PR Log - Jun 12, 2012 - Vaginal Mesh Helpline has expanded the Gynacare Vaginal Mesh Department with a Gynacare Vaginal mesh Helpline and vaginal mesh lawyers in light of the new news that J & J has opted to withdraw the Gynacare mesh from the market. The Gynacare division is here to offer help and information to women regarding their vaginal mesh. The manufacturer says it is not a recall however with the numbers of women experiencing mesh vaginal problems and the numbers of horror stories we have heard it may as well be a recall in our minds. This is something that should have happened a long time ago. We are still hearing disaster stories in 2012 about a mesh implanted just recently or in 2011. from women thru-out the United States.
On June 4, 2012, attorneys for Ethicon, a Johnson & Johnson subsidiary, sent letters to the judges overseeing multi district litigation transvaginal mesh claims in federal and state court. The letters provided notification that the company intends to stop marketing and selling the following vaginal mesh products:
Gynecare TVT Secur Gynecare Prosima Pelvic Floor System Gynecare Prolift Pelvic Floor System Gynecare Prolift+M Pelvic Floor System
In the past the FDA had reported that the Gynecare Prolift, had been sold for three years without proper regulatory approval. That followed the agency’s order in January that J&J and 30 other makers of vaginal mesh implants study organ damage and other health complications blamed on the products, which are used to treat incontinence and shore up weakened pelvic muscles.
Ethicon has asked the FDA for 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,” the J&J subsidiary said in its letter. “Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time.”
The FDA hadn’t responded to the request, according to the letter. The move covers the Prolift, Prolift+ M, TVT Secur and Prosima surgical meshes. Ethicon said it’s asked the agency to let it continue selling a fifth product, the Gyencare Gynemesh, with a change to the labeling that restricts its use. This produc will only be allowed to be implanted thru the abdomin and not the vaginal.
The above are Ethicon mesh products.
Vaginal mesh products have resulted in pain and suffering for many women:
Infections Erosion into the baldder, Bowel and organs Difficulty voiding or increase incontinence Severing of bowel resiltiningin septosis Bleeding Painful intercourse cutting th partner lower back pain pain on one side of the body severe agonizing pain
Doctors for the most part have been insensitive to the women experiencing real complications. If you have a Gynacare mesh implant and
are experiencing complications need help in finding a Urogynecologist or physician have had revision surgery have had the mesh removed have been told that your complications are due to a failed mesh can feel the mesh eroding thru your vaginal wall
We want to hear from you right away. You must seriously consider filing a Gynacare vaginal mesh or any other mesh product lawsuit. The statute of limitations may be running close. If you wait you may be out of luck. The time to act is now. We are alerting women thru-out the United States