| abstract |
Disclosed is a prosthesis for implantation into human soft tissue which is constructed of a suitable implantable envelope and contents to form a breast shape when implanted, such as silicone gel, saline, or a combination of silicone gel and saline contained within a silicone elastomer envelope, which has been labeled with radioopaque markers. The envelope is labeled with a marker that absorbs electromagnetic energy to an extent different from that of the envelope, its contents and the human soft tissue in the breast cavity into which the prosthesis is implanted which makes possible the use of roentgenographic imaging to determine whether the envelope has ruptured or whether the 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 the contents, such as silicone gel, have escaped from the envelope of the prosthesis by labeling the envelope with radioopaque materials, as mentioned above, and a method for determining whether fold-fault failure of the envelope of the implanted prostheses is likely to occur. |