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Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants | Clinical Trials | Clareo Health

TERMINATEDNA

Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants

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

NCT01785069•Allergan

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Female, age 18 or older
•Present with 1 or more of the following conditions:
•1. Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
•2. Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when the permanent implants are placed in the reconstructed breast)
•3. Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants
•Has adequate tissue available to cover implants
•Willing to undergo magnetic resonance imaging (MRI) at the specified follow-up visits for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)

Exclusion Criteria

•Does not have advance fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
•Does not have existing carcinoma of the breast, without mastectomy
•Does not have abscess or infection in the body at the time of enrollment
•Is not pregnant or nursing
•Does not have any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) \> 8%), that is clinically known to impact wound healing ability
•Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation inadequate tissue, compromised vascularity, or ulceration
•Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
•Does not show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
•Is not willing to undergo further surgery for revision, if medically required

Locations (29)

Laurence Berkowitz

Campbell, California, United States

Roy Hong

Palo Alto, California, United States

Eric Bachelor

Pleasanton, California, United States

Gregory Liebscher

Colorado Springs, Colorado, United States

Scott Spear

Washington D.C., District of Columbia, United States

Calvin Peters

Orlando, Florida, United States

Walter Erhardt

Albany, Georgia, United States

James Namnoum

Atlanta, Georgia, United States

Janet Turkle

Carmel, Indiana, United States

Julene Samuels

Louisville, Kentucky, United States

Key Dates

Start Date

December 10, 2012

Primary Completion Date

November 30, 2015

Completion Date

November 30, 2015

Last Updated

June 25, 2020

Enrollment

355

ACTUAL participants

Conditions

Breast AugmentationBreast ReconstructionBreast Implant Revision

Interventions

Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection

DEVICE

Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest

NCT07222514

DIEP Flap Breast Reconstruction

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RECRUITINGNA

Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

NCT06556654

Breast Reconstruction Surgery

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RECRUITINGNA

A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants

Inclusion Criteria

Exclusion Criteria

Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest

Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction

AFT: Introduction of a Full Breast Reconstructive Method

Endoscopic Nipple-Sparing Mastectomy (E-NSM) With Immediate Multistage Autologous Fat Grafting(IMAFG) for Total Breast Reconstruction Via the Axillary Incision