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Which breast implants fail? 3,000-Woman study tracks rupture clues

NCT ID NCT07810205

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 intact silicone breast implants for up to five years to find out which implant and surgical features predict rupture. Participants undergo annual ultrasound, with MRI used when imaging suggests a problem. The study records implant age, pocket plane, incision route, surface texture, and volume, then uses survival models to estimate how each factor relates to rupture risk. Confirmed rupture requires MRI or surgical evidence.

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 the study identifies which implant features raise rupture risk, doctors and patients could make more informed choices about implant type and surgical technique, and surveillance schedules could be tailored to higher-risk implants.
What could go wrong
This is an observational cohort, so it can show associations but cannot prove that any implant or surgical feature causes rupture. Rupture is uncommon, so even with 3,000 participants some risk factors may not reach statistical significance, and results may not apply to reconstructive implants or other implant types.

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 silicone breast implants documented as intact at cohort entry, including new implant recipients and prevalent implant carriers.

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 augmentation with permanent silicone implants. * Known implantation date or sufficiently precise implantation year, pocket plane, incision route, surface texture, and implant volume. * Both implants or the analyzed implant documented as intact at baseline by the study imaging algorithm. * Ability to complete annual surveillance for up to five years. * Written informed consent. Exclusion Criteria: * Reconstructive implantation after mastectomy, congenital deformity, or major trauma. * Tissue expander or nonpermanent device. * Confirmed rupture at cohort entry for the implant under analysis. * PIP implant or another recalled device if the final protocol elects to exclude it from etiologic modeling. * Missing core implant characteristics or implantation date. * Planned immediate explantation or exchange at enrollment for a reason unrelated to surveillance.

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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 rupture

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