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Regulatory Focus™ > News Articles > Bloomberg: J&J Sold Unapproved Medical Device for Years Prior to Approval

Bloomberg: J&J Sold Unapproved Medical Device for Years Prior to Approval

Posted 21 March 2012 | By Alexander Gaffney, RAC

Life sciences manufacturer Johnson & Johnson sold its now-controversial vaginal mesh implant for three years prior to being approved by the US Food and Drug Administration (FDA) in 2008, reports Bloomberg.

The unauthorized sale of the Prolift vaginal mesh implant product, manufactured by Johnson & Johnson's Ethicon unit, could place the 510(k) approval pathway under additional scrutiny.

The company marketed Prolift as early as 2005, reports Bloomberg, reasoning that it was substantially equivalent to the already-approved Gynecare Gynemesh.

FDA "disagreed with this assertion," said FDA press officer Morgan Liscinsky, when FDA learned of the device in 2007, but still approved the product under the 510(k) pathway in 2008.

The company is currently embroiled in hundreds of lawsuit over the devices, which plaintiffs claim caused injury to them. The revelation about the unapproved sales of Prolift, could make it considerably harder to settle or win some of the lawsuit, said Bloomberg.

Bloomberg - J&J Sold Vaginal Mesh Implant Without U.S. Regulatory Approval