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

• 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: Mentor Worldwide, LLC
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Primary Augmentation	Primary Reconstruction	Revision Augmentation	Revision Reconstruction
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

Baseline Characteristics

Arm/Group Title		Primary Augmentation	Primary Reconstruction	Revision Augmentation	Revision Reconstruction	Total
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
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

Outcome Measures

1. Primary Outcome

Title	10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
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

Outcome Measure Data

Analysis Population Description

All enrolled subjects are included.

Arm/Group Title	Primary Augmentation	Primary Reconstruction	Revision Augmentation	Revision Reconstruction
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
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

Outcome Measure Data

Analysis Population Description

All enrolled subjects are included.

Arm/Group Title	Primary Augmentation	Primary Reconstruction	Revision Augmentation	Revision Reconstruction
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
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

Outcome Measure Data

Analysis Population Description

All enrolled subjects are included.

Arm/Group Title	Primary Augmentation	Primary Reconstruction	Revision Augmentation	Revision Reconstruction
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
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

Outcome Measure Data

Analysis Population Description

All enrolled subjects are included.

Arm/Group Title	Primary Augmentation	Primary Reconstruction	Revision Augmentation	Revision Reconstruction
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
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

Outcome Measure Data

Analysis Population Description

All enrolled subjects are included.

Arm/Group Title	Primary Augmentation	Primary Reconstruction	Revision Augmentation	Revision Reconstruction
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)

Adverse Events

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
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	--/--	--/--	--/--	--/--
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
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.

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Michael Schwiers
• Organization: Mentor
• Phone: 513-337-1172
• EMail: mschwier@its.jnj.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Caplin DA. Indications for the use of MemoryShape breast implants in aesthetic and reconstructive breast surgery: long-term clinical outcomes of shaped versus round silicone breast implants. Plast Reconstr Surg. 2014 Sep;134(3 Suppl):27S-37S. doi: 10.1097/PRS.0000000000000609.

• 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