Trial Outcomes & Findings for Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial (NCT NCT00812097)
NCT ID: NCT00812097
Last Updated: 2016-04-05
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
955 participants
Primary outcome timeframe
10 years
Results posted on
2016-04-05
Participant Flow
Participant milestones
| Measure |
Primary Augmentation
The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Primary Reconstruction
The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Augmentation
The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Reconstruction
The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
572
|
190
|
124
|
69
|
|
Overall Study
COMPLETED
|
327
|
101
|
67
|
34
|
|
Overall Study
NOT COMPLETED
|
245
|
89
|
57
|
35
|
Reasons for withdrawal
| Measure |
Primary Augmentation
The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Primary Reconstruction
The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Augmentation
The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Reconstruction
The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
|---|---|---|---|---|
|
Overall Study
Death
|
3
|
10
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
14
|
12
|
8
|
2
|
|
Overall Study
Lost to Follow-up
|
90
|
14
|
17
|
5
|
|
Overall Study
Explantation of study device(s)
|
27
|
29
|
14
|
20
|
|
Overall Study
Unknown reasons and patient/doctor moves
|
111
|
24
|
15
|
5
|
Baseline Characteristics
Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
Baseline characteristics by cohort
| Measure |
Primary Augmentation
n=572 Participants
The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Primary Reconstruction
n=190 Participants
The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Augmentation
n=124 Participants
The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Reconstruction
n=69 Participants
The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Total
n=955 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 8.58 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 10.37 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 9.57 • n=4 Participants
|
40.7 years
STANDARD_DEVIATION 11.00 • n=21 Participants
|
|
Sex: Female, Male
Female
|
572 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
955 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 (NIH/OMB)
American Indian or Alaska Native
|
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 (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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 (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
518 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
881 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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 (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
572 participants
n=5 Participants
|
190 participants
n=7 Participants
|
124 participants
n=5 Participants
|
69 participants
n=4 Participants
|
955 participants
n=21 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=572 Participants
The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Primary Reconstruction
n=190 Participants
The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Augmentation
n=124 Participants
The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Reconstruction
n=69 Participants
The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
|---|---|---|---|---|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
|
22.3 percentage of subjects
Interval 19.0 to 26.0
|
52.7 percentage of subjects
Interval 45.5 to 60.2
|
35.0 percentage of subjects
Interval 27.0 to 44.7
|
59.7 percentage of subjects
Interval 48.0 to 71.8
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: All enrolled subjects are included.
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=572 Participants
The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Primary Reconstruction
n=190 Participants
The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Augmentation
n=124 Participants
The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Reconstruction
n=69 Participants
The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
|---|---|---|---|---|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
|
3.6 percentage of subjects
Interval 2.3 to 5.7
|
14.3 percentage of subjects
Interval 9.6 to 21.1
|
15.5 percentage of subjects
Interval 9.8 to 24.1
|
16.4 percentage of subjects
Interval 9.1 to 28.5
|
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=572 Participants
The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Primary Reconstruction
n=190 Participants
The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Augmentation
n=124 Participants
The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Reconstruction
n=69 Participants
The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
|---|---|---|---|---|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
|
0.7 percentage of subjects
Interval 0.3 to 1.9
|
1.6 percentage of subjects
Interval 0.5 to 5.0
|
1.9 percentage of subjects
Interval 0.5 to 7.4
|
2.9 percentage of subjects
Interval 0.7 to 11.3
|
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=572 Participants
The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Primary Reconstruction
n=190 Participants
The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Augmentation
n=124 Participants
The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Reconstruction
n=69 Participants
The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
|---|---|---|---|---|
|
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement
|
9.2 percentage of subjects
Interval 7.0 to 12.0
|
34.1 percentage of subjects
Interval 27.6 to 41.7
|
25.9 percentage of subjects
Interval 18.7 to 35.2
|
49.0 percentage of subjects
Interval 37.6 to 61.8
|
PRIMARY outcome
Timeframe: Change from baseline to 10 years post-baselinePopulation: All enrolled subjects are included.
