FDA Ban on Transvaginal Mesh Kits

In 2019, the FDA ban on transvaginal mesh kits for pelvic organ prolapse repair was implemented, responding to reports of severe complications. This article explores the reasons for the ban, the impact on women’s health, and examines possible surgical and non-surgical alternatives.

Key Takeaways

  • The FDA banned the sale of all transvaginal mesh products for pelvic organ prolapse in 2019 due to safety concerns and complications, following warnings and reports of adverse effects since 2005.

  • Alternative surgical options such as transabdominal mesh in sacrocolpopexy procedures remain available for treating pelvic organ prolapse, although they carry their own risks and require careful consideration and patient selection.

  • Transvaginal mesh complications have led to many lawsuits against manufacturers, resulting in billions of dollars in settlements; patients affected can seek legal compensation for medical costs, lost wages, and suffering.

The FDA Ban on Transvaginal Mesh Kits: Background and Reasons

Transvaginal mesh, a surgical mesh for transvaginal use, was designed to address weakened or damaged tissue in the bladder or pelvic region of women, offering an alternative to native tissue repair. Its primary purpose was to treat female pelvic floor disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). However, the device, primarily composed of polypropylene, a type of plastic, or animal tissue, has been the subject of considerable controversy surrounding surgical mesh devices, including transvaginal mesh surgery.

In April 2019, the Food and Drug Administration (FDA) banned the sales of all transvaginal mesh products for pelvic organ prolapse, citing safety concerns and complications associated with pelvic floor disorders. This decision was a culmination of years of warnings and surveillance orders, sparked by an influx of reports of complications from transvaginal mesh implants that the FDA started receiving in 2005.

Figure 3 from Vaginal Mesh Kits for Pelvic Organ Prolapse, Friend or Foe: A Comprehensive Review | Semantic Scholar

Timeline of FDA Actions and Warnings

In 2014, the FDA put forth two significant proposals addressing the issues surrounding transvaginal mesh as a surgical treatment. The first proposal involved reclassifying transvaginal mesh used in pelvic organ prolapse surgery as a class III (high-risk) device. The second proposal required companies to submit a premarket approval application. This application was to validate the use of mesh during surgery for pelvic organ prolapse.

Reports of complications from transvaginal mesh implants started surfacing in 2005, prompting the FDA to take this significant step. The culmination of these actions resulted in the FDA reaffirming its position in 2019 by directing manufacturers to stop the sale of mesh for transvaginal repair of pelvic organ prolapse. This decision was further reinforced by the FDA’s final report on devices such as the Coloplast mesh and Boston Scientific Transvaginal mesh for pelvic organ prolapse, which affirmed the risks associated with these devices and supported the initial ban.

Safety Concerns and Complications

A major concern associated with the use of transvaginal mesh is mesh erosion. This refers to the gradual deterioration of non-absorbable synthetic surgical mesh, potentially leading to serious complications such as the exposure of the mesh in the vaginal area and the possibility of organ perforation as the eroded mesh penetrates organ walls. The gravity of these complications often require more surgical procedures to address these issues.

The potential implications include persistent pain and the exposure of the vaginal epithelium to synthetic mesh. In many cases, these complications have led to a number of lawsuits from patients who have undergone transvaginal mesh procedures and experienced these adverse effects. This underlines the importance of thoroughly reviewing the safety and effectiveness of medical devices before they are made available to the public.

Transvaginal Mesh Around the World – Bans & Public Concern

Transabdominal Mesh and Sacrocolpopexy: Alternative Surgical Options

Despite the FDA’s ban on transvaginal mesh for pelvic organ prolapse repair, other surgical options for treating pelvic organ prolapse and stress urinary incontinence remain available. Abdominal mesh in sacrocolpopexy and mesh for stress urinary incontinence (SUI) in a sling procedure remain accessible and are not affected by the ban.  The mesh used in these surgeries are made of the very same polypropylene used in the banned transvaginal mesh kits, so it remains to be seen whether the frequency  of life changing complications will cause further action by the FDA, or a reluctance of surgeons to do these mesh procedures.

These alternative, surgical options are important to consider, especially for women suffering from pelvic organ prolapse and require surgical intervention. The procedure for transabdominal mesh surgery for pelvic organ prolapse includes:

  1. The creation of an abdominal incision or the use of laparoscopy.
  2. Then surgical mesh is affixed to the front and back walls of the vagina.
  3. The mesh is then connected to the sacrum (tail bone). This helps to support the vaginal wall and alleviate symptoms of pelvic organ prolapse.

Benefits and Risks of Transabdominal Mesh

Mesh manufacturers claim transabdominal mesh have these benefits:

  • Less invasive approach compared to traditional abdominal surgery
  • Improved ease of performance compared to other procedures
  • Alleviates pressure on the bladder
  • Contributes to a reduction in urinary leakage

Some surgeons implant this mesh for women suffering from pelvic organ prolapse.

However, like any surgical procedure, using transabdominal mesh is not without risks. While abdominal surgeries using transabdominal mesh, such as sacral colpopexy, show fewer instances of mesh-related complications compared to transvaginal mesh surgeries, they are not entirely without risks. The risks associated with transabdominal mesh include:

  • Infection
  • Mesh erosion
  • Pain
  • Bleeding
  • Organ damage

It is important to discuss these risks with your healthcare provider before undergoing any surgical procedure involving transabdominal mesh.

Sacrocolpopexy: Purpose, Procedure, Risks, Results & Recovery

Sacrocolpopexy Procedure and Outcomes

Sacrocolpopexy is another surgical procedure that uses mesh to support the vagina. The procedure involves a series of steps including:

  1. Sacral promontory dissection
  2. Extending the peritoneal incision
  3. Supracervical hysterectomy
  4. Anterior dissection

While the median reported rate of vaginal-mesh complications is 4% within 23 months post-surgery, patients have expressed favorable outcomes, enhanced quality of life, and overall contentment following Sacrocolpopexy surgery.

The long-term results of a Sacrocolpopexy procedure justify careful consideration. Over a 7-year follow-up period, there was an increase in failure rates for abdominal sacrocolpopexy. It is important to consider the effectiveness of the procedure alongside the long-term risks of mesh and/or suture erosion. Further research is needed to better understand the durability, complications, and pelvic floor symptoms following the procedure.

Polypropylene Material: Commonality Between Banned and Approved Mesh Products

An interesting fact to note is that both the banned transvaginal mesh kits and the approved alternatives use polypropylene material. This raises questions about the safety and effectiveness of the material itself and whether the issues lie in the application of the material or the material itself.

Polypropylene is a synthetic material extensively used in surgical mesh owing to its exceptional mechanical properties and chemical inertness, making it a highly favored option for procedures such as hernia repairs and the treatment of pelvic organ prolapse. However, despite its widespread use, polypropylene has been linked to a number of complications, prompting the need for further research and investigation.

Biomedicines | Free Full-Text | Polypropylene Pelvic Mesh: What Went Wrong and What Will Be of the Future?

 

Properties and Uses of Polypropylene Mesh

Type I polypropylene mesh is characterized by being monofilament, lightweight (less than 45g/m2), and macroporous (with pore sizes larger than 75 micrometers). These specific properties appeared  to make it suitable for various medical uses, particularly in the context of urogynecologic procedures.

The significant difference between Type I polypropylene mesh and Types II and III lies in the pore size and weight. Type I mesh is considered superior due to its large-pore size and light weight, which facilitate better vascular penetration and tissue integration. This reduces the risk of complications such as fibrosis and encapsulation associated with the smaller pores and heavier weight of Types II and III mesh.

Addressing Safety Concerns

Addressing safety concerns involves understanding the differences between transvaginal and transabdominal mesh, as well as proper surgical techniques and patient selection. While abdominal surgeries using transabdominal mesh have shown lower rates of mesh complications compared to transvaginal mesh surgeries, they are not completely risk-free.

Using appropriate surgical techniques that reinforce and bolster soft tissue weaknesses, such as the use of sutures or a mesh adjunct, can help mitigate safety concerns related to polypropylene mesh. Patient selection also plays a crucial role in ensuring the safety of using polypropylene mesh. Surgeons must take into account various factors, including:

  • Age
  • Defect size
  • Obesity
  • Underlying conditions

To determine the most suitable mesh for each individual case, it’s essential to consider the risk of mesh exposure.

Non-Surgical Alternatives for Pelvic Organ Prolapse and Incontinence Treatment

In addition to surgical options, non-surgical alternatives to treat pelvic organ prolapse and incontinence, which affect the pelvic organs, also exist. These alternatives are particularly useful for patients whose symptoms do not require surgery or who are not ideal candidates for surgery.

Among these non-surgical alternatives are pelvic floor exercises and physical therapy, as well as support devices such as pessaries. These treatments can be beneficial for managing symptoms and improving the quality of life for patients suffering from pelvic organ prolapse and incontinence.

Pelvic Organ Prolapse: Easy Help for the First 2 Stages | ELITONE

Pelvic Floor Exercises and Physical Therapy

Pelvic floor exercises and physical therapy, specifically pelvic floor muscle training (PFMT), have shown effectiveness in addressing:

  • Pelvic organ prolapse
  • Incontinence
  • Fecal incontinence
  • Sexual dysfunction

These interventions have the potential to enhance or alleviate symptoms of these conditions.

The suggested protocol for pelvic floor exercises involves contracting the pelvic muscles and maintaining the contraction for a duration of 10, followed by complete relaxation of the muscles for a duration of 10. Even though these exercises can offer benefits for pelvic organ prolapse and incontinence, many individuals may still require additional treatments.

