According to the Federal Register (05/01/2014), “the Daily Journal of the United States Government,” the United States Food and Drug Administration has recently called to reclassify transvaginal mesh in the repair of pelvic organ prolapse, an ailment that affects about 50% of women, even if only to a small extent.
The Register states that the FDA “is proposing to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is proposing this reclassification based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device.”
For clarity, the FDA medical device classification system is based on safety and likelihood to perform intended device function. There are three classes in all: Class I contains items such as dental floss, Class II contains items such as condoms, and Class III contains items such as replacement heart valves. The proposal by the FDA to move vaginal mesh to a higher class indicates that the Agency finds vaginal mesh more dangerous than previously thought.
This makes sense: over the past several decades, a number of peer-reviewed scientific studies have illustrated the danger of vaginal mesh, particularly with respect to mesh failure rates, mesh erosion into tissue, and the need for secondary surgery after mesh implantation.
Because this research was published in widely-read journals, and vaginal mesh manufacturers failed to update warning labels or discontinue the product, a number of vaginal mesh lawsuits have been filed. Furthermore, writes Matthew Perrone of The Washington Post, “In February, U.S. District Judge Cheryl Eifert in southern West Virginia, who is handling most of the implant lawsuits, concluded that [Johnson and Johnson] destroyed thousands of documents regarding development of its pelvic-mesh implants, but said there was no proof that it was done intentionally. The documents would have included reports on patient testing of the mesh implants and could have shown whether participants suffered serious complications.”
As it currently stands, there are more than 20,000 vaginal mesh lawsuits pending against Johnson and Johnson alone, one of many vaginal mesh manufacturers.
If you or a loved one used transvaginal mesh and suffered complications or required surgery, you too may be eligible to file a transvaginal mesh lawsuit and gain significant financial compensation. For a free, no-obligation case consultation, contact our team of transvaginal mesh lawyers at the information provided below. We have the compassion, experience, and resources required to win the justice you deserve. Call today and see how we can help.
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