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

Launched by SILIMED INDUSTRIA DE IMPLANTES LTDA · Apr 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of Silimed® smooth surface breast implants in women who are seeking either their first breast augmentation (primary) or a revision of a previous augmentation (secondary). Over a period of 10 years, researchers will look at any side effects or complications that might arise after the implants are placed, as well as how satisfied participants feel with their results and how their quality of life may improve.

To participate in this trial, women must be at least 18 years old, have concerns about breast size (hypomastia), and be eligible for breast augmentation with silicone implants. However, individuals with certain medical conditions or past complications related to breast surgery may not qualify. Participants will be asked to provide regular updates about their experiences and any issues they might face after getting the implants, helping researchers gather important information on both safety and satisfaction.

Gender

FEMALE

Eligibility criteria

• 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