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Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial (CPG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00812097
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Augmentation
Breast Reconstruction
Breast Revision
Intervention Device: Mentor Siltex® Contour Profile Gel Mammary Prosthesis
Enrollment 955
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 572 190 124 69
Completed 327 101 67 34
Not Completed 245 89 57 35
Reason Not Completed
Death             3             10             3             3
Withdrawal by Subject             14             12             8             2
Lost to Follow-up             90             14             17             5
Explantation of study device(s)             27             29             14             20
Unknown reasons and patient/doctor moves             111             24             15             5
Arm/Group Title Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction Total
Hide Arm/Group Description

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 572 190 124 69 955
Hide Baseline Analysis Population Description
All enrolled subjects are included.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 572 participants 190 participants 124 participants 69 participants 955 participants
35.9  (8.58) 47.6  (10.37) 45.4  (9.50) 53.2  (9.57) 40.7  (11.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 572 participants 190 participants 124 participants 69 participants 955 participants
Female
572
 100.0%
190
 100.0%
124
 100.0%
69
 100.0%
955
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 572 participants 190 participants 124 participants 69 participants 955 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
13
   2.3%
1
   0.5%
2
   1.6%
0
   0.0%
16
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   1.0%
9
   4.7%
0
   0.0%
1
   1.4%
16
   1.7%
White
518
  90.6%
178
  93.7%
119
  96.0%
66
  95.7%
881
  92.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
35
   6.1%
2
   1.1%
3
   2.4%
2
   2.9%
42
   4.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 572 participants 190 participants 124 participants 69 participants 955 participants
572 190 124 69 955
1.Primary Outcome
Title 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
Hide Description 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.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects are included.
Arm/Group Title Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 572 190 124 69
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
22.3
(19.0 to 26.0)
52.7
(45.5 to 60.2)
35.0
(27.0 to 44.7)
59.7
(48.0 to 71.8)
2.Primary Outcome
Title 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
Hide Description 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.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects are included.
Arm/Group Title Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 572 190 124 69
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
3.6
(2.3 to 5.7)
14.3
(9.6 to 21.1)
15.5
(9.8 to 24.1)
16.4
(9.1 to 28.5)
3.Primary Outcome
Title 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
Hide Description 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.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects are included.
Arm/Group Title Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 572 190 124 69
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
0.7
(0.3 to 1.9)
1.6
(0.5 to 5.0)
1.9
(0.5 to 7.4)
2.9
(0.7 to 11.3)
4.Primary Outcome
Title 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement
Hide Description 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.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects are included.
Arm/Group Title Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 572 190 124 69
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
9.2
(7.0 to 12.0)
34.1
(27.6 to 41.7)
25.9
(18.7 to 35.2)
49.0
(37.6 to 61.8)
5.Primary Outcome
Title Overall Mean Change in Circumferential Chest Size
Hide Description 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
Time Frame Change from baseline to 10 years post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects are included.
Arm/Group Title Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Hide Arm/Group Description:

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.

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.

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.

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 Number of Participants Analyzed 572 190 124 69
Mean (Standard Deviation)
Unit of Measure: inches
2.1  (1.69) 0.3  (2.03) 0.6  (1.85) 0.1  (1.33)
Time Frame Baseline (Surgery) to 10 Years
Adverse Event Reporting Description 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.
 
Arm/Group Title Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/572 (0.52%)   10/190 (5.26%)   3/124 (2.42%)   3/69 (4.35%) 
General disorders         
Death   3/572 (0.52%)  10/190 (5.26%)  3/124 (2.42%)  3/69 (4.35%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   91/572 (15.91%)   56/190 (29.47%)   20/124 (16.13%)   37/69 (53.62%) 
Skin and subcutaneous tissue disorders         
Baker III Capsular Contracture  [1]  18/572 (3.15%)  19/190 (10.00%)  10/124 (8.06%)  11/69 (15.94%) 
Baker IV Capsular Contracture  [1]  1/572 (0.17%)  4/190 (2.11%)  1/124 (0.81%)  5/69 (7.25%) 
Breast Sensation Changes  [1]  21/572 (3.67%)  2/190 (1.05%)  0/124 (0.00%)  4/69 (5.80%) 
Nipple Sensation Changes  [1]  30/572 (5.24%)  5/190 (2.63%)  0/124 (0.00%)  6/69 (8.70%) 
Position Dissatisfaction  [1]  12/572 (2.10%)  4/190 (2.11%)  5/124 (4.03%)  5/69 (7.25%) 
Ptosis  [1]  26/572 (4.55%)  4/190 (2.11%)  2/124 (1.61%)  10/69 (14.49%) 
Recurrent Breast Cancer  [1]  0/572 (0.00%)  10/190 (5.26%)  0/124 (0.00%)  0/69 (0.00%) 
Wrinkling  [1]  15/572 (2.62%)  9/190 (4.74%)  8/124 (6.45%)  8/69 (11.59%) 
Surgical and medical procedures         
Asymmetry  [1]  4/572 (0.70%)  19/190 (10.00%)  4/124 (3.23%)  3/69 (4.35%) 
Palpability-Implant  [1]  6/572 (1.05%)  2/190 (1.05%)  2/124 (1.61%)  5/69 (7.25%) 
Patient Dissatisfied With Aesthetic Appearance Of Breast  [1]  7/572 (1.22%)  0/190 (0.00%)  4/124 (3.23%)  5/69 (7.25%) 
Indicates events were collected by systematic assessment
[1]
Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Schwiers
Organization: Mentor
Phone: 513-337-1172
EMail: mschwier@its.jnj.com
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Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT00812097    
Other Study ID Numbers: A105-0601-4
First Submitted: December 17, 2008
First Posted: December 19, 2008
Results First Submitted: August 24, 2015
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016