10-Year checkup: are popular breast implants safe Long-Term?

NCT ID NCT02919592

Knowledge-focused Sponsor: Mentor Worldwide, LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study follows over 3,600 women who received MemoryShape or MemoryGel breast implants for augmentation or reconstruction. Researchers track complications like rupture, connective tissue disease, and cancer over 10 years. The goal is to gather real-world safety data, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: MemoryShape and MemoryGel silicone breast implants
What this could lead to: If successful, this study will provide reliable long-term safety data on these breast implants, helping patients and doctors make informed choices.
What could go wrong: This is an observational follow-up study, not a test of a new treatment. It cannot prove the implants work better than others, and risks like rupture or complications remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

3,603 people

The number who actually took part.

Started

Sep 2016

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled): 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, or equivalent documentation of discussion and acknowledgement; 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 during study participation; 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 (Prospectively Enrolled): 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 (Prospectively Enrolled): 1. Is a candidate for aesthetic surgery (for example, liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone or saline 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 (Prospectively Enrolled): 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. Inclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled): 1. Received MemoryShape Breast Implants for breast augmenation after January 01, 2015 and was at least 22 years old (primary or revision) at the time of surgery OR underwent breast reconstruction (primary or revision) with MemoryShape Breast Implants after January 01, 2015. A women who has since had her MemoryShape Breast Implants explanted may still be enrolled in the study. 2. Signed an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement is available from the time of surgery; 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 during study participation; 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 Breast Implant Patients (Retrospectively Enrolled): 1. Had an active infection anywhere in her body at the time of surgery; 2. For augmentation patients, had a history of cancer (prior to implantation) of any kind, except non-melanoma skin cancer; for reconstruction patients, had a history of cancer (prior to implantation) of any kind, except non melanoma skin cancer or adequately treated breast cancer; 3. Had a confirmed diagnosis of connective tissue disease or neurological disease prior to implantation OR was being evaluated for symptoms suggestive of connective tissue disease or neurological disease; 4. Was pregnant or nursing at the time of surgery; 5. Was planning on undergoing bariatric surgery at the time of breast implant surgery or has undergone bariatric surgery since breast implant 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.

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary breast augmentation Primary breast reconstruction Revision breast augmentation Revision breast reconstruction

Contacts and locations

Locations

A New You Plastic Surgery & Laser Center

Oak Lawn, Illinois, 60453, United States
AMAE Plastic & Reconstructive Surgery

Birmingham, Michigan, 48009, United States
Advanced Aesthetics

Fayetteville, Georgia, 30214, United States
Advanced Plastic Surgery Institute

Gilbert, Arizona, 85295, United States
Advanced Surgical Arts Center

Bismarck, North Dakota, 58503, United States
Advanced Surgical Associates

Mesa, Arizona, 85297, United States
Artisan Plastic Surgery

Atlanta, Georgia, 30342, United States
Atlantic Plastic Surgery

Portsmouth, New Hampshire, 03801, United States
Barrington Plastic Surgery

Inverness, Illinois, 60067, United States
Berardi Aesthetics and Plastic Surgery

Scottsdale, Arizona, 85260, United States
Carp Cosmetic Surgery

Uniontown, Ohio, 44685, United States
Christopher Craft Cosmetic Surgery

Miami, Florida, 33176, United States
Ciaravino Plastic Surgery

Houston, Texas, 77098, United States
Danielle DeLuca-Pytell, MD, PC

Troy, Michigan, 48084, United States
David Bogue MD, Plastic Surgery, PL

Boca Raton, Florida, 33431, United States
Doctors Plastic Surgery

Long Island City, New York, 11106, United States
Dr. Joshua Halpern MD, PA

Tampa, Florida, 33607, United States
Ellen A. Janetzke, MD

Bloomfield, Michigan, 48304, United States
First Coast Plastic Surgery

Jacksonville, Florida, 32257, United States
Forsyth Plastic Surgery

Winston-Salem, North Carolina, 27103, United States
Gryskiewicz Twin Cities Cosmetic Surgery

Burnsville, Minnesota, 55337, United States
Guerra Plastic Surgery Center

Scottsdale, Arizona, 85260, United States
Hankins and Sohn Plastic Surgery

Henderson, Nevada, 89074, United States
Hedden Plastic Surgery Center

Birmingham, Alabama, 35242, United States
Imagos Plastic Surgery

Miami, Florida, 33173, United States
Institute of Cosmetic and Reconstructive Surgery

