Clinical trial NCT02919592: Memory Gel and Shape Combined Cohort
Official title: MemoryShape® and MemoryGel® Breast Implants Post Approval New Enrollment Study ("Glow Study")
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Breast Augmentation
Primary Breast Reconstruction
Revision Breast Augmentation
Revision Breast Reconstruction
Lead sponsor: Mentor Worldwide, LLC
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 3613
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications
timeFrame: 10 years
Secondary outcomes:
measure: Rates of occurrence of connective tissue disease
timeFrame: 10 years
measure: Rates of occurrence of rheumatological signs and symptoms
timeFrame: 10 years
measure: Rates of occurrence of neurological signs and symptoms
timeFrame: 10 years
measure: Rates of occurrence of cancer
timeFrame: 10 years
measure: Rates of occurrence of suicide
timeFrame: 10 years
measure: Rates of lactation complications
timeFrame: 10 years
measure: Rates of MRI confirmed rupture
timeFrame: 10 years
measure: Effectiveness
timeFrame: 10 years
Other outcomes:
measure: PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue
timeFrame: Baseline, 10 years
measure: PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Cognitive Function Abilities
timeFrame: Baseline, 10 years
Locations:
city: Birmingham
country: United States
facility: Hedden Plastic Surgery Center
state: Alabama
city: Tuscaloosa
country: United States
facility: Plastic Surgery of Tuscaloosa
state: Alabama
city: Gilbert
country: United States
facility: Advanced Plastic Surgery Institute
state: Arizona
city: Mesa
country: United States
facility: Advanced Surgical Associates
state: Arizona
city: Phoenix
country: United States
facility: Robles Plastic Surgery
state: Arizona
city: Scottsdale
country: United States
facility: Berardi Aesthetics and Plastic Surgery
state: Arizona
city: Scottsdale
country: United States
facility: Guerra Plastic Surgery Center
state: Arizona
city: Scottsdale
country: United States
facility: Mark Malek, MD Plastic Surgery
state: Arizona
city: Fayetteville
country: United States
facility: Vanderpool Cosmetic Plastic Surgery
state: Arkansas
city: Beverly Hills
country: United States
facility: Jaime Schwartz, MD
state: California
city: Burbank
country: United States
facility: Susan E. Downey, MD Inc
state: California
city: Corte Madera
country: United States
facility: Mohebali Plastic Surgery
state: California
city: Fountain Valley
country: United States
facility: Institute of Cosmetic and Reconstructive Surgery
state: California
city: Newport Beach
country: United States
facility: Newport Beach Center for Plastic Surgery
state: California
city: Newport Beach
country: United States
facility: Newport Center for Special Surgery
state: California
city: Oceanside
country: United States
facility: North Coast Plastic Surgery
state: California
city: Ontario
country: United States
facility: Li Plastic Surgery
state: California
city: Redding
country: United States
facility: Summit Plastic Surgery
state: California
city: Solana Beach
country: United States
facility: Verve Plastic Surgery
state: California
city: Visalia
country: United States
facility: Kaweah Delta Health Care District
state: California
city: Lone Tree
country: United States
facility: Park Meadows Cosmetic Surgery
state: Colorado
city: Boca Raton
country: United States
facility: David Bogue MD, Plastic Surgery, PL
state: Florida
city: Coral Gables
country: United States
facility: The Plastic Surgery Institute of Miami
state: Florida
city: Coral Gables
country: United States
facility: University of Miami / Sylvester Comp Cancer Ctr
state: Florida
city: Fort Lauderdale
country: United States
facility: South Florida Plastic Surgery
state: Florida
city: Jacksonville
country: United States
facility: First Coast Plastic Surgery
state: Florida
city: Miami
country: United States
facility: Sean A. Simon, MD
state: Florida
city: Miami
country: United States
facility: Pierini Esthetic Surgery
state: Florida
city: Miami
country: United States
facility: Imagos Plastic Surgery
state: Florida
city: Miami
country: United States
facility: Christopher Craft Cosmetic Surgery
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Plastic Surgery
state: Florida
city: Tampa
country: United States
facility: Dr. Joshua Halpern MD, PA
state: Florida
city: Alpharetta
country: United States
facility: The Swan Center for Plastic Surgery
