J&J To Stop Sales of Vaginal Implants in 2013

WHAT ARE VAGINAL MESH IMPLANTS?

Vaginal mesh implants, also called pelvic mesh or bladder slings are used to treat stress urinary incontinence and pelvic organ prolapse. Unfortunately, these devices are failing at alarming rates causing women extraordinary pain and severe side effects such as: chronic pain, recurrence of prolapse and/or incontinence, urinary problems, bleeding, mesh shrinkage or migration, scar tissue formation, dysuria (painful urination), dyspareunia (painful sexual relations), neuropathic pain or mesh erosion.

JOHNSON & JOHNSON PLANS TO DISCONTINUE
VAGINAL MESH IMPLANT SALES IN 2013

Ethicon, a subsidiary of Johnson & Johnson, told a West Virginia federal judge it will discontinue the sales of four vaginal mesh implants worldwide after lawsuits are beginning to mount in America.

Ethicon plans to discontinue the sale of four pelvic mesh implants which include the Prolift, Prolift+ M, TVT Secur and Prosima systems. This is a very interesting move for Ethicon as they are not recalling meshes already sold or implanted and Johnson & Johnson says “it’s decision isn’t based on any safety concerns.”  

However, a report issued by the FDA last year found a fivefold increase in deaths, injuries or malfunctions tied to vaginal mesh for prolapsed organs because of weakened support. Also last year, an advisory panel urged the FDA to reclassify the devices as “high-risk” products needing human testing.

120 DAYS NEEDED FOR THE MARKET WITHDRAWAL

Ethicon wrote a letter to the FDA requesting 4 months (120 days) to end sales so it can “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients.” Additionally, Ethicon stated “[we] will also discontinue or revise, as appropriate, all marketing materials during this time.” It is believed that the FDA has not responded to Johnson & Johnson/Ethicon’s letter to discontinue sales.

Ethicon also said, in their letter to the FDA, it will continue selling the Gyencare Gynemesh, but change the label to restrict its use. 

CONTACT US TODAY

If you have suffered serious complications following pelvic organ prolapse (POP) or stress urinary incontinence (SUI) surgery involving a Transvaginal Mesh implant, please contact Jon Mann of Pittman, Dutton & Hellums toll-free at 866.515.8880 or by email for a free case evaluation. 

PDH has the resources to help navigate you through the judicial system and the experience to protect your rights.