The first transvaginal mesh lawsuit was introduced in court in 2012. Several transvaginal mesh manufacturers have lost multimillion-dollar cases since then. Many corporations have agreed to substantial legal settlements to avoid facing litigants in court, but others have postponed procedures and settlements.
Multiple juries have sided with plaintiffs who accused manufacturers like American Medical systems of developing defective surgical mesh products, falsely marketing device safety, and neglecting to warn of possible risks. Thousands more claims are still pending in state and federal courts.
What is a Transvaginal Mesh Implant?
Transvaginal mesh is a synthetic net-like fabric that supports weakened or injured connective tissue.
It is referred to as ‘transvaginal’ mesh since it is inserted during a surgical operation through the vagina. Transvaginal mesh is sometimes called tape, sling, ribbon, and hammock.
The surgical mesh devices are perforated to allow the body’s own tissues to grow into it. The devices treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Pelvic organ prolapse occurs when a pelvic organ, such as the bladder, rectum, or uterus, “sags” and slides out of position, affecting up to half of all women who have had children. This might occur when the pelvic floor muscles, ligaments, and tissue that support the pelvic organs become weak or injured.
On the other hand, stress urinary incontinence is a pelvic organ disorder that causes women to leak from their bladder when performing high-impact activities like jumping or running or when sneezing or coughing. It affects around 20% of women, which affects their quality of life.
How Does a Transvaginal Mesh Implant Work?
The mesh’s function is to provide permanent support to weakened pelvic organs and to restore damaged tissue.
Surgery can be performed via the abdomen (transabdominal) or through the vagina (vaginal/transvaginal).
Sutures or tissue fixation devices hold the vaginal mesh in place after a tiny incision is made in the vaginal or abdominal wall. The concept is that tissue will grow into the surgical mesh pores to form a support wall.
When Were Mesh Implants Introduced?
Since the 1950s, polypropylene mesh has been used to treat abdominal hernias. Historically, pelvic organ prolapse was treated using “native tissue,” or sutures that attached the prolapsed organ to a nearby ligament or muscle. Although this is still viable for many women, others lack sufficient or strong enough native tissue. Furthermore, this strategy is not always beneficial in the long run.
As a result, gynecologists and urologic surgeons began experimenting with transvaginal mesh implants in the 1970s, cutting them and inserting them through abdominal incisions. In the 1990s, a minimally invasive method was developed, which involved creating an incision in the vagina to insert the transvaginal mesh devices to reduce recovery time.
Meanwhile, the FDA authorized the first pelvic mesh for stress urinary incontinence (the mid-urethral sling) in 1996. The first transvaginal mesh implant for pelvic organ prolapse repair was authorized in 2002. Manufacturers began producing kits containing surgical instruments and mesh for transvaginal prolapse operations around this period, with the first receiving FDA approval in 2002.
What is the Current Controversy Surrounding Vaginal Mesh?
When the FDA originally authorized transvaginal mesh devices in 2002, mesh surgery was advertised as simple and successful, and it immediately became a popular choice among surgeons and patients.
However, there is some debate over whether the transvaginal mesh is a safe option for POP or SUI. The Food and Drug Administration (FDA) released a press statement in 2019 to prohibit the ongoing manufacture, sale, and distribution of surgical vaginal mesh for the treatment of POP.
As the mesh became more commonly used, women began to report transvaginal mesh complications, and vaginal mesh lawsuits were filed against manufacturers worldwide. Transvaginal mesh was classified as a high-risk device (class III device) by the US Food and Drug Administration in 2012.
The FDA claimed that Coloplast and Boston Scientific, vaginal mesh producers, had not demonstrated sufficient safety or efficacy in their devices. The FDA deemed this step essential due to increased reports of serious complications from using transvaginal mesh to treat POP.
Should women be worried?
We are not saying all vaginal mesh is bad, and every woman who underwent reconstructive surgery suffers from serious risks and complications. However, if you have the pelvic mesh implant and are experiencing complications, you may have a transvaginal mesh lawsuit.
Some of the complications you may experience include:
· irregular vaginal bleeding or discharge
· severe discomfort
· vaginal scarring
· discomfort during sex
· bowel and bladder problems like incontinence and infection
· pelvic pain or swelling
· sharp stabbing pain or prickling feeling in the vagina, which may become worse with exercise
· abdominal, buttock, or leg pain
While new treatments are often tested on patients after earlier choices have proven fruitless, patients should always be informed that the treatment is new and that there is little data on its efficacy so that they may offer informed consent. Women should feel at ease questioning their expert about complication rates, proof that the procedure would be effective, and surgeon training.
What does pelvic mesh do, and why are women suing over it?
In vaginal mesh lawsuits, firms are accused of a range of wrongdoing, including carelessness, warranty violations, design and manufacturing flaws, and misleading marketing regarding how surgical meshes were pushed to the public.
Plaintiffs alleged considerable emotional and physical anguish and suffering after having one or more pelvic mesh products surgically inserted to treat stress urinary incontinence or pelvic organ prolapse. Transvaginal mesh products occasionally corroded or became misplaced and protruded, resulting in sexual discomfort, bleeding, and other complications.
Women also claimed severe injuries, persistent and significant physical abnormalities, and the need for corrective operations or multiple surgeries. Many reported financial losses due to medical bills and current and future losses of wages.
Transvaginal Mesh Lawsuit: Verdicts and Settlements
In March 2021, Boston Scientific paid $188.7 million to resolve charges that it falsely promoted surgical mesh products to customers. The agreement with 47 states and the District of Columbia was announced in the same year. The company also promised to provide consumers with more accurate information about the safety and dangers of using mesh.
In September 2020, CR Bard signed a similar arrangement to pay $60 million in damages.
Ethicon (Johnson & Johnson) reached a $117 million multistate settlement over the devices in 2019.
Following a nine-day trial, two plaintiffs from Indiana, Barbara and Anton Kaisera, were awarded a $35 million settlement in March 2018. After the woman suffered from significant pelvic pain and other complications from using Johnson & Johnson’s Prolift mesh, a nine-member jury in the United States District Court for the Northern District of Indiana granted them $10 million in damages.
The jury also awarded J&J’s subsidiary Ethicon $25 million in punitive damages after concluding that the company recklessly created the device and failed to warn the public about its potential risks adequately.
Need a free consultation about mesh implant complications? Contact the Law Offices of Tom Plouff.