Trial Outcomes & Findings for Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study (NCT NCT00905645)
NCT ID: NCT00905645
Last Updated: 2024-01-11
Results Overview
Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1788 participants
Primary outcome timeframe
10 Years
Results posted on
2024-01-11
Participant Flow
Participant milestones
| Measure |
Primary Augmentation
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Augmentation
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Primary Reconstruction
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Reconstruction
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1116
|
363
|
225
|
84
|
|
Overall Study
COMPLETED
|
688
|
192
|
118
|
32
|
|
Overall Study
NOT COMPLETED
|
428
|
171
|
107
|
52
|
Reasons for withdrawal
| Measure |
Primary Augmentation
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Augmentation
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Primary Reconstruction
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Reconstruction
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
|---|---|---|---|---|
|
Overall Study
Death (not device related)
|
10
|
4
|
15
|
8
|
|
Overall Study
Explantation of study device(s)
|
78
|
47
|
28
|
21
|
|
Overall Study
Subject Request
|
41
|
17
|
13
|
11
|
|
Overall Study
Lost to Follow-up
|
299
|
103
|
51
|
12
|
Baseline Characteristics
Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
Baseline characteristics by cohort
| Measure |
Primary Augmentation
n=1116 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Augmentation
n=363 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Primary Reconstruction
n=225 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Reconstruction
n=84 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Total
n=1788 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
≤18
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Age, Customized
18-21
|
47 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
0 participants
n=4 Participants
|
57 participants
n=21 Participants
|
|
Age, Customized
22-25
|
102 participants
n=5 Participants
|
12 participants
n=7 Participants
|
5 participants
n=5 Participants
|
0 participants
n=4 Participants
|
119 participants
n=21 Participants
|
|
Age, Customized
26-39
|
566 participants
n=5 Participants
|
128 participants
n=7 Participants
|
55 participants
n=5 Participants
|
8 participants
n=4 Participants
|
757 participants
n=21 Participants
|
|
Age, Customized
40-49
|
335 participants
n=5 Participants
|
139 participants
n=7 Participants
|
67 participants
n=5 Participants
|
26 participants
n=4 Participants
|
567 participants
n=21 Participants
|
|
Age, Customized
50-59
|
57 participants
n=5 Participants
|
63 participants
n=7 Participants
|
62 participants
n=5 Participants
|
29 participants
n=4 Participants
|
211 participants
n=21 Participants
|
|
Age, Customized
60-69
|
8 participants
n=5 Participants
|
18 participants
n=7 Participants
|
17 participants
n=5 Participants
|
14 participants
n=4 Participants
|
57 participants
n=21 Participants
|
|
Age, Customized
70 & over
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
10 participants
n=5 Participants
|
7 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1116 Participants
n=5 Participants
|
363 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
1788 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
|
|
Race/Ethnicity, Customized
Caucasian
|
1014 participants
n=5 Participants
|
338 participants
n=7 Participants
|
204 participants
n=5 Participants
|
80 participants
n=4 Participants
|
1636 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
37 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
1 participants
n=4 Participants
|
55 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
29 participants
n=5 Participants
|
8 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
38 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Indian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
22 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Provided
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1116 participants
n=5 Participants
|
363 participants
n=7 Participants
|
225 participants
n=5 Participants
|
84 participants
n=4 Participants
|
1788 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 10 YearsPopulation: All subjects are included.
Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.
Outcome measures
| Measure |
Primary Augmentation
n=1116 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Augmentation
n=363 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Primary Reconstruction
n=225 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Reconstruction
n=84 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
|---|---|---|---|---|
|
Local Complications
Breast Pain
|
12 Participants
|
7 Participants
|
8 Participants
|
2 Participants
|
|
Local Complications
Baker grade III/IV Capsular Contracture
|
120 Participants
|
39 Participants
|
27 Participants
|
9 Participants
|
|
Local Complications
Rupture
|
42 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
|
Local Complications
Explantation with or without replacement for either cosmetic, medical, or surgical reasons
|
151 Participants
|
79 Participants
|
73 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 10 YearsPopulation: All patients that completed the Patient Satisfaction survey at Year 10.
Assessment of the effectiveness of Study Implants based on patient satisfaction using a 5-point scale where 1=strongly agree to 5= strongly disagree. The patient satisfaction measures through 10 years provided in the table below are based on questionnaire responses of "Strongly Agree" and "Agree."
