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Breast Implants

MemoryShape + MemoryGel Breast Implants for Breast Surgery (Glow 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

Is a candidate for breast augmentation with MemoryShape or MemoryGel Breast Implants and is at least 22 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with MemoryShape or MemoryGel Breast Implants and is at least 18 years old;

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is collecting data on how well MemoryShape and MemoryGel breast implants work in the long term.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in this summary, common side effects from breast implant surgery can include pain, swelling, infection risk around the implant area, changes in nipple sensation, scarring and potential implant leakage or rupture.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am eligible for breast implants and meet the age requirement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Effectiveness

Other study objectives

PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Cognitive Function Abilities

PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Revision Breast ReconstructionExperimental Treatment2 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 AugmentationExperimental Treatment2 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 ReconstructionExperimental Treatment2 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 AugmentationExperimental Treatment2 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 SurgeryActive Control1 Intervention

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

0 / 1Eligibility criteria met