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FDA proposes increased transvaginal mesh regulation

June 3rd, 2014

The U.S. Food and Drug Administration (FDA) announced proposed increased regulation of transvaginal mesh implants that have caused tens of thousands of injuries in women. Transvaginal mesh was approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse, but many of the mesh devices have been found to have a higher than expected rate of failure, often leading to severe side effects.

Several prominent manufacturers including C.R. Bard, Johnson & Johnson and Boston Scientific had their devices approved through the FDA’s 510(K) process, which allows products to forego significant clinical testing if companies can prove their device is nearly identical to other products on the market. Those companies now face thousands of transvaginal mesh lawsuits alleging that their devices were defective.

Several companies have issued transvaginal mesh recalls or stopped producing the products altogether in light of the risks associated with surgical mesh. Johnson & Johnson was recently ordered to pay $3.35 million in a transvaginal mesh lawsuits after a jury determined the company was responsible for the injuries the device caused a patient.

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