Pessaries and Other Support Devices

Pessaries are specialized removable devices intended to offer structural support where the walls of the uterus or vagina experience weakness. They are employed to provide support for vaginal or uterine prolapse and to help with issues related to bladder control.

Pessaries are effective in managing symptoms of pelvic organ prolapse. However, they only provide temporary relief and support, and do not address the root cause of the prolapse.

Legal Implications: Transvaginal Mesh Lawsuits and Compensation

 

Transvaginal Mesh Lawsuit Chicago

 

Given the complications and adverse effects associated with the use of transvaginal mesh, it comes as no surprise there have been many lawsuits against manufacturers of transvaginal mesh kits. Plaintiffs have achieved substantial financial results in these lawsuits, securing close to $1 billion from settlements and verdicts for cases involving pelvic mesh.

These lawsuits have been primarily based on claims of negligence, defective design, and failure to warn patients about potential complications. The companies involved in these lawsuits include major manufacturers of transvaginal mesh such as C.R. Bard, Inc., American Medical Systems, Boston Scientific, and Johnson & Johnson.

Overview of Transvaginal Mesh Lawsuits

Transvaginal mesh lawsuits have involved allegations of complications such as pain, bleeding, organ perforation, and autoimmune problems, which plaintiffs attribute to the use of the mesh. Evidence submitted in these lawsuits includes allegations of complications and claims of negligence, warranty breaches, and design and manufacturing defects.

Transvaginal mesh manufacturers have resolved a significant number of legal claims, totaling over $8 billion. Some legal representatives have suggested that the settlements could potentially reach $11 billion. In a recent instance, a recipient of transvaginal mesh implants was granted $7.76 million in punitive damages in addition to a $3.35 million settlement.

Seeking Compensation for Mesh-Related Injuries

Patients affected by mesh complications can seek compensation for medical expenses, lost wages, and pain and suffering through legal action. To pursue this legal action, patients are advised to seek the services of a lawyer with knowledge in transvaginal mesh litigation, such as Tom Plouff of Plouff Law Offices in Chicago. Tom handles mesh cases nationwide with the assistance of local counsel.

For some women, they are compensated by settlement in the range of $40,000 to $450,000 in a transvaginal mesh lawsuit settlement. Nonetheless, the actual compensation amount will vary based on the specifics of each individual case, including the severity of the injury and its impact on the patient’s quality of life.  Further, for those select cases that merit presenting the case to a jury, the results can vary from $0 to tens of millions of dollars. Tom Plouff, of Plouff Law Offices in Chicago, tried a case in 2018 against Johnson & Johnson that resulted in a jury verdict of $35 million.

 

Lawyer Tom Plouff

 

Summary

In conclusion, the FDA ban on transvaginal mesh kits has had significant implications on the medical field, particularly in the treatment of pelvic organ prolapse and stress urinary incontinence. The ban underscores the importance of patient safety, due diligence, and the need for effective and safer alternatives. While surgical options like transabdominal mesh and sacrocolpopexy remain available, they are not without risks. Therefore, it is crucial for patients and practitioners to be aware of the potential complications and to weigh the benefits and risks carefully.

Non-surgical alternatives such as pelvic floor exercises, physical therapy, and support devices like pessaries can also play an important role in managing symptoms and improving the quality of life for patients suffering from pelvic organ prolapse and incontinence. However, for patients who have experienced complications from mesh procedures, seeking legal compensation may provide some financial relief. As always, patient education and informed decision-making are key to ensuring the best outcomes for patients.

Frequently Asked Questions

What is the lawsuit against pelvic mesh?

The lawsuit against pelvic mesh involves actions seeking damages for alleged injuries suffered by individuals who used pelvic mesh products. The lawsuits have resulted in more than $8 billion in settlements from various manufacturers, with Johnson & Johnson denying wrongdoing.

What is the average payout for the bladder mesh lawsuit?

The average payout for a bladder mesh lawsuit can range from $40,000 to $450,000. However, some cases that went to trial have resulted in jury verdicts of millions, although these amounts may be reduced after appeal.

Why did the polypropylene meshes fail when used as a pelvic floor mesh?

Polypropylene meshes failed as pelvic floor mesh due to a mismatch between the mechanical properties of the mesh material and the biomechanical requirements of the female pelvic floor, leading to poor tissue integration and resultant complications.

What kind of mesh is used for sacrocolpopexy?

A ‘Y-shaped’ polypropylene mesh is typically used for sacrocolpopexy, which has a good success rate for anatomical  prolapse repair but complications can also be life changing for some women.

What are the alternatives to transvaginal mesh for treating pelvic organ prolapse?

Consider surgical options such as transabdominal mesh and sacrocolpopexy and non-surgical options like pelvic floor exercises and support devices like pessaries. These alternatives can effectively treat pelvic organ prolapse without using transvaginal mesh.

 

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