Did you undergo pelvic organ prolapse repair surgery and have transvaginal mesh implanted? Have you suffered from eroded mesh, infection, pain, or perforations of the bowel, bladder, or blood vessels? If so, you may be entitled to compensation.
Lawsuits are being filed across the nation alleging that the manufacturers of transvaginal mesh failed to warn both doctors and patients of the increased risk of complications associated with the material, which could possibly be permanently implanted in the body.
What is Transvaginal Mesh?
According to Mayo Clinic, “surgical mesh is a medical device that is used to provide extra support when repairing weakened or damaged tissue.” This device is either made from synthetic materials or animal tissue. Transvaginal mesh is a type of surgical mesh, commonly used for both pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Both of these conditions are frequently a result of carrying and delivering children, which weakens the pelvic floor.
Pelvic organ prolapse is when the muscles and ligaments that support the pelvic organs weaken, causing a risk of these organs to slip out of place. These organs include the bladder, uterus, rectum, top of the vagina and the bowel. Surgical mesh can strengthen the vaginal wall through surgery to implement the mesh, which is done either through the abdomen or vagina.
Stress urinary incontinence is when an individual experiences an unintentional loss of urine either from physical movement or activity, such as coughing, sneezing, running, heavy lifting, etc. These actions put pressure on the bladder. Surgical mesh is used to help by inserting a mesh implant through the vagina to support the urethra or bladder neck.
Eleven percent of women will have to have surgery for either prolapse or incontinence in their lifetime. Unfortunately, one-third will require reoperation for failed procedures, according to the National Center for Biotechnology Information. There is a long list of complications that are a direct result of having transvaginal mesh implanted. These include:
- Mesh erosion
- Pain during sex
- Organ perforation
- Urinary problems
- Vaginal scarring or shrinkage
- Neuro-muscular problems
- Emotional problems
- Reoccurrence of prolapse and/or incontinence
Many of these side effects may require additional treatment or more surgery.
UCLA Health reports that there are approximately 200,000 mesh implants for POP each year in the United States. When these surgical devices erode, the mesh dislodges from the vaginal wall and moves to surrounding tissues and organs. The mesh also has a risk of extrusion or exposure, where the mesh protrudes from the opening of the vagina.
Many times the transvaginal mesh implants are intended to be permanent. This poses an issue when complications arise from the medical device, and there is a need to surgically remove it. Doctors do try to remove as much of the mesh as possible, as well as try to repair the damaged tissue. Since they are meant to be permanent implants, the transvaginal mesh is very difficult to remove. Surgical removal could cause additional complications and require additional surgery to fix the POP or SUI.
The U.S. Food and Drug Administration (FDA) reports that the lifetime risk for pelvic organ prolapse is 30 – 50 percent for women and two percent of those cases become symptomatic. Stress urinary incontinence affects an estimated of 20 – 40 percent of women.
Many women will need surgery to help with either POP or SUI. Surgical mesh was intended to increase the longevity of these repairs. However, the FDA found that “transvaginally placed mesh does not improve clinical outcomes over traditional non-mesh repair.” They also found that the mesh could have a higher risk of complications without an increased benefit of life.
Below is a timeline of FDA updates for transvaginal mesh:
- 2008: In October, the FDA issued a Public Health Notification in order to inform clinicians and patients of the adverse events relating to surgical mesh.
- 2011: The FDA again warned about adverse event reports of surgical mesh. The department published a report with findings of 2,874 Medical Device Reports from 2008 – 2010. These included reports of injury, malfunctions and even death.
- 2012: The FDA required manufacturers of transvaginal mesh to conduct post market surveillance studies on the product to evaluate its safety and effectiveness.
- 2014: In May, the FDA issued two separate orders for surgical mesh. The first was to reclassify surgical mesh for POP to be a Class III instead of a Class II. This categorized surgical mesh as being a high-risk device instead of a moderate-risk device. The second order required manufacturers to submit a premarket approval application in order to have them address safety concerns.
Many companies who manufactured transvaginal mesh are either experiencing lawsuits or are under investigation.
Johnson & Johnson is the largest manufacturer of transvaginal mesh devices. In 2016, the attorney generals from Washington, D.C. and California sued the company for intentionally concealing risks associated with surgical mesh.
The company is being sued for their failure to warn of all the possible risks. These include:
- Chronic foreign body reaction
- Chronic inflammation
- Mesh infection
- Severe erosion, which is lifelong
In fact, the company is faced with an estimated 35,000 personal injury lawsuits. Other countries that also have lawsuits against Johnson & Johnson include: Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland, and Venezuela.
Other companies undergoing lawsuits or investigations include:
Boston Scientific is currently under investigation by the FDA because their surgical mesh may contain counterfeit raw material.
Endo International paid $830 million to settle more than 20,000 mesh injuries.
In 2015, C.R. Bard was set to pay $200 million to settle 3,000 lawsuits against the company filed by women who were injured by their bladder or vaginal sling. Many of the injuries required removal surgery.
Other manufacturers of surgical mesh are, American Medical Systems, Coloplast, Cook Medical and Neomedic.
Contact Us Today
If you or you know someone who suffered physical and emotional damages from a transvaginal mesh implant, you could be entitled to compensation for medical bills, pain and suffering and any other damages that were a direct result of complications of the surgical mesh. Our product liability attorneys at Tittle & Perlmuter are ready to hear your case. Call today at 216-308-1522 or fill out an online form for a free consultation. Our attorneys are ready to hear your case and advise you on your next steps. We can also arrange weekend and evening appointments, and we can come to you.