Another year, and there's a new international breast implant recall in France to worry about. The latest involves the French company Cereplas, which faces a government-ordered recall in France because its products came off the production line after substandard sterilization procedures. The crisis is already spreading to Australia, according to The Age and Australia's ABC.
Both news outlets reported on the French recall, noting that Australian regulators are urging women to avoid the company's Cereform breast implants until the mess can be sorted out. They caution that women who have not faced infection soon after surgery likely won't get one, but regulators have stopped their further use in Australia in favor of an investigation first.
ABC reported that 4,800 Cereform implants have been sold in Australia since 2009, but side effect reports are nil so far. That said, the side effect has pushed plastic surgeons in Australia to call for a government-funded national breast device registry.
The new crisis has erupted after we barely moved past the last one. Last December, 5 executives from the now-defunct French breast implant company Poly Implant Prothèse (PIP) were sentenced for their roles in concealing the fact that they were producing substandard products. When news of the practice got out, global hysteria followed, and problems spread from Europe to Australia and Latin America.
In France, an investigation knocked regulators there for not taking the substandard breast implants off the market as early as 2007. The scandal also led to a European Union-wide push to enact tougher medical device regulations that is still underway. But countries such as Ireland have resisted the change, calling it a move that will simply slow down the approval process and keep the EU population from accessing crucial medical devices in a timely fashion.