Clinical trials: Breast Implant Revision
Breast Augmentation, Breast Reconstruction
Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT00905645
- Testing
- Silimed Gel-Filled Mammary Implant
- Where
- United States
- Volunteers
- 1,788 people
- Sponsor
- Tiger Biosciences, LLC.
Ventral Hernia, Post-mastectomy Breast Reconstruction
Analysis and Characterization of Biologic Implants
The purpose of this study is to investigate what happens to biologic mesh in the body over time on a molecular level. To date, it is not known what agents, enzymes, or proteins are interacting at the implantation site that…
- Trial name
- NCT01060046
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Washington University School of Medicine
Breast Augmentation, Breast Reconstruction
Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- CPG (NCT00812097)
- Testing
- Mentor Siltex® Contour Profile Gel Mammary Prosthesis
- Where
- United States
- Volunteers
- 955 people
- Sponsor
- Mentor Worldwide, LLC
Breast Augmentation, Breast Reconstruction
NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01853605
- Testing
- Anatomically shaped silicone gel-filled breast implants
- Where
- United States
- Volunteers
- 3,811 people, healthy volunteers welcome
- Sponsor
- Allergan
Breast Augmentation
Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix
Post-marketing surveillance study to demonstrate the silent rupture rate and satisfaction of patients who underwent a primary and revision breast augmentation surgery with Motiva Implants®, 3 to 10 years before enrollment.
- Trial name
- MIRO (NCT05449587)
- Testing
- MRI and PRO
- Where
- 2 sites in Costa Rica
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00690339
- Testing
- Style 410 Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00689871
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 715 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Breast Reconstruction, Revision Breast Reconstruction
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
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
- Trial name
- Athena (NCT02724371)
- Testing
- Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
- Where
- 30 sites in United States
- Volunteers
- 400 people
- Sponsor
- Mentor Worldwide, LLC
Breast Implant Revision, Breast Augmentation Complications
Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery
The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation…
- Conditions
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- Trial name
- NCT07367698
- Testing
- Implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- 3 sites in Australia
- Volunteers
- 87 people
- Sponsor
- BellaSeno Pty Ltd
Breast Implant Revision, Congenital Breast Defect Correction
Scaffold-guided Breast Surgery
The clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits.
- Trial name
- NCT05437757
- Testing
- Surgical implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01785069
- Testing
- Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
- Where
- 29 sites in United States
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Allergan
Breast Implant
Motiva Implants® Post-Approval Study
This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.
- Trial name
- Motiva PAS (NCT06938399)
- Testing
- Silicone gel-filled breast implants - Motiva Implants®, Aesthetic Surgery
- Where
- 33 sites in United States
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Breast Reconstruction, Breast Augmentation
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- NCT00753922
- Testing
- Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
- Where
- United States
- Volunteers
- 1,008 people
- Sponsor
- Mentor Worldwide, LLC
Breast Augmentation, Breast Reconstruction
Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant
The Contour Profile Gel Continued Access Study is designed to demonstrate safety of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- CPG-CA (NCT00811525)
- Testing
- Mentor Siltex® Contour Profile Gel Mammary Prosthesis
- Sponsor
- Mentor Worldwide, LLC
Breast Augmentation, Breast Reconstruction
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants
- Trial name
- NCT07679594
- Testing
- Breast augmentation surgery, Breast reconstruction surgery
- Where
- 2 sites in France, Spain
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- GCA (Eurosilicone)
Breast Reconstruction, Breast Augmentation
Mentor MemoryGel Post-Approval Study
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional…
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- MGPAS (NCT00756652)
- Testing
- Mentor Silicone Gel-Filled Breast Implants, Saline Breast Implants
- Volunteers
- 42,491 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Breast Augmentation, Breast Reconstruction
CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01959880
- Testing
- The Contour Profile Gel (CPG) breast implants
- Where
- United States
- Volunteers
- 1,891 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Breast Augmentation, Breast Revision-Augmentation
Post Market Clinical Experience Study of Sientra 207 Breast Implants
A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants
- Trial name
- NCT02905617
- Testing
- Sientra 207 Silicone Gel Breast Implant
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Tiger Biosciences, LLC.
Subjects Requiring Revision Breast Augmentation Surgery
SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.
- Trial name
- NCT02030938
- Testing
- SERI® Surgical Scaffold
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Sofregen Medical, Inc.