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The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's 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 approximately 60 medical centers across the United States were enrolled in this research study. These patients were implanted with silicone breast prostheses and will be 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.
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.
In September of 2000 the Core Gel study began, leading the way to the November 2006 FDA approval of the Core Gel implant or Memory Gel breast implant.
The objective of the Contour Profile Gel Study, which started in 2002 is to determine the safety and effectiveness of the Silicone Contour Profile Gel Mammary Prostheses in women who are undergoing primary breast augmentation, primary breast reconstruction, or revision. In the duration of this study patients are required to have follow-up visits 10 weeks post-surgery and every year after surgery through the 10th year of completion. Additionally, out of the approximately 1000 patients enrolled in the CPG study, 400 have been randomly selected to have MRI scans at their 1,2,4,6,8,and 10 year post-surgery visits. Protocol changes now require all patients in this study to have MRI scans at years 6, 8, and 10.
In June of 2013 the FDA approved MENTOR® MemoryShape™ Breast Implants (CPG Style 321 Medium Height, Moderate Profile) for the following indications:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Augmentation | Other | The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants. |
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| Primary Reconstruction | Other | The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants. |
|
| Revision Augmentation | Other | The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery. |
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| Revision Reconstruction | Other | The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mentor Siltex® Contour Profile Gel Mammary Prosthesis | Device | The MENTOR® MemoryShape™ Breast Implant is a silicone elastomer mammary device with a textured surface. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| 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. | 10 years |
| 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. | 10 years |
| 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. | 10 years |
| Overall Mean Change in Circumferential Chest Size |
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Inclusion Criteria:
Subject is genetic female, 18 years of age or older
A candidate for:
Signs the Informed Consent
Agrees to return device to Mentor if explant necessary
Agrees to comply with follow-up procedures, including returning for all follow-up visits
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William P Adams Jr, M.D. | Dallas, TX | Principal Investigator |
| Dennis Hammond, M.D. | Grand Rapids, MI | Principal Investigator |
| John Canady, M.D. | Mentor Worldwide, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mentor Worldwide, LLC | Santa Barbara | California | 93111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25158767 | Derived | Caplin DA. Indications for the use of MemoryShape breast implants in aesthetic and reconstructive breast surgery: long-term clinical outcomes of shaped versus round silicone breast implants. Plast Reconstr Surg. 2014 Sep;134(3 Suppl):27S-37S. doi: 10.1097/PRS.0000000000000609. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Augmentation | The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| FG001 | Primary Reconstruction | The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants . Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| FG002 | Revision Augmentation | The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| FG003 | Revision Reconstruction | The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled subjects are included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Augmentation | The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All enrolled subjects are included. | Posted | Number | 95% Confidence Interval | percentage of subjects | 10 years |
|
Baseline (Surgery) to 10 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. All complications above 5% are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Augmentation | The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asymmetry | Surgical and medical procedures | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers | Mentor | 513-337-1172 | mschwier@its.jnj.com |
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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 |
| Change from baseline to 10 years post-baseline |
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Explantation of study device(s) |
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| Unknown reasons and patient/doctor moves |
|
| BG001 | Primary Reconstruction | The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants . Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| BG002 | Revision Augmentation | The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| BG003 | Revision Reconstruction | The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Primary Reconstruction | The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants . Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| OG002 | Revision Augmentation | The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
| OG003 | Revision Reconstruction | The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. |
|
|
| 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. | All enrolled subjects are included. | Posted | Number | 95% Confidence Interval | percentage of subjects | 10 years |
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|
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| 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. | All enrolled subjects are included. | Posted | Number | 95% Confidence Interval | percentage of subjects | 10 years |
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|
|
| 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. | All enrolled subjects are included. | Posted | Number | 95% Confidence Interval | percentage of subjects | 10 years |
|
|
|
| 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 | All enrolled subjects are included. | Posted | Mean | Standard Deviation | inches | Change from baseline to 10 years post-baseline |
|
|
|
| 3 |
| 572 |
| 91 |
| 572 |
| EG001 | Primary Reconstruction | The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants . Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. | 10 | 190 | 56 | 190 |
| EG002 | Revision Augmentation | The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. | 3 | 124 | 20 | 124 |
| EG003 | Revision Reconstruction | The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery. Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. | 3 | 69 | 37 | 69 |
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| Baker III Capsular Contracture | Skin and subcutaneous tissue disorders | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
|
| Baker IV Capsular Contracture | Skin and subcutaneous tissue disorders | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
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| Breast Sensation Changes | Skin and subcutaneous tissue disorders | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
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| Nipple Sensation Changes | Skin and subcutaneous tissue disorders | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
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| Palpability-Implant | Surgical and medical procedures | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
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| Patient Dissatisfied With Aesthetic Appearance Of Breast | Surgical and medical procedures | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
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| Position Dissatisfaction | Skin and subcutaneous tissue disorders | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
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| Ptosis | Skin and subcutaneous tissue disorders | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
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| Recurrent Breast Cancer | Skin and subcutaneous tissue disorders | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
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| Wrinkling | Skin and subcutaneous tissue disorders | Systematic Assessment | Complications are collected systematically using a pre-specified list of anticipated complications. Data collection did not include specification regarding each event as serious or non-serious, therefore all events are included as non-serious events. |
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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.