MemoryShape + MemoryGel Breast Implants for Breast Surgery

(Glow Trial)

Not currently recruiting at 78 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather more information on the long-term performance of MemoryShape and MemoryGel breast implants used in breast surgeries. It includes participants receiving breast implants for the first time or those needing a revision of existing implants. The trial seeks individuals planning to undergo breast augmentation or reconstruction, either initially or as a revision. Participants should not have a history of cancer (except non-melanoma skin cancer) or active infections and must agree to follow up with their surgeon and complete online questionnaires. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future breast implant procedures.

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 prior data suggests that MemoryShape and MemoryGel Breast Implants are safe for breast surgery?

Research has shown that MemoryGel and MemoryShape Breast Implants are generally safe for most women undergoing breast surgery. Studies have found that the body usually accepts these implants well. The most common issues include the need for additional surgery or implant removal. For instance, one study found that about 12% of women with implants required another surgery, and around 7% experienced capsular contracture, where scar tissue tightens around the implant. Overall, these implants have been used safely for many years, with long-term studies confirming their safety and effectiveness for breast enlargement and reconstruction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MemoryGel® and MemoryShape® Breast Implants because they offer unique advancements in breast surgery options. Unlike standard silicone or saline implants, these treatments are designed to provide a more natural feel and shape, closely mimicking natural breast tissue. MemoryGel® Implants are filled with a cohesive gel that holds together uniformly, while MemoryShape® Implants have a tapered design that gives a natural breast contour. These features aim to enhance both the aesthetic and tactile outcomes for patients, making them stand out from traditional options.

What evidence suggests that this trial's treatments could be effective for breast surgery?

Research has shown that MemoryGel and MemoryShape Breast Implants are safe and effective for breast enlargement and reconstruction. In this trial, participants will be assigned to different treatment arms: Primary Breast Augmentation, Revision Breast Augmentation, Primary Breast Reconstruction, and Revision Breast Reconstruction, using either MemoryGel or MemoryShape Breast Implants. Studies have found that these implants provide reliable results over time, with a low risk of complications such as the need for additional surgery or the development of capsular contracture (tightening of the scar tissue around the implant). MemoryGel Implants maintain their shape and feel natural, which is important for many individuals. Similarly, MemoryShape Implants offer good options for both cosmetic and reconstructive needs. This evidence supports the long-term use of these implants for those considering breast surgery. ^{1 2 3 5 6}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7899226/

MemoryGel Breast Implants: Final Safety and Efficacy Results ... The results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33620918/

Final Safety and Efficacy Results after 10 Years of Follow-Up The results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction.

3. academic.oup.com academic.oup.com/asj/article/43/12/NP1021/7248863

Clinical Results of Mentor MemoryGel Xtra Breast Implants ... For the primary reconstruction cohort, these rates were 12.0% for implant-related reoperation, 12.3% for explantation, and 7.3% for capsular contracture. For ...

4. jnj.com jnj.com/media-center/press-releases/plastic-and-reconstructive-surgery-journal-publishes-ten-year-clinical-study-data-highlighting-safety-of-mentor-memoryshape-gel-breast-implants

Plastic And Reconstructive Surgery Journal Publishes Ten ... “The results of this study document the important role MemoryShape® implants play in providing options in both aesthetic and reconstructive ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf6/p060028b.pdf

summary of safety and effectiveness data (ssed) The results indicated there were 5.3 and 8.0 ppm of platinum present in the gel filler and shell assembly of MemoryShape™ Breast Implants ...

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

Breast Implant & Expander Safety Info The most common complications with MemoryShape™ Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement ...