Trial Outcomes & Findings for Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study (NCT NCT00690339)
NCT ID: NCT00690339
Last Updated: 2014-10-13
Results Overview
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
941 participants
Primary outcome timeframe
10 years
Results posted on
2014-10-13
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
492
|
225
|
156
|
68
|
|
Overall Study
COMPLETED
|
375
|
144
|
99
|
43
|
|
Overall Study
NOT COMPLETED
|
117
|
81
|
57
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Baseline characteristics by cohort
| Measure |
Augmentation
n=492 Participants
Augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
Reconstruction
n=225 Participants
Reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
Revision-augmentation
n=156 Participants
Revision-augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
Revision-reconstruction
n=68 Participants
Revision-reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
Total
n=941 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
492 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
931 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
492 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
941 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: 10 yearsBy patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Outcome measures
| Measure |
Augmentation
n=492 Participants
Augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
Reconstruction
n=225 Participants
Reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
Revision-augmentation
n=156 Participants
Revision-augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
Revision-reconstruction
n=68 Participants
Revision-reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
|---|---|---|---|---|
|
Local Complications
Capsular Contracture
|
9.2 Percentage of Patients
Interval 6.7 to 12.6
|
14.5 Percentage of Patients
Interval 10.1 to 20.6
|
11.9 Percentage of Patients
Interval 7.2 to 19.3
|
26.8 Percentage of Patients
Interval 16.8 to 41.1
|
|
Local Complications
Asymmetry
|
1.2 Percentage of Patients
Interval 0.5 to 2.9
|
12.4 Percentage of Patients
Interval 8.4 to 18.1
|
6.9 Percentage of Patients
Interval 3.6 to 13.1
|
17.4 Percentage of Patients
Interval 9.6 to 30.5
|
|
Local Complications
Breast Pain
|
4.5 Percentage of Patients
Interval 2.8 to 7.1
|
8.2 Percentage of Patients
Interval 4.9 to 13.7
|
5.2 Percentage of Patients
Interval 2.3 to 11.5
|
7.8 Percentage of Patients
Interval 2.9 to 20.4
|
|
Local Complications
Wrinkling/Rippling
|
0.9 Percentage of Patients
Interval 0.3 to 2.4
|
6.2 Percentage of Patients
Interval 3.3 to 11.4
|
3.7 Percentage of Patients
Interval 1.5 to 8.6
|
12.8 Percentage of Patients
Interval 6.1 to 25.6
|
|
Local Complications
Infection
|
1.7 Percentage of Patients
Interval 0.8 to 3.3
|
6.1 Percentage of Patients
Interval 3.5 to 10.7
|
2.1 Percentage of Patients
Interval 0.7 to 6.3
|
8.5 Percentage of Patients
Interval 3.6 to 19.5
|
|
Local Complications
Implant Malposition
|
4.7 Percentage of Patients
Interval 3.1 to 7.3
|
5.7 Percentage of Patients
Interval 3.1 to 10.5
|
9.1 Percentage of Patients
Interval 5.2 to 15.6
|
8.0 Percentage of Patients
Interval 3.0 to 20.5
|
|
Local Complications
Swelling
|
4.0 Percentage of Patients
Interval 2.5 to 6.3
|
5.3 Percentage of Patients
Interval 2.8 to 9.7
|
2.7 Percentage of Patients
Interval 1.0 to 7.1
|
3.2 Percentage of Patients
Interval 0.8 to 12.4
|
|
Local Complications
Seroma/Fluid Accumulation
|
1.6 Percentage of Patients
Interval 0.8 to 3.3
|
2.8 Percentage of Patients
Interval 1.1 to 6.6
|
3.2 Percentage of Patients
Interval 1.2 to 8.4
|
6.2 Percentage of Patients
Interval 2.4 to 15.8
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: All patients who had a breast implant satisfaction rating
Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied
Outcome measures
| Measure |
Augmentation
n=292 Participants
Augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
Reconstruction
n=134 Participants
Reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
Revision-augmentation
n=72 Participants
Revision-augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
Revision-reconstruction
n=40 Participants
Revision-reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery
|
|---|---|---|---|---|
|
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.
Physician Satisfaction
|
4.8 units on a scale
Standard Deviation 0.7
|
4.6 units on a scale
Standard Deviation 0.8
|
4.5 units on a scale
Standard Deviation 1.0
|
4.4 units on a scale
Standard Deviation 0.9
|
|
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.
Patient Satisfaction
|
4.8 units on a scale
Standard Deviation 0.7
|
4.6 units on a scale
Standard Deviation 0.8
|
4.4 units on a scale
Standard Deviation 1.1
|
4.5 units on a scale
Standard Deviation 0.9
|
Adverse Events
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-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
Adverse event data not reported
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