Drugs & Medical Devices
Pelvic Mesh
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FDA Issues Advisory Regarding Transvaginal Surgical Mesh Products, Including Gynecare Mesh Devices
Our firm's attorneys are currently investigating cases of women who suffered serious injures after undergoing gynecological or bladder repair surgery where the Gynecare TVT mesh was implanted.
The following FDA information highlights possible problems related to Gynecare mesh surgery, as well as other manufacturers of transvaginal mesh patch products.
Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence
FDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is part of our commitment to keep healthcare professionals and the public informed about the medical products we regulate.
FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. These complications can have serious consequences. The reports have not been linked to a single brand or model of mesh.
The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.
In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.
Background
A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum. Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity.
Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.
Talking to your doctor
Before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene.
Questions you should ask the surgeon before you agree to surgery in which mesh will be used:
Get Information and Help from an Experienced Lawyer
If you or a loved one has experienced a serious injury after undergoing bladder or gynecological surgery that may be caused by the Gynecare TVT surgical mesh system, our lawyers may be able to help you to seek compensation for your injury, pain and suffering, and other money to help with bills and other expenses.
Please complete the form on this page for a free and confidential review of your potential lawsuit. A Weitz & Luxenberg representative will contact you as soon as possible.
see also:
Medical opinions on pelvic mesh dangers
Medical opinions on pelvic mesh dangersWarnings
Warnings about Gynecare TVT Mesh | Weitz & Luxenberg attorneysGynecare TVT mesh has been linked to serious post-surgical complications in women. Those affected can get a free lawsuit review from Weitz & Luxenberg
FDA News
Transvaginal Mesh Patch Injuries | Weitz & Luxenberg AttorneysFree defective medical device lawsuit is available for women who were injured after receiving a transvaginal mesh patch during pelvic organ surgery.
