What side effects are associated with this type of intervention?

The most common side effects of silicone gel-filled breast implants, such as the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants, include capsular contracture (tightening of the scar tissue around the implant), asymmetry, hematoma (collection of blood), and implant rupture or leakage. Other potential complications can include infection, changes in nipple or breast sensation, and the need for additional surgeries to address these issues. While less common, some patients may also experience implant malposition or rippling.

What prior FDA approvals exist?

The FDA has approved several silicone gel-filled breast implants for breast reconstruction, including products from manufacturers like Mentor, Allergan, and Sientra. These implants are used in both primary and revision reconstruction surgeries to provide a natural feel and appearance. The approvals are based on clinical trials that have demonstrated their safety and effectiveness in breast augmentation and reconstruction.

What other types of research exist?

Promising, novel alternatives to Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants for breast reconstruction include: 1) Injectable soft tissue fillers such as poly-L-lactic acid (PLLA) and calcium hydroxylapatite, which stimulate collagen production and provide volume. 2) Hydrogel polymers like polyacrylamide and polyalkylimide hydrogels, which augment soft tissue through direct volume filling. 3) Autologous fat transfer, which uses the patient's own fat for augmentation, reducing the risk of allergic reactions and providing a natural feel.

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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

Must not have

Infection or abscess anywhere in the body

Confirmed or suspected diagnosis of certain rheumatological autoimmune diseases or immune compromised status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new, larger breast implants for patients needing breast reconstruction after mastectomy or revision surgery. The implants are designed to provide a fuller, more natural look. The new implants allow for a significant improvement in shaping the final contour of the breast.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman over 18 needing surgery to revise a previous breast operation.

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I am a woman over 18 needing breast reconstruction due to surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any infections or abscesses.

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I have a rheumatological autoimmune disease or a weakened immune system.

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I will need a special material used during my implant surgery.

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I am HIV positive.

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I have a condition that could affect how my wounds heal.

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My breast tissue is not suitable for an implant.

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My diabetes is not under control right now.

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I have a condition that could cause serious problems after surgery.

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My breast cancer has not been treated or was not treated properly, and I haven't had surgery for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 11Eligibility criteria met

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.