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Breast Implant

MemoryGel Breast Implants for Breast Reconstruction (Athena Trial)

N/A
Waitlist Available
Research Sponsored by Mentor Worldwide, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A candidate for revision surgery in women at least 18 years old with surgically absent breast tissue
A candidate for primary breast reconstruction in women at least 18 years old with surgically absent breast tissue
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 year
Awards & highlights

Athena Trial Summary

This trial will study the safety and effectiveness of larger Mentor MemoryGel breast implants.

Who is the study for?
This trial is for women at least 18 years old needing primary or revision breast reconstruction due to absent breast tissue. Participants must agree to follow-up visits, return the implant if removed, and have a suitable body mass index (BMI) and chest width. Exclusions include pregnancy, uncontrolled diabetes, recent nursing of a child, conditions affecting wound healing or posing surgical risks, untreated breast cancer, certain autoimmune diseases or immune deficiencies.Check my eligibility
What is being tested?
The safety and effectiveness of Mentor MemoryGel Larger Size Ultra High Profile Breast Implants are being tested in women undergoing primary or revision breast reconstruction. The study focuses on how well these larger implants work and monitors any complications that may arise post-surgery.See study design
What are the potential side effects?
Potential side effects from using these implants can include pain at the surgery site, infection around the implant, changes in nipple sensation, scar tissue formation causing stiffness (capsular contracture), possible rupture of the implant with leakage of silicone gel material.

Athena Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 needing surgery to revise a previous breast operation.
Select...
I am a woman over 18 needing breast reconstruction due to surgery.

Athena Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation with or without replacement
+1 more

Athena Trial Design

2Treatment groups
Experimental Treatment
Group I: Revision Breast ReconstructionExperimental Treatment1 Intervention
participants who meet the requirements for revision breast reconstruction (have had previous silicone or saline breast implants) and have been implanted with Mentor Larger Size MemoryGel Ultra High Profile Breast implants
Group II: Primary Breast ReconstructionExperimental Treatment1 Intervention
Participants who meet the requirements for primary breast reconstruction (have not had previous silicone or saline breast implants, not including tissue expanders) and have been implanted with Mentor Larger Size MemoryGel Ultra High Profile Breast implants

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Silicone gel-filled breast implants, such as the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants, are commonly used in breast reconstruction to restore breast volume and shape after mastectomy. These implants contain a cohesive silicone gel that closely mimics the natural feel of breast tissue, providing a more natural appearance and texture compared to saline implants. The high profile design offers greater projection, which can be essential for achieving the desired aesthetic results. This is significant for breast reconstruction patients as it enhances their physical appearance, boosts self-esteem, and improves overall quality of life following surgery.

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Who is running the clinical trial?

Mentor Worldwide, LLCLead Sponsor
24 Previous Clinical Trials
52,538 Total Patients Enrolled
10 Trials studying Breast Reconstruction
46,813 Patients Enrolled for Breast Reconstruction
John Canady, M.D.Study DirectorMentor Worldwide, LLC
3 Previous Clinical Trials
45,337 Total Patients Enrolled
3 Trials studying Breast Reconstruction
45,337 Patients Enrolled for Breast Reconstruction
Medical DirectorStudy DirectorMentor Worldwide, LLC
2,788 Previous Clinical Trials
8,065,652 Total Patients Enrolled
2 Trials studying Breast Reconstruction
3,828 Patients Enrolled for Breast Reconstruction

Media Library

Mentor Larger Size MemoryGel Ultra High Profile Breast Implant (Breast Implant) Clinical Trial Eligibility Overview. Trial Name: NCT02724371 — N/A
Breast Reconstruction Research Study Groups: Primary Breast Reconstruction, Revision Breast Reconstruction
Breast Reconstruction Clinical Trial 2023: Mentor Larger Size MemoryGel Ultra High Profile Breast Implant Highlights & Side Effects. Trial Name: NCT02724371 — N/A
Mentor Larger Size MemoryGel Ultra High Profile Breast Implant (Breast Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02724371 — N/A
~144 spots leftby Jan 2029
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