MAERKT BROESTPROTES OCH FOERFARANDEN FOER DETEKTERING OCH FOERUTSAEGNING AV BRISTNING I PROTESEN.

摘要

Disclosed is a prosthesis for implantation into human soft tissue which is constructed of silicone gel, saline, or a combination of silicone gel and saline contained within a silicone elastomer envelope which has been labeled with radioopaque markers. Labeling the silicone elastomer envelope according to the present invention makes possible the use of roentgenographic imaging to determine whether the silicone elastomer envelope has ruptured and whether the silicone elastomer envelope is folded persistently in a particular location increasing the probability that the envelope may rupture along the fold line. Also disclosed is a method for using roentgenography to determine whether silicone gel has escaped from the silicone elastomer envelope of a prosthesis by labeling the silicone elastomer envelope with radioopaque materials and a method for determining whether fold-fault failure of the silicone elastomer envelope of implanted prostheses is likely to occur.