Library Subscription: Guest
Begell Digital Portal Begell Digital Library eBooks Journals References & Proceedings Research Collections
Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v12.i4.70
18 pages

An In Vitro Study of the Effect of In-Folds on the Durability of Mammary Implants

D. Coleman Richardson
Office of Science and Technology, Center for Devices and Radiological Health (HFZ-150), Food & Drug Administration, 9200 Corporate Boulevard, Rockville, MD 20850
Michael C. Long
Office of Science and Technology, Center for Devices and Radiological Health, Food & Drug Administration, Rockville, Maryland
LeRoy W. Schroeder
Office of Science and Technology, Center for Devices and Radiological Health, Food & Drug Administration, Rockville, Maryland
Richard W. Kisielewski
Office of Science and Technology, Center for Devices and Radiological Health, Food & Drug Administration, Rockville, Maryland

ABSTRACT

We hypothesize that the presence of in-folding in a filled mammary shell leads to shortening of the time to failure under tensile fatigue. Specimens, cut from pristine shells, were mounted in S-folded, creased, and unfolded configurations. A characteristic change, occurring in a transmembrane capacitance-proportional alternating current (AC) signal, which was used to monitor working of each specimen, was chosen as a robust marker that preceded frank shell perforation. Subjecting all specimens to stringent, controlled conditions led to time-to-fatigue failure estimates that demonstrated an order-of-magnitude reduction in lifetime for the folded specimens when compared with that for pair-matched, unfolded specimens. Creases also reduced the fatigue lifetime, but not to the degree that folds did. Observations based on the experimental behavior of folded shell material provide possible mechanisms for the potential lifetime clinical reduction of in-folded implants as well as for the development of silicone-on-silicone abrasive wear and generation of debris.