The 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. This concerned implant rupture associated
with capsular contracture and the presence of approximately 30 ml of straw coloured
fluid in the breast pocket. Since the product was withdrawn, around 50 cases have
been reported to MHRA, in which breast swelling has typically been associated with
the presence of fluid in the pocket surrounding the implant. The manufacturer, PIP,
has carried out testing of the periprosthetic fluid, when it has been made available
for investigation. However, to date, no new information of clinical significance has
come to light either on the nature of the periprosthetic fluid or on any degradation
products of the filler material.To read this article in full you will need to make a payment
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References
- A late complication following the insertion of hydrogel breast implants.J Plast Reconstr Aesthet Surg. 2007; 60: 210
The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) is an independent scientific committee that provides advice to the Food Standards Agency, the Department of Health and other Government Departments and Agencies on matters concerning the toxicity of chemicals.
COT Statement 2006/03 at www.advisorybodies.doh.gov.uk/cotnonfood/hydrogel.htm
http://www.mhra.gov.uk/mhra/breastimplants
Article info
Publication history
Published online: May 17, 2007
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© 2007 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Inc. All rights reserved.
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- A late complication following the insertion of hydrogel breast implantsJournal of Plastic, Reconstructive & Aesthetic SurgeryVol. 60Issue 2
- PreviewThis 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.
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