The medical industry introduced a device in 1996 that could possibly reduce the effects of various pelvic floor disorders. With approval from the U.S. Food and Drug Administration (FDA), vaginal mesh implants became a well-accepted treatment option for stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
On average, 50% of women suffer from POP, whereas 37% of women will develop SUI. Therefore, thousands of women suffering from pelvic floor issues once opted for transvaginal mesh implants.
However, in 2008, the FDA issued warnings about the complications associated with this surgical mesh used for POP and SUI. Soon after, the victims filed lawsuits against the manufacturing companies for failing to warn them about the side effects.
In this article, we will discuss everything you need to know about the vaginal mesh lawsuit.
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What Happened to the Transvaginal Mesh Devices?
The transvaginal mesh manufacturers wanted to create a device that could reinforce pelvic structures and provide stability. These implantable mesh products were supposed to alleviate the symptoms of POP and SUI.
Initially, the medical industry was overjoyed to finally have a simple solution to these pelvic floor disorders. That’s because these were less invasive than the alternative surgical methods. The manufacturers, C.R. Bard, Ethicon, Coloplast, and Boston Scientific, also promised quicker recovery times after mesh insertion.
However, it was soon found out that they used low-quality synthetic materials in the mesh structure. That’s why the device eroded inside the pelvis, and the patients started to feel severe pain and experience other health complications, like organ perforation, bleeding, etc. As a result, they filed lawsuits against these manufacturers to seek compensation for their suffering.
The Transvaginal Mesh Legal Battles: 3 Reasons Plaintiffs Have Won
Reports suggest that manufacturing companies have paid an estimated USD 8 billion to settle most vaginal mesh lawsuits. According to TorHoerman Law, approximately 95% of these claims have been settled. That means most of the victims have received justice.
How do you think that was possible? The plaintiffs have won this lawsuit because of the following reasons:
#1. Manufacturing Defects and Deceptive Marketing
The plaintiff’s lawyers were able to prove that the manufacturers used deceptive marketing tactics to sell their mesh products. They also disregarded the public’s safety by providing misleading information to healthcare professionals.
Apart from that, the companies lied about their manufacturing, development, and research processes. They used low-quality materials as a cost-saving method. That’s why thousands of women suffered the consequences when the product failed.
These women filed a transvaginal mesh lawsuit to seek compensation for failing to warn them about these issues. They only wanted to hold the companies liable for shattering their expectations and trust.
#2. Complications and Health Consequences
The plaintiffs successfully proved that their health complications were due to transvaginal mesh failures. They used medical reports and doctor’s notes as evidence to back their claims.
Since the vaginal mesh was prone to erosion, it led women to develop organ perforation, internal bleeding, infections, etc. These complications also created issues in their careers, disrupted their daily routines, and affected their relationships. Due to this, they have developed depression, anxiety, etc.
Thankfully, the lawsuits successfully addressed these complications by offering compensation to help make their lives better. That means the plaintiffs have successfully proved to the jury that the vaginal mesh implants destroyed their quality of life.
#3. Medical Expenses and Financial Strain
Women experienced intense financial strain because of mesh complications. They had to undergo revision surgeries and extensive rehabilitation to deal with the health issues.
All these expensive medical interventions have financially drained the victims. They couldn’t deal with the medical bills because of the lost wages and their inability to work.
That’s another thing that convinced the judge and jury to rule in favor of the plaintiffs. Each victim is now eligible for an estimated compensation between USD 150,000 and USD 400,000.
What Did Regulatory Bodies Do to Mitigate This Issue?
The news of transvaginal mesh complications slowly took over the medical industry. As the reports grew, regulatory agencies like the FDA started to take notice. In 2011, this government body issued a safety communication. With this, they expressed concerns about the severe complications of implanting transvaginal mesh.
After that, the medical industry started to scrutinize the safety of these devices. They wanted to expose the truth about the risks of vaginal mesh products to compel patients to seek alternative treatment options. In response, some manufacturers discontinued their mesh products, while others were banned.
All these emphasize the importance of stringent regulations overseeing medical device manufacturing. The government and the medical industry can learn from their mistakes, support those who are affected, and prepare for the future.
In summary, the transvaginal mesh was created as a safety net for most women, but it soon turned out to be a nightmare. Using this medical device had a negative impact on most women’s lives.
They suffered physical ailments, which also affected their emotional well-being. Moreover, the complications led to financial instability. That’s why they filed lawsuits against the manufacturers and distributors.
This incident also highlights the complexities of the medical industry. It proves that manufacturers need to be more aware of such painful realities and focus on transparent communication.