What is transvaginal mesh? Transvaginal mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable material or absorbable biologic materials.Which conditions require transvaginal mesh treatment? Surgical mesh is used in urogynecologic procedures to treat two conditions suffered by many women – pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
What is pelvic organ prolapse (POP)?
Pelvic Organ Prolapse: Pelvic organ prolapse (POP), sometimes referred to as a pelvic floor disorder, occurs when the tissues that hold the pelvic organs in place become weak or stretched, causing the organs to bulge (or prolapse) into the vagina and sometimes past the vaginal opening. More than one pelvic organ can prolapse at once. Organs involved in POP can include the bladder (the most common kind), urethra, uterus, vagina, small bowel and rectum.
What is stress urinary incontinence (SUI)?
stress Urinary Incontinence: Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity,
such as coughing, sneezing, laughing, or exercise. SUI may occur due to weakened pelvic muscles that are no longer capable of properly supporting the bladder and urethra or because the urethral sphincter is not working correctly. Pelvic weakness also may be caused by:
- Injury to the urethra area
- Some medications
- Surgery on the prostate or in the pelvic area
What are the most popular transvaginal mesh manufacturers and brands?
- C.R. Bard – Avaulta, Uretex
- Boston Scientific – Advantage Sling System, Uphold Vaginal Support System, Lynx Suprapubic Mid-Urethral Sling System, Obtryx Curved Single, Obtryx Mesh Sling, Prefyx Mid U Mesh Sling System, Prefyx PPS System
- Ethicon (subsidiary of Johnson & Johnson) – Gynecare Systems
- Tyco Healthcare (now Covidien) – IVS Tunneller
- American Medical Systems (AMS) – AMS Apogee, AMS Perigee, AMS BioArc, AMS Elvate, In-Fast Ultra, MiniArc, Monarc, SPARC, Straight-In mesh.
- Coloplast Corp – Novasilk Synthetic Flat Mesh, Restorelle Smartmesh, Exair Mesh
What potential complications are associated with transvaginal mesh?
According to the U.S. Food and Drug Administration (FDA), the most common complications associated with transvaginal mesh may include:
- Mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
Did the FDA Approve Transvaginal Mesh?
Transvaginal mesh implants on the market today were approved through the FDA’s 510(k) process, which allows a product to sidestep clinical testing if its maker can prove it is equivalent to a product that has already been approved. Interestingly, many of the pelvic mesh devices involved in the thousands of transvaginal mesh lawsuits were modeled after Boston Scientific’s ProtoGen implant, which was recalled in 1999.
Does the FDA have concerns about the safety of transvaginal mesh?
In July 2011, the FDA warned surgeons and patients that surgical placement of mesh in the pelvis to repair POP may
expose patients to greater risk than other surgical options.
Has the FDA ordered a vaginal mesh recall?
To date, the FDA has not issued a recall. On September 8 and 9, 2011, the FDA’s Obstetrics and Gynecology Devices Advisory Panel met to discuss the safety of using transvaginal mesh devices in POP repair. Though no formal vote was taken, the majority of outside medical experts on the panel backed the FDA’s proposal to reclassify transvaginal mesh devices as high risk, which would make such devices ineligible for the agency’s 510(k) protocols.
In January 2012, the FDA directed the makers of transvaginal mesh products, including Johnson & Johnson and Ethicon, to conduct post-market safety studies of their products in order to enable the agency to better understand the safety and effectiveness profiles of these devices.
In June 2012, Ethicon, a subsidiary of Johnson & Johnson, announced it was voluntarily stopping production of the following mesh products used to treat POP and SUI:
- Gynecare TVT Secure System
- Gynecare Prosima Pelvic Floor Repair System
- Gynecare Prolift Pelvic Floor Repair System
- Gynecare Prolift +M Pelvic Floor Repair System.
I am suffering from complications that I believe are related to my transvaginal mesh surgery; can I file a lawsuit?
If you are suffering from the side effects of a mesh implant, your first step is to obtain medical attention. Unfortunately, many women who undergo mesh implant surgery for POP or SUI treatment usually require multiple revision surgeries to manage their symptoms. Many have also filed claims against the manufacturers.
If you are among the thousands of women suffering from the side effects associated with a transvaginal mesh implant, we would be pleased to discuss a potential claim with you.
Are there any upfront fees that I will be charged?
No. Case reviews are free and we only get paid if you win.
How much compensation can be awarded in lawsuits over mesh-related injuries?
In any personal injury lawsuit, there is no telling how much a jury will award. Each case is different, just as every person’s injury is different. Factors such as age, pre-existing illnesses, and severity of the injury are all variables that juries take into account. It can be said is that, so far, juries and settlements have awarded between $2 million and $11.11 million in lawsuits over mesh-related injuries. But again, this is in no way a guarantee that a future lawsuit will be settled or awarded with a figure within that range. It could be less than the lower amount – or possibly greater than the larger one.
Here are some recent vaginal mesh lawsuit settlements and jury verdicts:
In July of last year a California jury awarded Christine Scott and her husband $5.5 million. Mrs. Scott had required nine revision surgeries up until that time. The Scotts had sued C.R. Bard back in 2009 over its Avaulta Plus mesh product.
In February 2013 in Atlantic City, N.J., Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product. Gross was forced to undergo 18 revision surgeries after the mesh device was implanted.
In August 2013, a West Virginia jury awarded $2 million to Donna Cisson. Cisson had sued C.R. Bard after she was implanted with the company’s Avaulta Plus mesh and suffered serious complications.