Clinical trial NCT03356132: An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants
Official title: Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants with Textured Surface and Polyurethane Foam-coated Surface
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Implant; Complications
Quality of Life
Satisfaction
Keywords: breast implant
complication
satisfaction
quality of life
augmentation
textured
polyurethane
Lead sponsor: Silimed Industria de Implantes Ltda
Sponsor class: INDUSTRY
First posted: 2017-11-29
Enrollment: 632
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 years old or older who have undergone breast augmentation using Silimed® silicone gel-filled breast implants with textured surface or Silimed® silicone gel-filled breast implants with polyurethane foam coated surface.

Brief summary: 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.


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.

Primary outcomes:
measure: Expected Adverse Events
timeFrame: Every three years through the 10 years length of the study.
measure: Unexpected Adverse Events
timeFrame: Every three years through the 10 years length of the study.
Secondary outcomes:
measure: Patient's Satisfaction in Relation to Aesthetic Result
timeFrame: Every three years through the 10 years length of the study.
measure: Patient's Satisfaction in General
timeFrame: Every three years through the 10 years length of the study.
measure: Evaluator's Satisfaction in Relation to Aesthetic Result
timeFrame: Every three years through the 10 years length of the study.
measure: Patient's Quality of Life
timeFrame: Every three years through the 10 years length of the study.
Other outcomes:
Locations:
city: Niterói
country: Brazil
facility: Perfektua Serviços Médicos Ltda
state: Rio de Janeiro
Study officials:
affiliation: Perfektua Serviços Médicos Ltda
name: Celso EJ Boechat, MD
role: PRINCIPAL_INVESTIGATOR
References: