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Can implant age and texture predict shell fissure?

NCT ID NCT07810257

Knowledge-focused Sponsor: Research Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are following 3,000 women with aesthetic breast implants for up to five years to learn what predicts a tear in the implant shell. Participants have no sign of fissure or rupture at the start. Each year they receive ultrasound, and MRI when needed, to check the implant shell. The study tracks implant age, pocket plane, incision route, surface texture, and volume to see which factors link to the first confirmed fissure.

What this could mean

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

What this could lead to
If researchers identify which implant features predict shell fissure, that could guide safer implant choices and earlier detection for women with breast implants.
What could go wrong
This is an observational study, so it can show links but not prove cause and effect. Findings may not apply to all implant types or to women with reconstructive implants, who are excluded.

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.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2014

Expected to finish

Dec 2026

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.

Who is studied

Adult women with aesthetic breast implants that are intact and without a documented shell fissure at baseline.

Ages

18 years and older

Sex

Anyone

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: * Female sex and age 18 years or older. * Aesthetic breast implant with known implantation date or year and known pocket plane, incision route, surface texture, and volume. * No fissure or rupture identified by the baseline imaging algorithm. * Ability to undergo annual ultrasound and confirmatory MRI when indicated. * Written informed consent. Exclusion Criteria: * Confirmed fissure or rupture at cohort entry. * Reconstructive breast implantation or tissue expander. * Immediate planned implant removal or exchange. * Missing core implant characteristics. * MRI contraindication when MRI is required to adjudicate a suspected event. * Recalled/PIP implant if excluded by the final analytic plan.

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Conditions

The condition(s) this trial relates to.

Surgical Wound

As listed by the trial registrant

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

Breast implant complication Breast implant shell defect

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • IQ interquirofanos

    RECRUITING

    Medellín, Colombia