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Memory Gel and Shape Combined Cohort (Glow)

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ClinicalTrials.gov Identifier: NCT02919592
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Breast Augmentation Primary Breast Reconstruction Revision Breast Augmentation Revision Breast Reconstruction Device: MemoryShape® Breast Implants Device: MemoryGel® Breast Implants Procedure: Other Aesthetic Surgery Not Applicable

Detailed Description:
The post-approval study will include 2518 women undergoing breast augmentation or reconstruction with MemoryShape or MemoryGel Breast Implants. Four cohorts will be included: primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction. For the purpose of assessing rheumatological and neurological signs and symptoms, a control group of 300 women will be selected from the participating investigators' practices, who are undergoing an aesthetic surgery other than breast implant surgery. Breast implant patients and the concurrent control group patients will be followed for 10 years. Baseline and operative data will be collected at the beginning of the study, and follow-up data will be collected annually for 10 years through online questionnaires.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2818 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MemoryShape® and MemoryGel® Breast Implants Post Approval New Enrollment Study ("Glow Study")
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : September 1, 2028
Estimated Study Completion Date : September 1, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primary Breast Augmentation
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
Device: MemoryShape® Breast Implants
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.

Device: MemoryGel® Breast Implants
MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. . MemoryShape Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.

Experimental: Revision Breast Augmentation
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
Device: MemoryShape® Breast Implants
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.

Device: MemoryGel® Breast Implants
MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. . MemoryShape Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.

Experimental: Primary Breast Reconstruction
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
Device: MemoryShape® Breast Implants
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.

Device: MemoryGel® Breast Implants
MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. . MemoryShape Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.

Experimental: Revision Breast Reconstruction
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
Device: MemoryShape® Breast Implants
MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.

Device: MemoryGel® Breast Implants
MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. . MemoryShape Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.

Active Comparator: Other Aesthetic Surgery
Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise)
Procedure: Other Aesthetic Surgery
Other aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants)




Primary Outcome Measures :
  1. 10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Rates of occurrence of connective tissue disease [ Time Frame: 10 years ]
  2. Rates of occurrence of rheumatological signs and symptoms [ Time Frame: 10 years ]
  3. Rates of occurrence of neurological signs and symptoms [ Time Frame: 10 years ]
  4. Rates of occurrence of cancer [ Time Frame: 10 years ]
  5. Rates of occurrence of suicide [ Time Frame: 10 years ]
  6. Rates of lactation complications [ Time Frame: 10 years ]
  7. Rates of MRI confirmed rupture [ Time Frame: 10 years ]
  8. Effectiveness [ Time Frame: 10 years ]
    Patient satisfaction rates



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria MemoryShape and MemoryGel Breast Implant Patients:

  1. 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;
  2. Signs an Acknowledgement of Informed Decision from the patient brochure;
  3. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
  4. Agrees to answer baseline questions;
  5. Agrees to authorize return of the device(s) to Mentor if the device is explanted;
  6. Agrees via Informed Consent to comply with study follow-up, including following the surgeon's standard of care for office visits and responding to questionnaires in their entirety; and
  7. Has a valid e-mail address and access to the internet to complete online questionnaires.

Exclusion Criteria MemoryShape and MemoryGel Breast Implant Patients:

  1. Has active infection anywhere in her body;
  2. For augmentation patients, has a history of cancer of any kind, except non-melanoma skin cancer; for reconstruction patients, has a history of cancer of any kind, except non melanoma skin cancer or adequately treated breast cancer;
  3. Has a confirmed diagnosis of connective tissue disease or neurological disease OR is currently being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
  4. Is currently pregnant or nursing;
  5. Is planning on undergoing or has undergone bariatric surgery; or
  6. Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.

Inclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients:

  1. Is a candidate for aesthetic surgery (for example, liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants) and is at least 22 years of age;
  2. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
  3. Agrees to answer baseline questions;
  4. Agrees via Informed Consent to comply with study follow-up, including responding to questionnaires in their entirety; and
  5. Has a valid e-mail address and access to the internet to complete online questionnaires.

Exclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients:

  1. Has ever had unilateral or bilateral breast implants (including breast tissue expanders);
  2. Expects to undergo breast implant surgery during the study period;
  3. Has ever had silicone implants anywhere in her body;
  4. Has active infection anywhere in her body;
  5. Has a history of cancer of any kind, except non-melanoma skin cancer;
  6. Has a confirmed diagnosis of connective tissue disease or neurological disease OR is currently being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
  7. Is currently pregnant or nursing;
  8. Is planning on undergoing or has undergone bariatric surgery; or
  9. Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919592


Contacts
Contact: Patricia Chen PChen126@its.jnj.com

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Sponsors and Collaborators
Mentor Worldwide, LLC
Investigators
Study Director: John Canady, M.D. Mentor Worldwide, LLC

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT02919592     History of Changes
Other Study ID Numbers: MEN-15-003
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No