|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030053 / PAS009 |
| Date Original Protocol Accepted |
01/16/2015
|
| Date Current Protocol Accepted |
08/28/2020
|
| Study Name |
Re-Op Phase
|
| Device Name |
MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| 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 (listed below) 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).
This Re-Op study requirement was designed as part of the re-design of the LARGE PAS for the MemoryGel® breast implants. In this Re-Op Phase of the study, data will be collected when the subjects with MemoryGel® breast implants have secondary surgical procedures/re-operations. This Re-Op Phase will serve as a bridge between the Large PAS and NBIR.
|
| Study Population |
Women with MemoryGel breast implants who were enrolled in the Large PAS.
|
| Sample Size |
41,900
|
| Key Study Endpoints |
Implant removal and reoperation rates; Reasons for reoperation.
|
| Follow-up Visits and Length of Follow-up |
The follow쳌]up data will be collected when the participant requires a secondary procedure/reoperation.
|
