With the scandals of the Dow Cornings recall and the PIP breast implant crisis now comes the recall of French-manufactured, Cereform silicon gel-filled breast implants due to regulatory non-compliance.
The French Government demanded a recall of the implants on the 21st of February because the sterilisation process was not consistent with current international standards.
Although the Therapeutic Goods Association (TGA) of Australia have not ordered their recall here in Australia, they have as a precautionary measure contacted the Australian distributor (Medical Vision Australia Plastic & Cosmetic) who have in turn contacted surgeons who have been supplied with the implants and arranged for any planned implant surgeries to be postponed.
Approximately 4800 of the implants have been sold in Australia since 2009, and the Australian Society of Plastic Surgeons advises women who may be concerned to speak with the surgeon who provided their implants.
Though there have been no reports of adverse health reactions to the implants, the further supply of the implants has been suspended until the TGA has finalised its investigation and determined the implants are safe for use or whether a recall is necessary.
“Our Society will maintain a watching brief. While women will understandably be concerned, we advise them that, at this point, there is no cause for panic as there is no evidence of any adverse reaction to the implants,” says Dr Geoff Lyons, President of the Australian Society of Plastic Surgeons.
With this Cereform silicon gel-filled breast implant recall on top of the PIP incident and Dow Cornings recall; The Australian Society of Plastic Surgeons are now calling for urgent government funding for a Breast Device Registry.
This Breast Registry is currently being piloted but requires urgent Government funding for a rapid, national roll out. The registry would be established to ensure women are offered the best possible protection when seeking breast implants.
“This latest recall only reinforces the urgent need for a Breast Device Registry in Australia to provide an early warning system and the opportunity to take timely action, should problems be identified,” said Dr. Lyons.
Again if any women have any concerns about their implants they are urged to contact their surgeon.