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=572 Participants
The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Primary Reconstruction
n=190 Participants
The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Augmentation
n=124 Participants
The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Reconstruction
n=69 Participants
The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
|---|---|---|---|---|
|
Overall Mean Change in Circumferential Chest Size
|
2.1 inches
Standard Deviation 1.69
|
0.3 inches
Standard Deviation 2.03
|
0.6 inches
Standard Deviation 1.85
|
0.1 inches
Standard Deviation 1.33
|
Adverse Events
Primary Augmentation
Serious events: 3 serious events
Other events: 91 other events
Deaths: 0 deaths
Primary Reconstruction
Serious events: 10 serious events
Other events: 56 other events
Deaths: 0 deaths
Revision Augmentation
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Revision Reconstruction
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Augmentation
n=572 participants at risk
The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Primary Reconstruction
n=190 participants at risk
The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Augmentation
n=124 participants at risk
The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Reconstruction
n=69 participants at risk
The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
|---|---|---|---|---|
|
General disorders
Death
|
0.52%
3/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
5.3%
10/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
2.4%
3/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
4.3%
3/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
Other adverse events
| Measure |
Primary Augmentation
n=572 participants at risk
The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Primary Reconstruction
n=190 participants at risk
The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants .
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Augmentation
n=124 participants at risk
The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
Revision Reconstruction
n=69 participants at risk
The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel \[CPG\]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Asymmetry
|
0.70%
4/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
10.0%
19/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
3.2%
4/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
4.3%
3/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
|
Skin and subcutaneous tissue disorders
Baker III Capsular Contracture
|
3.1%
18/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
10.0%
19/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
8.1%
10/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
15.9%
11/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
|
Skin and subcutaneous tissue disorders
Baker IV Capsular Contracture
|
0.17%
1/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
2.1%
4/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
0.81%
1/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
7.2%
5/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
|
Skin and subcutaneous tissue disorders
Breast Sensation Changes
|
3.7%
21/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
1.1%
2/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
0.00%
0/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
5.8%
4/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
|
Skin and subcutaneous tissue disorders
Nipple Sensation Changes
|
5.2%
30/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
2.6%
5/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
0.00%
0/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
8.7%
6/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
|
Surgical and medical procedures
Palpability-Implant
|
1.0%
6/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
1.1%
2/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
1.6%
2/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
7.2%
5/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
|
Surgical and medical procedures
Patient Dissatisfied With Aesthetic Appearance Of Breast
|
1.2%
7/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
0.00%
0/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
3.2%
4/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
7.2%
5/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
|
Skin and subcutaneous tissue disorders
Position Dissatisfaction
|
2.1%
12/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
2.1%
4/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
4.0%
5/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
7.2%
5/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
|
Skin and subcutaneous tissue disorders
Ptosis
|
4.5%
26/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
2.1%
4/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
1.6%
2/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
14.5%
10/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
|
Skin and subcutaneous tissue disorders
Recurrent Breast Cancer
|
0.00%
0/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
5.3%
10/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
0.00%
0/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
0.00%
0/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
|
Skin and subcutaneous tissue disorders
Wrinkling
|
2.6%
15/572 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
4.7%
9/190 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
6.5%
8/124 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
11.6%
8/69 • Baseline (Surgery) to 10 Years
Adverse events were collected as Complications in alignment with 2006 FDA Guidance. Consistent with this document, complications are not classified as serious or non-serious. Key safety endpoints are summarized under Outcome Measures. All complications above 5% are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator and his/her collaborators are 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 the sponsor to prevent premature disclosure of trade secrets or proprietary information. The review will occur 30 days prior to submission of manuscript or abstract for consideration of publication or to a conference. Sponsor reserves right to publish or present the overall study results.
- Publication restrictions are in place
Restriction type: OTHER