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

NAActive, not recruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

April 1, 2016

Primary Completion Date

January 31, 2029

Study Completion Date

January 31, 2029

Conditions
Breast Reconstruction, Revision Breast Reconstruction
Interventions
DEVICE

Mentor Larger Size MemoryGel Ultra High Profile Breast Implant

The Mentor smooth and Siltex® larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity.

Trial Locations (30)

10029

The Mount Sinai Medical Center, New York

19087

Paul Glat, MD, PC, Bala-Cynwyd

19104

Hospital of the University of Pennsylvania, Philadelphia

22903

UVA Health System, Charlottesville

30342

Buckhead Plastic Surgery, P.C, Atlanta

31405

Georgia Institute of Plastic Surgery, Savannah

36117

Plastic Surgery Associates of Montgomery, Montgomery

37232

Vanderbilt University Medical Center, Nashville

37403

The Plastic Surgery Group PC, Chattanooga

37701

The Center for Dermatology and Plastic Surgery at Springbrook, Alcoa

43212

The Ohio State University Plastic Surgery, Columbus

44195

The Cleveland Clinic, Cleveland

45227

The Plastic Surgery Group, Cincinnati

45458

Plastic Surgery Institute of Dayton, Centerville

46545

The Centre, PC, Mishawaka

52242

University of Iowa Hospitals & Clinics, Iowa City

55407

Abbott Northwestern Hospital, Minneapolis

63110

Washington University School of Medicine, St Louis

66160

The University of Kansas, Kansas City

76508

Baylor Scott & White Health, Temple

77030

Houston Methodist Hospital, Houston

The University of Texas MD Anderson Cancer Center, Houston

85028

Mosharrafa Plastic Surgery, Phoenix

85054

Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB), Phoenix

85260

Andres Plastic Surgery, Scottsdale

91505

Susan E Downey MD, Inc, Burbank

93301

Adventist Health Bakersfield, Bakersfield

94305

Stanford University School of Medicine, Stanford

95032

Liu Plastic Surgery, Los Gatos

97210

Legacy Good Samaritan Medical Center, Portland

All Listed Sponsors
lead

Mentor Worldwide, LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter