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10-Year study tracks safety of silimed smooth breast implants

NCT ID NCT05345821

Disease control Sponsor: Silimed Industria de Implantes Ltda 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 384 women receiving Silimed smooth surface breast implants for augmentation over 10 years. Researchers will track complications and patient satisfaction to evaluate the implant's safety and performance. Participants must be 18 or older and seeking breast enlargement for the first time or as a revision.

What this could mean

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

Active substance
Silimed smooth surface breast implant
What this could lead to
If successful, this study could confirm that Silimed smooth breast implants are safe and effective for breast augmentation, providing reliable data for patients and doctors.
What could go wrong
This is an observational post-market study, not a controlled trial, so results may not prove cause and effect. Long-term risks like rupture or capsular contracture 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.

Participants

About 384 people

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

Started

Oct 2022

Expected to finish

Aug 2036

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

Born females with indication of primary and secondary augmentation (revision).

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Provide written informed consent * Female at birth * Be 18 years of age or older * Have a complaint of hypomastia * Have an indication for breast augmentation with silicone implants * Ability to comply with the protocol throughout the follow-up period. Exclusion Criteria: * Replacement of breast implants due to a complication * Breast reconstruction in at least one breast * Informed pregnancy or breastfeeding at the time of inclusion * Sequelae of mastopexy * Ptosis requiring mastopexy * Breast changes or lumps rated BI-RADS 3 or higher on preoperative ultrasound or mammograms * Advanced fibrocystic disease at the time of implantation * Neoplasia of any type not yet treated or undergoing treatment at the time of implantation, - Active infection not yet treated or undergoing treatment at any site at the time of implantation * Report or record of adverse reactions or intolerance to silicone prior to implantation * Report or record of immune diseases affecting the active or undergoing treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation * Signs of inflammation of the breast or implant site at the time of implantation * Increased risk of post-implantation complications -immediate surgical complications caused by illicit drug use or medication use * Having participated in another clinical trial within 6 months prior to implant placement * Any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, make study participation unsafe, compromise protocol adherence, complicate the interpretation of study outcome data, or otherwise interfere with the achievement of study objectives

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Conditions

The condition(s) this trial relates to.

Personal Satisfaction

As listed by the trial registrant

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

Breast implant complications Quality of life Safety and performance Satisfaction

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

  • Fundação do ABC - Centro universitário FMABC

    RECRUITING

    Santo André, São Paulo, 09060-870, Brazil

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