What exactly was wrong with the Trilucent breast implants? A unifying hypothesis

Area of Science:

• Plastic Surgery
• Biomaterials Science
• Medical Device Safety

Background:

• Trilucent soybean oil-filled breast implants were marketed as advanced prostheses.
• Concerns arose regarding local complications and hazardous metabolites from lipid oxidation.
• Regulatory agencies in the UK and Belgium advised against their use and recommended removal.

Purpose of the Study:

• To investigate the complications and explantation outcomes of triglyceride-filled breast implants.
• To analyze the physical and biochemical properties of explanted soybean oil-filled implants.
• To identify the underlying causes of adverse events associated with these prostheses.

Main Methods:

• Clinical examination of 13 patients who received soybean oil-filled implants.
• Exploration of 12 explanted prostheses, including assessment of shape, volume, and firmness.
• Magnetic resonance imaging (MRI), blood and urine analyses, and biochemical examination of implant contents.

Main Results:

• Five patients experienced prosthesis rupture leading to unilateral breast enlargement.
• Explanted implants showed shell deterioration, filler material degradation, increased osmotic pressure, and inflammatory reactions.
• Biochemical analysis revealed lipid infiltration, formation of soap-like material, and toxic oxidation products.

Conclusions:

• Triglyceride-filled implants are associated with significant risks including bleeding, shell deterioration, and inflammation.
• Lipid oxidation and degradation of filler material contribute to implant failure and adverse patient outcomes.
• A unifying hypothesis suggests implant bleeding, lipid infiltration, and inflammation explain the variety of adverse events.