Saturday, June 02, 2012

June 2012 Mesh News: FDA Didn’t Approve Vaginal Mesh Products?

It's being reported that  vidence 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.

men have already been wounded by vaginal mesh devices that have caused serious complications for them. According to a report by, the device manufacturer began selling the Gynecare Prolift vaginal mesh device in March of 2005, which was 3 years  before the device was approved by theFDA. 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 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.

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