In a press release put out this morning by the FDA, the administration has issued two final orders to both the public and mesh manufacturers strengthening the data requirements for use of the mesh transvaginally, or through the vagina, for the purpose of treating pelvic organ prolapse. Under the FDA's order, surgical mesh has been reclassified from a class II device (a device with moderate risk to the patient) to a class III device (which includes high-risk devices). In addition, they have also made it a requirement for manufacturers to submit a premarket approval (PMA) application to support the efficacy and safety of the product as a viable treatment for pelvic organ prolapse.
Manufacturers will be required to address serious safety concerns in order to demonstrate the benefits of the device. This requirement will only apply to devices marketed for the transvaginal repair of pelvic organ prolapse and does not include devices used for abdominal repair or stress urinary incontinence. These increased clinical requirements are aimed at addressing the significant risks associated with the product, which is currently the subject of numerous of lawsuits throughout the country. The FDA has given manufacturers 30 months to submit a PMA for devices that are already on the market, and will need to submit PMAs for any new devices before they can be approved.
The FDA has received thousands of reports of adverse effects from the device over the past several years, including extreme pain, organ perforation, painful intercourse, bleeding, chronic infection, and urinary problems. In some instances, multiple surgeries have been necessary to remove the mesh, and in the worst cases, the mesh might not be removable at all. There are currently five manufacturers producing and marketing this product.
Read more about transvaginal mesh injuries on our website.
If you have suffered harm from a surgical mesh implant, please speak with a San Antonio personal injury attorney at Tracey & Fox. Our seasoned attorneys have decades of experience handling dangerous medical device cases! Schedule a free consultation with our firm by calling us at 713-955-7855.