FDA Considered Grace Period for Manufacturers of Hazardous Transvaginal Mesh

Early in 2011, the U.S. Food and Drug Administration (FDA) acknowledged officially that transvaginal mesh could possibly have exposed users to substantial risk. This medical device, a kind of surgical mesh, was designed and used to treat a condition known as pelvic organ prolapse. The device, which resembled a woven fabric, was implanted in the vagina to provide what is known as a pelvic or bladder sling. Prior to its official acknowledgement, the FDA received an increasing number of complaints of adverse conditions which prompted it to issue a warning.

Class III

Patients and healthcare providers were informed of the agency's findings and intentions of re-classifying the device as a class III medical device. This would make it more difficult for new transvaginal mesh products to gain approval after more rigorous testing.

Overwhelming Evidence

The FDA however expressed its willingness to a 'grace period' for makers of transvaginal mesh to pull their products off the market and conduct further study. This concession was granted despite the FDA having received several thousand reports over the preceding six years of acute complications resulting from the use of this product. There had been a five-fold increase in the number of reports since 2008. Continued marketing during this grace period placed many more women at reckless risk.

Do not Walk Away

If you feel you have been injured by transvaginal mesh or any other medical device you should contact a personal injury or medical malpractice attorney at the earliest. An experienced attorney would take on the medical industry which has, in the past, had to make multi-million dollar payouts for causing injury through defective medical devices. Do not look at this though as a get rich quick scheme. You may not receive that much but you should receive something to indicate to these companies that their products need to be sound before they are promoted and sold.

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