Memory Gel and Shape Combined Cohort

Launched by MENTOR WORLDWIDE, LLC · Sep 27, 2016

Keywords

ClinConnect Summary

The Memory Gel and Shape Combined Cohort trial is studying the long-term performance of MemoryShape and MemoryGel Breast Implants, which are used for breast augmentation and reconstruction. The goal of the study is to gather more information about how these implants perform over time after they have been approved for use in patients. The trial is currently active but not recruiting new participants.

To be eligible for this trial, women must be at least 22 years old and planning to have either primary or revisional breast augmentation or reconstruction. Those who have certain health conditions, such as active infections or a history of cancer (other than non-melanoma skin cancer), cannot participate. Participants will be asked to sign consent forms, answer some questions, and agree to follow-up visits with their surgeon. They will also need to have a valid email address to complete online questionnaires. Overall, this study aims to ensure the safety and effectiveness of these breast implants for women who choose to undergo these procedures.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled):
• • 1. 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;
• • 2. Signs an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement;
• • 3. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
• • 4. Agrees to answer baseline questions;
• • 5. Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
• • 6. 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
• • 7. Has a valid e-mail address and access to the internet to complete online questionnaires.
• Exclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled):
• • 1. Has active infection anywhere in her body;
• • 2. For augmentation patients, has a history of cancer of any kind, except non-melanoma skin cancer; for reconstruction patients, has a history of cancer of any kind, except non melanoma skin cancer or adequately treated breast cancer;
• • 3. Has a confirmed diagnosis of connective tissue disease or neurological disease OR is currently being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
• • 4. Is currently pregnant or nursing;
• • 5. Is planning on undergoing or has undergone bariatric surgery; or
• • 6. Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.
• Inclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients (Prospectively Enrolled):
• • 1. 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;
• • 2. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
• • 3. Agrees to answer baseline questions;
• • 4. Agrees via Informed Consent to comply with study follow-up, including responding to questionnaires in their entirety; and
• • 5. Has a valid e-mail address and access to the internet to complete online questionnaires.
• Exclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients (Prospectively Enrolled):
• • 1. Has ever had unilateral or bilateral breast implants (including breast tissue expanders);
• • 2. Expects to undergo breast implant surgery during the study period;
• • 3. Has ever had silicone implants anywhere in her body;
• • 4. Has active infection anywhere in her body;
• • 5. Has a history of cancer of any kind, except non-melanoma skin cancer;
• • 6. Has a confirmed diagnosis of connective tissue disease or neurological disease OR is currently being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
• • 7. Is currently pregnant or nursing;
• • 8. Is planning on undergoing or has undergone bariatric surgery; or
• • 9. Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.
• Inclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):
• • 1. 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.
• • 2. Signed an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement is available from the time of surgery;
• • 3. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
• • 4. Agrees to answer baseline questions;
• • 5. Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
• • 6. 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
• • 7. Has a valid e-mail address and access to the internet to complete online questionnaires.
• Exclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):
• • 1. Had an active infection anywhere in her body at the time of surgery;
• • 2. For augmentation patients, had a history of cancer (prior to implantation) of any kind, except non-melanoma skin cancer; for reconstruction patients, had a history of cancer (prior to implantation) of any kind, except non melanoma skin cancer or adequately treated breast cancer;
• • 3. Had a confirmed diagnosis of connective tissue disease or neurological disease prior to implantation OR was being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
• • 4. Was pregnant or nursing at the time of surgery;
• • 5. Was planning on undergoing bariatric surgery at the time of breast implant surgery or has undergone bariatric surgery since breast implant surgery; or
• • 6. Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.