An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants with Smooth Surface

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-05

Study Completion Date

2035-12-31

Brief Summary

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The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.

Detailed Description

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Conditions

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Breast Implant; Complications Quality of Life Satisfaction Safety and Performance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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primary augmentation group

Women undergoing primary breast augmentation with Silimed® smooth surface Breast Implant.

No interventions assigned to this group

secondary (revision) augmentation group

Women undergoing secundary or revision breast augmentation with Silimed® smooth surface Breast Implant.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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André Luiz P de Freitas

Role: PRINCIPAL_INVESTIGATOR

Fundação do ABC - Centro Universitário FMABC

Locations

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Fundação do ABC - Centro universitário FMABC

Santo André, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Ludmila C Donato

Role: CONTACT

[email protected]

+552198399-0573 ext. 2184-2771

Julia Maria V Roberto

Role: CONTACT

[email protected]

+55212784 - 2772

Facility Contacts

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David E Uip

Role: primary

Other Identifiers

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6001022

Identifier Type: -

Identifier Source: org_study_id