MemoryGel Breast Implants for Breast Reconstruction

(Athena Trial)

Recruiting at 29 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mentor Worldwide, LLC

Disqualifiers: Pregnancy, Smoking, Uncontrolled diabetes, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate post-operative period

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctor to understand any specific requirements.

What data supports the effectiveness of the treatment Mentor Larger Size MemoryGel Ultra High Profile Breast Implant for breast reconstruction?

The effectiveness of Mentor MemoryGel breast implants is supported by long-term studies, including a 10-year follow-up study showing their safety and effectiveness for breast reconstruction. These implants are designed to maintain a natural feel while minimizing complications like wrinkling and rippling. ^{1 2 3 4 5}

Is it safe to use MemoryGel Breast Implants for breast reconstruction?

MemoryGel Breast Implants have been studied for over 10 years, showing they are generally safe for use in breast reconstruction, with ongoing evaluations confirming their safety and effectiveness. ^{1 2 3 4 5}

What makes the Mentor Larger Size MemoryGel Ultra High Profile Breast Implant unique for breast reconstruction?

The Mentor Larger Size MemoryGel Ultra High Profile Breast Implant is unique because it is designed to provide a soft, natural feel while enhancing fullness and projection, and it minimizes complications like wrinkling and rippling through optimized gel-fill technology. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Mentor Worldwide, LLC

Eligibility Criteria

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.

Inclusion Criteria

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

Subject understands and signs the Informed Consent

Subject agrees to return device to Mentor if device is explanted

Exclusion Criteria

I do not have any infections or abscesses.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary or revision breast reconstruction using Mentor Larger Size MemoryGel Ultra High Profile Breast Implants

Surgery and immediate post-operative period

Follow-up

Participants are monitored for safety and effectiveness of the breast implants

12 months

Treatment Details

Interventions

• Mentor Larger Size MemoryGel Ultra High Profile Breast Implant

Trial Overview 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.

Participant Groups

Group I: Revision Breast Reconstruction Experimental Treatment 1 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 Reconstruction Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Mentor Worldwide, LLC

Lead Sponsor

Trials

25

Recruited

52,900+

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical Results of Mentor MemoryGel Xtra Breast Implants From the GLOW Clinical Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

MemoryGel Breast Implants: Final Safety and Efficacy Results after 10 Years of Follow-Up. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Results from the MemoryGel Post-approval Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Indications for the use of MemoryShape breast implants in aesthetic and reconstructive breast surgery: long-term clinical outcomes of shaped versus round silicone breast implants. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of Mentor's MemoryGel implants at 6 years. [2009]