MGPAS: Mentor MemoryGel Post-Approval Study
Study Details
Study Description
Brief Summary
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
MemoryGel Breast Implant Participants MemoryGel Breast Implant Participants received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery |
Device: Mentor Silicone Gel-Filled Breast Implants
Other Names:
|
Saline Breast Implant Control Participants Saline Breast Implant Control Participants received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery |
Device: Saline Breast Implants
|
Outcome Measures
Primary Outcome Measures
- Kaplan Meier Estimated Cumulative Incidence of Reported Complications [10 years]
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.
- Kaplan Meier Estimated Cumulative Incidence of Explantation [10 years]
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.
Secondary Outcome Measures
- Reasons for Reoperations [10 Years]
Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female, age 18 years or older (22 or older for breast augmentation patients)
-
U.S. resident
Exclusion Criteria:
-
If a saline participant, current or past, unilateral or bilateral, silicone breast implants
-
Active infection anywhere in her body
-
Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
-
Currently pregnant or nursing
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mentor Worldwide, LLC
Investigators
- Study Director: John Canady, M.D., Mentor Worldwide, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.- P030053
- NCT00495534
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 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. |
Arm/Group Title | MemoryGel Breast Implant Participants | Saline Breast Implant Control Participants |
---|---|---|
Arm/Group Description | Subjects who received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery | Subjects who received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery |
Period Title: Original Phase | ||
STARTED | 41452 | 1039 |
COMPLETED | 6063 | 118 |
NOT COMPLETED | 35389 | 921 |
Period Title: Original Phase | ||
STARTED | 11101 | 0 |
COMPLETED | 8225 | 0 |
NOT COMPLETED | 2876 | 0 |
Baseline Characteristics
Arm/Group Title | Original Phase - MemoryGel Participants | Original Phase - Saline Breast Implant Control Participants | Total |
---|---|---|---|
Arm/Group Description | Subjects implanted with MemoryGel breast implants | Subjects implanted with saline filled breast implants | Total of all reporting groups |
Overall Participants | 41452 | 1039 | 42491 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
40.3
(11.4)
|
32.1
(9.9)
|
40.1
(11.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
41452
100%
|
1039
100%
|
42491
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Number) [Number] | |||
White, not of Hispanic origin |
32216
77.7%
|
575
55.3%
|
32791
77.2%
|
White, of Hispanic origin |
4123
9.9%
|
262
25.2%
|
4385
10.3%
|
Black, not of Hispanic origin |
891
2.1%
|
28
2.7%
|
919
2.2%
|
Black, of Hispanic origin |
146
0.4%
|
11
1.1%
|
157
0.4%
|
Asian, Asian American, Pacific Islander |
1873
4.5%
|
74
7.1%
|
1947
4.6%
|
Native American or Alaskan Native |
306
0.7%
|
8
0.8%
|
314
0.7%
|
Other |
1025
2.5%
|
44
4.2%
|
1069
2.5%
|
Missing |
872
2.1%
|
37
3.6%
|
909
2.1%
|
Surgery Indication (Number) [Number] | |||
Primary Augmentation |
26173
63.1%
|
937
90.2%
|
27110
63.8%
|
Revision Augmentation |
8382
20.2%
|
75
7.2%
|
8457
19.9%
|
Primary Reconstruction |
5023
12.1%
|
15
1.4%
|
5038
11.9%
|
Revision Reconstruction |
1761
4.2%
|
9
0.9%
|
1770
4.2%
|
Unknown Indication |
113
0.3%
|
3
0.3%
|
116
0.3%
|
Outcome Measures
Title | Kaplan Meier Estimated Cumulative Incidence of Reported Complications |
---|---|
Description | 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. |
Time Frame | 10 years |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | MemoryGel Participants |
---|---|
Arm/Group Description | Subjects who received MemoryGel breast implants |
Measure Participants | 41452 |
0 Years |
0.0
|
1 Year |
6.7
|
2 Years |
10.8
|
3 Years |
11.2
|
4 Years |
11.7
|
5 Years |
12.5
|
6 Years |
13.0
|
7 Years |
13.2
|
8 Years |
13.3
|
9 Years |
13.6
|
10 Years |
13.7
|
Title | Kaplan Meier Estimated Cumulative Incidence of Explantation |
---|---|
Description | 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. |
Time Frame | 10 years |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | MemoryGel Participants |
---|---|
Arm/Group Description | Subjects who received MemoryGel breast implants |
Measure Participants | 41452 |
0 Years |
0
|
1 Year |
3.0
|
2 Years |
5.0
|
3 Years |
5.2
|
4 Years |
5.5
|
5 Years |
6.0
|
6 Years |
6.4
|
7 Years |
6.5
|
8 Years |
6.6
|
9 Years |
6.8
|
10 Years |
6.9
|
Title | Reasons for Reoperations |
---|---|
Description | Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years |
Time Frame | 10 Years |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | MemoryGel Participants |
---|---|
Arm/Group Description | Subjects who received MemoryGel breast implants |
Measure Participants | 1141 |
Asymmetry |
465
|
Biopsy |
17
|
Breast - unacceptably high sensation |
2
|
Breast pain not associated with other complication |
26
|
Calcification |
1
|
Capsular Contracture (Baker Grade II) |
238
|
Capsular Contracture (Baker Grade III) |
423
|
Capsular Contracture (Baker Grade IV) |
224
|
Capsule / Pocket tear |
23
|
Delayed wound healing |
37
|
Extrusion |
90
|
Granuloma |
2
|
Hematoma |
128
|
Hypertrophic scarring |
104
|
Implant removal |
76
|
Infection |
142
|
Irritation / Inflammation |
12
|
Lack of projection |
54
|
Necrosis |
11
|
New diagnosis of breast cancer |
17
|
New diagnosis of rheumatic disease |
1
|
Nipple - unacceptably low sensitivity |
2
|
Nipple complications |
25
|
Palpability - implant |
9
|
Position change (dissatisfaction) |
313
|
Ptosis |
128
|
Rupture |
41
|
Seroma |
33
|
Size change - patient request |
624
|
Size change - physician assessment only |
37
|
Staged Reconstruction |
7
|
Symmastia |
26
|
Wrinkling |
76
|
Unknown |
513
|
Other |
139
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | In the Original study, follow-up data were to be collected by survey in years 1-10. Surgeons were also to see MemoryGel participants in years 1, 4-6, and 9-10. All local complications, reasons for reoperation, and reasons for removal reported by the participant or surgeon were to be recorded. In 2015 FDA approved a redesign of the study whereby data collection was limited to only reoperation data for MemoryGel participants and the reasons for reoperation. These are presented as Outcome Measures. | |
Arm/Group Title | Overall Study | |
Arm/Group Description | Subjects in either the MemoryGel group or the saline breast implant control group | |
All Cause Mortality |
||
Overall Study | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | |
Serious Adverse Events |
||
Overall Study | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
Overall Study | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title | Sponsor |
---|---|
Organization | Mentor Worldwide, LLC |
Phone | 949-453-6408 |
mgpas@its.jnj.com |
- P030053
- NCT00495534