FDA Didn’t Approve Vaginal Mesh Products

Some evidence has surfaced that indicates that device manufacturer Johnson & Johnson did not have Food and Drug Administration approval for the transvaginal mesh product they were selling for three years. This could mean a new wave of litigation might be filed against the drug manufacturing giant, as many women have already been wounded by vaginal mesh devices that have caused serious complications for them. According to a report by Bloomberg.com, the device manufacturer began selling the Gynecare Prolift vaginal mesh device in March of 2005, which was three years to the month before the device was approved by the Food and Drug Administration, which took place in March of 2008. Between the time it was released on the market until it was approved, the FDA received 123 reports of complications associated with the Gynecare Prolift device.

Vaginal mesh complications concern patients

Vaginal mesh devices are ways of treating stress urinary incontinence and pelvic organ prolapse, which are both conditions dealing with the weakening of pelvic organs. Complications associated with the devices, however, can cause even further problems, including recurrence of the original problems, urinary tract infections, and mesh erosion. Hundreds of women—more than 550—have filed lawsuits after suffering from transvaginal mesh complications. They are hoping to gain compensation that would help cover medical bills they have incurred due to their side effects.

The Food and Drug Administration reported a fivefold increase in complications associated with vaginal mesh devices, including deaths and malfunctions, in July of 2011. This decision resulted in an advisory panel for the organization recommending that such devices should be reclassified as “high risk” devices that are in need of human testing before it can be determined whether or not they are safe.

FDA process questioned

The Food and Drug Administration was apparently unaware of the Gynecare Prolift device before 2007, at which point the device manufacturer sought to approve a similar product. The device, according to Johnson & Johnson, did not need explicit FDA approval because it was already similar to a product that had already been approved for the market, and therefore didn’t need to be checked individually. Many plaintiffs who have filed a vaginal mesh lawsuit do not believe this should be the case and have taken legal action.

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