The Recalled Ethicon Gynecare Prolift Kit: A Brief Review of The Failed Transvaginal Mesh Device

Bladder sling complications

Overview of the Problem

The Gynecare Prolift device kit and other similar transvaginal mesh products were intended to revolutionize the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. However, what was initially heralded as a groundbreaking advancement soon became synonymous with severe complications and widespread health concerns. This blog provides a brief review of the Ethicon Gynecare Prolift device, its recall by the Food and Drug Administration (FDA), and the broad implications of transvaginal mesh products on women’s health. Additionally, we will delve into the role of an experienced transvaginal mesh attorney in aiding women affected by these devices.

 

Understanding Pelvic Organ Prolapse and the Introduction of Transvaginal Mesh

Pelvic organ prolapse is a condition where the muscles and tissues supporting the pelvic organs (such as the bladder or uterus) weaken, causing these organs to drop from their normal positions. Stress urinary incontinence is the involuntary leakage of urine during physical activities, and is another common issue related to weakened pelvic floor muscles. Traditional treatments for these conditions range from physical therapy to surgical repair. The introduction of transvaginal mesh devices aimed to offer a more durable solution to these health conditions. A synthetic mesh device must be surgically implanted to provide additional support to the weakened pelvic structure at issue.

The Gynecare Prolift Device

The Gynecare Prolift kit, introduced by Johnson & Johnson’s Ethicon subsidiary in 2005, was one such device and was marketed as a comprehensive solution to POP and SUI, promising improved outcomes and reduced recovery times compared to traditional surgical methods. Its design incorporated a synthetic polypropylene mesh, intended to provide long-term support to the pelvic organs. The device was promoted as an innovative approach to a prevalent problem, offering hope to countless women suffering from POP and SUI.

Safety Concerns and Complications with the Prolift Device

Despite the initial optimism, the Gynecare Prolift device faced serious scrutiny due to a myriad of safety concerns and complications reported by patients implanted with the device. The Prolift kit was voluntarily withdrawn from the market by its manufacturer Jonhson & Johnson in 2012. Some of the primary issues associated with the device included:

Erosion of the Mesh: One of the most significant complications was the erosion of the mesh into surrounding tissues, leading to severe pain, infection, and damage to organs. This occurs when the synthetic mesh material used in the device erodes through the vaginal wall or other surrounding tissues, leading to pain, infection, and possibly urinary or vaginal fistulae.

Chronic Pain: Many women reported chronic pelvic pain following the implantation, significantly impacting their quality of life. Patients who have had mesh devices implanted have reported chronic pelvic pain, dyspareunia (painful intercourse), sexual impairment, nerve injuries, and painful urination.

Infection: As with any surgery, the introduction of foreign material inside the body heightens the risk of infection, sometimes requiring additional surgical interventions after the mesh has been placed.

Dyspareunia: Pain during intercourse, or dyspareunia, is a common complaint among those experiencing complications from vaginal mesh and can affect intimate relationships and emotional well-being.

Organ Perforation: In some cases, after being implanted the mesh would perforate adjacent organs such as the bladder or rectum, necessitating further surgeries and longer recovery times.

Recurrent Prolapse or Incontinence: Unfortunately, some patients dealing with complications may even experience a recurrence of the very issue that the mesh was supposed to resolve, leading to multiple corrective surgeries.

 

These complications highlight the significant risks associated with the Gynecare Prolift device and similar recalled transvaginal mesh products, which prompted regulatory bodies like the FDA and other healthcare professionals to reevaluate their assessment of the safety and efficacy of these mesh implants.

The FDA Recall and Regulatory Response

In response to the mounting evidence of severe complications, the FDA issued several warnings and mandates concerning transvaginal mesh products. In 2008, the FDA released a public health notification, highlighting the risks associated with transvaginal mesh used in POP and SUI surgeries. This was followed by an updated safety communication in 2011, which emphasized the serious complications linked to these devices.

 

The turning point came in 2012 when Johnson & Johnson voluntarily withdrew the Gynecare Prolift and several other transvaginal mesh products from the market. The FDA continued its scrutiny, and in 2016, it reclassified transvaginal mesh for POP repair as a high-risk (Class III) device, necessitating more rigorous premarket approval processes. In 2019, the FDA ordered a complete prohibition on the sales of transvaginal mesh products for the treatment of POP.

Broader Implications of Transvaginal Mesh Products on Women’s Health

The recall of the Gynecare Prolift mesh and the heightened regulatory oversight cast a light on the broader implications of transvaginal mesh products. While intended to offer a permanent solution to POP and SUI, these devices often resulted in debilitating complications, leading to long-term physical, emotional, and financial burdens for many women.

 

The initial promise of transvaginal mesh highlighted the gap between innovation and patient safety. It underscored the need for comprehensive clinical trials and post-market surveillance to ensure that such devices do more good than harm. The experiences of countless women who suffered due to transvaginal mesh products serve as a poignant reminder of the importance of patient-centered care and stringent regulatory standards.

Mesh Atty

The Role of Transvaginal Mesh Attorneys

For women who have been harmed by devices like the Ethicon Gynecare Prolift, seeking legal help is an essential step toward obtaining justice and fair compensation. Transvaginal mesh attorneys represent individuals who have experienced adverse effects from these medical devices. An attorney with a track record of successful transvaginal mesh litigation can provide valuable insights and strategies to navigate the complexities of these cases. Here’s how they can help:

 

Legal Knowledge and Trial Experience

A transvaginal mesh attorney must possess knowledge and understanding of both product liability law and personal injury claims related to medical devices. They can evaluate the specifics of a case, determine the viability of a lawsuit, and advise on the best course of action. Mesh attorney Tom Plouff has over a decade of experience representing clients who have suffered harm from transvaginal mesh, including a $35 million jury award against transvaginal mesh manufacturer Johnson & Johnson. As an advocate for women who experience mesh-related injuries, Tom has taken to trial or settled various other cases representing millions of dollars of damages paid to his clients.

Mesh Atty Book

Gathering Evidence and Building a Strong Case

A crucial aspect of any legal claim is the collection of evidence. Mesh attorneys work diligently to gather medical records, expert testimonies, and documentation of the complications suffered by the client. They build a compelling case to demonstrate the link between the transvaginal mesh device and the harm caused. A transvaginal mesh attorney plays an important role in the litigation process and advocates for you as a plaintiff against corporate manufacturers responsible for the harm their devices cause. Mesh litigation involves powerful pharmaceutical companies with vast resources. Overcoming the legal defenses and tactics used by these companies is a significant challenge.

 

Navigating Legal Complexities

The legal landscape surrounding medical device litigation can be complex and may involve multiple parties including multi-million-dollar manufacturers, and various healthcare providers. Experienced transvaginal mesh attorneys navigate these complexities, ensuring that the case is presented effectively in court or during settlement negotiations. Tom Plouff has extensive experience as a trial attorney and has been fortunate to have secured on behalf of his clients many multimillion-dollar jury verdicts. In March 2018, a federal jury seated in Indiana agreed that Tom’s client in a transvaginal mesh lawsuit against Johnson & Johnson was entitled to $35 million in damages. The jury awarded $10 million in actual damages and $25 million in punitive damages due to injuries she sustained from her Ethicon Prolift transvaginal mesh implant.

Providing Legal Guidance and Compassionate Support

Dealing with the aftermath of a medical device injury can be emotionally and financially taxing. Transvaginal mesh attorneys like Tom Plouff not only offer legal guidance but also provide compassionate support, helping clients navigate the various challenges of their situation. Through years of experience, Tom has gained the knowledge and ability required to navigate the intricacies of transvaginal mesh cases effectively and promptly. Tom values open and honest communication with his clients and will always ensure that your interests are the top priority.

 

Conclusion

Stories of recalled transvaginal mesh products like the Ethicon Gynecare Prolift device highlight the critical importance of patient safety in the realm of medical devices. While these products were designed to address debilitating conditions like pelvic organ prolapse and stress urinary incontinence, the severe complications they are associated with have left a lasting impact on many women’s lives. Accordingly, an FDA recall was a necessary step toward protecting patients, but it also shows that it is necessary to conduct more rigorous testing and advocate for more comprehensive oversight in the development and marketing of transvaginal mesh devices.

If you believe you have been harmed by the implanting of a mesh device, you are encouraged to contact an experienced transvaginal mesh attorney like Tom Plouff of Plouff Law Offices, PC, to discuss if you have a potential transvaginal mesh case and if there is any legal remedy available.

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