Trial Outcomes & Findings for Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses (NCT NCT00753922)
NCT ID: NCT00753922
Last Updated: 2014-04-16
Results Overview
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1008 participants
Primary outcome timeframe
10 years
Results posted on
2014-04-16
Participant Flow
Participant milestones
| Measure |
Primary Augmentation
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
Asymmetry is one or more of the following conditions:
* One cup size difference in breast size.
* The need to differentially pad one bra cup to match the opposite breast size.
* Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other.
|
Revision Augmentation
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
|
Revision Reconstruction
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
552
|
251
|
145
|
60
|
|
Overall Study
COMPLETED
|
306
|
157
|
82
|
37
|
|
Overall Study
NOT COMPLETED
|
246
|
94
|
63
|
23
|
Reasons for withdrawal
| Measure |
Primary Augmentation
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
Asymmetry is one or more of the following conditions:
* One cup size difference in breast size.
* The need to differentially pad one bra cup to match the opposite breast size.
* Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other.
|
Revision Augmentation
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
|
Revision Reconstruction
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
155
|
24
|
28
|
5
|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
4
|
2
|
|
Overall Study
Patient Non-compliance
|
55
|
22
|
14
|
11
|
|
Overall Study
Patients Not Completing Visit
|
11
|
0
|
1
|
0
|
|
Overall Study
Death
|
2
|
23
|
2
|
1
|
|
Overall Study
Discontinuation Due to Explantation
|
14
|
14
|
14
|
4
|
Baseline Characteristics
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
Baseline characteristics by cohort
| Measure |
Primary Augmentation
n=552 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=251 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
Asymmetry is one or more of the following conditions:
* One cup size difference in breast size.
* The need to differentially pad one bra cup to match the opposite breast size.
* Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other.
|
Revision Augmentation
n=145 Participants
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
|
Revision Reconstruction
n=60 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
Total
n=1008 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
551 Participants
n=93 Participants
|
245 Participants
n=4 Participants
|
145 Participants
n=27 Participants
|
54 Participants
n=483 Participants
|
995 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 8.09 • n=93 Participants
|
45.3 years
STANDARD_DEVIATION 10.87 • n=4 Participants
|
41.8 years
STANDARD_DEVIATION 9.66 • n=27 Participants
|
50.8 years
STANDARD_DEVIATION 10.82 • n=483 Participants
|
39.2 years
STANDARD_DEVIATION 10.74 • n=36 Participants
|
|
Sex: Female, Male
Female
|
552 Participants
n=93 Participants
|
251 Participants
n=4 Participants
|
145 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
1008 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
|
|
Region of Enrollment
United States
|
552 participants
n=93 Participants
|
251 participants
n=4 Participants
|
145 participants
n=27 Participants
|
60 participants
n=483 Participants
|
1008 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: All enrolled subjects are included
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Outcome measures
| Measure |
Primary Augmentation
n=552 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=251 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=145 Participants
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
|
Revision Reconstruction
n=60 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
|
25.5 percentage of subjects
Interval 21.9 to 29.5
|
49.0 percentage of subjects
Interval 42.6 to 55.7
|
43.6 percentage of subjects
Interval 35.8 to 52.4
|
50.7 percentage of subjects
Interval 38.7 to 64.0
|
PRIMARY outcome
Timeframe: Change from baseline to 10 years post-baselinePopulation: All enrolled subjects
Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study
Outcome measures
| Measure |
Primary Augmentation
n=552 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=251 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=145 Participants
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
|
Revision Reconstruction
n=60 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
Overall Mean Change in Circumferential Chest Size
|
7.45 centimeters
Standard Deviation 4.50
|
4.88 centimeters
Standard Deviation 7.25
|
2.89 centimeters
Standard Deviation 4.56
|
4.18 centimeters
Standard Deviation 5.68
|
PRIMARY outcome
Timeframe: 10 YearsPopulation: All enrolled subjects
Baker III was identified as "firm with visible distortion" and Baker IV was identified as "obvious spherical distortion". Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Outcome measures
| Measure |
Primary Augmentation
n=552 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=251 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=145 Participants
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
|
Revision Reconstruction
n=60 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
|
12.1 percentage of subjects
Interval 9.6 to 15.2
|
20.5 percentage of subjects
Interval 15.5 to 26.7
|
24.4 percentage of subjects
Interval 18.1 to 32.5
|
36.9 percentage of subjects
Interval 25.0 to 52.2
|
PRIMARY outcome
Timeframe: 10 YearsPopulation: All enrolled subjects
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Outcome measures
| Measure |
Primary Augmentation
n=552 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=251 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=145 Participants
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
|
Revision Reconstruction
n=60 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
|
1.6 percentage of subjects
Interval 0.9 to 3.1
|
6.2 percentage of subjects
Interval 3.8 to 10.1
|
1.4 percentage of subjects
Interval 0.4 to 5.5
|
0.0 percentage of subjects
Since there were no Infections observed in this arm, the 95% Confidence is not estimable under the Kaplan-Meier framework.
