Study Design
breast augmentation, connective tissue disease or neurological disease, active infection
ADVERSE EVENTS, BREAST CANCER
The MemoryGel and MemoryShape Combined Cohort Clinical Study (NCT02919592) is a prospective, open label study in which postapproval clinical performance and safety of MemoryShape and MemoryGel breast implants produced by Mentor Worldwide LLC were evaluated, as indicated for primary or revisional breast augmentation and primary or revisional breast reconstruction. The study includes both smooth and Siltex microtextured devices. IRB approval for each site was obtained from Sterling IRB, University of Tennessee Health Science Center IRB, or Providence Health and Services IRB. Implant patients were enrolled in 4 cohorts (Inclusion criteria for prospectively enrolled patients in the study included females receiving MemoryShape or MemoryGel breast implants for augmentation purposes who were at least 22 years old or a candidate for reconstruction, who signed an acknowledgment of informed consent and authorization to disclose health information and release medical records, had a valid email address and access to the Internet to complete online questionnaires, and agreed to answer baseline questions, authorize return of explanted device(s) to Mentor, and comply with study follow-up requirements.Exclusion criteria included active infection anywhere in the body, a confirmed diagnosis of connective tissue disease or neurological disease at the time of study entry, pregnancy or nursing at the time of study entry, planning on or undergoing bariatric surgery, or a plan to undergo experimental procedures or procedures with investigational products or devices during the study period that could compromise the results of this study. An additional exclusion criterion for augmentation patients was a history of cancer of any kind other than non-melanoma skin cancer. For reconstruction patients this criterion was a history of cancer of any kind other than non-melanoma skin cancer or adequately treated breast cancer. For the MemoryGel Xtra–specific analyses included herein, all study participants with at least 1 MemoryGel Xtra device were included. All participants had had these devices implanted at least 3 years previous to the data cutoff date.Baseline and operative data were collected at the beginning of the study, and follow-up data will be collected annually through 10 years using online patient questionnaires. All study patients will be seen by the investigator surgeon at any standard-of-care office visits, and relevant adverse events will be captured in the study database.Data presented were entered into the study database from February 12, 2016, through December 9, 2022. Because this is an ongoing study, results are subject to change.