Transvaginal mesh is a surgical implant used to support the bladder, uterus, or fallopian tube. It’s made of flexible plastic and coated with synthetic fibers that hold cells together in order to prevent urine leaks during pregnancy. Despite its benefits for many women who need it for medical complications like pelvic organ prolapse (POP), some doctors are now saying transvaginal meshes can cause serious health problems including infertility and chronic pain due to nerve damage
The “mid urethral sling lawsuit” is a device that is used to support the bladder, which can be helpful for women who experience stress urinary incontinence. However, the device has been linked to complications such as vaginal mesh erosion and infection.
In transvaginal mesh litigation, over 100,000 women and their families allege that the mesh did not work as intended and even caused significant damage.
Multimillion-dollar settlements have been reached in several transvaginal mesh claims.
The Food and Drug Administration (FDA) has just issued a warning that transvaginal mesh, which is used to treat women who have symptoms of pelvic muscle weakness caused by delivery, surgery, or aging, is linked to serious consequences and is riskier than previously believed. In cases, women say that they were given incorrect and misleading information regarding the safety and efficacy of the products.
Endo agreed to pay $775 million to settle the remaining 22,000 claims over their vaginal mesh implants in August 2017.
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How Does Transvaginal Mesh Work?
POP (pelvic organ prolapse) and stress urine incontinence are treated using transvaginal mesh, a medical device (SUI). Both of these illnesses are prevalent, with POP affecting an estimated 3 million women in the United States and SUI affecting an estimated 15 million adult women.
Approximately 75,000 transvaginal mesh surgeries for POP and 200,000 transvaginal mesh treatments for SUI are done each year.
The term “transvaginal” refers to the surgical mesh being inserted via the vaginal canal. Although mesh may be introduced via an abdominal incision, transvaginal insertion is thought to be a faster and less invasive process.
While surgery is not always required to treat POP or SUI, it may be advised. One surgical option is the implantation of transvaginal mesh. Surgery to correct POP and SUI may also be done using tissue taken from other regions of the body. Surgical mesh proponents claim that the devices produce superior long-term results than native tissue healing. Furthermore, some patients are not ideal candidates for POP/SUI native tissue restoration.
The Consequences of Transvaginal Mesh
Transvaginal mesh has been linked to serious health problems that were not discovered for many years after mesh devices were first offered on the market.
The majority of vaginal mesh is constructed of polypropylene, a polymer that may compress significantly after implantation, putting strain on pelvic nerves. Because polypropylene is not compatible with human tissue, the body perceives mesh as a foreign item and responds with inflammation. Furthermore, since transvaginal mesh insertion is done “blind” (meaning the surgeon cannot see the mesh being inserted), there’s a danger that surgical tools can injure crucial organs during the procedure.
These problems may result in vaginal mesh injuries, such as:
- Urinary issues
- Mesh protrusion through the vaginal canal
- Intercourse that is excruciating
- Prolapse/incontinence recurrence
- Perforation of the bowel, bladder, and blood vessels
- Scarring and shrinking of the vaginal area
- Neuromuscular issues
Hundreds of thousands of women are believed to have had transvaginal mesh issues, many of which might have been averted if the devices had been thoroughly tested before to their release.
Surgical mesh has been around since the 1950s, when it was first used to treat hernias. In the 1990s, mesh meant to treat POP and SUI was released, resulting in a massive increase in transvaginal mesh surgeries. Despite a paucity of clinical trial data confirming their safety and usefulness, the new devices were authorized.
A pelvic surgeon compared mesh removal to “trying to remove the rebar from a sidewalk with a hammer and chisel while keeping the cement otherwise intact and without injuring the water mains and electricity lines below.”
Manufacturers seeking sales certification for transvaginal mesh are not obliged to produce clinical proof of safety and efficacy, according to FDA rules. To receive marketing approval, mesh producers must merely “show significant equivalence of their product to a device that is lawfully sold in the United States.”
This is made feasible by the FDA’s “510(k)” fast track approval scheme, which has been heavily scrutinized in recent years. One surgeon said that the 510(k) procedure “cannot assure that mesh implants for transvaginal repair of POP are both safe and efficacious,” in response to a petition to prohibit surgical mesh for POP repair. The 510(k) procedure has been dubbed “fatally defective” by the Institute of Medicine.
In 2008 and 2011, the FDA issued transvaginal mesh warnings in response to a substantial number of adverse event (injury) reports filed by manufacturers and patients.
Additional surgery may be required to manage transvaginal mesh issues, however due to tissue development into the mesh and the mesh’s closeness to important structures, total removal of the device is difficult or impossible.
A pelvic surgeon characterized mesh removal as “similar to taking a hammer and chisel and attempting to remove the rebar from a sidewalk while keeping the cement otherwise intact and without destroying the water mains and power lines underneath” during an FDA hearing on transvaginal mesh.