|
PRIMARY outcome
Timeframe: 10 YearsPopulation: All enrolled subjects
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Outcome measures
| Measure |
Primary Augmentation
n=552 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=251 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=145 Participants
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
|
Revision Reconstruction
n=60 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement
|
11.6 percentage of subjects
Interval 9.1 to 14.8
|
33.4 percentage of subjects
Interval 27.6 to 40.1
|
24.1 percentage of subjects
Interval 17.7 to 32.3
|
37.8 percentage of subjects
Interval 26.7 to 51.7
|
POST_HOC outcome
Timeframe: 10 yearsPopulation: All Enrolled Subjects
The safety analyses were conducted in accordance with the FDA November 17, 2006 "Guidance for Industry and FDA Staff - Saline, Silicone Gel, and Alternative Breast Implants." The study investigator assessed any complications durign study follow-up visits in alignment with this guidance. Time of occurrence was calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. Complications with an incidence \> 5.0% are reported.
Outcome measures
| Measure |
Primary Augmentation
n=552 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=251 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=145 Participants
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
|
Revision Reconstruction
n=60 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications
Breast Mass
|
5.6 percentage of subjects
Interval 3.9 to 7.9
|
8.6 percentage of subjects
Interval 5.5 to 13.4
|
6.0 percentage of subjects
Interval 3.0 to 11.6
|
5.1 percentage of subjects
Interval 1.7 to 15.1
|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications
Breast Pain
|
2.9 percentage of subjects
Interval 1.8 to 4.8
|
5.2 percentage of subjects
Interval 2.9 to 9.2
|
3.2 percentage of subjects
Interval 1.2 to 8.2
|
5.2 percentage of subjects
Interval 1.7 to 15.2
|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications
Metastatic Disease
|
0 percentage of subjects
Interval 0.0 to 0.0
|
6.9 percentage of subjects
Interval 4.2 to 11.2
|
0 percentage of subjects
Interval 0.0 to 0.0
|
3.8 percentage of subjects
Interval 1.0 to 14.6
|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications
Nipple Sensation Changes
|
12.8 percentage of subjects
Interval 10.2 to 16.0
|
2.1 percentage of subjects
Interval 0.9 to 5.0
|
13.6 percentage of subjects
Interval 8.9 to 20.4
|
4.0 percentage of subjects
Interval 1.0 to 15.2
|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications
Implant Malposition/Displacement
|
1.0 percentage of subjects
Interval 0.4 to 2.5
|
2.3 percentage of subjects
Interval 1.0 to 5.5
|
2.3 percentage of subjects
Interval 0.7 to 7.0
|
6.7 percentage of subjects
Interval 2.6 to 16.9
|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications
Lack of Projection
|
0 percentage of subjects
Interval 0.0 to 0.0
|
1.0 percentage of subjects
Interval 0.3 to 4.2
|
0 percentage of subjects
Interval 0.0 to 0.0
|
5.5 percentage of subjects
Interval 1.8 to 16.3
|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications
Patient Dissatisfaction
|
0.4 percentage of subjects
Interval 0.1 to 1.5
|
4.8 percentage of subjects
Interval 2.5 to 9.2
|
3.6 percentage of subjects
Interval 1.5 to 8.5
|
9.0 percentage of subjects
Interval 3.4 to 23.0
|
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
Revison 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 Sponsor acknowledges that the Investigator and his/her collaborators shall be free to publish the background, methods and results of their own research without restraint. Prior review of any proposed manuscript or abstract will be provided to Sponsor to prevent premature disclosure of trade secrets or proprietary information. The Investigator acknowledges that the Sponsor reserves the right to publish and present the overall study results, including assigning authorship.
- Publication restrictions are in place
Restriction type: OTHER