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Transvaginal Mesh
Transvaginal mesh is a medical implant that has been used for decades to address various health issues affecting women, such as Pelvic Organ Prolapse (POP), urinary stress incontinence, and other related conditions. While this mesh was initially developed for hernia repair in the 1950s, its application expanded to treat a broader range of medical concerns. This article delves into the history of transvaginal mesh, its intended use, and the concerning issues associated with its utilization, including serious health complications. Additionally, we will explore the legal consequences faced by manufacturers of these mesh implants and the avenues available for those who have suffered harm to seek justice.
Understanding Transvaginal MeshTransvaginal mesh, also known as pelvic mesh or bladder sling, is typically crafted from various materials, including biologic substances, plastic, or stainless steel. Surgeons use this mesh to provide support and create a sort of hammock beneath organs that may be collapsing due to conditions like POP or urinary stress incontinence. The mesh is usually attached to surrounding muscle tissue during the surgical procedure. This method was initially effective in addressing hernias but has raised significant concerns when applied to conditions like POP and urinary stress incontinence.
The Risks and ComplicationsOne of the primary concerns associated with transvaginal mesh implants is the erosion of the mesh material, which can lead to its invasion of nearby organs. This erosion can result in serious side effects, including:
- Erosion of the vaginal epithelium: The mesh can damage the vaginal lining, leading to discomfort and complications.
- Bowel perforation: In some cases, the mesh may puncture the bowel, causing severe health issues.
- Return of Pelvic Organ Prolapse: Instead of providing the desired support, the mesh may fail to address the condition adequately.
These complications have had a profound impact on the lives of many women who have undergone transvaginal mesh procedures.
Manufacturers and FDA WarningsSeveral manufacturers produce transvaginal mesh implants, including Johnson & Johnson Ethicon Division, American Medical Systems, C.R. Bard, Coloplast, Cook Medical, and Boston Scientific. The Food and Drug Administration (FDA) issued a public health advisory concerning these mesh implants between 2005 and 2008, citing over 1,000 “Adverse Events” related to their use. Notably, there was a sevenfold increase in bladder perforations associated with transvaginal mesh procedures during this period.
In December 2011, serious medical journals began advising gynecologists that transvaginal mesh was not beneficial in most cases. Despite these warnings, manufacturers continued to aggressively market their mesh “kits” while downplaying the known risks associated with them.
Legal Consequences and VerdictsAs awareness of the dangers of transvaginal mesh grew, legal action followed. In April 2014, the FDA reclassified transvaginal mesh implants as a high-risk procedure. Numerous lawsuits have been filed against manufacturers, and juries have delivered substantial verdicts against them. For example:
- Ethicon faced a verdict of $3.27 million.
- Johnson & Johnson was ordered to pay $1.2 million.
- Boston Scientific was penalized with a staggering $73 million, including $50 million in punitive damages.
These verdicts reflect the seriousness of the situation and the manufacturers’ responsibility for the harm caused to patients.
Seeking Legal AssistanceIf you or someone close to you has had to endure the life-altering repercussions of a transvaginal mesh surgery that did not go as planned, it is absolutely imperative to promptly seek the counsel of a qualified legal professional. You could potentially have a valid claim for compensation to address the considerable pain and suffering you have endured and the substantial medical expenses you may have incurred. Call our law firm at (916) 921-6400 or (800) 404-5400 for a free consultation.
Editor’s Note: updated 11.8.23 Photo by National Cancer Institute on Unsplash [cs 616]