Outcome measures
| Measure |
Primary Augmentation
n=614 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Augmentation
n=176 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Primary Reconstruction
n=91 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Reconstruction
n=26 Participants
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
|---|---|---|---|---|
|
Satisfaction Determined by Patients
Patient thinks her breast implants make her look healthy.
|
414 Participants
|
110 Participants
|
58 Participants
|
20 Participants
|
|
Satisfaction Determined by Patients
Patient thinks her breast implants make her look normal.
|
444 Participants
|
121 Participants
|
68 Participants
|
22 Participants
|
|
Satisfaction Determined by Patients
Patient thinks her breast implants make her feel more feminine.
|
549 Participants
|
153 Participants
|
70 Participants
|
24 Participants
|
|
Satisfaction Determined by Patients
Patient thinks her breast implants make her feel more sensual.
|
504 Participants
|
141 Participants
|
57 Participants
|
17 Participants
|
|
Satisfaction Determined by Patients
Patient thinks her breast implants make her clothes feel better.
|
482 Participants
|
138 Participants
|
65 Participants
|
23 Participants
|
|
Satisfaction Determined by Patients
Patient thinks her breast implants make her feel more attractive.
|
525 Participants
|
145 Participants
|
64 Participants
|
21 Participants
|
|
Satisfaction Determined by Patients
Patient thinks her breast implants make her feel better about herself.
|
469 Participants
|
137 Participants
|
63 Participants
|
22 Participants
|
|
Satisfaction Determined by Patients
Patient thinks her breast implants improve her family life.
|
118 Participants
|
29 Participants
|
18 Participants
|
10 Participants
|
|
Satisfaction Determined by Patients
Patient thinks her breast implants improve her social life.
|
178 Participants
|
47 Participants
|
26 Participants
|
12 Participants
|
|
Satisfaction Determined by Patients
Patient thinks her breast implants improve her daily relations with husband or partner.
|
295 Participants
|
79 Participants
|
32 Participants
|
13 Participants
|
|
Satisfaction Determined by Patients
Patient thinks her breast implants improve her sex life.
|
319 Participants
|
85 Participants
|
31 Participants
|
9 Participants
|
Adverse Events
Primary Augmentation
Serious events: 0 serious events
Other events: 360 other events
Deaths: 10 deaths
Revision-Augmentation
Serious events: 0 serious events
Other events: 122 other events
Deaths: 4 deaths
Primary Reconstruction
Serious events: 0 serious events
Other events: 100 other events
Deaths: 15 deaths
Revision-Reconstruction
Serious events: 0 serious events
Other events: 45 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Primary Augmentation
n=1116 participants at risk
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Augmentation
n=363 participants at risk
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Primary Reconstruction
n=225 participants at risk
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
Revision-Reconstruction
n=84 participants at risk
Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant
|
|---|---|---|---|---|
|
Surgical and medical procedures
Asymmetry
|
1.7%
19/1116 • Baseline (Surgery) to 10 Years
|
2.5%
9/363 • Baseline (Surgery) to 10 Years
|
9.8%
22/225 • Baseline (Surgery) to 10 Years
|
13.1%
11/84 • Baseline (Surgery) to 10 Years
|
|
Skin and subcutaneous tissue disorders
Capsular Contracture(Baker Grade II)
|
11.8%
132/1116 • Baseline (Surgery) to 10 Years
|
11.3%
41/363 • Baseline (Surgery) to 10 Years
|
12.0%
27/225 • Baseline (Surgery) to 10 Years
|
19.0%
16/84 • Baseline (Surgery) to 10 Years
|
|
Skin and subcutaneous tissue disorders
Capsular Contracture (Baker Grade III/IV)
|
10.8%
120/1116 • Baseline (Surgery) to 10 Years
|
10.7%
39/363 • Baseline (Surgery) to 10 Years
|
12.0%
27/225 • Baseline (Surgery) to 10 Years
|
10.7%
9/84 • Baseline (Surgery) to 10 Years
|
|
Surgical and medical procedures
Implant Malposition
|
2.3%
26/1116 • Baseline (Surgery) to 10 Years
|
4.1%
15/363 • Baseline (Surgery) to 10 Years
|
4.0%
9/225 • Baseline (Surgery) to 10 Years
|
8.3%
7/84 • Baseline (Surgery) to 10 Years
|
|
Infections and infestations
Infection
|
0.81%
9/1116 • Baseline (Surgery) to 10 Years
|
1.4%
5/363 • Baseline (Surgery) to 10 Years
|
4.9%
11/225 • Baseline (Surgery) to 10 Years
|
1.2%
1/84 • Baseline (Surgery) to 10 Years
|
|
Skin and subcutaneous tissue disorders
Nipple Sensation Changes
|
4.8%
54/1116 • Baseline (Surgery) to 10 Years
|
3.6%
13/363 • Baseline (Surgery) to 10 Years
|
1.8%
4/225 • Baseline (Surgery) to 10 Years
|
1.2%
1/84 • Baseline (Surgery) to 10 Years
|
|
Surgical and medical procedures
Explantation with or without replacement
|
13.5%
151/1116 • Baseline (Surgery) to 10 Years
|
21.8%
79/363 • Baseline (Surgery) to 10 Years
|
32.4%
73/225 • Baseline (Surgery) to 10 Years
|
42.9%
36/84 • Baseline (Surgery) to 10 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place