MemoryShape + MemoryGel Breast Implants for Breast Surgery

(Glow Trial)

Recruiting at 77 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mentor Worldwide, LLC

Disqualifiers: Active infection, Cancer history, Connective tissue disease, Pregnant or nursing, Bariatric surgery, others

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

Compensation: Varies

Number of Visits: Unknown

3613 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or revisional breast reconstruction.

Do I need to stop my current medications for 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 trial coordinator or your doctor.

What data supports the effectiveness of MemoryShape and MemoryGel breast implants for breast surgery?

Research shows that MemoryShape and MemoryGel breast implants have been used successfully for up to 10 years in women undergoing breast augmentation or reconstruction, with positive clinical outcomes and high satisfaction rates. These implants are designed to mimic the natural shape and firmness of the breast, which may contribute to their effectiveness in achieving desired aesthetic results. ^{1 2 3 4 5}

Is the MemoryShape and MemoryGel breast implant generally safe for use in humans?

The MemoryShape and MemoryGel breast implants have been studied for safety over several years. A 10-year study on MemoryGel implants was conducted to gather long-term safety data, and another study showed no postoperative complications for the MemoryGel Xtra implants in a subgroup analysis. However, safety profiles can vary, and it's important to consider individual circumstances. ^{1 2 4 6 7}

How do MemoryShape and MemoryGel breast implants differ from other breast implant options?

MemoryShape and MemoryGel breast implants are unique because they offer a variety of shapes and textures, including a form-stable, cohesive gel that mimics the natural feel and firmness of a youthful breast. The MemoryShape implants, in particular, have an anatomic shape and a textured shell that help maintain their position and provide a more natural appearance compared to traditional round implants. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Mentor Worldwide, LLC

Eligibility Criteria

This trial is for individuals at least 22 years old seeking primary or revision breast augmentation, or those at least 18 years old looking into breast reconstruction. Participants must be able to sign consent forms, have an email and internet access for online surveys, agree to return implants if removed, and follow the study's check-up schedule.

Inclusion Criteria

I have signed a form acknowledging I understand the trial.

You have an email address and can use the internet to fill out online surveys.

You agree to give back the medical device(s) to the manufacturer, Mentor, if it is removed during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and Operative Data Collection

Baseline and operative data will be collected at the beginning of the study

1-2 weeks

Follow-up

Participants are monitored annually for 10 years through online questionnaires

10 years

Annual online questionnaires

Treatment Details

Interventions

• MemoryGel® Breast Implants
• MemoryShape® Breast Implants
• Other Aesthetic Surgery

Trial Overview The study is evaluating the long-term performance of two types of breast implants: MemoryShape® and MemoryGel®. It aims to gather more data after these products were approved. The research includes people who are getting these implants for the first time or as a replacement.

Participant Groups

Group I: Revision Breast Reconstruction Experimental Treatment 2 Interventions

Participants who meet the requirements for revision breast reconstruction (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants

Group II: Revision Breast Augmentation Experimental Treatment 2 Interventions

Participants who meet the requirements for revision breast augmentation (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast implants

Group III: Primary Breast Reconstruction Experimental Treatment 2 Interventions

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 MemoryGel® Breast Implants or MemoryShape® Breast Implants

Group IV: Primary Breast Augmentation Experimental Treatment 2 Interventions

Participants who meet the requirements for primary breast augmentation (have not had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants

Group V: Other Aesthetic Surgery Active Control 1 Intervention

Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise)

Who Is Running the Clinical Trial?

Mentor Worldwide, LLC

Lead Sponsor

Trials

25

Recruited

52,900+

References

1. 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]

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

The design and engineering of the MemoryShape breast implant. [2021]

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

Mentor Contour Profile Gel implants: clinical outcomes at 6 years. [2022]

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

Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea. [2022]