For many years, transvaginal or vaginal mesh has been used to treat pelvic organ prolapse (POP) and other pelvic floor disorders in older women. Some used this medical device for stress urinary incontinence (SUI) that occurred after giving birth. Due to its effectiveness, this product became a holy grail for a lot of women in the world.
However, they soon experienced devastating and severe health complications. Fiona Bicknell called this a “prolapse mesh nightmare.” She had used this product for over ten years but eventually developed emotional and physical issues. Fiona became suicidal, developed chronic pain, and had a reduced libido.
Other women suffered nerve damage and vaginal scarring because the medical device shrank and eroded inside the body. In some cases, doctors found perforations in organs near the implant areas. These prove that the complications have become more severe than the original disorders they were meant to treat.
In this blog, we will discuss how common the mesh complications were, the scandal’s timeline, and more.
Are Vaginal Mesh Complications Common?
According to Drugwatch, the exact number might vary because of the discrepancies in the studies conducted. Some reports show that the implants for POP have come under scrutiny, while the devices for SUI are barely targeted. It makes it hard for the researchers to provide a specific number or rate for vaginal mesh complications.
Even then, a review in BioMed Research International suggests the average rate of complications is between 15% and 25%. Similarly, studies from Canada found a lower complication rate when compared to America. The Food and Drug Administration (FDA) reported that 10% of women suffered vaginal extrusion, while only 2.6% experienced this in Canada.
That means no one can highlight an exact number of women who experienced health complications arising from a defective vaginal mesh.
The Timeline of the Transvaginal Mesh Scandal
Initially, this medical device was considered a modern marvel. However, it soon turned into a disaster and a medical menace. Unfortunately, the manufacturers hid the mesh’s structural defects from buyers, leading to the transvaginal mesh scandal.
To understand this scandal better, take a look at the journey this medical device went through.
Transvaginal Mesh Was Officially Introduced
In 1996, the FDA approved the first vaginal mesh to treat SUI by Boston Scientific, called the ProteGen Sling. Then, after six years, the first implantable device for POP was approved.
Once these products were approved, other companies mimicked the design to create a legal equivalent. According to TruLaw, these companies were Johnson & Johnson, C.R. Bard, Coloplast, Ethicon, Cook Medical, and American Medical Systems.
Health Issues Were Discovered
After multiple reports of failures, the FDA finally issued a public health notice in 2008 to recall this product. They highlighted the serious complications women faced due to poor manufacturing quality. Ideally, the device eroded, scarred, and shrank inside the body, causing irreparable damage and reactions.
The serious complications associated with transvaginal mesh included the following:
- Persistent discomfort and pain
- Organ perforation
- Internal and irregular bleeding
- Urinary tract infections
- Nerve damage
The Era of the Product Liability Lawsuit
Once the affected women learned that the distributors and manufacturers knew about the potential defects, they wanted justice. Hence, the first vaginal mesh lawsuit was filed in 2012, seeking justice for failure to warn and the manufacturing of defective products. Any woman who received a defective mesh implant and suffered severe complications could seek compensation.
Since then, thousands of transvaginal mesh claims have been settled privately for almost USD 8 billion. Moreover, the jury ordered the manufacturers to pay the plaintiffs up to USD 525 million, depending on the extent of injury and proof. For example, in 2019, Patricia Mesigian received USD 80 million after proving that she suffered pelvic infections, pain, and inflammation from a vaginal mesh.
How Can Affected Individuals File This Lawsuit?
Women can seek legal avenues if they experience complications. However, they’ll need enough medical proof to seek justice. For example, victims must show medical bills, proof of lost wages, etc.
Therefore, affected individuals should follow these tips to file a transvaginal lawsuit:
- Seek medical assistance from healthcare providers and get proof of an official diagnosis.
- Maintain a record of the hospital visit dates, symptoms, treatments, and impact on regular life.
- Retain a copy of hospital records, medical documents, and test results provided by the doctors.
- Seek advice from a lawyer experienced in personal injury or product liability lawsuits.
- Identify the medical device manufacturer and type before filing a complaint.
Once filed, plaintiffs must await trial and seek settlement amounts ranging from USD 40,000 to USD 450,000 or more.
In conclusion, vaginal mesh complications can be life-limiting for many women. That’s why the medical industry has come up with alternative surgical treatments. These include native tissue repair, the use of bulking agents, and more.
Even then, women who suffered injuries due to the use of this product could file a lawsuit. They can build cases against surgeons, manufacturers, hospitals, and sales representatives.
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