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Safety Information

Published: 8 June 2012

Silicone Gel Breast Implants Manufactured by Poly Implant Prosthese (PIP)

8 June 2012

Medsafe is providing the following information to the public and media about silicone gel breast implants manufactured by Poly Implant Prosthese (PIP) of France.

Issue

Breast implants manufactured by PIP have been filled with a non-approved silicone gel. The use of non-approved silicone gel may have an impact on the safety and performance of these implants. It is believed the filling of the implants with the non-approved gel commenced in 2001, so all PIP breast implants manufactured since January 2001 are implicated.

Testing of the breast implants by regulators in France, Australia, and the UK has found no evidence of toxicity with the filler used inside the implants.

PIP also manufactured or filled breast implants supplied by Rofil Medical (Netherlands) and Gfe Medizintechnik GmbH (Germany).

Since 2004 it has been a regulatory requirement for suppliers of medical devices (including breast implants) in New Zealand notify details of their devices to a database known as the Web Assisted Notification of Devices, or WAND, database. To date there have been no device notifications to the database for breast implants manufactured or filled by PIP. Medsafe believes there has been no commercial supply of these implants in New Zealand since 2004.

Medsafe has been advised that a small number of patients may have received PIP implants which had been imported from Australia by a New Zealand surgeon around 2003. Medsafe is investigating this report and will work with the New Zealand Association of Plastic Surgeons to further clarify the extent of usage.

Information for Patients

Ministry of Health has published a series of questions and answers about PIP implants which is available for download from the Ministry website via the link below.

PIP Frequently Asked Questions

Patients with concerns about their breast implants should contact their surgeon or healthcare professional to discuss their situation.

Information for Healthcare Professionals

Advisory information for GPs and healthcare professionals concerning PIP implants has been published on the Ministry of Health website at the link below.
http://www.health.govt.nz/news-media/news-items/pip-breast-implants

Links to more information

Links to information from the New Zealand Association of Plastic Surgeons and medical device Regulators concerning PIP Breast Implants

New Zealand Association of Plastic Surgeons
http://www.plasticsurgery.org.nz/

Australian Therapeutic Goods Administration (TGA)
http://www.tga.gov.au/safety/alerts-device-breast-implants-pip.htm

UK Medicines and Healthcare products Regulatory Authority (MHRA)
http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice-A-F/Breastimplants/PIPbreastimplants/index.htm

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