
New reports from the U.K.’s Medicines & Healthcare Products Regulatory Agency warn that even more women may have received breast implants with substandard silicone that’s prone to rupture.
The agency advised health care providers to begin assessing patients who received breast implants made by Poly Implant Prosthèse, expanding the warning which originally applied only to implants distributed after January 2001.
"A proportion of these women are likely to have had these implants removed and changed for new implants since this time," MHRA clinical director Dr. Susanne Ludgate said in prepared remarks. "If women have any questions, they should speak to their surgeon or doctor.
Late last year, news broke that France was considering a recall of 30,000 sets of breast implants supplied by PIP after regulators discovered that the company had been secretly filling the implants with non-authorized silicone. Since then, the founder and former head of the company was arrested and the controversy led some to question the foundation of the European CE Marking program.
Researchers warned last month that the devices may rupture in as many as 1 in 3 women, and U.K. regulators added last week that the population of at-risk patients might be much larger than previously estimated.
"The French regulator has confirmed this week that more women may be affected by the criminal activity of the French breast implant manufacturer PIP," U.K. health secretary Andrew Lansley said in a statement. "These women are the victims of a fraudulent company and I know this situation is causing a huge amount of anxiety."
The country’s National Health Service will provide explantation for any PIP breast implants that it previously paid for, according to the press release.