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

NCT03356132 | Recruiting

• 1 other identifier: 6002030
• Study Type: observational
• Target: 632
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Implant; Complications; Quality of Life; Satisfaction

Keywords

breast implant; complication; satisfaction; quality of life; augmentation; textured; polyurethane

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• Patient's Satisfaction in Relation to Aesthetic Result

  Every three years through the 10 years length of the study.

• Patient's Satisfaction in General

  Every three years through the 10 years length of the study.

• Evaluator's Satisfaction in Relation to Aesthetic Result

  Every three years through the 10 years length of the study.

• Patient's Quality of Life

  Every three years through the 10 years length of the study.

Study Arms (2)

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

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

Interventions

Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant DEVICE

Women undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface.

Polyurethane Group

Silimed® Textured Silicone Gel-Filled Breast Implant DEVICE

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

Textured Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 years old or older who have undergone breast augmentation using Silimed® silicone gel-filled breast implants with textured surface or Silimed® silicone gel-filled breast implants with polyurethane foam coated surface.

You may qualify if:

• 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.

You may not qualify if:

• mammary reconstruction in at least one breast or augmentation after previous reconstruction,
• 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.

Sponsors & Collaborators

• Silimed Industria de Implantes Ltda: lead

Study Sites (1)

Perfektua Serviços Médicos Ltda

Niterói, Rio de Janeiro, 24230-052, Brazil

RECRUITING

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Celso EJ Boechat, MD

  Perfektua Serviços Médicos Ltda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludmila C Donato

CONTACT

+552198399-0573; pesquisaclinica@silimed.com.br

Maria Clara M Sodré

CONTACT

+55212784-2764; pesquisaclinica@silimed.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 29, 2017
• Study Start: July 31, 2018
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): December 1, 2036
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD will be shared starting 6 months after the end of the study.
• Access Criteria: It was not defined yet.

Locations

BR (1)