Clinical trial NCT02724371: A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Official title: A Study of the Safety and Effectiveness of the Mentor Smooth and Textured Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Reconstruction, Revision Breast Reconstruction
Lead sponsor: Mentor Worldwide, LLC
Sponsor class: INDUSTRY
First posted: 2016-03-31
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.

Detailed description: Subjects, whose body shape is suited to a larger size implant than are currently available, will have their breasts reconstructed using the UHP-L Breast Implants either for the first time after a full mastectomy or as a revision of a previous breast reconstruction.

Eligibility criteria: Inclusion Criteria:

* Subject is female and is at least 18 years old
* A candidate for:
* Primary breast reconstruction in women at least 18 years old with surgically absent breast tissue (two-stage reconstruction \[tissue expanders utilized with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement\] to replace breast tissue post-mastectomy)
* Revision surgery in women at least 18 years old with surgically absent breast tissue (previous reconstruction with silicone-filled or saline-filled implants or revision reconstruction requiring expansion surgery prior to surgery for study device implantation, with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement)
* Subject understands and signs the Informed Consent
* Subject agrees to return device to Mentor if device is explanted
* Subject agrees to comply with follow-up procedures, including returning for all follow-up visits
* Physician determines implant volume appropriate for the patient taking into account the subject's BMI and chest width

Exclusion Criteria:

* Subject is pregnant at time of enrollment
* Subject is a current smoker, or has smoked within 3 months prior to enrollment, or plans to resume smoking within 3 months post-enrollment
* Currently has uncontrolled diabetes (at time of screening or enrollment)
* Has nursed a child within 3 months of study enrollment
* Confirmed or suspected diagnosis of the following rheumatological autoimmune diseases or immune compromised status: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
* Currently has a condition that could compromise or complicate wound healing. Note, obesity alone is not an exclusion. All surgical risk factors (obesity, diabetes, smoking history, and prior radiation) should be considered in totality for proper subject selection
* Infection or abscess anywhere in the body
* Demonstrates tissue characteristics that are clinically incompatible with successful use of a breast implant (e.g. inadequate tissue or compromised vascularity)
* Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
* Anatomic or physiologic abnormality that could lead to significant postoperative adverse events
* Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
* Untreated active, or inappropriately/inadequately treated breast malignancy, without surgical treatment
* Anticipated need for use of ADM/mesh at the time of implant or implant exchange
* Subject is HIV positive
* Works for Mentor or the study doctor or is directly related to anyone who works for Mentor or the study doctor
* Implanted metal or metal devices that make a MRI scan prohibitive, history of claustrophobia or other condition that would make a MRI scan prohibitive

Primary outcomes:
measure: 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
timeFrame: 10 years
measure: 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
timeFrame: 10 year
measure: 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
timeFrame: 10 year
measure: 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation with or without replacement
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Plastic Surgery Associates of Montgomery
state: Alabama
city: Phoenix
country: United States
facility: Mosharrafa Plastic Surgery
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB)
state: Arizona
city: Scottsdale
country: United States
facility: Andres Plastic Surgery
state: Arizona
city: Bakersfield
country: United States
facility: Adventist Health Bakersfield
state: California
city: Burbank
country: United States
facility: Susan E Downey MD, Inc
state: California
city: Los Gatos
country: United States
facility: Liu Plastic Surgery
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Atlanta
country: United States
facility: Buckhead Plastic Surgery, P.C
state: Georgia
city: Savannah
country: United States
facility: Georgia Institute of Plastic Surgery
state: Georgia
city: Mishawaka
country: United States
facility: The Centre, PC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas
state: Kansas
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: Centerville
country: United States
facility: Plastic Surgery Institute of Dayton
state: Ohio
city: Cincinnati
country: United States
facility: The Plastic Surgery Group
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Plastic Surgery
state: Ohio
city: Portland
country: United States
facility: Legacy Good Samaritan Medical Center
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Paul Glat, MD, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Alcoa
country: United States
facility: The Center for Dermatology and Plastic Surgery at Springbrook
state: Tennessee
city: Chattanooga
country: United States
facility: The Plastic Surgery Group PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Health
state: Texas
city: Charlottesville
country: United States
facility: UVA Health System
state: Virginia
Study officials:
affiliation: Mentor Worldwide, LLC
name: Medical Director
role: STUDY_DIRECTOR
References: