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Study: PIP breast implant failure rate higher than thought

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Remember Poly Implant Prosthèse (PIP), the now-bankrupt French maker of breast implants that launched a European crisis last winter over the use of substandard material? Well, it turns out the company's beleaguered implants had a rupture rate that could surpass 33%--that's much, much higher than previously thought.

That's according to a new study published online in the Journal of Plastic, Reconstructive and Aesthetic Surgery. Previous studies that had raised initial concern reported a failure rate of between 2% and 5%, the authors noted.

Researchers looked through PIP implant data from January 2000 through August 2005 for patients with either primary or secondary breast implant surgeries. They found the failure rate after 7 to 12 years hit nearly 16%, assuming those patients who did not respond to the survey had no ruptures. But they concluded that the rupture rate could hit 33.8% if the non-responders had the same rupture rate as responders.

Officials in France have recommended that patients with the PIP implants see their doctors for an evaluation. They pushed for removal after a French woman with the notorious implants died of cancer--and after reports broke that the PIP implants ruptured more easily. EU regulators are seeking tougher diagnostics/device approval regulations in the wake of the scandal. And some observers believe that the scandal could affect future breast implant approvals in the U.S.

- read the study release
- check out the journal abstract
- consider MassDevice's take

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EU seeks greater oversight after breast implant hysteria
EU breast implant scandal may affect FDA's view on faster device approvals