TGA Safety AdvisorySafety advisory, 27 January 2012Source: http://www.tga.gov.au/safety/alerts-device-breast-implants-120127.htmAs part of its regulatory activities, the TGA encourages reports of problems with medical devices to help identify and respond to safety concerns. The publicity surrounding the problems with PIP breast implants, including direct contact by the TGA with every surgeon known to have used these implants, has resulted in a continual increase of the number of ruptures reported to the TGA.As of 26 January 2012, the TGA had received:
102 confirmed reports* of rupture of PIP breast implants
14 unconfirmed reports of rupture of PIP breast implants.
* = The TGA categorises reports as ‘confirmed’ if there is sufficient information to uniquely identify:
the patient
the implant used
that an X-Ray or other diagnostic image showed that the device was ruptured; or the implant was found to be ruptured when it was removed.
The TGA is continuing to investigate these reports.
TGA Laboratory testing program
The TGA has convened an international laboratory testing group to share information on testing of PIP implants. In collaboration with this group, the TGA is continuing to undertake testing of PIP implants, including some that have been surgically removed, and will progressively release information on the outcomes of its scientific testing as confirmed results become available.
Information for patients
Patients with PIP implants or who are unsure about the brand of their breast implants should consult their general practitioner or surgeon for individual clinical assessment and advice.
The Australian Government has set up a free call Breast Implant Information Line on 1800 217 257. Anyone concerned about their breast implants can call this line for further information.
Industry messages regarding device safety
Allergan and Mentor have released communications regarding the safety of their devices. The statements are available on the ASPS website. To read them, please click here.
TGA and Chief Medical Officer
In December 2011 ASPS President, A/Prof Cooter, was invited by the TGA to join the Chief Medical Officer’s Advisory Group on PIP. A/Prof Cooter has been engaged in confidential dialogue over several weeks on how best to manage the PIP situation.
Guidance for patients and doctors will be coming soon. .
Top News – added 9.2.12New Developments in PIP Breast Implant ScandalTo keep pace with breaking news in Europe’s ever-evolving PIP Breast Implant scandal, Plastic Surgery Practice will now provide a weekly roundup of the top PIP stories. Italian Plastic Surgeons Sue PIP Italy’s plastic surgeons association is suing the Poly Implant Prothèse (PIP) company that made substandard breast implants as well as TUV Rheinland, the German certification company that inspected these implants, which were filled with industrial-grade silicone gel. The association states that surgeons who used these implants were misled because the implants had the European Union’s mark of approval. German Gov’t: TiBREEZE Implants Must Be Removed The International Society for Aesthetic Plastic Surgery was informed by the German authorities at the BfArM Institute that the former company, GfE Medizintechnik GmbH, sold implants that were manufactured using PIP’s industrial-grade silicone gel. From September 2003 to August 2004, these implants were sold under the name TiBREEZE. As result, German authorities at the BfArM Institute now state that TiBREEZE implants should also be removed even in the absence of symptoms. They had previously stated that PIP and Medro Implants, which were manufactured in the Netherlands, be removed ASAP. It is estimated that 728 TiBREEZE implants may be tainted. Most of those implants were sold in Germany to about 280 patients. In addition, TiBREEZE implants were delivered to Belgium, Italy, Finland, South Africa, Switzerland, England, Austria, and Lichtenstein. A total of 400 patients worldwide may be affected. PIP Execs Arrested in France In other PIP news, French police arrested two top former PIP executives. Founder Jean-Claude Mas and Claude Couty were detained in France, according to media reports. [Source: media reports] |
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