Trial Outcomes & Findings for CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study) (NCT NCT01959880)
NCT ID: NCT01959880
Last Updated: 2016-11-11
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
1891 participants
Primary outcome timeframe
6 years
Results posted on
2016-11-11
Participant Flow
Participant milestones
| Measure |
Primary Augmentation
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
|
Revision Reconstruction
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1132
|
369
|
209
|
181
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1132
|
369
|
208
|
181
|
Reasons for withdrawal
| Measure |
Primary Augmentation
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
|
Revision Reconstruction
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
13
|
8
|
7
|
|
Overall Study
Death
|
1
|
10
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
95
|
18
|
15
|
8
|
|
Overall Study
Explantation w/o study device reimplant.
|
22
|
17
|
5
|
12
|
|
Overall Study
Study completed early-FDA approved
|
1003
|
311
|
179
|
152
|
Baseline Characteristics
CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
Baseline characteristics by cohort
| Measure |
Primary Augmentation
n=1132 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=369 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=209 Participants
Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
|
Revision Reconstruction
n=181 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
Total
n=1891 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 9.88 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 10.58 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 9.37 • n=4 Participants
|
40.7 years
STANDARD_DEVIATION 12.86 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1132 Participants
n=5 Participants
|
369 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
181 Participants
n=4 Participants
|
1891 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
|
58 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
68 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
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
986 Participants
n=5 Participants
|
334 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
1674 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
|
73 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1132 participants
n=5 Participants
|
369 participants
n=7 Participants
|
209 participants
n=5 Participants
|
181 participants
n=4 Participants
|
1891 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 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=1132 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=369 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=209 Participants
Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
|
Revision Reconstruction
n=181 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
|
8.3 percentage of subjects
Interval 6.6 to 10.5
|
31.7 percentage of subjects
Interval 25.5 to 39.1
|
13.8 percentage of subjects
Interval 8.6 to 21.6
|
31.3 percentage of subjects
Interval 23.8 to 40.4
|
PRIMARY outcome
Timeframe: 6 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=1132 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=369 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=209 Participants
Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
|
Revision Reconstruction
n=181 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
|
1.5 percentage of subjects
Interval 0.8 to 2.7
|
8.8 percentage of subjects
Interval 5.3 to 14.4
|
1.6 percentage of subjects
Interval 0.5 to 5.0
|
7.8 percentage of subjects
Interval 3.6 to 16.6
|
PRIMARY outcome
Timeframe: 6 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=1132 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=369 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=209 Participants
Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
|
Revision Reconstruction
n=181 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
|
1.0 percentage of subjects
Interval 0.6 to 1.8
|
2.4 percentage of subjects
Interval 1.2 to 4.8
|
1.0 percentage of subjects
Interval 0.2 to 3.8
|
2.3 percentage of subjects
Interval 0.9 to 6.0
|
PRIMARY outcome
Timeframe: 6 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=1132 Participants
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=369 Participants
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=209 Participants
Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
|
Revision Reconstruction
n=181 Participants
Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
|
|---|---|---|---|---|
|
6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement
|
5.0 percentage of subjects
Interval 3.5 to 7.1
|
20.2 percentage of subjects
Interval 14.6 to 27.5
|
8.6 percentage of subjects
Interval 4.5 to 16.2
|
16.5 percentage of subjects
Interval 10.9 to 24.6
|
Adverse Events
Primary Augmentation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Primary Reconstruction
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Revison Augmentation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Revision Reconstruction
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Augmentation
n=1132 participants at risk
The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
|
Primary Reconstruction
n=369 participants at risk
The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.
Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
|
Revison Augmentation
n=209 participants at risk
Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
|
Revision Reconstruction
n=181 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Death
|
0.09%
1/1132 • Baseline (Surgery) to 6 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. Complications are collected systematically using a pre-specified list of anticipated complications. No individual complications met the 5% threshold for reporting.
|
2.7%
10/369 • Baseline (Surgery) to 6 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. Complications are collected systematically using a pre-specified list of anticipated complications. No individual complications met the 5% threshold for reporting.
|
0.48%
1/209 • Baseline (Surgery) to 6 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. Complications are collected systematically using a pre-specified list of anticipated complications. No individual complications met the 5% threshold for reporting.
|
1.1%
2/181 • Baseline (Surgery) to 6 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. Complications are collected systematically using a pre-specified list of anticipated complications. No individual complications met the 5% threshold for reporting.
|
Other adverse events
Adverse event data not 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