FDA Clears New Caldera Medical Transvaginal Mesh, Even as Lawsuits Increase
Recently, the U.S. Food and Drug Administration (FDA) approved a new version of a pelvic mesh produced by Caldera Medical, even as last week, Medtronic settled with more than 11,000 vaginal mesh patients. This new iteration of the Vertessa Lite mesh (pictured left) has been cleared to be used in surgery for pelvic organ prolapse. Caldera claims that this newer version will have larger pores which will improve the acceptance of the mesh by the host tissue. They have not claimed any specific safety advantages, however. The mesh is also purportedly lighter and stronger.
Manufacturers of transvaginal mesh and sling products continue to push forward for approval of new products, even as lawsuits continue to mount against them. Additionally, the FDA’s Center for Devices and Radiological Health have considered reclassifying pelvic mesh from a moderate risk, class II device to a high-risk, class III device that would require premarket approval application. Even as all these apparent risks seem apparent to agencies like the FDA, new, seemingly improved transvaginal mesh and sling products continue to enter the market.
The complications caused by these devices have left many women to suffer with horrid recoveries, large medical bills, lost wages, and ongoing pain. From a civil standpoint, our firm has represented numerous families who are the victims of the complications from the transvaginal mesh device. If you or a loved one has experienced any of these problems because of an implanted or removed Mentor transvaginal mesh or sling, we encourage you to consult with one of our transvaginal mesh attorneys as soon as possible. A successful civil claim pursued against the responsible party will help compensate the victims for the costly medical expenses, and hopefully for their pain, suffering, and lost wages for time missed from work. Further questions can be directed to the Fears | Nachawati Law Firm by emailing the lead TV Mesh lawyer, Majed Nachawati at firstname.lastname@example.org, or by calling our office at 1.866.705.7584.