Clinical trial NCT05345821: An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants with Smooth Surface
Official title: Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants with Smooth Surface (STEPS S)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Implant; Complications
Quality of Life
Satisfaction
Safety and Performance
Keywords: Breast Implant
satisfaction
qualify of life
smooth surface
post-market
safety
efficacy
Lead sponsor: Silimed Industria de Implantes Ltda
Sponsor class: INDUSTRY
Collaborators: name: Centro Universitário Saúde ABC
First posted: 2022-04-26
Enrollment: 384
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Born females with indication of primary and secondary augmentation (revision).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Expected Adverse Events
timeFrame: Every three years over the 10-year duration of the study
measure: Unexpected Adverse Events
timeFrame: Every three years over the 10-year duration of the study
Secondary outcomes:
measure: Patient's Satisfaction in Relation to Aesthetic Result
timeFrame: Every three years over the 10-year duration of the study
measure: Patient's Satisfaction in General
timeFrame: Every three years over the 10-year duration of the study
measure: Evaluator's Satisfaction in Relation to Aesthetic Result
timeFrame: Every three years over the 10-year duration of the study
measure: Patient's Quality of Life
timeFrame: Every three years over the 10-year duration of the study
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Fundação do ABC - Centro universitário FMABC
state: São Paulo
Study officials:
affiliation: Fundação do ABC - Centro Universitário FMABC
name: André Luiz P de Freitas
role: PRINCIPAL_INVESTIGATOR
References: