Pelvic mesh, also known as transvaginal mesh or pelvic sling, is a medical device. It has been at the center of controversy and legal disputes in recent years. Designed to treat various pelvic floor disorders in women, pelvic mesh has been the subject of numerous lawsuits and regulatory actions.
In this article, we’ll explore what pelvic mesh is, how it is used, and why women have taken legal action against its manufacturers.
Table of Contents
Understanding Pelvic Mesh
Pelvic mesh is a medical implant made of synthetic materials such as polypropylene, polyester, or polytetrafluoroethylene (PTFE). It is used to reinforce and support weakened or damaged pelvic tissues, particularly in cases of pelvic organ prolapse (POP) and stress urinary incontinence. These conditions can occur as a result of childbirth, surgery, or age-related weakening of the pelvic floor muscles.
The primary functions of pelvic mesh include:
- Support: Pelvic mesh is implanted to provide structural support to the pelvic organs. This is necessary when these organs, such as the bladder, uterus, or rectum, sag or drop due to weakened connective tissues.
- Stabilization: It stabilizes the pelvic floor by maintaining the correct anatomical position of the organs, which helps alleviate symptoms like incontinence and discomfort.
- Reinforcement: The mesh acts as a scaffold, promoting the growth of new tissue around it to strengthen the pelvic area.
- Symptom relief: In many cases, pelvic mesh is utilized to alleviate the uncomfortable and distressing symptoms of POP and SUI. These symptoms include urinary incontinence, pelvic pain, and discomfort during sexual intercourse.
Why Women Have Been Suing Over Pelvic Mesh
Pelvic mesh has garnered acclaim as an effective solution for addressing pelvic floor disorders. Nevertheless, it has also been linked to significant complications and adverse effects, resulting in a substantial number of lawsuits.
In 2008, the U.S. Food and Drug Administration (FDA) first issued a warning concerning the serious complications associated with transvaginal mesh. This warning subsequently prompted the filing of thousands of lawsuits.
The majority of these vaginal mesh lawsuits were consolidated into seven federal multidistrict litigation cases against major manufacturers. According to TruLaw, many of these cases have been resolved, with the companies reaching settlements worth hundreds of millions of dollars.
Notable settlements include one that resolved 20,000 cases for $830 million, in addition to several multi-state settlements not brought in federal court.
Starting in 2012, women who filed the transvaginal mesh lawsuit secured at least 20 verdicts in both state and federal courts. These verdicts collectively amounted to around $300 million.
Several patients have been awarded multimillion-dollar verdicts against manufacturers. For instance, in 2018, one jury granted Mary McGinnis and her husband a $68 million verdict. Additionally, in 2019, another jury awarded Patricia Mesigian $80 million. Despite the multidistrict litigation (MDL) closing in November 2022, women still have the option to file lawsuits in state courts.
Women have taken legal action against manufacturers for several reasons:
Severe Complications
Several women who have undergone pelvic mesh implantation have encountered severe complications, which may include chronic pain, infections, bleeding, and mesh erosion.
Notably, post-surgical pain stands out as a prevalent issue among women who have received pelvic mesh implants. According to available reports, approximately 70 out of 110 studies have documented instances of women experiencing pain following a mesh procedure. This results in an overall rate of 9.1 percent, roughly translating to nine individuals for every 100 cases.
In one of the studies included in this review, 23 women underwent mesh removal surgery due to complications. Among the 11 women who reported pain, 10 found relief from their pain after the mesh removal procedure.
Organ Perforation
Organ perforation is defined as the penetration of an organ’s wall within the body. When pelvic mesh erodes through internal tissues, it can potentially perforate other organs, often involving the bladder, urethra, or rectum. Medical professionals consider this one of the most severe complications of mesh surgery due to the increased risk of infection and organ damage.
In 2011, a study compared transvaginal mesh procedures to colporrhaphy, a surgical technique used to repair the vaginal wall. The study involved 389 women with pelvic organ prolapse, all of whom had a prolapse in the anterior (front) vaginal wall.
Significantly higher complication rates were observed in the mesh group, especially in relation to perforation, among the 200 women who underwent transvaginal mesh repairs. This was in contrast to the 189 women who underwent colporrhaphy. In the mesh group, bladder perforation occurred in 3.5 percent of cases, whereas the colporrhaphy group experienced only a 0.5 percent incidence.
Inadequate Information and Long-Term Safety Concerns
Some plaintiffs claim that manufacturers failed to provide sufficient information about the potential risks and complications associated with pelvic mesh. This lack of information, they argue, led to uninformed decisions by patients.
Additionally, concerns have arisen due to the absence of comprehensive long-term safety data for pelvic mesh implants. This is particularly concerning because certain adverse effects may only become apparent years after the surgical procedure.
As a result, both patients and healthcare providers face challenges in evaluating the full extent of potential risks associated with these implants.
Legal Actions and Regulatory Responses
Due to the increasing number of lawsuits and concerns expressed by patients and healthcare professionals, regulatory agencies have taken action. These agencies have initiated efforts to address the issues related to pelvic mesh.
In 2019, the U.S. Food and Drug Administration (FDA) took regulatory action. They ordered manufacturers to halt the sale of transvaginal mesh for pelvic organ prolapse (POP) due to concerns about its safety and efficacy.
In addition to regulatory actions, many manufacturers of pelvic mesh have faced legal repercussions, resulting in significant financial settlements to compensate injured patients.
Conclusion
Pelvic mesh was introduced as a solution to help women suffering from pelvic floor disorders like POP and SUI. While it has been effective for some, the device has also been associated with significant complications and adverse effects. Many women have filed lawsuits against manufacturers, alleging that they were not adequately informed about the potential risks.
Regulatory actions, such as the FDA’s ban on transvaginal mesh for POP, reflect the ongoing concerns about the safety and efficacy of these implants. For women considering pelvic mesh, it is crucial to carefully assess the potential benefits and risks. Consulting with their healthcare providers is vital to ensure informed decision-making regarding their treatment options.
