STORY FROM: Drugs & Medical Devices

Ohio Federal Judge Dismisses Mentor Saline Breast Implant Case

CLEVELAND — An Ohio federal judge has dismissed a case involving Mentor’s saline breast implants, ruling that the plaintiff’s failure-to-warn and manufacturing defect claims are preempted because they do not allege that the devices’ labeling deviated from FDA-approved warnings.

In a Sept. 30 order, Judge Benita Y. Pearson of the U.S. District Court for the Northern District of Ohio found that the plaintiff’s complaint impermissibly sought to impose requirements that differ from federal regulations.

Jessica Williams was implanted with Mentor’s saline breast implants in 2002; she subsequently underwent additional surgeries to replace the implants due to ruptures and for treatment ...

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