MemoryShape + MemoryGel Breast Implants for Breast Surgery
(Glow Trial)
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.12345
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.12356
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline and Operative Data Collection
Baseline and operative data will be collected at the beginning of the study
Follow-up
Participants are monitored annually for 10 years through 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?
5
Treatment groups
Experimental Treatment
Active Control
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
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
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
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
Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mentor Worldwide, LLC
Lead Sponsor
Citations
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.
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.
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 ...
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 ...
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 ...
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 ...
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