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Council Bluffs, Iowa

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Craig Kelley
Craig Kelley
Attorney • (800) 642-1242

Johnson & Johnson Transvaginal Mesh Sold Without FDA Approval

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Transvaginal mesh implants used to repair pelvic organ prolapsed have caused thousands of women unnecessary pain and suffering. Now, news is out that Johnson & Johnson, one of the makers of these transvaginal mesh products, was marketing and selling the product despite explicit instructions from the FDA to halt marketing.

In August of 2007, the FDA sent a letter to the company in relation to its Gynecare Prolift product. According to the report in Bloomberg Businessweek, that letter specifically informed Johnson & Johnson that “you may not market this device until you have provided adequate information” in relation to 16 potential deficiencies and received FDA approval. Failure to follow the requirements set forth in the letter is a violation of federal law.

This letter could prove to be a key piece of evidence in over 1,400 lawsuits unfolding against Johnson & Johnson. The company began selling the Gynecare Prolift product in 2005, without a new application to the FDA, on the basis that it was substantially similar to another product with FDA approval. The 2007 letter addressed that issue, with the FDA communicating that a new application was indeed necessary and that outstanding concerns needed to be addressed. Among those concerns was the “significant number” of complications related to infection, abscess and organ perforation.

The letter apparently sparked an extended negotiation process between the FDA and Johnson & Johnson that culminated with the granting of FDA approval in 2008. During that interim period, when approval had not yet been granted, the company continued to market and sell the product. But now—in light of the massive amount of litigation over these devices and the evidence of their harmfulness—Johnson & Johnson has stopped selling four vaginal mesh implants, including the Prolift.