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Recruiting NCT03356132

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

— Observational Breast Implant; Complications Quality of Life Satisfaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Silimed® Textured Silicone Gel-Filled Breast Implant, Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant.
Who it may be relevant to
Registry conditions: Breast Implant; Complications, Quality of Life, Satisfaction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Textured Surface and Polyurethane Foam-coated Surface

Overview

The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.

Interventions

  • Device Silimed® Textured Silicone Gel-Filled Breast Implant
    Women undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant.
  • Device Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
    Women undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface.

Primary outcome measures

  • Expected Adverse Events [Time frame: Every three years through the 10 years length of the study.]
  • Unexpected Adverse Events [Time frame: Every three years through the 10 years length of the study.]
Secondary outcome measures (4)
  • Patient's Satisfaction in Relation to Aesthetic Result [Time frame: Every three years through the 10 years length of the study.]
  • Patient's Satisfaction in General [Time frame: Every three years through the 10 years length of the study.]
  • Evaluator's Satisfaction in Relation to Aesthetic Result [Time frame: Every three years through the 10 years length of the study.]
  • Patient's Quality of Life [Time frame: Every three years through the 10 years length of the study.]

Eligibility criteria

Inclusion criteria

  • provide written informed consent.
  • female at birth
  • be 18 years of age or older
  • have received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window)
  • having received a breast implant with a textured surface or a breast implant with a surface coated with Silimed® polyurethane foam
  • ability to comply with the protocol throughout the follow-up period.

Exclusion criteria

  • mammary reconstruction in at least one breast or augmentation after previous reconstruction,
  • pregnancy informed or breastfeeding at the inclusion moment,
  • advanced fibrocystic disease at the time of implantation,
  • neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation,
  • reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation,
  • immune diseases affecting active connective tissue or (eg, 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 immediate postoperative complications due to use of illicit drugs or medications,
  • Increased risk of immediate post-surgical complications caused by illicit drug use or medication use,
  • have participated in another clinical study up to 6 months prior to the placement of the implant,
  • any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, renders participation in the study is unsafe, compromises adherence to the protocol, complicates the interpretation of data from the study outcome, or otherwise interferes with the achievement of study objectives.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Brazil · 1 center
  • Perfektua Serviços Médicos Ltda — Niterói

Identifiers

NCT: NCT03356132 · 6002030

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