๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-27

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 (NCT02724371)

Post-Approval Study of the Safety and Effectiveness of the Mentor Smooth Larger Size MemoryGel Ultra High Profile (UHP-L) Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Mentor Worldwide, LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGelยฎ Larger Size Ultra High Profile (UHP-L) Breast Implants.

Who can join: Review the eligibility criteria below.

Location: Plastic Surgery Associates of Montgomery โ€” Montgomery, Alabama

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (30 Sites)

Showing the first 25 of 30 sites.

  • Plastic Surgery Associates of Montgomery โ€” Montgomery, Alabama
  • Mosharrafa Plastic Surgery โ€” Phoenix, Arizona
  • Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB) โ€” Phoenix, Arizona
  • Andres Plastic Surgery โ€” Scottsdale, Arizona
  • Adventist Health Bakersfield โ€” Bakersfield, California
  • Susan E Downey MD, Inc โ€” Burbank, California
  • Liu Plastic Surgery โ€” Los Gatos, California
  • Stanford University School of Medicine โ€” Stanford, California
  • Buckhead Plastic Surgery, P.C โ€” Atlanta, Georgia
  • Georgia Institute of Plastic Surgery โ€” Savannah, Georgia
  • The Centre, PC โ€” Mishawaka, Indiana
  • University of Iowa Hospitals & Clinics โ€” Iowa City, Iowa
  • The University of Kansas โ€” Kansas City, Kansas
  • Abbott Northwestern Hospital โ€” Minneapolis, Minnesota
  • Washington University School of Medicine โ€” St Louis, Missouri
  • The Mount Sinai Medical Center โ€” New York, New York
  • Plastic Surgery Institute of Dayton โ€” Centerville, Ohio
  • The Plastic Surgery Group โ€” Cincinnati, Ohio
  • The Cleveland Clinic โ€” Cleveland, Ohio
  • The Ohio State University Plastic Surgery โ€” Columbus, Ohio
  • Legacy Good Samaritan Medical Center โ€” Portland, Oregon
  • Paul Glat, MD, PC โ€” Bala-Cynwyd, Pennsylvania
  • Hospital of the University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • The Center for Dermatology and Plastic Surgery at Springbrook โ€” Alcoa, Tennessee
  • The Plastic Surgery Group PC โ€” Chattanooga, Tennessee

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก 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.
๐Ÿ›๏ธ View Official NIH Record โ†—