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Johnson & Johnson sold mesh after FDA told the company to stop

July 7th, 2012

Johnson & Johnson continued to sell Gynecare Prolift Transvaginal Mesh for nearly nine months after the Food and Drug Administration ordered the company to halt sales, according to court records. On August 24, 2007, the agency sent Johnson & Johnson a letter telling it to halt sales of the Gynecare Prolift device for fear of a “potential high risk of organ perforation.”

Despite the FDA’s warning of 16 potential deficiencies, Johnson & Johnson allegedly continued to sell the transvaginal mesh product. The company now faces more than 1,400 transvaginal mesh lawsuits from women who allege it caused organ damage, severe pain, scarring and nerve damage.

The Gynecare Prolift product and others like it were originally approved by the FDA without significant clinical testing after manufacturers claimed they was similar to mesh products already on the market. Johnson & Johnson announced in June 2012 it would halt the sale of several of its transvaginal mesh products citing lack of “commercial viability.”

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