Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation, Revision Breast Reconstruction
Conditions
Brief summary
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.
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.
Interventions
DEVICEMemoryShape® 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.
DEVICEMemoryGel® 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.
PROCEDUREOther Aesthetic Surgery
Other aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants)
Sponsors
Mentor Worldwide, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications | 10 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of occurrence of connective tissue disease | 10 years | — |
| Rates of occurrence of rheumatological signs and symptoms | 10 years | — |
| Rates of occurrence of neurological signs and symptoms | 10 years | — |
| Rates of occurrence of cancer | 10 years | — |
| Rates of occurrence of suicide | 10 years | — |
| Rates of lactation complications | 10 years | — |
| Rates of MRI confirmed rupture | 10 years | — |
| Effectiveness | 10 years | Patient satisfaction rates |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Mentor Worldwide, LLC
Outcome results
None listed