| Summary: | Background: Preoperative signs and symptoms of patients with Poly Implant Prothese (PIP) implants could be predictive of device failure. Based on clinical observation and intraoperative findings 4 hypotheses were raised: (1) Preoperative clinical signs including acquired asymmetry, breast enlargement, fullness of the lower pole, decreased mound projection, and change in breast consistency could be indicative of implant rupture. (2) Device failure correlates with a low preoperative Baker grade of capsule. (3) Brown-stained implants are more prone to implant failure. (4) The brown gel could be indicative of iodine ingression through a substandard elastomer shell.
Methods: Preoperative clinical signs were compared with intraoperative findings for 27 patients undergoing PIP implant explantation.
Results: Acquired asymmetry (P = 0.0003), breast enlargement (P = 0.0002), fuller lower pole (P < 0.0001), and loss of lateral projection (P < 0.0001) were all significantly predictive of device failure. Capsule Baker grade was lower preoperatively for ruptured implants. The lack of palpable and visible preoperative capsular contracture could be secondary to the elastic nature of the capsular tissue found. Brown implants failed significantly more often than white implants. Analysis of brown gel revealed the presence of iodine, suggesting povidone iodine ingression at implantation.
Conclusions: Preoperative signs can be predictive of PIP implant failure. Brown-stained implants are more prone to rupture. The presence of iodine in the gel suggests unacceptable permeability of the shell early in the implant’s life span. A noninvasive screening test to detect brown implants in situ could help identify implants at risk of failure in those who elect to keep their implants.
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