Quelle horreur! Another French breast implant scare
Implants of a French-made silicon breast prosthesis have been suspended after the manufacturer was found to be in breach of quality standards.
French health authorities have shut down production of Cereform implants and recalled all non-implanted products after it was found that the sterilisation processes used by the manufacturer Cereplas had not been fully validated in accordance with current international standards.
So far, Australian authorities have not recalled implants sold here, but surgeons supplied with the implants have been contacted and planned implant surgeries have been postponed. Further supply of these implants has been suspended.
The French health regulator ANSM has not yet found evidence that the breach in manufacturing standards has resulted in any health risk, and the Therapeutic Goods Administration said its contact with surgeons who had implanted these devices had not found anything to suggest problems with the sterility of implants used in Australia.
The TGA said it had sought additional information from both ANSM and Cereplas, and “once this information is received, a decision as to whether or not a product recall is required will be made”.
The incident comes just two months after the founder of infamous breast implant manufacturer Poly Implant Prothese (PIP), Jean-Claude Mas, was convicted of fraud and sentenced to four years imprisonment by a French court following revelations in 2010 that PIP implants were being manufactured using industrial-grade silicone.
The discovery prompted a global safety alert, including in Australia, where health authorities imposed an immediate ban on the use of PIP implants amid fears rupture could leak toxic substances into the body.
Around 300,000 women worldwide have PIP implants, including an estimated 13,000 in Australia. In its latest update, the Therapeutic Goods Administration has confirmed 490 cases where PIP implants have ruptured, and a further 24 instances of unconfirmed ruptures.
Plans for a class action by Australian women against the company’s local distributor were abandoned after it was revealed it had only limited product liability insurance.
The scandal prompted the previous Government to agree to establish an opt-out breast implant registry after the TGA came under criticism over its vigilance regarding implantable medical devices, and the information it provided to the public.
In an alert issued on 21 February, the TGA assured women who have a Cereform implant that, unless they experienced an infection soon after surgery, they were unlikely to experience any problems “associated with this issue”.
It advised doctors with patients who have received a Cereform implant to be alert to the possibility of infection, and to reassure them that “if they were going to experience an infection related to this issue, it would occur in the immediate post-operative period”.