A late complication following the insertion of hydrogel breast implants

This case report draws attention to an unusual presentation and subsequent complication following the insertion of a PIP Hydrogel(R) implant for breast augmentation. A cutaneous and capsular foreign body giant cell reaction was identified, and was preceded by the development of a notable increase in breast volume prior to spontaneous discharge. We believe that this was caused by subclinical leakage of the implant contents through a degrading shell. The biodegradability of hydrogel makes it impossible to ascertain the precise nature of the material that leaked out. Given this demonstrable leakage, the adverse clinical effects and the potential for toxicity that is currently unknown, we question whether this product (and other hydrogel breast implants like it) should be formally recalled for the benefit of patient safety. (C) 2006 The British Association of Plastic Surgeons. Published by Elsevier Ltd. All rights reserved.