An estimated 100,000 transvaginal mesh lawsuits have been filed alleging that the devices causes harmful complications such as bleeding, organ perforation and urinary problems. The U.S. Food and Drug Administration (FDA) can reclassify a medical device if more regulation is required for safety purposes. On January 4, 2016, the FDA reclassified transvaginal mesh devices, previously determined to be safe, as a high risk medical device. This marks a significant action by the FDA that indicates transvaginal mesh devices, previously thought to be safe, may actually be dangerous.
What Is A High Risk Device?
The FDA classifies medical devices into three categories (Class I, Class II and Class III) based on their risks for safety and effectiveness. Class I medical devices are low risk devices that may not present an unreasonable risk of illness or injury. Class II devices are a higher level of classification and is designed to provide reasonable assurance of the device’s safety. Transvaginal mesh devices were originally classified in this category as a reasonably safe device. However, after the thousands of reported complications and injuries, transvaginal mesh devices were reclassified as a Class III device by the FDA. Class III devices are the highest risk devices that may pose a potentially unreasonable risk of illness or injury. The FDA now considers the use of transvaginal mesh devices to be high risk.
Why Did The FDA Reclassify Transvaginal Mesh Devices?
This reclassification was to specifically address concerns of the use of the transvaginal mesh to repair pelvic organ prolapse (POP), when the muscles of the vaginal wall become weak and can no longer support pelvic organs. Reclassifying a medical device is not easy. First, the process is time consuming because extensive research has to be done to prove that a medical device is dangerous. Additionally, government regulatory agencies such as the FDA are not quick to admit that they might have been wrong about the safety of a medical device, especially after thousands of patients have suffered harmful complications.
Contact a Transvaginal Mesh Lawyer
If you or someone you know has suffered after being treated with a transvaginal mesh, contact one of our transvaginal mesh lawyers at d’Oliveira & Associates. You may be entitled to compensation for your medical bills, lost income and pain and suffering, among other losses. We work with experienced lawyers that can evaluate your case and can file a transvaginal mesh lawsuit on your behalf. They charge no fees unless you win an award or settlement. For a free (no obligation) case evaluation, call us today toll free at 1-800-992-6878 or fill out our contact form online.
Paul d’Oliveira
Attorney Paul d’Oliveira has been practicing personal injury and disability law for over 30 years. He started his personal injury law practice in 1989 with two offices in Fall River, MA and East Providence, RI. Today his firm has 16 offices in RI and Southeastern, MA.
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