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California: News and Insight on Business in the Golden
State | THE STATE / MEDICAL DEVICES

Mentor Agrees to Upgrade Quality Controls

May 06, 1998|Associated Press

Mentor Corp., a breast-implant manufacturer, agreed to significantly upgrade its quality controls in a consent decree filed with the Food and Drug Administration. The Santa Barbara-based company makes saline-filled breast implants and some silicone-gel breast implants. FDA regulations require that medical-device makers institute specific manufacturing processes that help ensure defective products don't come off the assembly line. The FDA had attempted for several years to get Mentor to upgrade its manufacturing to meet the quality rules. The company wasn't upgrading fast enough, so the FDA went to court to negotiate the consent decree, officials said. The decree requires Mentor to be in full compliance with FDA regulations by the end of the year. The company's stock lost 6 cents to close at $26.44 on Nasdaq.

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