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Breast implant safety under review in 400 women

NCT ID NCT02724371

Disease control Sponsor: Mentor Worldwide, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study follows 400 women for 10 years to see how safe and effective Mentor MemoryGel Ultra High Profile breast implants are for breast reconstruction after mastectomy or for revision surgery. Researchers track problems like repeat surgeries, infection, and capsular contracture. The goal is to confirm long-term safety in real-world use.

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

400 people

The number who actually took part.

Started

Apr 2016

Expected to finish

Jan 2029

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: * Subject is female and is at least 18 years old * A candidate for: * Primary breast reconstruction in women at least 18 years old with surgically absent breast tissue (two-stage reconstruction \[tissue expanders utilized with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement\] to replace breast tissue post-mastectomy) * Revision surgery in women at least 18 years old with surgically absent breast tissue (previous reconstruction with silicone-filled or saline-filled implants or revision reconstruction requiring expansion surgery prior to surgery for study device implantation, with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement) * Subject understands and signs the Informed Consent * Subject agrees to return device to Mentor if device is explanted * Subject agrees to comply with follow-up procedures, including returning for all follow-up visits * Physician determines implant volume appropriate for the patient taking into account the subject's BMI and chest width Exclusion Criteria: * Subject is pregnant at time of enrollment * Subject is a current smoker, or has smoked within 3 months prior to enrollment, or plans to resume smoking within 3 months post-enrollment * Currently has uncontrolled diabetes (at time of screening or enrollment) * Has nursed a child within 3 months of study enrollment * Confirmed or suspected diagnosis of the following rheumatological autoimmune diseases or immune compromised status: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome * Currently has a condition that could compromise or complicate wound healing. Note, obesity alone is not an exclusion. All surgical risk factors (obesity, diabetes, smoking history, and prior radiation) should be considered in totality for proper subject selection * Infection or abscess anywhere in the body * Demonstrates tissue characteristics that are clinically incompatible with successful use of a breast implant (e.g. inadequate tissue or compromised vascularity) * Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk * Anatomic or physiologic abnormality that could lead to significant postoperative adverse events * Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure * Untreated active, or inappropriately/inadequately treated breast malignancy, without surgical treatment * Anticipated need for use of ADM/mesh at the time of implant or implant exchange * Subject is HIV positive * Works for Mentor or the study doctor or is directly related to anyone who works for Mentor or the study doctor * Implanted metal or metal devices that make a MRI scan prohibitive, history of claustrophobia or other condition that would make a MRI scan prohibitive

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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.

Breast reconstruction Breast reconstruction, revision breast reconstruction Revision breast reconstruction

Contacts and locations

Locations

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Adventist Health Bakersfield

    Bakersfield, California, 93301, United States

  • Andres Plastic Surgery

    Scottsdale, Arizona, 85260, United States

  • Baylor Scott & White Health

    Temple, Texas, 76508, United States

  • Buckhead Plastic Surgery, P.C

    Atlanta, Georgia, 30342, United States

  • Georgia Institute of Plastic Surgery

    Savannah, Georgia, 31405, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Legacy Good Samaritan Medical Center

    Portland, Oregon, 97210, United States

  • Liu Plastic Surgery

    Los Gatos, California, 95032, United States

  • Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB)

    Phoenix, Arizona, 85054, United States

  • Mosharrafa Plastic Surgery

    Phoenix, Arizona, 85028, United States

  • Paul Glat, MD, PC

    Bala-Cynwyd, Pennsylvania, 19087, United States

  • Plastic Surgery Associates of Montgomery

    Montgomery, Alabama, 36117, United States

  • Plastic Surgery Institute of Dayton

    Centerville, Ohio, 45458, United States

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

  • Susan E Downey MD, Inc

    Burbank, California, 91505, United States

  • The Center for Dermatology and Plastic Surgery at Springbrook

    Alcoa, Tennessee, 37701, United States

  • The Centre, PC

    Mishawaka, Indiana, 46545, United States

  • The Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • The Mount Sinai Medical Center

    New York, New York, 10029, United States

  • The Ohio State University Plastic Surgery

    Columbus, Ohio, 43212, United States

  • The Plastic Surgery Group

    Cincinnati, Ohio, 45227, United States

  • The Plastic Surgery Group PC

    Chattanooga, Tennessee, 37403, United States

  • The University of Kansas

    Kansas City, Kansas, 66160, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UVA Health System

    Charlottesville, Virginia, 22903, United States

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.