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

Quality of Life Clinical Trial

— STEPS A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03356132
• Other study ID #: 6002030
• Status: Recruiting
• Start date: July 31, 2018
• Est. completion date: December 2034

Study information

• Verified date: January 2023
• Source: Silimed Industria de Implantes Ltda
• Contact: Ludmila C Donato
• Phone: +552198399-0573
• Email: pesquisaclinica[@]silimed.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 632
• Est. completion date: December 2034
• Est. primary completion date: July 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Implant; Complications
• Quality of Life
• Satisfaction

Intervention

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

Locations

Country	Name	City	State
Brazil	Perfektua Serviços Médicos Ltda	Niterói	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Silimed Industria de Implantes Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Every three years through the 10 years length of the study.
Primary	Unexpected Adverse Events	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	Every three years through the 10 years length of the study.
Secondary	Patient's Satisfaction in Relation to Aesthetic Result	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.	Every three years through the 10 years length of the study.
Secondary	Patient's Satisfaction in General	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.	Every three years through the 10 years length of the study.
Secondary	Evaluator's Satisfaction in Relation to Aesthetic Result	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.	Every three years through the 10 years length of the study.
Secondary	Patient's Quality of Life	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.	Every three years through the 10 years length of the study.