FDA Clears New Caldera Medical Transvaginal Mesh, Even as Lawsuits Increase

July 23, 2015

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.

Legal Commentary
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 mn@fnlawfirm.com, or by calling our office at 1.866.705.7584.

More Blog Posts

CONTACT US

Use the form below to send us a note, call us at 214.890.0711 or chat with us live. We are eager to help with all your legal needs. Please keep in mind that any unsolicited information sent through our website cannot be treated as confidential. Contacting us through this site does not create a representation relationship with Fears | Nachawati.

Inquiry Type

  • General
  • Personal Injury
  • Immigration
  • Bankruptcy
  • Drug Litigation
  • Family Law

Locations

With offices in Texas, Florida and Colorado and attorneys licensed in Texas, Florida, Colorado, Arkansas and Oklahoma, Fears | Nachawati is dedicated to attaining the best possible solutions for our clients’ business and personal needs. We strive to be professionals who are creative, empathetic and reliable.

All Areas Served

We Can Help

Contact Fears Nachawati today

Free Consulation

Live Chat (Online Now)