Women’s health has often been an overlooked and under-researched medical discipline. For example, pelvic health problems such as pelvic pain and vaginal prolapse are common ailments for women.
According to the NIH, Pelvic organ prolapse (POP) is common in up to 50% of female patients in the U.S. The symptoms range from extreme pain to bulging of the vagina. This usually occurs during pregnancy, childbirth or menopause.
Previously, when women reported these manifestations to their healthcare provider, their symptoms were trivialized. Or, their physicians knew little of pelvic floor dysfunction (PFD).
When the FDA approved the first mesh implant for SUI (stress urinary incontinence) in 1996, it was seen as a lifesaver. However, the reality had been far from relief.
While manufacturers marketed it as safe and effective, the device led to severe complications and a wave of vaginal mesh lawsuit claims.
Chronic pelvic pain, urinary problems and infections were the main concerns. Due to the scope of the problems, many women required multiple corrective surgeries.
In 2012, the first vaginal mesh lawsuit went to trial.
Lawsuits Continue to Pile Up
Lawsuits alleged that companies failed to adequately warn patients about the potential risks of the pelvic mesh.
The FDA became aware of the mass transvaginal mesh lawsuits and the complications associated with the device in 2019. They immediately ordered manufacturers of surgical mesh products used for transvaginal repair to cease sales and distribution in the U.S.
Despite settling about 95% of the lawsuits, TorHoerman Law says cases are still being filed in state courts.
Thankfully, several landmark cases have resulted in significant settlements. Issues highlighted in the lawsuits were:
- Inadequate testing
- Lack of informed consent
- Failure to warn patients and healthcare providers about potential risks
In 2022, Johnson & Johnson settled two class action lawsuits amounting to $300 million. They marked the largest settlement in a product liability class action in Australian history, the Guardian reported.
And while some cases have been resolved, others await trial or negotiation. A report from the BBC claims a 57-year-old woman was unable to have sex following a transvaginal mesh implant procedure.
The mom of two opted for tension-free vaginal tape as an implant. A year after the surgery, she noticed the net-like implant protruding through her vagina. She has since settled a medical negligence claim with Swansea Bay University Health Board.
Many others have shared their terrifying stories. A British mother said she was left in extreme pain and considered taking her own life. Another battled fecal incontinence and constant bleeding.
What Are the Other Options?
The NIH published an extensive study in 2023. The findings suggested vaginal mesh complications were far-reaching and life-changing. Researchers also added that greater awareness was needed to provide support for women experiencing difficulty.
In response to the controversy, medical professionals have become more cautious in recommending vaginal mesh implants. Instead, they’re opting for alternative treatments with proven long-term safety records.
More women are turning to physiotherapy treatment, says senior clinical lecturer Jennifer King. She believes this course of action can improve incontinence symptoms. For those suffering from mild to moderate vaginal prolapse, there’s the option of physiotherapy.
UT Southwestern specializes in female urology. Although the FDA ban only applies to transvaginal mesh for prolapse repairs, Dr Maud Carmel believes there are other avenues to explore:
- Bladder or vaginal slings
- Robotic prolapse repair
- Transvaginal prolapse repair using native tissue
Advocating for More Awareness
The Implant Files published by the ICIJ in 2018 exposed the flaws of the global medical device industry. It documented how devices were approved with little or no safety testing.
Years later, advocates are still urging health regulators to do more to protect patient safety. Some have called for a long-term study into the effects on all vaginal mesh patients.
A Cautionary Tale
The vaginal mesh lawsuits serve as a warning shot in the arm for the medical fraternity. As regulations evolve, they will hopefully influence advancements in women’s health.
But even with innovations come obstacles to achieving the best possible health outcomes for women. Access to healthcare, lack of representation in clinical trials, and biases in diagnostics are major key points.
The lawsuit has resulted in academic research that aims to better understand pelvic floor disorders. Who knows, it could be the silver lining in a very dark cloud.
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