Have you or your loved ones been diagnosed with primary breast augmentation?
You may be eligible to participate in a primary breast augmentation clinical trial.
Have you or your loved ones been diagnosed with primary breast augmentation? You may be eligible to participate in a primary breast augmentation clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Primary Breast Augmentation Clinical Trial in Alpharetta GA
Have you or your loved ones been diagnosed with primary breast augmentation?
You may be eligible to participate in a primary breast augmentation clinical trial.
Have you or your loved ones been diagnosed with primary breast augmentation? You may be eligible to participate in a primary breast augmentation clinical trial.
Active not recruiting
Female
18 Years +
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.
Details for the study
Brief Title
Memory Gel and Shape Combined Cohort
Official Title
MemoryShape® and MemoryGel® Breast Implants Post Approval New Enrollment Study ("Glow Study")
Brief Summary
The purpose of this study is to collect additional post-approval clinical data on the <br /> long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary <br /> or revisional breast augmentation and primary or revisional breast reconstruction.
Detailed Description
The post-approval study will include a maximum of 3500 women undergoing breast augmentation
or reconstruction with MemoryShape or MemoryGel Breast Implants. Four cohorts will be
included: primary augmentation, revision-augmentation, primary reconstruction, and
revision-reconstruction. For the purpose of assessing rheumatological and neurological signs
and symptoms, a control group with 300-480 women will be selected from the participating
investigators' practices, who are undergoing an aesthetic surgery other than breast implant
surgery. Breast implant patients and the concurrent control group patients will be followed
for 10 years. Baseline and operative data will be collected at the beginning of the study,
and follow-up data will be collected annually for 10 years through online questionnaires.
Treatments and/or Procedures
Memory shape breast implants
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.
Memory gel breast implants
MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.
Other aesthetic surgery
Other aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants)
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Secondary
Effectiveness
Patient satisfaction rates
Other
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Cognitive Function Abilities
Short Form 6a
Other
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue
Short Form 4a
Study 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.