Study of the Safety and Effectiveness of Motiva Implants®

Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery

This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Implants
• Intervention / Treatment: Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants

Detailed Description

Prospective, Single Arm, Multicenter Study. Following FDA approval, follow-up data will continue to be collected for all cohorts on adverse events, reoperations, patient satisfaction, physician satisfaction and quality of life for a total of 10 years.

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dusseldorf, Germany, 40221
    • Plastische Chirurgie im Medienhafen
• Sweden
  • Stockholm, Sweden, 11542
    • Akademikliniken HJ AB
  • Stockholm, Sweden, 13336
    • Victoriakliniken
• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Brian M. Kinney, MD, FACS-Excellence in Plastic Surgery
    • Beverly Hills, California, United States, 90212
      • Gerald Minitti, MD, FACS
    • Santa Monica, California, United States, 90404
      • Steven Teitelbaum, MD, FACS
    • Westlake Village, California, United States, 91361
      • Westlake Cosmetic Surgery Center
  • Colorado
    • Golden, Colorado, United States, 80401
      • The Center for Cosmetic Surgery
  • Florida
    • South Miami, Florida, United States, 33143
      • Rafael Gottenger, MD Plastic Surgery
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Plastic Surgery
    • Chicago, Illinois, United States, 60611
      • Northwestern Specialists in Plastic Surgery, S.C.
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Meridian Plastic Surgery Center
  • Kentucky
    • Louisville, Kentucky, United States, 40222
      • CaloAesthetics® Plastic Surgery Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • The Wall Center for Plastic Surgery
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Partners in Plastic Surgery of West Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Parkcrest Plastic Surgery
  • New Jersey
    • Sea Girt, New Jersey, United States, 08750
      • Glicksman Plastic Surgery
  • New York
    • Hauppauge, New York, United States, 11788
      • Mark D. Epstein, MD, FACS/ Center for Aesthetic Surgery
    • New York, New York, United States, 10017
      • NYU Plastic Surgery Associates
    • New York, New York, United States, 10029
      • May Center for Mount Sinai Doctors
    • New York, New York, United States, 10128
      • Fifth Avenue Millennium Aesthetic Surgery, PLLC
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Movassaghi Plastic Surgery & Ziba Medical Spa
    • Portland, Oregon, United States, 97209
      • Portland Plastic Surgery
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Body by Z
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Maxwell Aesthetics, PLLC
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Strock Plastic Surgery
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • University Park, Texas, United States, 75205
      • William P. Adams Plastic Surgery
  • Washington
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria

• Genetic female.
• Patient is seeking one of the following procedures:

Primary Breast Augmentation Primary Breast Reconstruction Revision Augmentation Revision Reconstruction

• Patient has adequate tissue available to cover implant(s).
• Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.
• Agrees to have device returned to Establishment Labs if explanted.
• Willing to undergo Magnetic Resonance Imaging (MRI) evaluation of medically advised.

Exclusion Criteria:

• Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2 without a previous bilateral mastectomy or an untreated cancer of any type.
• Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration compromised vascularity, history of compromised wound healing).
• Has an abscess or infection.
• Is pregnant or nursing or has had a full-term pregnancy or lactated within 6 months of enrollment.
• Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and or significant postoperative complications.
• Has any medical condition such as obesity (BMI ≥ 40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and or significant postoperative complications.
• Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others.
• Has any condition that impedes the use of magnetic resonance imaging (MRI) including implanted metal device, claustrophobia or other conditions that would make MRI scan prohibited.
• Has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure.
• Has been implanted with any non-FDA approved breast implant.
• Has been implanted with any silicone implant other than breast implants.
• HIV positive (based on medical history).
• Has been diagnosed with anaplastic large cell lymphoma (ALCL).
• Works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or ICON the Contract Research Organization (CRO) that is helping to conduct the study or are directly-related to anyone that works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or the CRO.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Primary Breast Augmentation; Subjects age 22 and over, indicated to increase breast size	Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants; Breast augmentation
Other: Primary Breast Reconstruction; Subjects age 18 and over, Surgery to replace breast tissue that has been removed due to cancer, prophylactic mastectomy, breast trauma or that has failed to develop properly due to a severe breast anomaly.	Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants; Breast augmentation
Other: Revision Augmentation; Revision surgery to correct or improve the results of a previous breast augmentation	Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants; Breast augmentation
Other: Revision Reconstruction; Revision surgery to correct or improve the results of a previous breast reconstruction.	Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants; Breast augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Analyze and report the total adverse events rate ("any complication)" of the Silicone Gel filled Motiva Implants®. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event.	10 Years
Analyze patient satisfaction on a 5-point Likert scale post-implant for all implantation groups.	10 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
Kaplan-Meier analysis of all complications, including reoperation and explantation	10 Years
Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture	10 Years
Kaplan-Meier analysis of rupture.	10 Years
Kaplan-Meier analysis of connective tissue disease (CTD) and CTD signs/symptoms	10 Years
Kaplan-Meier analysis of Cancer (Breast Cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others)	10 Years
Patient Satisfaction with Breast (BREAST-Q™) Questionnaire	10 Years
Physician Satisfaction (5-point Likert scale)	10 Years
Validated Quality of Life questionnaires	10 Years
Breast Measurements (Net Chest Circumference and Hemi-Circumference) change from baseline	10 Years

Collaborators and Investigators

• Sponsor: Motiva USA LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2018
• Primary Completion (Anticipated): August 30, 2032
• Study Completion (Anticipated): February 28, 2033

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: July 5, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Breast Reconstruction; Breast Augmentation; Breast Surgery; Breast Implants
• Other Study ID Numbers: CLIN-17-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes