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

A Study of the Safety and Effectiveness of the Mentor Smooth and Textured Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Mentor Worldwide, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Subjects, whose body shape is suited to a larger size implant than are currently available, will have their breasts reconstructed using the UHP-L Breast Implants either for the first time after a full mastectomy or as a revision of a previous breast reconstruction.

Conditions

• Breast Reconstruction, Revision Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	Mentor Larger Size MemoryGel Ultra High Profile Breast Implant	The Mentor smooth 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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2029-01-31
• Completion: 2029-01-31
• First posted: 2016-03-31
• Last updated: 2026-04-14

Locations

30 sites across 1 country: United States