Mesh Victims Speak Out in Their Own Words
FDA’s Obstetrics and Gynecology Devices Panel will convene in 2011 in response to rising concerns regarding the safety of transvaginal mesh. Women who had been damaged by vaginal mesh were given the chance to speak out about their medical traumas during the public hearing section of the conference. Here are some of their comments:
- “For months, the discomfort from the mesh rendered me unable to sit, exercise, or have any significant quality of life.” I was in agonizing agony 24 hours a day, seven days a week. “Believing my position was hopeless, I seriously considered suicide at the age of 42, as a mother of three, to escape the clutches of severe and unremitting anguish.” Amy Gezon is a writer who lives in New York City.
- “I was seriously harmed by a permanent medical gadget made of synthetic mesh. On January 26, 2006, I underwent surgery and had major hematoma problems. One week later, I had [the gadget] medically removed. This medical item continues to cause me agony and suffering to this day.” Linda Dodson (Linda Dodson)
- “I exchanged the discomfort and shame of stress urine incontinence for a transvaginal mesh sling.” Today, I wish I hadn’t taken that decision. It has radically altered every element of my personal and professional life. I still have SUI, but I’m having a lot of trouble peeing, and I’m having continuous pelvic floor discomfort that won’t go away.” Deborah Tedford (Deborah Tedford)
- “[My doctor] recommended that I have a sling placed in my vaginal canal to support my bladder. The operation was performed as an outpatient day procedure. After the procedure, I was sent home with an implanted catheter and assured by the doctor that I should be OK in two to three weeks. Well, it took me two to three weeks to recuperate. Just getting out of bed took me five months.” –Diane Maassen is a writer who lives in the Netherlands.
- “I underwent emergency surgery to remove part of the mesh’s posterior arms shortly after it was installed.” I had no idea I’d be out of the hospital for nine weeks with open, draining [cysts] attempting to heal. More physicians were called in, more tests were performed, and a conclusion was reached. The remainder of the arms were too risky to remove, so simply leave it alone and see a pain doctor.” –Beverly Pennington is a writer who lives in New York City.
Allegations in a Lawsuit
In general, women who bring transvaginal mesh claims claim that mesh manufacturers:
- They failed to uphold their legal obligation to assure the safety and efficacy of mesh goods.
- Prior to commercialization, they did not undertake appropriate and well-controlled trials on their goods.
- Inadequate warnings about possible mesh problems and patient damage were provided.
- Intentionally deceived the public into thinking mesh is both safe and effective.
- Mesh goods that have been developed and constructed in a careless manner
Consolidated Cases in Federal and State Courts
In the United States, seven companies, including Boston Scientific, Johnson & Johnson, and C.R. Bard, are facing an estimated 100,000 lawsuits over transvaginal mesh. The majority of these lawsuits have been merged as part of a multidistrict litigation (MDL) in federal court in West Virginia. Thousands more mesh cases are also consolidated in state court in New Jersey.
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Settlements in Mesh Lawsuits
A good development for transvaginal mesh sufferers is that certain cases have been resolved in plaintiffs’ favor, with payouts including:
- A lady who was implanted with Boston Scientific’s Pinnacle and Advantage fit mesh implants received a $100 million judgment.
- A lady who was implanted with Boston Scientific’s Obtryx sling received a $73.5 million judgement.
- Three plaintiffs were granted $14.3 million in damages after being injured by Boston Scientific’s Obtryx pelvic mesh implants.
- A victim of Ethicon’s (J&J) Transvaginal Tape was awarded $13.5 million.
- A woman who was wounded by Ethicon’s Prolift pelvic mesh implant was granted $12.5 million.
- Avaulta Plus vaginal implant sufferer receives $3.6 million in damages from C.R. Bard.
Aside from these individual settlements, American Medical Systems has put aside $1.9 billion to pay up to 49,000 mesh lawsuits, Endo has paid $830 million to settle roughly 20,000 claims, and Coloplast has paid $16 million to settle 400 cases.
What Can a Lawsuit Do for You?
If you have had problems with transvaginal mesh, you may be able to file a lawsuit. Medical expenditures, lost earnings (past and future), and pain and suffering may all be compensated via a lawsuit.
Contact us for a free, no-obligation case evaluation to take the next step in the legal process.
Frequently Asked Questions
What is the settlement average on mesh bladder sling cases?
A: Mesh bladder sling cases, in general, have a breakdown point of approximately 1 year.
What are the symptoms of pelvic mesh complications?
A: Some signs and symptoms of pelvic mesh complications include pain, bleeding during intercourse or urination, difficulty with urinating on one side only, lower back ache that will not go away.
What are the symptoms of mesh erosion?
A: Mesh erosion is a process in which the strands of wire that make up an electronic devices circuit board deteriorate and eventually break.
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