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Research & Clinical Trials > Study Search Tool > Study of Safety and Effectiveness of Motiva® Breast Implants

Study of Safety and Effectiveness of Motiva® Breast Implants

This study is open to:

Basic eligibility criteria include the following (participant must meet ALL criteria below):

  • You are a biological female
  • You are aged 22 years or older
  • You require a breast implant reconstruction surgery, either primary (first-time reconstruction) or revision (surgery to correct or improve the results of a previous reconstruction)
  • You have adequate tissue conditions to cover breast implants
  • You are willing to follow all study requirements and visits
  • You agree to return your breast implants to the Sponsor if they need to be removed to conduct additional testing on them
  • You agree to participate in magnetic resonance imaging (MRI) at the designated post-op timepoints and/or if requested by your study doctor.

Your study surgeon will discuss and confirm with you any additional eligibility criteria.

This study is not open to:
  • 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.
  • 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.

Your study surgeon will discuss and confirm any additional criteria that may make you ineligible for the study.

Study of Safety and Effectiveness of Motiva® Breast Implants

Study of Safety and Effectiveness of Motiva® Breast Implants

Clinicaltrials.gov identifier:
NCT03579901

Quality of Life:
Breast Cancer Survivor
High Risk But No Cancer

Study Contact Information

For questions about the study, please contact your preferred study doctor, or request additional information by email.

About the Study

Consider volunteering to participate in a breast implant research study. The study sponsor is seeking participants for breast reconstruction for:

  • Immediate reconstruction:  implant placement immediately after a mastectomy (i.e. during the same procedure)
  • Delayed reconstruction: implant placement at a later date after a mastectomy (i.e. during a separate procedure)
  • Revision reconstruction: implant replacement to change size/type, and/or to correct complications from previous surgery

The purpose of this study is to determine the safety and effectiveness of Motiva Implants®. Motiva® USA, the study’s sponsor, is a subsidiary of Establishment Labs – a global medical device manufacturer whose smooth silicone gel breast implants are commercially available in more than 70 countries.  

We invite participation by women aged 22 or older who meet the study’s eligibility criteria (detailed in the Eligibility section). If you participate, your progress will be closely followed by an experienced plastic surgeon through 10 years to review the status and health of your breast implants.

The participating surgeons and study locations are listed below. You will be compensated for your time and effort to participate in this study. For more information, visit https://motivaimplants.com/ustrial/ and https://clinicaltrials.gov/ct2/show/NCT03579901.

How to Participate

Participation in the Motiva Implants® study involves:

Enrollment

  • Call your preferred study surgeon (contact information below)
  • Provide information (including relevant personal and family history) to confirm your eligibility to participate
  • Clarify any questions you may have with the study surgeon
  • Give consent: read and sign the informed consent form to enroll
  • Complete questionnaires about the current status of your breast(s)

Breast Implant Surgery

  • With routine care procedures in place, undergo primary or revision breast reconstruction surgery with an experienced, board-certified plastic surgeon.

Follow-Up Visits

  • Return for follow-up visits through 10 years following implant surgery with your plastic surgeon to ask about how you feel with your breast implants, how satisfied you are, and whether or not you’ve experienced any complications. This information is captured to continuously support the safety and performance of breast implants through research. You will fill some questionnaires about the current status of your breast after the surgery.
Investigational
Site
Investigator Name Location Contact Information

PeaceHealth Medical Group
Plastic Surgery

Dr. Allen Gabriel      Vancouver, Washington (360)
514-1010
Glicksman Plastic Surgery

Dr. Caroline Glicksman

Sea Girt,
New Jersey
(732)
974-2424

Northwestern Specialists in
Plastic Surgery

Dr. Neil Fine
Dr. Clark Schierle

Chicago, Illinois     (312)
266-6240

Maxwell Aesthetics, PLLC

Dr. Jacob Unger Nashville, Tennessee    (615)
932-7700
MD Anderson Cancer Center    

Dr. Mark Clemens
Dr. Summer Hanson

Houston, Texas (877)
651-4559
Cleveland Clinic   

Dr. Andrea Moreira
Dr. Graham Schwarz 
Dr. Risal Djohan     

Cleveland, Ohio (800)
223-2273

 

 

 

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