Breast Augmentation, Breast Reconstruction, Breast Revision
Conditions
Keywords
Breast Reconstruction, Breast Augmentation, Revision, Silicone breast implants, Round low-bleed
Brief summary
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. Approximately 1000 patients at centers across the United States will be enrolled in this research study. These patients will be implanted with silicone breast prostheses and monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.
Detailed description
Silicone gel-filled breast implants were introduced in the early sixties and were in wide-scale distribution by the time the Medical Device Amendments to the Food Drug and Cosmetic Act was passed in 1976. In 1983, gel-filled breast implants were designated as Class III devices requiring premarket approval. In May 1990, the Food and Drug Administration (FDA) published a proposed request (515(b)) for Premarket Approval Applications (PMA) and in April 1991 published the final request. This final publication put manufacturers of gel-filled breast implants on notice that for continued marketing of gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date. A premarket approval (PMA) for the Mentor gel-filled breast implants was filed with the FDA in July 1991. At the FDA General and Plastic Surgery Advisory Committee meeting in November 1991, the committee recommended the submission of additional information to establish the safety and effectiveness of gel-filled breast implants. In January 1992, the FDA Commissioner announced a voluntary moratorium of the sale of gel-filled breast implants to allow the advisory panel time to assess additional information. In April 1992, the moratorium was lifted but only for reconstruction and revision patients. Every patient implanted had to be part of an adjunct study, and had to be offered participation in a registry of gel-filled breast implant patients. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in a core clinical study. The objective of this study is to determine the safety and effectiveness of the smooth and textured surface Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary breast augmentation, primary breast reconstruction or revision.
Interventions
DEVICEMentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
Two types of Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses will be used in the study: the Siltex textured surface device and the smooth surface device. Each implant is a silicone elastomer (rubber) mammary device that is supplied individually packaged in a doubled wrapped packaging system, sterile, and non-pyrogenic (does not cause fever). Each device consists of a silicone shell encasing a silicone gel filler material with a patch on the posterior side of the device. The basic smooth device shell consists of a silicone layer sandwiched in between two other silicone layers. This construction acts as a barrier to slow the diffusion of (spread) any gel filler materials through the shell. The Siltex textured shell consists of a smooth shell to which is bonded an additional layer of silicone with a textured pattern imprinted into its surface. The Siltex shell is intended to prevent tissue ingrowth. The implants will be available in sizes 100cc through 800ccs.
Sponsors
Mentor Worldwide, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is Genetic female and at least 18 years old * A candidate for: * Primary breast augmentation (for post-lactational mammary involution or general breast enlargement) * Primary breast reconstruction (for cancer, trauma, surgical loss of breast or congenital deformity) * Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants) * Signs the Informed Consent * Agrees to follow the procedures for explant analysis * Agrees to comply with follow-up procedures, including returning for all follow-up visits
Exclusion criteria
* Patient is pregnant * Has nursed a child within three months of study enrollment * Been implanted with any silicone implant other than breast implants (e.g. silicone artificial joints or facial implants) * Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infections arthritis, spondylarthropathies, any other inflammatory arthritis, osteoarthritis, fibromyalgia, or chronic fatigue syndrome * Currently has a condition that could compromise or complicate wound healing (except reconstruction patients) * Patient in Augmentation cohort and has diagnosis of active cancer of any type * Infection or abscess anywhere in the body * Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity) * Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk * Anatomic or physiologic abnormality which could lead to significant postoperative adverse events * Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure * Premalignant breast disease without a subcutaneous mastectomy * Untreated or inappropriately treated breast malignancy, without mastectomy * Implanted metal or metal devices, history of claustrophobia or other condition that would make a MRI scan prohibitive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation | 10 years | 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. |
| Overall Mean Change in Circumferential Chest Size | Change from baseline to 10 years post-baseline | 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 |
| 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture | 10 Years | 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. |
| 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection | 10 Years | 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. |
| 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement | 10 Years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Augmentation The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement. | 552 |
| 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.
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. | 251 |
| Revision Augmentation Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants. | 145 |
| 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. | 60 |
| Total | 1,008 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 23 | 2 | 1 |
| Overall Study | Discontinuation Due to Explantation | 14 | 14 | 14 | 4 |
| Overall Study | Lost to Follow-up | 155 | 24 | 28 | 5 |
| Overall Study | Patient Non-compliance | 55 | 22 | 14 | 11 |
| Overall Study | Patients Not Completing Visit | 11 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 11 | 4 | 2 |
Baseline characteristics
| Characteristic | Primary Reconstruction | Revision Augmentation | Primary Augmentation | Revision Reconstruction | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 0 Participants | 1 Participants | 6 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 245 Participants | 145 Participants | 551 Participants | 54 Participants | 995 Participants |
| Age, Continuous | 45.3 years STANDARD_DEVIATION 10.87 | 41.8 years STANDARD_DEVIATION 9.66 | 34.5 years STANDARD_DEVIATION 8.09 | 50.8 years STANDARD_DEVIATION 10.82 | 39.2 years STANDARD_DEVIATION 10.74 |
| Region of Enrollment United States | 251 participants | 145 participants | 552 participants | 60 participants | 1008 participants |
| Sex: Female, Male Female | 251 Participants | 145 Participants | 552 Participants | 60 Participants | 1008 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 552 | 0 / 251 | 0 / 145 | 0 / 60 |
| serious Total, serious adverse events | 0 / 552 | 0 / 251 | 0 / 145 | 0 / 60 |
Outcome results
Primary
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
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
Population: All enrolled subjects are included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation | 25.5 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation | 49.0 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation | 43.6 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation | 50.7 percentage of subjects |
Primary
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
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
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture | 12.1 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture | 20.5 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture | 24.4 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture | 36.9 percentage of subjects |
Primary
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement
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
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement | 11.6 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement | 33.4 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement | 24.1 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement | 37.8 percentage of subjects |
Primary
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
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
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection | 1.6 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection | 6.2 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection | 1.4 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection | 0.0 percentage of subjects |
Primary
Overall Mean Change in Circumferential Chest Size
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
Population: All enrolled subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Augmentation | Overall Mean Change in Circumferential Chest Size | 7.45 centimeters | Standard Deviation 4.5 |
| Primary Reconstruction | Overall Mean Change in Circumferential Chest Size | 4.88 centimeters | Standard Deviation 7.25 |
| Revison Augmentation | Overall Mean Change in Circumferential Chest Size | 2.89 centimeters | Standard Deviation 4.56 |
| Revision Reconstruction | Overall Mean Change in Circumferential Chest Size | 4.18 centimeters | Standard Deviation 5.68 |
Post Hoc
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications
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
Population: All Enrolled Subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Implant Malposition/Displacement | 1.0 percentage of subjects |
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Nipple Sensation Changes | 12.8 percentage of subjects |
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Metastatic Disease | 0 percentage of subjects |
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Patient Dissatisfaction | 0.4 percentage of subjects |
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Lack of Projection | 0 percentage of subjects |
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Breast Pain | 2.9 percentage of subjects |
| Primary Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Breast Mass | 5.6 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Nipple Sensation Changes | 2.1 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Breast Mass | 8.6 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Breast Pain | 5.2 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Metastatic Disease | 6.9 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Implant Malposition/Displacement | 2.3 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Lack of Projection | 1.0 percentage of subjects |
| Primary Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Patient Dissatisfaction | 4.8 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Breast Pain | 3.2 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Nipple Sensation Changes | 13.6 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Implant Malposition/Displacement | 2.3 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Patient Dissatisfaction | 3.6 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Lack of Projection | 0 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Breast Mass | 6.0 percentage of subjects |
| Revison Augmentation | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Metastatic Disease | 0 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Metastatic Disease | 3.8 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Breast Pain | 5.2 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Nipple Sensation Changes | 4.0 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Patient Dissatisfaction | 9.0 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Lack of Projection | 5.5 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Implant Malposition/Displacement | 6.7 percentage of subjects |
| Revision Reconstruction | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications | Breast Mass | 5.1 percentage of subjects |