Millions of women worldwide have undergone surgery using vaginal mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). While this procedure offered a minimally invasive solution, concerns have risen about potential complications associated with vaginal mesh.
In 2024, women must be well-informed about the risks and benefits of this treatment option.
This article will explore the potential injuries and complications associated with vaginal mesh. We’ll provide you with essential knowledge to make informed decisions about your healthcare.
What is Vaginal Mesh?
Vaginal mesh is a medical device used in the treatment of POP and SUI. Surgically implanted to provide support to weakened pelvic floor tissue, it is typically made from lab-made materials or, less commonly, animal tissues.
According to Mayo Clinic, while mesh offers additional support to weakened or damaged tissue, its use has been associated with various complications. For instance, when used for pelvic organ prolapse repair via vaginal insertion, there is an increased risk of mesh-related problems.
These potential issues include protrusion through the vaginal wall, pelvic pain, and discomfort during intercourse. Although these complications may not always manifest symptoms, individuals experiencing issues may require additional surgery or specialized vaginal creams for relief.
Patients should remain alert for symptoms such as vaginal bleeding, pelvic or groin pain, and discomfort during intercourse. Further, they must promptly consult healthcare providers for evaluation and management. Regular follow-up appointments are essential to monitor for potential complications, ensuring timely intervention if issues arise.
Potential Complications of Vaginal Mesh
The potential complications associated with vaginal mesh procedures underscore the significant risks that some women may face. Among these complications, mesh erosion stands out as the most prevalent issue.
Mesh erosion occurs when the mesh wears through the vaginal tissue, leading to its protrusion into the vagina or neighboring organs. This distressing condition can trigger a cascade of problems, including pain, bleeding, infection, and challenges with sexual intercourse.
Chronic pain is another common consequence, with women experiencing persistent pelvic discomfort, pain during intercourse, and discomfort during urination. Furthermore, mesh increases the risk of infection, as it can serve as a breeding ground for bacteria.
Urinary problems are another troubling complication, particularly if the mesh erodes into the bladder. This can result in urinary urgency, frequency, and incontinence, significantly impacting a woman’s quality of life. Additionally, over time, the mesh may contract, leading to vaginal shortening and tightening, culminating in further pain and sexual dysfunction.
According to Drugwatch, the seriousness of these complications prompted regulatory action by the Food and Drug Administration (FDA). In 2016, the FDA reclassified mesh for transvaginal POP repair as a high-risk device, acknowledging that complications are “not rare.”
Subsequently, in April 2019, the FDA ordered all manufacturers to cease the sale of mesh due to their failure to demonstrate its safety. Women must be aware that complications can arise immediately after surgery or manifest many years later, emphasizing the need for ongoing monitoring.
Legal Landscape of Vaginal Mesh
The safety of vaginal mesh has been a subject of ongoing controversy, with numerous lawsuits filed against manufacturers alleging various forms of misconduct.
According to TorHoerman Law, companies have been accused of negligence and breaches of warranty. Additionally, they are accused of design and manufacturing defects and deceptive marketing practices in the promotion of surgical meshes to the public.
These lawsuits resulted in consolidating cases into seven multidistrict litigations (MDLs). They involved major manufacturers like C.R. Bard, Inc., Boston Scientific Corp., American Medical Systems, Inc., Coloplast Corp., Ethicon, Inc., Cook Medical, Inc., and Neomedic. With over 100,000 cases combined, this litigation became one of the largest mass tort litigations in U.S. history.
According to Forbes, approximately 95 percent of the cases have been resolved or dismissed with companies paying a total of $525 million in settlements.
However, lawsuits also extend to state courts. Notable cases include a New Jersey jury awarding $33 million in compensatory damages and $35 million in punitive damages against C.R. Bard in 2016. This verdict was later reversed in 2021 due to a trial judge’s evidence error.
The vaginal mesh lawsuit continues in various courts across the country, both at the federal and state levels. Women who have experienced complications from this device are encouraged to seek legal recourse.
Men who have been affected may also be eligible to file lawsuits, especially if their ability to engage in physical contact has been impacted. Individuals also need to be aware of the statutes of limitations in their jurisdiction, as it may impact the eligibility to file a lawsuit.
Who is Liable for Vaginal Mesh Complications?
Determining liability for vaginal mesh complications involves assessing the role of both manufacturers and healthcare providers. Identifying the device manufacturer responsible for the complications is crucial in pursuing legal action.
Additionally, healthcare providers, particularly physicians, may face liability through medical malpractice claims. A notable case involved a woman suing Ethicon, a mesh manufacturer, and her medical doctor.
Ethicon was accused of negligence for distributing defective devices and inadequate warnings. The doctor was alleged to have failed in timely diagnosis and misrepresented the terms of the revision surgery.
This underscores the importance of examining the responsibilities of healthcare professionals in addressing complications arising from vaginal mesh procedures. Ultimately, determining liability requires a comprehensive assessment of all parties involved and their respective roles in the chain of events leading to the complications.
In conclusion, vaginal mesh surgery offers a potential solution for POP and SUI, but it’s vital to understand its associated risks and complications. This article provided insight into potential pain, infection, erosion, and other issues that can significantly impact your well-being.
Remember, open communication with your doctor is crucial. Discuss alternative treatments, thoroughly understand the risks, and ask questions until you feel fully informed.
If you have experienced complications from vaginal mesh, know that you are not alone. Several resources exist, including support groups and legal counsel. You may be eligible to seek legal recourse against the manufacturer depending on the specific circumstances of your case.
