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

Silimed Industria de Implantes Ltda632 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

632

Conditions

Breast Implant; Complications Quality of Life Satisfaction

Interventions

Silimed® Textured Silicone Gel-Filled Breast Implant

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Expected Adverse Events

Estimate the known short-term and long-term risk / adverse event rate for Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface