News > The Truth Behind Transvaginal Mesh Litigation
The Truth Behind Transvaginal Mesh Litigation
A vast number of women have taken legal action against the transvaginal mesh in recent years. The lawsuits have alleged various physical complications and autoimmune problems caused by the transvaginal mesh.
Here, the claims on transvaginal mesh filled in the U.S. are analyzed to identify their characteristics for clinical decision making.
What Is Transvaginal Mesh?
Transvaginal mesh is a net-like synthetic surgical tool used to treat pelvic organ prolapse among female patients. Organ pelvic prolapse is a condition that makes women leak from their bladder while doing activities like running, jumping or even sneezing and coughing.
It provides extra support to repair damaged or weakened internal tissues. It is implanted in the vagina vis surgical procedure. Transvaginal mesh can be also be known as sling, tape or hammock. It is usually impossible to remove the implant after it has been implanted.
Problems Described in the Transvaginal Litigation
Women who received the implant filed lawsuits claiming that they suffered from painful injuries. The complications include pain, bleeding, organ perforation, infection and autoimmune problems. According to the lawsuit, these ladies experienced issues walking, sitting, and engaging in other high-impact activities.
The problems described by the women who received the implant were so bad that they had to suffer multiple revision surgeries to remove the implant. Studies show that bacterial infections can grow on the implants.
The implant damages internal organs causing erosion in the vaginal wall. In addition, the implant cuts through tissues and damages nerves that cause pain during impact activities. In some claims, the mesh blocks the bladder, which causes urinary problems.
Studies show that in most cases, the complications were relatively minor. However, in some cases, the complications were severe. Studies also show that the implant can fail even after surgery, causing recurring prolapse. Some women even experience worsened unitary incontinence.
Allegations against Manufacturers
Five companies manufactured transvaginal mesh in the United States. American Medical System, Boston Scientific, C.R. Bard, Ethicon and Proxy Biomedical are transvaginal mesh manufacturers.
The lawsuit claims that the manufacturer had a legal duty to ensure the safety and effectiveness of its products. But the patients were misled with false information. According to a study in 2017, the products were cleared against the charge based on weak evidence.
● Lack of proper test of the implant
● Lack of research on the risk of the implant
● Failing to create a compelling and safe method to remove the implant
● Inadequate in waring the potential complications and injuries to the patients
● Misleading the patients, medical community and the public about the effectiveness of the product
The manufacturing companies have agreed to settle outstanding lawsuits and have set aside hundreds of millions of dollars for this. As of November 2019, Ethicon faced 1,202 lawsuits, followed by Boston Scientific with 965, American Medical with 80 and Bard with 16.
Current Controversy Surrounding Transvaginal Mesh
As of November 2019, more than 108,000 lawsuits have been filed against the mesh manufacturer.
More than 2,263 lawsuits are still pending. One of the largest settlements to date was $830 million for 20,000 claims.
In 2019, the U.S. Food & Drug Administration stopped all sales of transvaginal mesh for pelvic organ prolapse treatment. In the short-term clinical trial, studies found high efficiency and low complication rate in the transvaginal mesh implant for unitary incontinence. However, there is huge evidence of low efficiency and high complication rate for pelvic organ prolapse treatment.
The UK NHS study shows that one in 15 women who had the implant later removed them surgically. In a survey of 2,220 women who received the transvaginal mesh implant, 59% said that the treatment did not resolve the original issue. 58% of women said that they experienced pain during physical activity.
Settlement and Verdicts
So far, mesh manufacturers have paid billions for the lawsuit settlements. As of February 2019, 32 women had filed cases in the state court, out of which 24 women received a jury award of $345 million. The mesh manufacturer has paid $8 billion in settlement of the lawsuit.
As of March 2021, Boston Scientific agreed to settle deceptive marketing claims by paying $188.7 million.
The transvaginal mesh litigation involves a sling for the procedure. However, the rise in the lawsuit does not reflect low complication rates in the report. The complication seems to be expected in women who had received the implant to treat pelvic organ prolapse.
New treatments are trialled on patients when other treatments have proven ineffective. However, patients should always be informed about the treatment and its efficiency to give informed consent for the procedure.
The patient should be comfortable asking their specialist about the procedure and complication rates. They should feel comfortable with the evidence that the surgery will work.
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