Fountain Valley, California, 92708, United States
Iowa Plastic Surgery

Davenport, Iowa, 52807, United States
Jaime Schwartz, MD

Beverly Hills, California, 90210, United States
Kai Morimoto MD PLLC

Spokane Valley, Washington, 99216, United States
Kaweah Delta Health Care District

Visalia, California, 93291, United States
Li Plastic Surgery

Ontario, California, 91764, United States
MAE Plastic Surgery

Northbrook, Illinois, 60062, United States
Marietta Plastic Surgery

Marietta, Georgia, 30060, United States
Mark Malek, MD Plastic Surgery

Scottsdale, Arizona, 85260, United States
Michael D. Marion Plastic Surgery

Lehi, Utah, 84043, United States
Mohebali Plastic Surgery

Corte Madera, California, 94925, United States
Music City Plastic Surgery

Nashville, Tennessee, 37215, United States
Newport Beach Center for Plastic Surgery

Newport Beach, California, 92660, United States
Newport Center for Special Surgery

Newport Beach, California, 92660, United States
North Atlanta Plastic Surgery

Atlanta, Georgia, 30342, United States
North Coast Plastic Surgery

Oceanside, California, 92056, United States
Park Meadows Cosmetic Surgery

Lone Tree, Colorado, 80124, United States
Parkcrest Plastic Surgery

St Louis, Missouri, 63141, United States
Partners in Plastic Surgery

Grand Rapids, Michigan, 49546, United States
Paul Glat, MD, PC

Bala-Cynwyd, Pennsylvania, 19087, United States
Piedmont Plastic Surgery & Dermatology - Blakeney

Charlotte, North Carolina, 28277, United States
Piedmont Plastic Surgery & Dermatology - Cox Road

Gastonia, North Carolina, 28054, United States
Piedmont Plastic Surgery & Dermatology - Hickory

Hickory, North Carolina, 28602, United States
Piedmont Plastic Surgery & Dermatology Center - New Hope

Gastonia, North Carolina, 28054, United States
Pierini Esthetic Surgery

Miami, Florida, 33166, United States
Plastic Surgery Center of Hampton Roads

Newport News, Virginia, 23606, United States
Plastic Surgery Group

Chattanooga, Tennessee, 37403, United States
Plastic Surgery of Fredericksburg

Fredericksburg, Virginia, 22401, United States
Plastic Surgery of Tuscaloosa

Tuscaloosa, Alabama, 35406, United States
Premier Plastic Surgery

Draper, Utah, 84020, United States
Providence Plastic Surgery & Skin Center

Charlotte, North Carolina, 28277, United States
Richmond Plastic Surgeons

Richmond, Virginia, 23233, United States
Robles Plastic Surgery

Phoenix, Arizona, 85014, United States
Sean A. Simon, MD

Miami, Florida, 33146, United States
Snodgrass and Robinson Plastic Surgery Specialists

Rome, Georgia, 30161, United States
South Florida Plastic Surgery

Fort Lauderdale, Florida, 33308, United States
Southeastern Plastic Surgery

Tallahassee, Florida, 32308, United States
Spa Renaissance & Renaissance Plastic Surgery

Troy, Michigan, 48083, United States
Summit Medical Group

Berkeley Heights, New Jersey, 07922, United States
Summit Plastic Surgery

Redding, California, 96001, United States
Susan E. Downey, MD Inc

Burbank, California, 91505, United States
The Center for Dermatology and Plastic Surgery

Alcoa, Tennessee, 37701, United States
The Center for You

Traverse City, Michigan, 49684, United States
The Columbus Institute for Plastic Surgery

Columbus, Ohio, 43212, United States
The Georgia Institute for Plastic Surgery

Savannah, Georgia, 31405, United States
The Hague Center for Cosmetic and Plastic Surgery

Norfolk, Virginia, 23510, United States
The Plastic Surgery Institute of Miami

Coral Gables, Florida, 33134, United States
The Swan Center for Plastic Surgery

Alpharetta, Georgia, 30005, United States
Tim R. Love, M.D., P.C.

Oklahoma City, Oklahoma, 73120, United States
University of Miami / Sylvester Comp Cancer Ctr

Coral Gables, Florida, 33146, United States
Upstate Plastic Surgery

Greer, South Carolina, 29650, United States
Vanderpool Cosmetic Plastic Surgery

Fayetteville, Arkansas, 72703, United States
Verve Plastic Surgery

Solana Beach, California, 92075, United States

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