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J&J Sold Vaginal Mesh ImplantAfter Sales Halt Ordered

According to a recent article in Business Week and Bloomberg, citing court records, Johnson & Johnson (JNJ), continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device. Thousands of vaginal mesh cases are pending across the United States.

Apparently, The U.S. Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales while they determined whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally.

“If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.” According to sources, this type of indignant response to FDA requirements without consequence is like having a “Sheriff use a water pistol” to enforce its determinations.

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