🏛️ Verified NIH Record • Updated 2025-11-10

Study of the Safety and Effectiveness of Motiva Implants® (NCT03579901)

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

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Motiva USA LLC

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Gerald Minitti, MD, FACS — Beverly Hills, California

Age range: 18 Years to 70 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (29 Sites)

Showing the first 25 of 29 sites.

  • Gerald Minitti, MD, FACS — Beverly Hills, California
  • Steven Teitelbaum, MD, FACS — Santa Monica, California
  • Westlake Cosmetic Surgery Center — Westlake Village, California
  • The Center for Cosmetic Surgery — Golden, Colorado
  • Emory University Hospital — Atlanta, Georgia
  • Northwestern Plastic Surgery — Chicago, Illinois
  • Northwestern Specialists in Plastic Surgery, S.C. — Chicago, Illinois
  • Meridian Plastic Surgery Center — Indianapolis, Indiana
  • CaloAesthetics® Plastic Surgery Center — Louisville, Kentucky
  • The Wall Center for Plastic Surgery — Shreveport, Louisiana
  • Partners in Plastic Surgery of West Michigan — Grand Rapids, Michigan
  • Parkcrest Plastic Surgery — St Louis, Missouri
  • Glicksman Plastic Surgery — Sea Girt, New Jersey
  • Mark D. Epstein, MD, FACS/ Center for Aesthetic Surgery — Hauppauge, New York
  • NYU Plastic Surgery Associates — New York, New York
  • May Center for Mount Sinai Doctors — New York, New York
  • Fifth Avenue Millennium Aesthetic Surgery, PLLC — New York, New York
  • Cleveland Clinic Main Campus — Cleveland, Ohio
  • Movassaghi Plastic Surgery & Ziba Medical Spa — Eugene, Oregon
  • Portland Plastic Surgery — Portland, Oregon
  • Body by Z — Providence, Rhode Island
  • Maxwell Aesthetics, PLLC — Nashville, Tennessee
  • Strock Plastic Surgery — Fort Worth, Texas
  • Houston Methodist — Houston, Texas
  • MD Anderson Cancer Center — Houston, Texas

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Implants clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