Aging of non-implanted Natrelle™ gel breast implants

Area of Science:

• Biomaterials Science
• Medical Device Engineering
• Plastic Surgery Research

Background:

• Non-implanted breast prostheses are widely used in reconstructive and aesthetic surgery.
• Understanding the long-term mechanical integrity of these devices is crucial for patient safety and outcomes.
• Previous research has explored various aspects of breast implant aging, but long-term mechanical property changes require further investigation.

Purpose of the Study:

• To investigate the aging process of non-implanted breast prostheses (Natrelle™) over a 9-60 month period.
• To analyze the changes in mechanical properties, including strength at break, elongation at break, and shell thickness.
• To determine the influence of aging duration, manufacturing lot, and prosthesis side (anterior vs. posterior) on these properties.

Main Methods:

• Testing of Natrelle™ prostheses every 6 months for up to 60 months.
• Measurement of strength at break, elongation at break, and shell thickness from anterior and posterior samples.
• Calculation of breaking stress.
• Statistical analysis using one-way ANOVA to assess the impact of aging, lot, and side.

Main Results:

• Shell thickness and elongation at break showed significant variations with aging, irrespective of the side, but without a discernible trend.
• Significant disparities were observed in other mechanical properties between the anterior and posterior sides.
• Differences were noted between prostheses from different manufacturing lots, while prostheses from the same lot showed similarities.
• Shell thickness was consistently lower on the anterior side compared to the posterior side.

Conclusions:

• Shell thickness is a critical parameter influenced by the manual manufacturing process and significantly affects mechanical properties.
• The observed variations in thickness and mechanical properties between anterior and posterior sides highlight the need for stringent quality control during manufacturing.
• Ensuring homogeneous shell thickness on both sides is recommended as part of routine quality control procedures for breast prostheses.