Trial Outcomes & Findings for Mentor MemoryGel Post-Approval Study (NCT NCT00756652)
NCT ID: NCT00756652
Last Updated: 2020-06-04
Results Overview
The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.
COMPLETED
42491 participants
10 years
2020-06-04
Participant Flow
In January 2015, the FDA approved a protocol amendment that limited the scope of the study to the collection of only secondary procedure and reoperation data for the MemoryGel arm participants. No data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm.
Participant milestones
| Measure |
MemoryGel Breast Implant Participants
Subjects who received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery
|
Saline Breast Implant Control Participants
Subjects who received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery
|
|---|---|---|
|
Original Phase
STARTED
|
41452
|
1039
|
|
Original Phase
COMPLETED
|
6063
|
118
|
|
Original Phase
NOT COMPLETED
|
35389
|
921
|
|
Re-Op Phase
STARTED
|
11101
|
0
|
|
Re-Op Phase
COMPLETED
|
8225
|
0
|
|
Re-Op Phase
NOT COMPLETED
|
2876
|
0
|
Reasons for withdrawal
| Measure |
MemoryGel Breast Implant Participants
Subjects who received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery
|
Saline Breast Implant Control Participants
Subjects who received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery
|
|---|---|---|
|
Original Phase
Withdrawal by Subject
|
864
|
23
|
|
Original Phase
Lost to Follow-up
|
601
|
0
|
|
Original Phase
Other Discontinuation
|
797
|
5
|
|
Original Phase
Participant Noncompliance
|
18622
|
424
|
|
Original Phase
Unknown Discontinuation Reason
|
2
|
0
|
|
Original Phase
Participants without data
|
3259
|
466
|
|
Original Phase
Death
|
168
|
1
|
|
Original Phase
Not due for F/U at Phase One closure
|
11076
|
2
|
|
Re-Op Phase
Withdrawal by Subject
|
62
|
0
|
|
Re-Op Phase
Death
|
6
|
0
|
|
Re-Op Phase
Lost to Follow-up
|
340
|
0
|
|
Re-Op Phase
Site Closed
|
2454
|
0
|
|
Re-Op Phase
Withdrawn after explant
|
14
|
0
|
Baseline Characteristics
Mentor MemoryGel Post-Approval Study
Baseline characteristics by cohort
| Measure |
Original Phase - MemoryGel Participants
n=41452 Participants
Subjects implanted with MemoryGel breast implants
|
Original Phase - Saline Breast Implant Control Participants
n=1039 Participants
Subjects implanted with saline filled breast implants
|
Total
n=42491 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.3 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
32.1 Years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
40.1 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41452 Participants
n=5 Participants
|
1039 Participants
n=7 Participants
|
42491 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not of Hispanic origin
|
32216 Participants
n=5 Participants
|
575 Participants
n=7 Participants
|
32791 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, of Hispanic origin
|
4123 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
4385 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, not of Hispanic origin
|
891 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
919 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, of Hispanic origin
|
146 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, Asian American, Pacific Islander
|
1873 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
1947 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American or Alaskan Native
|
306 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1025 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
1069 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
872 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
909 Participants
n=5 Participants
|
|
Surgery Indication
Primary Augmentation
|
26173 Participants
n=5 Participants
|
937 Participants
n=7 Participants
|
27110 Participants
n=5 Participants
|
|
Surgery Indication
Revision Augmentation
|
8382 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
8457 Participants
n=5 Participants
|
|
Surgery Indication
Primary Reconstruction
|
5023 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
5038 Participants
n=5 Participants
|
|
Surgery Indication
Revision Reconstruction
|
1761 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1770 Participants
n=5 Participants
|
|
Surgery Indication
Unknown Indication
|
113 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: Per the FDA-approved protocol amendment, no data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm. The number of participants each year is based on participants with post-op follow-up in that year
The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.
Outcome measures
| Measure |
MemoryGel Participants
n=41452 Participants
Subjects who received MemoryGel breast implants
|
|---|---|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
0 Years
|
0.0 Cumulative Reoperation Events
Interval 0.0 to 0.0
|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
1 Year
|
6.7 Cumulative Reoperation Events
Interval 6.2 to 7.2
|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
2 Years
|
10.8 Cumulative Reoperation Events
Interval 10.1 to 11.4
|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
3 Years
|
11.2 Cumulative Reoperation Events
Interval 10.5 to 11.8
|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
4 Years
|
11.7 Cumulative Reoperation Events
Interval 11.0 to 12.4
|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
5 Years
|
12.5 Cumulative Reoperation Events
Interval 11.8 to 13.2
|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
6 Years
|
13.0 Cumulative Reoperation Events
Interval 12.3 to 13.8
|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
7 Years
|
13.2 Cumulative Reoperation Events
Interval 12.5 to 14.0
|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
8 Years
|
13.3 Cumulative Reoperation Events
Interval 12.6 to 14.1
|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
9 Years
|
13.6 Cumulative Reoperation Events
Interval 12.8 to 14.4
|
|
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
10 Years
|
13.7 Cumulative Reoperation Events
Interval 12.9 to 14.5
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: Per the FDA-approved protocol amendment, no data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm. The number of participants each year is based on participants with post-op follow-up in that year.
The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.
Outcome measures
| Measure |
MemoryGel Participants
n=41452 Participants
Subjects who received MemoryGel breast implants
|
|---|---|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
0 Years
|
0 Cumulative Explantation Events
Interval 0.0 to 0.0
|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
1 Year
|
3.0 Cumulative Explantation Events
Interval 2.7 to 3.4
|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
2 Years
|
5.0 Cumulative Explantation Events
Interval 4.6 to 5.5
|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
3 Years
|
5.2 Cumulative Explantation Events
Interval 4.7 to 5.7
|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
4 Years
|
5.5 Cumulative Explantation Events
Interval 5.0 to 6.1
|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
5 Years
|
6.0 Cumulative Explantation Events
Interval 5.4 to 6.5
|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
6 Years
|
6.4 Cumulative Explantation Events
Interval 5.8 to 6.9
|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
7 Years
|
6.5 Cumulative Explantation Events
Interval 6.0 to 7.1
|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
8 Years
|
6.6 Cumulative Explantation Events
Interval 6.1 to 7.2
|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
9 Years
|
6.8 Cumulative Explantation Events
Interval 6.2 to 7.4
|
|
Kaplan Meier Estimated Cumulative Incidence of Explantation
10 Years
|
6.9 Cumulative Explantation Events
Interval 6.3 to 7.6
|
SECONDARY outcome
Timeframe: 10 YearsPopulation: In January 2015, the FDA approved a protocol amendment that limited the scope of the study to the collection of only secondary procedure and reoperation data for the MemoryGel arm participants. No data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm.
Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years
Outcome measures
| Measure |
MemoryGel Participants
n=1141 Participants
Subjects who received MemoryGel breast implants
|
|---|---|
|
Reasons for Reoperations
Nipple - unacceptably low sensitivity
|
2 Reoperation events
|
|
Reasons for Reoperations
Ptosis
|
128 Reoperation events
|
|
Reasons for Reoperations
Asymmetry
|
465 Reoperation events
|
|
Reasons for Reoperations
Biopsy
|
17 Reoperation events
|
|
Reasons for Reoperations
Breast - unacceptably high sensation
|
2 Reoperation events
|
|
Reasons for Reoperations
Breast pain not associated with other complication
|
26 Reoperation events
|
|
Reasons for Reoperations
Calcification
|
1 Reoperation events
|
|
Reasons for Reoperations
Capsular Contracture (Baker Grade II)
|
238 Reoperation events
|
|
Reasons for Reoperations
Capsular Contracture (Baker Grade III)
|
423 Reoperation events
|
|
Reasons for Reoperations
Capsular Contracture (Baker Grade IV)
|
224 Reoperation events
|
|
Reasons for Reoperations
Capsule / Pocket tear
|
23 Reoperation events
|
|
Reasons for Reoperations
Delayed wound healing
|
37 Reoperation events
|
|
Reasons for Reoperations
Extrusion
|
90 Reoperation events
|
|
Reasons for Reoperations
Granuloma
|
2 Reoperation events
|
|
Reasons for Reoperations
Hematoma
|
128 Reoperation events
|
|
Reasons for Reoperations
Hypertrophic scarring
|
104 Reoperation events
|
|
Reasons for Reoperations
Implant removal
|
76 Reoperation events
|
|
Reasons for Reoperations
Infection
|
142 Reoperation events
|
|
Reasons for Reoperations
Irritation / Inflammation
|
12 Reoperation events
|
|
Reasons for Reoperations
Lack of projection
|
54 Reoperation events
|
|
Reasons for Reoperations
Necrosis
|
11 Reoperation events
|
|
Reasons for Reoperations
New diagnosis of breast cancer
|
17 Reoperation events
|
|
Reasons for Reoperations
New diagnosis of rheumatic disease
|
1 Reoperation events
|
|
Reasons for Reoperations
Nipple complications
|
25 Reoperation events
|
|
Reasons for Reoperations
Palpability - implant
|
9 Reoperation events
|
|
Reasons for Reoperations
Position change (dissatisfaction)
|
313 Reoperation events
|
|
Reasons for Reoperations
Rupture
|
41 Reoperation events
|
|
Reasons for Reoperations
Seroma
|
33 Reoperation events
|
|
Reasons for Reoperations
Size change - patient request
|
624 Reoperation events
|
|
Reasons for Reoperations
Size change - physician assessment only
|
37 Reoperation events
|
|
Reasons for Reoperations
Staged Reconstruction
|
7 Reoperation events
|
|
Reasons for Reoperations
Symmastia
|
26 Reoperation events
|
|
Reasons for Reoperations
Wrinkling
|
76 Reoperation events
|
|
Reasons for Reoperations
Unknown
|
513 Reoperation events
|
|
Reasons for Reoperations
Other
|
139 Reoperation events
|
Adverse Events
Overall Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place