Judge Rules Mesh Maker, Ethicon Inc. Must Disclose FDA Communication

Transvaginal Mesh LawsuitsA recent ruling in New Jersey is requiring Ethicon Inc., a maker of defective transvaginal mesh, to release previous communications regarding their defective medical device, to the FDA.

The ruling comes amidst claims that the defective device’s manufacturer did not act quickly enough when information questioning the safety of the product emerged.

Although the ruling was completed in New Jersey, safety advocates are already speculating that it will affect cases and transvaginal mesh claims across the nation.

A subsidiary of Johnson & Johnson, Ethicon Gynecare began selling the transvaginal mesh without FDA approval, claiming the product was very similar to a previously approved medical device they manufactured.

Interaction between the FDA and Ethicon may reveal more about prior demands made by the Administration that demanded the manufacturer to pull the defective mesh. Despite demands made by the FDA in 2007, Ethicon, reportedly, continued to sell the product.

As a result of inattention to warnings and demands made the FDA, advocates estimate that thousands of women continued to be placed at risk as a result of use of the transvaginal mesh and bladder slings. In addition to the Ethicon Gynecare Prolift, Johnson & Johnson, later discontinued the sale of TVT Secur, Prosima, Prolift and Prolift+M devices, which they noted was not tied to a recall or safety danger.

Officials hope that revealing the correspondence between the Ethicon and the FDA may help authorities uncover potential violations that the company knew could negatively affect consumers and those outfitted with the defective product.

If you or someone you know has endured serious injuries, complications or death as a result of surgical mesh, or more specifically, transvaginal mesh, call our transvaginal mesh lawsuit attorneys for a free consultation at 800-359-5690 or fill out the contact form to the right for additional information. We care. We can help.

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