subjects Interval 4.92 to 8.51	7.29 Percentage of Subjects Interval 5.19 to 10.21
Local Complications Asymmetry	0.83 Percentage of Subjects Interval 0.51 to 1.35	0.87 Percentage of Subjects Interval 0.39 to 1.93	5.94 Percentage of Subjects Interval 4.46 to 7.9	3.32 Percentage of Subjects Interval 1.98 to 5.54

Adverse Events

Augmentation

Serious events: 0 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

Reconstruction

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

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allergan Inc.,

Allergan, Inc

Email: [email protected]

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