Memory Gel and Shape Combined Cohort

Not Applicable

Active, not recruiting

• Conditions: Revision Breast Augmentation; Revision Breast Reconstruction; Primary Breast Augmentation; Primary Breast Reconstruction

• Registration Number: NCT02919592
• Lead Sponsor: 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.

Detailed Description

The post-approval study will include a maximum of 3500 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 with 300-480 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 Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-18
• Primary Completion: 2031-06-16
• Study Completion: 2031-06-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 3613

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications	10 years

Secondary Outcome Measures

Name	Time	Method
Rates of lactation complications	10 years
Effectiveness	10 years	Patient satisfaction rates
Rates of occurrence of rheumatological signs and symptoms	10 years
Rates of occurrence of cancer	10 years
Rates of occurrence of connective tissue disease	10 years
Rates of occurrence of neurological signs and symptoms	10 years
Rates of occurrence of suicide	10 years
Rates of MRI confirmed rupture	10 years

Trial Locations

Locations (78)

Hedden Plastic Surgery Center; 🇺🇸 Birmingham, Alabama, United States

Plastic Surgery of Tuscaloosa; 🇺🇸 Tuscaloosa, Alabama, United States

Advanced Plastic Surgery Institute; 🇺🇸 Gilbert, Arizona, United States

Advanced Surgical Associates; 🇺🇸 Mesa, Arizona, United States

Robles Plastic Surgery; 🇺🇸 Phoenix, Arizona, United States

Berardi Aesthetics and Plastic Surgery; 🇺🇸 Scottsdale, Arizona, United States

Guerra Plastic Surgery Center; 🇺🇸 Scottsdale, Arizona, United States

Mark Malek, MD Plastic Surgery; 🇺🇸 Scottsdale, Arizona, United States

Vanderpool Cosmetic Plastic Surgery; 🇺🇸 Fayetteville, Arkansas, United States

Jaime Schwartz, MD; 🇺🇸 Beverly Hills, California, United States

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