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Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses

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ClinicalTrials.gov Identifier: NCT00753922
Recruitment Status : Completed
First Posted : September 17, 2008
Results First Posted : August 23, 2013
Last Update Posted : April 16, 2014
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 Reconstruction
Breast Augmentation
Breast Revision
Intervention Device: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
Enrollment 1008
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction
Hide Arm/Group Description The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.

The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.

Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.

Asymmetry is one or more of the following conditions:

  • One cup size difference in breast size.
  • The need to differentially pad one bra cup to match the opposite breast size.
  • Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other.
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants. Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
Period Title: Overall Study
Started 552 251 145 60
Completed 306 157 82 37
Not Completed 246 94 63 23
Reason Not Completed
Lost to Follow-up             155             24             28             5
Withdrawal by Subject             9             11             4             2
Patient Non-compliance             55             22             14             11
Patients Not Completing Visit             11             0             1             0
Death             2             23             2             1
Discontinuation Due to Explantation             14             14             14             4
Arm/Group Title Primary Augmentation Primary Reconstruction Revision Augmentation Revision Reconstruction Total
Hide Arm/Group Description The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.

The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.

Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.

Asymmetry is one or more of the following conditions:

  • One cup size difference in breast size.
  • The need to differentially pad one bra cup to match the opposite breast size.
  • Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other.
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants. Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery. Total of all reporting groups
Overall Number of Baseline Participants 552 251 145 60 1008
Hide Baseline Analysis Population Description
All enrolled subjects are included
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 552 participants 251 participants 145 participants 60 participants 1008 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
551
  99.8%
245
  97.6%
145
 100.0%
54
  90.0%
995
  98.7%
>=65 years
1
   0.2%
6
   2.4%
0
   0.0%
6
  10.0%
13
   1.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 552 participants 251 participants 145 participants 60 participants 1008 participants
34.5  (8.09) 45.3  (10.87) 41.8  (9.66) 50.8  (10.82) 39.2  (10.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 552 participants 251 participants 145 participants 60 participants 1008 participants
Female
552
 100.0%
251
 100.0%
145
 100.0%
60
 100.0%
1008
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 552 participants 251 participants 145 participants 60 participants 1008 participants
552 251 145 60 1008
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 Revison Augmentation Revision Reconstruction
Hide Arm/Group Description:
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.

The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.

Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.

Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
Overall Number of Participants Analyzed 552 251 145 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
25.5
(21.9 to 29.5)
49.0
(42.6 to 55.7)
43.6
(35.8 to 52.4)
50.7
(38.7 to 64.0)
2.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
Arm/Group Title Primary Augmentation Primary Reconstruction Revison Augmentation Revision Reconstruction
Hide Arm/Group Description:
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.

The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.

Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.

Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
Overall Number of Participants Analyzed 552 251 145 60
Mean (Standard Deviation)
Unit of Measure: centimeters
7.45  (4.50) 4.88  (7.25) 2.89  (4.56) 4.18  (5.68)
3.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
Arm/Group Title Primary Augmentation Primary Reconstruction Revison Augmentation Revision Reconstruction
Hide Arm/Group Description:
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.

The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.

Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.

Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
Overall Number of Participants Analyzed 552 251 145 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
12.1
(9.6 to 15.2)
20.5
(15.5 to 26.7)
24.4
(18.1 to 32.5)
36.9
(25.0 to 52.2)
4.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
Arm/Group Title Primary Augmentation Primary Reconstruction Revison Augmentation Revision Reconstruction
Hide Arm/Group Description:
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.

The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.

Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.

Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
Overall Number of Participants Analyzed 552 251 145 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
1.6
(0.9 to 3.1)
6.2
(3.8 to 10.1)
1.4
(0.4 to 5.5)
0.0 [1] 
(NA to NA)
[1]
Since there were no Infections observed in this arm, the 95% Confidence is not estimable under the Kaplan-Meier framework.
5.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
Arm/Group Title Primary Augmentation Primary Reconstruction Revison Augmentation Revision Reconstruction
Hide Arm/Group Description:
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.

The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.

Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.

Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
Overall Number of Participants Analyzed 552 251 145 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
11.6
(9.1 to 14.8)
33.4
(27.6 to 40.1)
24.1
(17.7 to 32.3)
37.8
(26.7 to 51.7)
6.Post-Hoc Outcome
Title 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications
Hide Description The safety analyses were conducted in accordance with the FDA November 17, 2006 “Guidance for Industry and FDA Staff – Saline, Silicone Gel, and Alternative Breast Implants.” The study investigator assessed any complications durign study follow-up visits in alignment with this guidance. Time of occurrence was calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. Complications with an incidence > 5.0% are reported.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Enrolled Subjects
Arm/Group Title Primary Augmentation Primary Reconstruction Revison Augmentation Revision Reconstruction
Hide Arm/Group Description:
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.

The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.

Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.

Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
Overall Number of Participants Analyzed 552 251 145 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Breast Mass
5.6
(3.9 to 7.9)
8.6
(5.5 to 13.4)
6.0
(3.0 to 11.6)
5.1
(1.7 to 15.1)
Breast Pain
2.9
(1.8 to 4.8)
5.2
(2.9 to 9.2)
3.2
(1.2 to 8.2)
5.2
(1.7 to 15.2)
Metastatic Disease
0
(0 to 0)
6.9
(4.2 to 11.2)
0
(0 to 0)
3.8
(1.0 to 14.6)
Nipple Sensation Changes
12.8
(10.2 to 16.0)
2.1
(0.9 to 5.0)
13.6
(8.9 to 20.4)
4.0
(1.0 to 15.2)
Implant Malposition/Displacement
1.0
(0.4 to 2.5)
2.3
(1.0 to 5.5)
2.3
(0.7 to 7.0)
6.7
(2.6 to 16.9)
Lack of Projection
0
(0 to 0)
1.0
(0.3 to 4.2)
0
(0 to 0)
5.5
(1.8 to 16.3)
Patient Dissatisfaction
0.4
(0.1 to 1.5)
4.8
(2.5 to 9.2)
3.6
(1.5 to 8.5)
9.0
(3.4 to 23.0)
Time Frame Baseline to 10 Years.
Adverse Event Reporting Description Adverse events were not coded according to the MedDRA dictionary, rather they were collected as Complications in alignment with the 2006 FDA Guidance. Safety endpoints are summarized under Primary, Secondary, and Post-Hoc Outcome Measures. All complications with a frequency above 5% are reported in the Outcome Measures section.
 
Arm/Group Title Primary Augmentation Primary Reconstruction Revison Augmentation Revision Reconstruction
Hide Arm/Group Description The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.

The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.

Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.

Asymmetry is one or more of the following conditions:

  • One cup size difference in breast size.
  • The need to differentially pad one bra cup to match the opposite breast size.
  • Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other.
Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants. Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
All-Cause Mortality
Primary Augmentation Primary Reconstruction Revison Augmentation Revision Reconstruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Primary Augmentation Primary Reconstruction Revison Augmentation Revision Reconstruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/552 (0.00%)   0/251 (0.00%)   0/145 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Primary Augmentation Primary Reconstruction Revison Augmentation Revision Reconstruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/552 (0.00%)   0/251 (0.00%)   0/145 (0.00%)   0/60 (0.00%) 
Adverse events were not coded according to the MedDRA dictionary, rather they were collected as Complications in alignment with the 2006 FDA Guidance for Industry and FDA Staff – Saline, Silicone Gel, and Alternative Breast Implants.
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.
Sponsor acknowledges that the Investigator and his/her collaborators shall be free to publish the background, methods and results of their own research without restraint. Prior review of any proposed manuscript or abstract will be provided to Sponsor to prevent premature disclosure of trade secrets or proprietary information. The Investigator acknowledges that the Sponsor reserves the right to publish and present the overall study results, including assigning authorship.
Results Point of Contact
Name/Title: Michael L. Schwiers
Organization: Ethicon Endo-Surgery
Phone: 513-337-1172
Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT00753922     History of Changes
Other Study ID Numbers: 10-009-0799-01
First Submitted: September 15, 2008
First Posted: September 17, 2008
Results First Submitted: June 12, 2013
Results First Posted: August 23, 2013
Last Update Posted: April 16, 2014