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

Silimed Industria de Implantes

Status

Enrolling

Conditions

Breast Implant; Complications

Satisfaction

Quality of Life

Safety and Performance

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05345821

6001022

Details and patient eligibility

About

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.

Enrollment

384 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 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