state: Georgia
city: Atlanta
country: United States
facility: Artisan Plastic Surgery
state: Georgia
city: Atlanta
country: United States
facility: North Atlanta Plastic Surgery
state: Georgia
city: Fayetteville
country: United States
facility: Advanced Aesthetics
state: Georgia
city: Marietta
country: United States
facility: Marietta Plastic Surgery
state: Georgia
city: Rome
country: United States
facility: Snodgrass and Robinson Plastic Surgery Specialists
state: Georgia
city: Savannah
country: United States
facility: The Georgia Institute for Plastic Surgery
state: Georgia
city: Inverness
country: United States
facility: Barrington Plastic Surgery
state: Illinois
city: Northbrook
country: United States
facility: MAE Plastic Surgery
state: Illinois
city: Oak Lawn
country: United States
facility: A New You Plastic Surgery & Laser Center
state: Illinois
city: Davenport
country: United States
facility: Iowa Plastic Surgery
state: Iowa
city: Birmingham
country: United States
facility: AMAE Plastic & Reconstructive Surgery
state: Michigan
city: Bloomfield
country: United States
facility: Ellen A. Janetzke, MD
state: Michigan
city: Grand Rapids
country: United States
facility: Partners in Plastic Surgery
state: Michigan
city: Traverse City
country: United States
facility: The Center for You
state: Michigan
city: Troy
country: United States
facility: Spa Renaissance & Renaissance Plastic Surgery
state: Michigan
city: Troy
country: United States
facility: Danielle DeLuca-Pytell, MD, PC
state: Michigan
city: Burnsville
country: United States
facility: Gryskiewicz Twin Cities Cosmetic Surgery
state: Minnesota
city: Saint Louis
country: United States
facility: Parkcrest Plastic Surgery
state: Missouri
city: Henderson
country: United States
facility: Hankins and Sohn Plastic Surgery
state: Nevada
city: Portsmouth
country: United States
facility: Atlantic Plastic Surgery
state: New Hampshire
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Long Island City
country: United States
facility: Doctors Plastic Surgery
state: New York
city: Charlotte
country: United States
facility: Piedmont Plastic Surgery & Dermatology - Blakeney
state: North Carolina
city: Charlotte
country: United States
facility: Providence Plastic Surgery & Skin Center
state: North Carolina
city: Gastonia
country: United States
facility: Piedmont Plastic Surgery & Dermatology - Cox Road
state: North Carolina
city: Gastonia
country: United States
facility: Piedmont Plastic Surgery & Dermatology Center - New Hope
state: North Carolina
city: Hickory
country: United States
facility: Piedmont Plastic Surgery & Dermatology - Hickory
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Plastic Surgery
state: North Carolina
city: Bismarck
country: United States
facility: Advanced Surgical Arts Center
state: North Dakota
city: Columbus
country: United States
facility: The Columbus Institute for Plastic Surgery
state: Ohio
city: Uniontown
country: United States
facility: Carp Cosmetic Surgery
state: Ohio
city: Oklahoma City
country: United States
facility: Tim R. Love, M.D., P.C.
state: Oklahoma
city: Bala-Cynwyd
country: United States
facility: Paul Glat, MD, PC
state: Pennsylvania
city: Greer
country: United States
facility: Upstate Plastic Surgery
state: South Carolina
city: Alcoa
country: United States
facility: The Center for Dermatology and Plastic Surgery
state: Tennessee
city: Chattanooga
country: United States
facility: Plastic Surgery Group
state: Tennessee
city: Nashville
country: United States
facility: Music City Plastic Surgery
state: Tennessee
city: Houston
country: United States
facility: Ciaravino Plastic Surgery
state: Texas
city: Draper
country: United States
facility: Premier Plastic Surgery
state: Utah
city: Lehi
country: United States
facility: Michael D. Marion Plastic Surgery
state: Utah
city: Fredericksburg
country: United States
facility: Plastic Surgery of Fredericksburg
state: Virginia
city: Newport News
country: United States
facility: Plastic Surgery Center of Hampton Roads
state: Virginia
city: Norfolk
country: United States
facility: The Hague Center for Cosmetic and Plastic Surgery
state: Virginia
city: Richmond
country: United States
facility: Richmond Plastic Surgeons
state: Virginia
city: Spokane Valley
country: United States
facility: Kai Morimoto MD PLLC
state: Washington
Study officials:
affiliation: Mentor Worldwide, LLC
name: Medical Director
role: STUDY_DIRECTOR
References: