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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P030053 / PAS008 |
| Date Original Protocol Accepted |
10/01/2014
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| Date Current Protocol Accepted |
03/08/2022
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| Study Name |
MemoryGel and Shape Glow Study
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| Device Name |
MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
On August 30th -31st, 2011, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (link) met to discuss updates on the postmarket experience of silicone gel-filled breast implants and to make recommendations on issues related to the monitoring of silicone gel-filled breast implants. The Advisory Panel recommended more efficient approaches to assessing the performance of silicone gel-filled breast implants than continuing new enrollment in the large prospective studies. Their recommendations included conducting a systematic literature review and re-designing the Large Post-Approval Studies (PAS) to have more efficient methodologies to assess rare outcomes. In response, FDA entered a collaboration with the American Society of Plastic Surgeons (ASPS), the Plastic Surgeons Foundation (PSF), breast implant manufacturers and patient advocate groups, to establish the National Breast Implant Registry (NBIR) and the PROFILE Registry (established to collect data on potential cases of breast-implant anaplastic large cell lymphoma (BI-ALCL)). Tufts University was tasked with conducting a systematic literature review to look at rare endpoints and silicone gel-filled breast implants. Details on the literature review methodology and findings can be found here (Balk EM, et al., Long-Term Health Outcomes in Women With Silicone Gel Breast Implants: A Systematic Review. Ann Intern Med. 2016. 2;164(3):164-75).
The MemoryGel and Shape Glow Study was designed as part of the re-design of the LARGE PAS. This is a smaller cohort study (10 years follow-up) designed to address safety outcomes (i.e., including local complications, less rare connective tissue diseases, rheumatologic and neurologic signs and symptoms, breast cancer, lung cancer and suicide), reproduction and pregnancy outcomes, lactation problems, effects on mammography, effects on patient satisfaction with breasts and psychosocial wellbeing, and silicone subject compliance with magnetic resonance imaging (MRI) recommendations.
This restructured PAS, once completed as designed, would satisfy the post-approval requirements for both the MemoryGel® (P030053) and Memory Shape (P060028) silicone breast implants. In addition, information gained from the NBIR will help strengthen the general understanding of implantation rates and certain risks associated with breast implants.
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| Study Population |
Women who receive Mentor’s MemoryGel and MemoryShape breast implants for the purpose of primary or revisional breast augmentation and primary or revisional breast construction. Additionally, women who undergo aesthetic surgery (for example liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty) will be enrolled as concurrent controls.
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| Sample Size |
The study will enroll 2,518 women who receive Memory Gel and MemoryShape Breast Implants for augmentation, reconstruction, augmentation revision, or reconstruction revision. The study will also enroll 300 women undergoing aesthetic surgery who will serve as concurrent control group.
The study was designed to have 80% power to be able to detect as statistically significant a relative risk of 2.0 for adverse events that occur,
without implants with a frequency of 5.0 per 10,000 person-years, based on a one-sided test conducted at level of significance of 0.05. Based on these specifications, it was determined that approximately 20,328 person-year, a total of at least 2,518 breast implants patients would be required. Patient are to be followed for 10 years. For purposes of sample size calculationns, assuming a follow-up rate of 65% at 10 years and a linear loss to follow-up, there would be an average of 8, 075 person-years per patient. Thus, in order to obtain the 20,328 person-years, a total of 2,518
breast implants patients would be required.
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| Key Study Endpoints |
Safety Endpoints to be evaluated are as follows:
Local complications, connective tissue diseases, rheumatologic and neurologic signs and symptoms, cancer, suicide, and lactation complications
and magnetic resonance imaging (MRI) compliance and results.
Effectiveness BREAST-Q will be assessed in a subset of breast implant patients, approximately 500 patients, by responses to questions addressing their perceived quality-of-life and satisfaction with their breast implants.
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| Follow-up Visits and Length of Follow-up |
Patients will be followed for 10 years. MemoryGel and Memory Shape Breast Implant patients will be evaluated by the investigator at baseline and years 1, 5, and 10, and will complete questionnaires at baseline and annually for 10 years. A concurrent control group of women undergoing other aesthetic surgery (patients are referred to as Control participants) will complete questionnaires at baseline and annually for 10 years.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
3,611 total subjects
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| Actual Number of Sites Enrolled |
62
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| Patient Follow-up Rate |
The 2 year follow-up rates are:
82.6% - MemoryGel cohort
90.6% - MemoryShape Prospective cohort
83.3% - MemoryShape Retrospective cohort
76.7% - Control cohort
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