MemoryShape® and MemoryGel® Breast Implants Post Approval New Enrollment Study (Glow Study)
The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or revisional breast reconstruction.
• Is a candidate for breast augmentation with MemoryShape or MemoryGel Breast Implants and is at least 22 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with MemoryShape or MemoryGel Breast Implants and is at least 18 years old;
• Signs an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement;
• Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
• Agrees to answer baseline questions;
• Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
• Agrees via Informed Consent to comply with study follow-up, including following the surgeon's standard of care for office visits and responding to questionnaires in their entirety; and
• Has a valid e-mail address and access to the internet to complete online questionnaires.
• Is a candidate for aesthetic surgery (for example, liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone or saline implants) and is at least 22 years of age;
• Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
• Agrees to answer baseline questions;
• Agrees via Informed Consent to comply with study follow-up, including responding to questionnaires in their entirety; and
• Has a valid e-mail address and access to the internet to complete online questionnaires.
• Received MemoryShape Breast Implants for breast augmenation after January 01, 2015 and was at least 22 years old (primary or revision) at the time of surgery OR underwent breast reconstruction (primary or revision) with MemoryShape Breast Implants after January 01, 2015. A women who has since had her MemoryShape Breast Implants explanted may still be enrolled in the study.
• Signed an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement is available from the time of surgery;
• Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
• Agrees to answer baseline questions;
• Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
• Agrees via Informed Consent to comply with study follow-up, including following the surgeon's standard of care for office visits and responding to questionnaires in their entirety; and
• Has a valid e-mail address and access to the internet to complete online questionnaires.