MemoryGel Breast Implants for Breast Reconstruction

(Athena Trial)

Not currently recruiting at 30 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the Mentor MemoryGel® Larger Size Ultra High Profile Breast Implants for breast reconstruction. It targets women who have either never had breast implants or wish to replace existing ones. Participants should have undergone a mastectomy and show interest in breast reconstruction. This study may suit those who have had tissue expanders placed in preparation for breast implants. As an unphased trial, it offers participants the opportunity to contribute to important research in breast reconstruction options.

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 prior data suggests that the Mentor Larger Size MemoryGel Ultra High Profile Breast Implant is safe for breast reconstruction?

Research has shown that Mentor MemoryGel® Breast Implants are safe based on previous studies. These implants are designed to prevent the gel inside from leaking easily, reducing the risk of complications. Thorough testing ensures they meet high quality and safety standards.

Although specific numbers are not provided, the evidence suggests that patients generally tolerate these implants well. The FDA has approved them for breast augmentation and reconstruction, indicating a strong safety record for other uses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mentor Larger Size MemoryGel Ultra High Profile Breast Implant because it offers a unique option for breast reconstruction. Unlike standard implants, this new implant is designed with an ultra-high profile, which can provide a more projected shape and fuller appearance. This feature is particularly beneficial for individuals undergoing primary or revision breast reconstruction, as it might offer enhanced aesthetic outcomes. Moreover, the MemoryGel technology is known for its cohesive gel that closely mimics the natural feel of breast tissue, which can improve comfort and satisfaction among patients.

What evidence suggests that the Mentor Larger Size MemoryGel Ultra High Profile Breast Implant is effective for breast reconstruction?

Studies have shown that Mentor MemoryGel breast implants perform well and are popular for breast reconstruction. They achieve a high satisfaction rate, with 99% of patients pleased with their initial reconstruction results. Research has indicated low complication rates, based on a three-year follow-up of women using similar implants. These larger implants are designed to look and feel natural, making them a popular choice for women seeking breast reconstruction. Early findings suggest that the Mentor Larger Size MemoryGel Ultra High Profile implants, which participants in this trial will receive, are safe and effective for women undergoing either their first or a follow-up breast reconstruction. ^{4 5 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Mentor Worldwide, LLC

Are You a Good Fit for This Trial?

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

Subject understands and signs the Informed Consent

Subject agrees to return device to Mentor if device is explanted

My doctor agrees the implant size is right for my body type.

Exclusion Criteria

I do not have any infections or abscesses.

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

Works for Mentor or the study doctor or is directly related to anyone who works for Mentor or the study doctor

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02724371

NCT02724371 | A Study of the Safety and Effectiveness ... Study Plan · The Mentor smooth and Siltex® larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants.

2. jnj.com jnj.com/media-center/press-releases/mentor-memorygel-enhance-breast-implant-receives-fda-approval-for-largest-size-breast-implants-for-reconstruction

MENTOR™ MemoryGel™ Enhance Breast Implant ... MemoryGel™ Enhance Breast Implant is the first and only implant line created specifically for women with larger breast cup sizes undergoing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10653354/

Clinical Results of Mentor MemoryGel Xtra Breast Implants ... MemoryGel Xtra devices show low complication rates based on 3-year follow-up on over 81% of 287 females who were implanted with the devices, including 151 ...

4. cms.gov cms.gov/medicare/coverage/ide/approved-ide-studies-items/g150173-nct02724371-

A Study of the Safety and Effectiveness of the Mentor ... 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 ...

5. jnjmedtech.com jnjmedtech.com/en-US/product/mentor-memorygel-implants

MENTOR™ MemoryGel™ Breast Implants MENTOR™ MemoryGel™ Breast Implants have a 97% satisfaction rate for primary augmentation patients and 99% satisfaction rate for primary reconstruction patients.

6. breastimplantsbymentor.net breastimplantsbymentor.net/en-US/mentor-safety

Breast Implant & Expander Safety Info Read about our commitment to patient safety and how MENTOR™ Breast Implants are backed by clinical data, rigorous testing & the highest quality standards.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/p030053b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA IV. WARNINGS AND PRECAUTIONS. The warnings and precautions can be found in the Mentor MemoryGel Silicone Gel-Filled. Breast Implants physician ...

8. breastimplantsbymentor.net breastimplantsbymentor.net/en-GB/mentor-safety

Safety | Breast Implants by MENTOR™ GB MENTOR® MemoryGel® Breast Implants have been shown to have low gel bleed (gel diffusion). 13 The overall body of available evidence supports that the extremely ...