FDA Investigates Transvaginal Mesh Implant Devices
The FDA is currently reviewing transvaginal mesh and the effects that it has on patients who have this implant. The first warnings from the FDA appeared in 2008 and were significantly increased in July 2011. The July 2011 safety communication advised patients to use alternative treatments as transvaginal mesh could expose them to increased risk and should be considered experimental.
The FDA's Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee met Thursday September 8th and Friday September 9th to review the effects of transvaginal mesh to discuss the safety of these devices.
There have been a variety of negative side effects reported due to the implantation of transvaginal mesh including erosion, pain, infection, and bleeding. Many women have needed painful revision surgeries. In a review of Medicare data on the treatment of Pelvic Organ Prolapse (POP), women with mesh implants were 2.6 times more likely to need revision surgeries.
If you have suffered after a transvaginal mesh implant, contact our experienced attorneys right away for a FREE and confidential initial consultation.
Makers of these meshes including Johnson & Johnson, told the FDA advisers they agreed on the need for more safety studies of the implants as well as labeling changes to warn of potential risks. This mesh has been used for nearly 30 years for hernias, but its uses have evolved over the past few years to be used in treating POP. According to Herbert Lerner, an acting director in the FDA's device-approval center, "As industry modified surgical mesh for these indications, none of the mesh has been evaluated for clinical data."
Last year alone nearly 300,000 women had revision surgeries to repair Pelvic Organ Prolapse (POP). Of these, more than 75,000 women received vaginal mesh implants to assist weak pelvic muscles that fail to support internal organs.
The transvavinal meshes currently on the market was approved by the FDA through the 510(k) process in which "a new device only needs to be as good as a device currently on the market and we are concerned that is not good enough," Julia Corrado, a clinical reviewer for the agency, told the FDA panel. The FDA has cleared more than 100 mesh products for POP repair under the 510(k) process since 2002.
In the most recent meetings, the FDA was meeting to reconsider if the devices should be moved from Class II which uses the 510(k) process for approval to Class III which would require more clinical data. This would also mean that manufacturers could not "fast track" the devices for approval. In an informal vote taken on Thursday, September 8th, 13 of the 17 member panel indicated they would favor this reclassification.
Pelvic Mesh Ligitation Cases
Pelvic mesh litigation is currently underway and there was a conference on September 1 in New Jersey to discuss current orders, procedures and the status of discovery.
If you have been injured due to a transvaginal mesh implant, contact our experienced attorneys right away for a free and confidential initial consultation.