No abstract

No abstract

The discussion on possible side effects of implanted silicone has resulted in a growing number of patients inquiring whether or not their mammary prostheses are intact and when failure of the prostheses is to be expected. Between November 1988 and May 1995, 182 patients had their silicone mammary prostheses replaced, repositioned, or removed one to three times. Capsular contraction, dislocation, pain paresthesia, and/or suspected rupture were common indications for surgery. To try and be able to provide an indication as to the correlation of implant age and integrity, we recorded the status of all 426 prostheses observed during secondary surgery. In this selected group of patients, approximately 50 percent of the mammary prostheses with an implant age of 7 to 10 years showed gel bleed or rupture. Applying the survival Kaplan-Meier curve, 50 percent of implants may be expected to bleed or be ruptured at the age of 15 years. Rupture was observed more frequently than gel bleed. It seems that there is no chronologic relation between gel bleed and rupture.

We prospectively studied the accuracy of magnetic resonance imaging (MRI) and ultrasonography (US) for preoperative detection of rupture in 35 single-lumen implants filled with silicone gel in 18 patients. The positive predictive value of US for rupture of an implant was 70% and the negative predictive value 64%. Sensitivity and specificity were 44% and 87%, respectively. Accuracy, defined as the total true positive and true negative values divided by the total number of implants studied was 66%. The positive predictive value of MRI was 100% and the negative predictive value 90%. The corresponding sensitivity and specificity were 88% and 100% and the accuracy 94%. MRI offers significantly better diagnostic sensitivity (p = 0.02) and accuracy (p = 0.004), and should be regarded as the "gold standard" in the evaluation of rupture of breast implants filled with silicone gel. When MRI is not readily available, US is an acceptable alternative.