About this trial
Last updated 6 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 9 years ago
What is this trial about?
What are the Participation Requirements?
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.