This case report draws attention to an unusual presentation and subsequent complication following the insertion of a PIP Hydrogel® 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.
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Published online: March 18, 2006
Accepted: January 12, 2006
Received: February 21, 2005
© 2006 The British Association of Plastic Surgeons. Published by Elsevier Inc. All rights reserved.
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- In response to ‘A late complication following the insertion of hydrogel breast implants’Journal of Plastic, Reconstructive & Aesthetic SurgeryVol. 60Issue 8
- PreviewThe experience of Adams et al.1 following explantation of a PIP Hydrogel implant is consistent with that of several other UK plastic surgeons who have reported problems to the Medicines and Healthcare products Regulatory Agency (MHRA). The product was recalled from the UK market in December 2000 following an MHRA investigation that revealed inadequate pre-clinical testing. At that time, there was no evidence of toxic effects that would indicate the need for prophylactic explantation and, prior to this, MHRA had received only one report of a problem with this implant.