Category Archives: Breast Implants
Cancellation of all Silimed Medical Devices
The TGA cancelled all medical devices manufactured by Silimed (sponsored in Australia by Device Technologies) from the Australian Register of Therapeutic Goods on 5 November 2016. The TGA is required to cancel an ARTG entry where the entry has been suspended and the time applied to the suspension has expired prior to the suspension being …
FAQS on breast implant associated with anaplastic large cell lymphoma (BIA-ALCL)
28 August 2017 The Therapeutic Goods Administration (TGA) has recently provided updated information regarding breast implant associated-anaplastic large cell lymphoma. The TGA has been posting updated information about this condition since 2011 and this updated alert was been generated following a recent expert advisory panel in view of additional generated from research performed by a …
Women with breast implants urged not to be alarmed by inaccurate reports on cancer link
FAQs on information about Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) 19 December 2016 The Therapeutic Goods Administration (TGA) has recently provided updated information regarding breast implant associated-anaplastic large cell lymphoma. The TGA has been posting updated information about this condition since 2011 and this updated alert was been generated following a recent expert …
Update on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA‐ALCL)
Women who are concerned about their breast implants following reports of a study linking infection caused by implants to a rare cancer, anaplastic large cell lymphoma (ALCL), should discuss their concerns with their doctor. The Therapeutic Goods Authority continues not to recommend preventative breast implant removal in patients without symptoms or other abnormality. ASPS is developing a …
Silimed medical devices suspended
The Therapeutic Goods Administration (TGA) is aware of the suspension in Europe of devices manufactured by Silimed that followed an audit of its manufacturing procedures. The TGA is urgently investigating to determine what action is required in Australia including testing of samples. As a precautionary measure, Device Technologies (the Australian distributor) has stopped any further …
Cereform breast implants and associated sizers recalled in Australia
The TGA has suspended the Cereform silicone gel-filled breast implants and associated sizers from the Australian Register of Therapeutic Goods effective 23 May 2014 for a period of 6 months unless earlier revoked by the TGA. The TGA advises consumers of the following: “If you have received a Cereform breast implant and did not experience …
New TGA device safety advisory highlights urgent need for device registry funding
The recall in France of French-manufactured, Cereform, silicon gel-filled breast implants highlights the urgent need for Government funding for a Breast Device Registry to ensure women are offered the best possible protection, according to the Australian Society of Plastic Surgeons. “A world-class registry has been developed in Australia and is ready for national roll-out pending …
PIP Implants – Lessons learned
The French court’s decision to jail PIP founder Jean Claud Mas for four years brings to a close this particular chapter in the PIP breast implant crisis and reminds us that earlier detection of the problems with the PIP implants could’ve prevented the number of women affected. Read more on the lesson’s learned. Related story – …
Information on PIP implants
The Therapeutic Goods Administration (TGA) has previously posted regular updates on the status of PIP Implants. Visit the TGA website to find out more. The Department of Health published a list of informative links regarding Poly Implant Prothèse (PIP) Breast Implants. Visit the Department of Health website to find out more.
