Prospective study on Trilucent soybean oil-filled breast prosthesis

Area of Science:

• Biomaterials Science
• Plastic Surgery
• Medical Device Analysis

Background:

• Trilucent breast implants, introduced in 1995, utilized a soybean oil filler aiming to improve upon saline and silicone gel implants.
• These implants were marketed as biodegradable and biocompatible but were later found to be prone to premature aging and shell rupture.
• The manufacturer withdrew Trilucent implants from the market due to these issues, offering removal or replacement.

Purpose of the Study:

• To investigate the clinical performance and failure mechanisms of Trilucent breast implants.
• To analyze the physical characteristics of removed Trilucent implants and identify causes of degradation.

Main Methods:

• A clinical study involving 36 patients who received 63 Trilucent implants and 33 patients who had 58 implants removed.
• Visual inspection and scanning electron microscopy (SEM) analysis of the removed implant shells to assess aging and rupture.

Main Results:

• Removed Trilucent implants exhibited discoloration (yellow and brown) and numerous whitish-yellow nodules, increasing with implantation time.
• SEM analysis revealed a heterogeneous inner surface of the implant shell, characterized by fissures and globoid deposits.
• These findings indicate significant material degradation and structural compromise.

Conclusions:

• The observed deterioration of Trilucent implants is consistent with findings for other breast implant types, showing rapid degradation after an initial period.
• The study highlights the material instability and failure modes associated with Trilucent breast implants.
• These results underscore the importance of long-term material integrity in implantable medical devices.