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

Launched by SILIMED INDUSTRIA DE IMPLANTES LTDA · Nov 22, 2017

Keywords

ClinConnect Summary

This clinical trial is studying two types of Silimed® silicone gel breast implants to see how safe they are and how satisfied women feel after getting them. The implants being compared have different surfaces: one has a textured surface, and the other is coated with a special foam. Women who have had breast augmentation for the first time or have had it done before will be followed for up to 10 years to track any side effects or complications and to assess their quality of life and overall satisfaction after the procedure.

To join the study, participants need to be assigned female at birth, at least 18 years old, and have received their implants within 21 days before joining the study. They should also be able to follow the study rules over the follow-up period. However, this study is not for women who have had previous breast reconstructions, are currently pregnant or breastfeeding, or have certain health conditions that could complicate the results. Those who participate can expect regular follow-ups to monitor their health and satisfaction with the implants over time.

Gender

FEMALE

Eligibility criteria

• 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.