Over the past decade, nearly 110,000 women have filed lawsuits against several medical device manufacturers. These lawsuits stem from reports of severe chronic pain, organ damage, infections, bleeding, and emotional pain caused by transvaginal mesh implants. While medical device manufacturers have settled over $8 billion worth of legal claims to date, there are many thousands of lawsuits still pending.
As this is an active and ongoing lawsuit, it is our goal to keep you informed of the recent developments should you or a loved one be affected by this medical device. In this article, we’ll provide a brief introduction to what a transvaginal mesh is and is used for, as well as what complications have been reported by plaintiffs in association with the device. We will also provide an overview of some of the major lawsuits to date, the companies involved, and a timeline leading up to the latest updates on this ongoing legal situation.
A Background on Transvaginal Mesh Implants
Surgical mesh was developed in the 1950s to address a range of reconstructive surgery needs, including hernia repairs. It was not until the 1970’s that medical professionals began using surgical mesh in the gynecological setting. From there, transvaginal mesh was used to pelvic organ prolapse and stress urinary incontinence in women. Since the device was already in use, when the FDA gained the authority to regulate medical devices, transvaginal mesh was technically grandfathered into Class II medical device status, thus skipping premarket trial. This unfortunate oversight became apparent when numerous individuals came forward reporting major transvaginal mesh complications.
The many thousands of women who have since come forward citing medical device injury have spoken out about numerous adverse effects. Women who have received transvaginal mesh implants have reported experiencing difficulty performing everyday activities such as walking, sitting, performing physical work, and participating in sexual intercourse. These difficulties are often attributed to chronic pain and scarring caused by the device cutting through tissue, shrinking, or damaging nerves.
Other adverse conditions associated with transvaginal mesh implants include erosion of the vaginal walls and internal organs, bacterial growth on the mesh leading to infections, difficulty urinating due to blockage of the bladder, and new or worsened incontinence of the rectum or bladder. Finally, the mesh may fail to perform correctly, resulting in a recurrence of pelvic organ prolapse. Many women had to further suffer through multiple revision surgeries in order to correct and remove the faulty implants. All of this leads to great and long-term physical, emotional, and financial damage.
A Brief Timeline of FDA Actions
Between 2005 and 2010, the FDA carefully reviewed nearly 4,000 reports of adverse conditions associated with transvaginal mesh implants. In 2014, the FDA then published a proposal ordering that any surgical mesh device to be used in transvaginal pelvic organ prolapse repairs must be approved premarket. In 2017, the premarket approval proposal went into effect, with the updated order published in the Federal Register. By early 2018, the FDA ended the sale of all transvaginal mesh implant devices by ordering a full market withdrawal of any surgical mesh to be used transvaginally.
Medical Device Lawsuits
The very first company to lose to a transvaginal mesh lawsuit was C.R. Bard, which was ordered to pay out a $3.6 Million verdict to a woman in 2012. Since then, numerous lawsuits have been pursued and won on behalf of the women who were victims of these faulty surgical mesh implants. In these lawsuits, mesh manufacturers are accused of failing to fully research and test the devices, neglecting to warn people of the potential risks for complications, and neglecting to devise safe methods for removing the medical devices. Moreover, the medical device manufacturers stand accused of not only intentionally misleading patients and medical professionals, but also the FDA itself in terms of the actual safety of their products.
Since the first victory against C.R. Bard in 2012, more companies quickly found themselves in similar situations.
In 2013, Johnson & Johnson became the first company to lose a federal mesh lawsuit. Shortly thereafter, American Medical Systems was the first company to agree to provide a large settlement. By 2017, American Medical Systems had settled nearly 22,000 mesh claims. From there, several companies agreed to a major class action settlement in California, resolving over 2,000 claims in 2016. By 2017, nearly every company that faced a federal mesh lawsuit agreed to pay out settlements. American Medical System has since topped out at 40,000 claims settled for $2.6 Billion to date.
Johnson & Johnson’s Ethicon is the one mesh manufacturer that is particularly slow to agree to settlements. In 2015, they had only settled on 4 lawsuits. It was not until 2016 that Ethicon settled 3,000 cases. As of late 2019, Ethicon still had over 40,000 outstanding transvaginal mesh lawsuits against them. While the company has issued some recalls on mesh devices, they still have not accurately expressed safety concerns to the public. Due to the great volume of these outstanding lawsuits, the cases have since been consolidated into multi-district litigation. Several hundred of these are still pending.
More recently, other companies have taken their subsequent turns in making large settlements. Boston Scientific had lost several jury verdicts before finally settling on 3,000 lawsuits in 2015. However, the company continued to fight against the accusations of the plaintiffs.
In 2019, Boston Scientific had entered into the final stages of settling about 50,000 claims. In March of 2021, Boston Scientific agreed to settle claims made by 47 states that accused the company of creating deceptive marketing for vaginal mesh implants. These settlements total $188.7 Million. Still, there are several thousand outstanding lawsuits against the company. Covid-19 has also resulted in several multidistrict litigations against transvaginal mesh manufacturers being closed. But rest assured, the fight for compensation will carry on.
Conclusion
As you can see, the scope and impact of faulty transvaginal mesh implants are enormous. Faulty medical device lawsuits related to the product are not restricted to the US alone. A few thousand women in Australia and the UK have also come forward with their cases, and thousands more are expected to come forward globally in the near future. Meanwhile, so many thousands of women remain in pain with limited treatment options for their faulty mesh implant injuries. The monetary cost of these faulty devices will likely be in the billions, while the mental and physical anguish remains much more difficult to quantify.
If you or a loved one have been the recipient of a transvaginal mesh implant and also experience chronic pain and health conditions related to the mesh, then you deserve to be compensated for your troubles. You may be eligible to file a lawsuit against your device’s manufacturer. If you would like to seek out legal counsel on what your options may be, please do not hesitate to contact us for a free case evaluation. Help is here.
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