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

Sponsor

Silimed Industria de Implantes Ltda (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03356132

Collaborator

(none)

1,052

Enrollment

Location

196

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Implant; Complications Quality of Life Satisfaction	Device: Silimed® Textured Silicone Gel-Filled Breast Implant Device: Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant

Study Design

Study Type:

Observational

Anticipated Enrollment :

1052 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 31, 2018

Anticipated Primary Completion Date :

Jul 1, 2033

Anticipated Study Completion Date :

Dec 1, 2034

Arms and Interventions

Arm	Intervention/Treatment
Textured Group Women undergoing primary and secondary breast augmentation with Silimed® Textured Silicone Gel-Filled Breast Implant.	Device: Silimed® Textured Silicone Gel-Filled Breast Implant Women undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant.
Polyurethane Group Women undergoing primary and secondary breast augmentation with Silimed® Polyurethane Foam Covered 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.

Arm

Intervention/Treatment

Textured Group

Women undergoing primary and secondary breast augmentation with Silimed® Textured Silicone Gel-Filled Breast Implant.

Device: Silimed® Textured Silicone Gel-Filled Breast Implant

Women undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant.

Polyurethane Group

Women undergoing primary and secondary breast augmentation with Silimed® Polyurethane Foam Covered 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.

Outcome Measures

Primary Outcome Measures

Expected Adverse Events [Annually through the 10 years length of the study.]
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
Unexpected Adverse Events [Annually through the 10 years length of the study.]
Estimate the unknown 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

Secondary Outcome Measures

Patient's Satisfaction in Relation to Aesthetic Result [Annually through the 10 years length of the study.]
Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface through the satisfaction of the patient regarding the aesthetic result after breast augmentation. The assessment of patient's satisfaction will be done by means of a likert scale, where the following satisfaction options can be selected: 1 = definitely satisfied, 2 = satisfied, 3 = slightly satisfied, 4 = slightly dissatisfied and 5 = definitely unsatisfied.
Patient's Satisfaction in General [Annually through the 10 years length of the study.]
Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface after breast augmentation by means of a questionnaire, the Breast Self-Assessment Questionnaire (BEQ-Brazil), which consist of 55 questions related to satisfaction and comfort with the overall appearance of the breasts.
Evaluator's Satisfaction in Relation to Aesthetic Result [Annually through the 10 years length of the study.]
Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface through the satisfaction of the evaluator regarding the aesthetic result after patient's breast augmentation. The assessment of evaluator's satisfaction will be done by means of a likert scale, where the following satisfaction options can be selected: 1 = definitely satisfied, 2 = satisfied, 3 = slightly satisfied, 4 = slightly dissatisfied and 5 = definitely unsatisfied.
Patient's Quality of Life [Annually through the 10 years length of the study.]
Estimate the performance of Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface through the quality of life of the patient after breast augmentation. The assessment of patient's quality of life will be done by means of the Rosemberg Global Self-Esteem Scale, in order to evaluate the overall self-esteem of the sample.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

women aged 18 years or older,
who had received breast implant(s) up to 21 days prior because of the need for primary or secondary breast augmentation,
ability to comply with the protocol for the entire follow-up time,
have received Silimed® textured breast implants or polyurethane foam coated surface breast implants,
provide free and informed consent.

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,
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.