Popular breast implant banned
One of the most popular breast implants used in Australian women has been pulled from the market in Europe - and Australia's medical watchdog is considering how to respond.
The rough textured Biocell implant made by Allergan is one of several that have been linked to a rare form of cancer and around four in ten of the 40,000 women a year who have a breast implants in Australia are fitted with it.
Australia's Therapeutic Goods Administration (TGA) yesterday said it had "not yet proposed to initiate a recall because no new safety information has been provided" about the implant.
The medical safety watchdog said it was aware of the French recall action and was in discussions with both Allergan and European authorities.
News Corp has been campaigning for the company to pay for the removal of the devices in cancer cases, for all breast devices to be recorded on a device registry and for it to be made mandatory for surgeons to check women with the implants every 12 months.
There have been 81 cases of the rare blood cancer ALCL reported and three deaths in Australia.
Worldwide around 500 cases of the ALCL cancer have been linked to breast implants and there have been 16 deaths.
France's medical watchdog Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) earlier this week suspended the CE (Conformité Européenne) safety approval for Allergan's Microcell and Biocell products.
As a result the implants cannot be made or sold in Europe and those already distributed to clinics are being recalled.
The French authorities did not mention the ALCL cancer in their statement and said they had not "identified any immediate risk for the health of women carrying the implants concerned".
Allergan said the ANSM action was not based on any new scientific evidence and the body had not identified any immediate risk to the health of women with textured breast implants.
"Although Allergan disagrees with ANSM's request, the Company is fully co-operating with the authority. Allergan stands behind the benefit/risk profile of our breast implant products," the company said in a statement.
The TGA says Allergan will be able to continue to supply stock in Australia that was manufactured prior to the expiring of their CE Certificate on 17 December 2018.
World leading research by Australian researchers Professors Anand Deva and Mark Magnusson have found women with Silimed Polyurethane breast implants have a 23.4 times higher risk of causing ALCL cancer and those with Allergan's Biocell implant a 16.5 times higher risk compared to women with smoother Siltex implants.
Their research shows one in every 3,200 women fitted with an Allergan Biocell implants is at risk of the cancer.
Doctors are predicting a surge in cancer cases in the near future because of a rise in the number of implants and because these implants were the most common type used in booming discount surgery clinics.
Plastic surgeons are advising Australian women not to panic and say they do not need to have the devices removed unless a check up reveals problems.
Professor Deva said women with the implants should get regular 12 month check ups of their implant by the surgeon who put them in.
If women with the implants have excessive fluid build-up around the breast implant, pain, swelling, or lumps in the breast or armpit they should go to their doctor.
The Australian Society of Plastic Surgeons said it was waiting advice from the Therapeutic Goods Administration (TGA) in the wake of the European ban.
"While we take this issue very seriously we urge women not to be unduly alarmed," said Professor Mark Ashton, President of the Australian Society of Plastic Surgeons.
"We urge women to make sure they are registered with the Australian Breast Device Registry."
Allergan said it would cover $5,000 of the out of pocket medical costs women face when they have the implants removed because of cancer and it will also provide them with new implants for free.
But women affected by the cancer said the money was not enough, the offer of new implants was offensive and they feared many may miss out under fine print contained in the warranty.
The $5,000 payment is also less than the $7,500 offered to American women. The company said this was because the value had been calculated based on the typical costs of recommended correction in Australia.