Trial Outcomes & Findings for Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants (NCT NCT00689871)
NCT ID: NCT00689871
Last Updated: 2014-10-13
Results Overview
By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
715 participants
Primary outcome timeframe
10 years
Results posted on
2014-10-13
Participant Flow
Enrollment: January 6, 1999-June 30, 2000 at multiple US sites
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
455
|
98
|
147
|
15
|
|
Overall Study
COMPLETED
|
280
|
46
|
74
|
8
|
|
Overall Study
NOT COMPLETED
|
175
|
52
|
73
|
7
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
123
|
13
|
37
|
1
|
|
Overall Study
Explanted of All Study Devices
|
36
|
25
|
29
|
3
|
|
Overall Study
Withdrawal by Subject
|
13
|
3
|
4
|
1
|
|
Overall Study
Death
|
1
|
10
|
2
|
2
|
|
Overall Study
Physician Decision
|
2
|
1
|
1
|
0
|
Baseline Characteristics
Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Baseline characteristics by cohort
| Measure |
Primary Augmentation
n=455 Participants
All women implanted for an indication of primary breast augmentation
|
Primary Reconstruction
n=98 Participants
All women implanted for an indication of primary breast reconstruction
|
Revision-augmentation
n=147 Participants
All women implanted for revision of a breast augmentation
|
Revision-reconstruction
n=15 Participants
All women implanted for revision of a breast reconstruction
|
Total
n=715 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=40 years
|
319 participants
n=93 Participants
|
10 participants
n=4 Participants
|
61 participants
n=27 Participants
|
0 participants
n=483 Participants
|
390 participants
n=36 Participants
|
|
Age, Customized
Between 40 and 60 years
|
136 participants
n=93 Participants
|
73 participants
n=4 Participants
|
84 participants
n=27 Participants
|
9 participants
n=483 Participants
|
302 participants
n=36 Participants
|
|
Age, Customized
>=60 years
|
0 participants
n=93 Participants
|
15 participants
n=4 Participants
|
2 participants
n=27 Participants
|
6 participants
n=483 Participants
|
23 participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
455 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
147 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
715 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: all enrolled patients
By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts
Outcome measures
| Measure |
Primary Augmentation
n=455 Participants
All women implanted for an indication of primary breast augmentation
|
Primary Reconstruction
n=98 Participants
All women implanted for an indication of primary breast reconstruction
|
Revision-augmentation
n=147 Participants
All women implanted for revision of a breast augmentation
|
Revision-reconstruction
n=15 Participants
All women implanted for revision of a breast reconstruction
|
|---|---|---|---|---|
|
Local Complications
Capsular Contracture
|
18.9 percentage by patient
Interval 15.4 to 23.1
|
24.6 percentage by patient
Interval 16.2 to 36.2
|
28.7 percentage by patient
Interval 21.3 to 37.9
|
6.7 percentage by patient
Interval 0.2 to 31.9
|
|
Local Complications
Breast Pain
|
11.5 percentage by patient
Interval 8.7 to 15.0
|
6.8 percentage by patient
Interval 2.8 to 16.1
|
11.7 percentage by patient
Interval 7.1 to 18.8
|
0 percentage by patient
Interval 0.0 to 0.0
|
|
Local Complications
Swelling
|
9.2 percentage by patient
Interval 6.8 to 12.4
|
7.1 percentage by patient
Interval 3.5 to 14.4
|
8.2 percentage by patient
Interval 4.6 to 14.5
|
0 percentage by patient
Interval 0.0 to 0.0
|
|
Local Complications
Nipple Complications
|
6.3 percentage by patient
Interval 4.3 to 9.1
|
3.3 percentage by patient
Interval 1.1 to 9.8
|
1.4 percentage by patient
Interval 0.3 to 5.4
|
0 percentage by patient
Interval 0.0 to 0.0
|
|
Local Complications
Hypertrophic/Other Abnormal Scarring
|
4.2 percentage by patient
Interval 2.6 to 6.5
|
5.5 percentage by patient
Interval 2.3 to 12.7
|
6.6 percentage by patient
Interval 3.5 to 12.3
|
0 percentage by patient
Interval 0.0 to 0.0
|
|
Local Complications
Asymmetry
|
3.3 percentage by patient
Interval 2.0 to 5.6
|
23.2 percentage by patient
Interval 15.4 to 33.9
|
6.5 percentage by patient
Interval 3.2 to 12.8
|
6.7 percentage by patient
Interval 0.2 to 31.9
|
|
Local Complications
Wrinkling
|
1.8 percentage by patient
Interval 0.8 to 3.7
|
10.2 percentage by patient
Interval 5.2 to 19.6
|
5.4 percentage by patient
Interval 2.6 to 11.0
|
0 percentage by patient
Interval 0.0 to 0.0
|
|
Local Complications
Implant Palpability/Visibility
|
1.6 percentage by patient
Interval 0.8 to 3.4
|
6.4 percentage by patient
Interval 2.3 to 12.7
|
6.0 percentage by patient
Interval 3.0 to 11.6
|
6.7 percentage by patient
Interval 0.2 to 31.9
|
|
Local Complications
Seroma/Fluid Accumulation
|
1.8 percentage by patient
Interval 0.9 to 3.4
|
2.3 percentage by patient
Interval 0.3 to 15.4
|
6.0 percentage by patient
Interval 3.0 to 11.6
|
6.7 percentage by patient
Interval 0.2 to 31.9
|
|
Local Complications
Implant Malposition
|
6.9 percentage by patient
Interval 4.8 to 9.7
|
2.3 percentage by patient
Interval 0.6 to 8.9
|
6.0 percentage by patient
Interval 3.1 to 11.7
|
13.3 percentage by patient
Interval 1.7 to 40.5
|
|
Local Complications
Bruising
|
0.4 percentage by patient
Interval 0.1 to 1.8
|
1.0 percentage by patient
Interval 0.1 to 7.1
|
3.0 percentage by patient
Interval 1.1 to 7.8
|
6.7 percentage by patient
Interval 0.2 to 31.9
|
|
Local Complications
Skin Rash
|
0.9 percentage by patient
Interval 0.3 to 2.3
|
2.0 percentage by patient
Interval 0.5 to 7.9
|
0.7 percentage by patient
Interval 0.1 to 4.9
|
6.7 percentage by patient
Interval 0.2 to 31.9
|
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 |
Primary Augmentation
n=279 Participants
All women implanted for an indication of primary breast augmentation
|
Primary Reconstruction
n=44 Participants
All women implanted for an indication of primary breast reconstruction
|
Revision-augmentation
n=74 Participants
All women implanted for revision of a breast augmentation
|
Revision-reconstruction
n=8 Participants
All women implanted for revision of a breast reconstruction
|
|---|---|---|---|---|
|
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
|
4.7 units on a scale
Standard Deviation 0.6
|
4.4 units on a scale
Standard Deviation 1.1
|
4.6 units on a scale
Standard Deviation 1.1
|
|
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 0.7
|
4.4 units on a scale
Standard Deviation 1.2
|
4.5 units on a scale
Standard Deviation 1.4
|
Adverse Events
Primary Augmentation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Primary 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 The timing of separate presentation or publication of the study by the PI is subject to mutual agreement in advance between the Sponsor and PI.
- Publication restrictions are in place
Restriction type: OTHER