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

Silimed Industria de Implantes

Status

Enrolling

Conditions

Breast Implant; Complications

Satisfaction

Quality of Life

Treatments

Device: Silimed® Textured Silicone Gel-Filled Breast Implant

Device: Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant

Study type

Observational

Funder types

Industry

Identifiers

NCT03356132

6002030

Details and patient eligibility

About

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.

Enrollment

632 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.