What are vaginal mesh implants?
Vaginal mesh implants or slings, which have been put in millions of women during urogynecologic surgeries to treat POP (pelvic organ prolapse) and SUI (stress urinary incontinence), have been associated with a high prevalence of significant mesh problems.
Women demanding compensation for catastrophic injuries such as mesh erosion and extrusion, organ perforation, vaginal bleeding, persistent infection, discomfort, pelvic pain, and mental distress have brought transvaginal or pelvic mesh cases around the country.
Transvaginal mesh products are placed to offer transvaginal repair to a woman’s pelvic organs that drop, fall, bulge, or protrude (prolapse) into the vaginal wall. As a result of weakened or strained muscles, transvaginal pain can be caused by delivery, pregnancy, and other factors.
In severe situations, the bulge that might happen during a collapse can be seen protruding. Surgical mesh can repair prolapse of the bladder (cystocele), the top of the vagina, the uterus, the rectum, the colon, and the urethra.
What is pelvic organ prolapse?
Pelvic organ prolapse is frequent in women after delivery, especially in those who have had children later in age. The organs involved, the bladder, rectum, and uterus, tend to descend, causing the pelvic anatomical organization to become unstable.
The weakened or damaged tissue (typically caused by delivery) to the ligaments supporting pelvic floor muscles and tissues that keep the organs in place causes organ drooping. Because of the absence of hormones after menopause, the pelvic muscles can weaken and cause pelvic floor disorders. Obesity and a family history of pelvic organ prolapse are other risk factors.
What is stress urinary incontinence?
Stress urinary incontinence is a disorder in which urine leaks from the bladder during high-impact activities such as sprinting, running, or jumping, as well as during sneezing and coughing. The condition is frequent in women following delivery and menopause; this affects roughly 20% of women daily.
When is transvaginal mesh surgery needed?
Suppose you are a woman suffering from either of these conditions, stress incontinence or pelvic floor disorder. In that case, doctors will use surgical mesh devices to treat pelvic floor disorders or stress incontinence when more conservative remedies fail.
Some of the other traditional non-mesh repairs includes
- Vaginal pessaries
- Pelvic floor exercises
- Mesh-free surgery (in which the surgeon uses the patient’s own tissue as support)
However, the use of transvaginal mesh has remained doctors’ first choice. In POP instances, it is permanently implanted to strengthen the weakened vaginal wall. It acts as a sling to support the bladder, neck, or urethra to treat stress incontinence.
Transvaginal mesh implants complications
The following are the mesh-related complications linked with surgical mesh meant to treat stress urinary incontinence and pelvic organ prolapse:
- Perforation or puncture of the intestines, bladder, or bowels, and the blood vessels around the vaginal wall
- Pelvic Organ Prolapse (POP)
- Mesh erosion through the vaginal tissue
- Mesh extrusion or exposure, which can require multiple surgeries
- Lump in the vagina opening or something protruding from the vagina
- Painful sex (dyspareunia)
- Urinary problems
- Vaginal bleeding
- Vaginal chronic drainage, discharge, and infections
- Debilitating pain
- Vaginal scarring and shortening
Many women require transvaginal mesh removal surgery, which may necessitate two or three further procedures. Despite the removal of the mesh, issues may persist, and women continue to have vaginal discomfort and a worse quality of life.
Vaginal mesh implant lawsuits
Victims of failed synthetic mesh implants and slings who file a transvaginal mesh lawsuit may be eligible to get compensation for:
- Loss of quality of life
- Lost wages
- Out-of-pocket medical, surgical, and hospital expenses
- Pain and Suffering
- Spousal loss of consortium
- Additional surgery and multiple surgical revisions
- Emotional distress
- Loss of the ability to experience sexual relations
Surgical mesh lawsuits have been filed on behalf of women all across the country against some manufacturers of transvaginal mesh kits (TVM), and sling devices used to treat Pelvic Organ Prolapse and SUI repair, including:
- Johnson & Johnson/Ethicon: Sold under the names Gynemesh, Gynecare, Gynecare Prolift, Gynecare Prolift+M, Gynecare Prosima, and Gynecare TVT
- Boston Scientific: Sold under Pinnacle and Uphold
- C.R. Bard, Inc.: which are sold under Avaulta, Pelvisoft BioMesh, Pelivicol Acellular Collagen Matrix, Pelvitext, and Pelvilace
- American Medical Systems: Sold under the names Elevate, Perigee, and Apogee
Contact Thomas Plouff if you or a loved one needs help with a failed transvaginal mesh procedure.
Vaginal Mesh Products and the FDA (Food and Drug Administration)
In a Safety Communication issued on July 13, 2011, the FDA stated that it had received 2,874 new reports of problems connected with transvaginal surgical mesh operations from January 2008 to December 2010.
There were 1,503 reports related to POP repairs and 1,371 with SUI fixes. According to the studies evaluated by the agency, around 10% of women who have the mesh inserted transvaginally develop mesh erosion within 12 months after surgery, and more than half of them require further procedures to remove the mesh. Even several procedures will not alleviate the issues in certain circumstances.
According to the FDA, there is no clear evidence that transvaginal meshes in POP repair is more successful than traditional non-mesh surgery in all POP patients and that “it may expose patients to increased risk.”
On August 25, 2011, Ralph Nader’s Public Citizen watchdog group recommended that the US Food and Drug Administration (FDA) should recall mesh devices owing to safety concerns and adverse effects.
According to an “Executive Summary” issued by the FDA on August 31, 2011, it “believes that vaginal implantation of surgical mesh for Pelvic Organ Prolapse repair inherently adds risks of problems that are specific to the mesh itself.”
The FDA convened a meeting on September 8 and 9, 2011, and a majority of the Obstetrics & Gynecology (OB/GYN) Medical Device advisory panel agreed that the safety, effectiveness and benefit of transvaginal mesh in Pelvic Organ Prolapse (POP) repair is not well established and warrants long-term prospective patient follow-up.
The FDA proposed reclassifying transvaginal mesh devices used in the repair of pelvic organ prolapse from a Class 2 to a Class 3 medical device, making surgical mesh for POP repair ineligible for the FDA’s less stringent 510(k) approval protocols and requiring human clinical trials to gain FDA approval.
You might be entitled to compensation if you or a loved one suffered serious complications due to POP or SUI repair, including a surgical mesh implant. Please get in touch with attorney at Tom Plouff Law to learn more about receiving compensation for transvaginal mesh complications.