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Manufacturer sold transvaginal mesh without FDA approval

March 29th, 2012

The manufacturer of a transvaginal mesh patch sold the device for three years without receiving approval from the Food and Drug Administration, according to several recent lawsuits. Johnson & Johnson began marketing the Gynecare Prolift in March 2005, but did not receive approval from the FDA until May 2008.

Johnson & Johnson claimed the Prolift was exempt from human testing because it was similar to other devices already on the market, but the FDA says it didn’t even know the device was being sold until the manufacturer submitted another device for approval in 2007. The company claimed its new device, the Prolift+M, was exempt from the same tests because Johnson & Johnson was already selling the Prolift.

More than 550 transvaginal mesh lawsuits involving the Prolift have since been filed against the manufacturer, alleging that Johnson & Johnson released a defective product. Women in the lawsuits allege that the device failed and caused them severe injuries, such as tissue damage, organ prolapse and limited mobility.

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