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Which breast implants trigger hardening? 3,000 women tracked for five years

NCT ID NCT07810231

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 silicone or saline breast implants to see whether implant age, pocket plane, incision route, surface texture, and volume predict capsular contracture, a complication where scar tissue tightens around the implant. Women with mild or no contracture at the start receive standardized annual breast exams for up to five years. The study tracks how often and when painful or visibly distorted contracture appears, along with imaging, treatment, and patient-reported outcomes.

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 predict capsular contracture, surgeons could use that information when planning implant choice and placement, and women could get clearer guidance on long-term risks.
What could go wrong
This is an observational cohort, so it can show links between implant features and contracture but cannot prove cause and effect. Five years of follow-up may miss problems that appear later, and women who leave the study could skew the picture.

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 and no clinically significant capsular contracture at cohort entry.

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 or saline implants under the final protocol. * Baker grade I or II in the analyzed breast at cohort entry, confirmed by standardized examination. * Known implantation date or year and known pocket plane, incision route, surface texture, and volume. * Ability to complete annual clinical assessment for up to five years. * Written informed consent. Exclusion Criteria: * Baker grade III or IV contracture at cohort entry in the analyzed breast. * Reconstructive implantation after mastectomy or major trauma. * Tissue expander. * Active breast infection or open wound at enrollment. * Planned immediate implant exchange or explantation. * Missing core implant or operative data.

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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.

Capsular contracture of breast implant

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