On March 30, 2010, France's health regulators issued a recall of all pre-filled silicone breast implants manufactured by Poly Implant Prothese (PIP), a company based in southern France. The breast implant recall is said to affect an estimated 35,000 to 45,000 women worldwide.
AFSSAPS, the health regulatory agency of France, discovered an unauthorized type of silicone gel being used in the pre-filled implants. Following the recall, the French court ordered the company to shut down entirely for the manufacturing of fraudulent implants.
The recalled PIP implants have been associated with abnormally high rupture rates, as well as a higher incidence of local inflammatory reactions.
Unauthorized gel used in pre-filled silicone implants can damage the coating of breast implants and allow the shell to leak more easily and cause unwanted complications.
"Clinicians should not implant these devices and they should quarantine any stock," said Dr. Susanne Ludgate from the Medicines and Healthcare products Regulatory Agency (MHRA). "Patients who have concerns about their PIP silicone gel-filled breast implants should contact their breast implant surgeon."
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