A proposed ban of speciﬁc textured breast implants has been announced by the Therapeutic Goods Administration (TGA) due to the increased risk of cancer they present.
Many parts of Europe have already enacted a similar ban due to the well documented link the implants have with a rare cancer know as anaplastic large cell lymphoma (BIA-ALCL). There has been criticism directed at the TGA by consumers and legal academics wanting a swifter response from the regulator.
The Therapeutic Goods Administration is the Australian pharmaceuticals and medical devices regulator. The TGA has been criticised as exhibiting a lack of motivation to act, with a perception of being reactionary rather than proactive often caving to corporate pressure.
The issue of the textured breast implants is not new. Last year new breast implants were banned from importation but there was no restriction on textured implants from being used on patients. Further the TGA had not determined it necessary or advisable to inform patients who had already received the textured implants of the potential risks. The full list of the restricted impacts are listed on the TGA website.
The proposed ban does not require the removal of the textured breast implants already in use by consumers. However consumers with the identiﬁed implants should be mindful and monitor their breasts for changes.
It is estimated that the risk of anaplastic large cell lymphoma associated with the breast implants is between 1 in 1000 and 1 in 10,000. This is a substantial risk considering approximately 20,000 people undergo breast augmentation every year. That number is predicted to increase, with Australians spending over $1 Billion on cosmetic procedures.
This new ban shines the spot light on the vetting process the TGA has in place, across the board, for all medical implants. The ABC in conjunction with the International Consortium of Investigative Journalists (ICIJ) revealed Australia’s almost blind acceptance of the FDA and other jurisdictions in Europe vetting processes for new medical devices and pharmaceutical products.
Risky medical devices undergo a process called “conformity assessment” before being approved for use in Australia. Assessment for approximately 90% of new devices is carried out in Europe by for-proﬁt private certiﬁers. In 2011, during US congressional hearings the system was described as “pick and pay” by Jerry Shuren, direction of the US Food and Drug Administration Centre for devices.
There is a concerning trend that Australia has been quickly increasing the number of approved medical implants. The investigation revealed world leading nations, particularly across Europe, export risky devices deemed unsafe for use in their home nations.
Whilst some individuals will take the pre-emptive decision to remove the breast implants associated with the higher risk, they will have to pay from their own pocket. It is not possible to commence proceedings against the TGA for its failures, due to an exemption it has in its enabling Act regarding civil litigation. In some cases, it may be possible to commence legal proceedings against a manufacturing company under the Australian Consumer law or the individual doctor for not warning of the relevant risks of the product and ensuring informed consent before the procedure.