Evaluation of Asymptomatic Rupture of Breast Implants Filled with Silimed Silicone Gel

Abstract

Introduction

Breast augmentation is a cosmetic surgery dating back to 1895, which gained popularity in the 1960s with the introduction of silicone implants. Although it is a common procedure, complications such as implant rupture can occur. “Silent” rupture is particularly concerning, as it presents no symptoms and requires careful monitoring. The United States Food and Drug Administration (FDA) recommends ultrasound (USG) or magnetic resonance imaging (MRI) to identify silent rupture.

Objective

To evaluate the rate of asymptomatic rupture in patients with smooth and textured external envelope breast implants from the Silimed (Silimed Indústria de Implantes Ltda.) brand through MRI.

Materials and Methods

We selected 97 surgeons from different cities in Brazil who kept records of patients with Silimed. Patients with implants from other manufacturers, pregnant women, and those with contraindications for MRI were excluded. The selected patients underwent clinical exams and MRI scans, with image analysis performed by independent radiologists. Suspected ruptures were confirmed surgically.

Results

Of the 161 patients evaluated, only 2 (0.63%) had a suspected implant rupture confirmed surgically, both after 9 years of implantation: one with a smooth implant and the other with a textured implant. Most Silimed implants were considered intact: 99.67% of the textured and 95.24% of the smooth implants.

Conclusion

The present study contributes to scientific knowledge about breast implant ruptures and suggests that Silimed implants are safe. The rate of asymptomatic rupture observed in implants with a duration of 5 to 10 years was low.

Keywords

adverse events - asymptomatic rupture - breast implant - implant rupture - silicone gel

Ethics Committee Number

174.

Study performed at Hospital Pró-Cardíaco, Rio de Janeiro, RJ, Brazil.

Publication History

Received: 10 November 2023

Accepted: 24 March 2025

Article published online:
20 June 2025

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