Overview
A transvaginal mesh commonly called vaginal mesh is a surgical implant used in the treatment of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Both POP and SUI are referred under the umbrella term ‘pelvic floor disorders. The surgical mesh used to correct pelvic floor disorders is referred to as Urogynaecological mesh.
Surgical mesh products for pelvic floor disorders are manufactured in the U.S. by several companies like American Medical Systems, C.R. Bard Inc., Boston Scientific Corp., and Johnson & Johnson.
Before catching on to transvaginal meshes, vaginal mesh problems, and vaginal mesh lawsuits, let’s have a quick look at pelvic floor disorders.
Pelvic Organ Prolapse (POP)
The pelvic organs comprise the vagina, cervix, uterus, bladder, urethra, and rectum. Pelvic organ prolapse occurs when the tissue and muscles of the pelvic floor get weakened and no longer support the pelvic organs. This causes a prolapse or pushing of the pelvic organs from their normal position into or outside of the vaginal canal or anus.
The common symptoms of pelvic organ prolapse are vaginal bleeding, pain, sexual dysfunction, etc. It is estimated that around 30-40% of women suffer from pelvic organ prolapse. However, only 3- 8 % of them have associated symptoms demanding medical attention.
Based on the organ that prolapses, POP could be classified as follows.
Cystocele: Descending of the bladder into the vagina
Urethrocele: Prolapse of the urethra
Uterine prolapse: Prolapse of the uterus
Vaginal vault prolapse: Prolapse of the vagina
Enterocele: Prolapse of the small bowel
Rectocele: Prolapse of the rectum
Stress Urinary Incontinence (SUI)
Stress Urinary Incontinence in layman’s terms is the unintentional loss of urine during activities like coughing, laughing, sneezing, running, or heavy lifting. It occurs due to the weakness in the pelvic floor muscles and sphincter muscle that prevents urine from leaking through the urethra. The weakness puts pressure on the urinary bladder resulting in leakage of urine. Surveys indicate that one in 3 women suffers from SUI at some point in their lives. SUI is often found interwoven with pelvic organ prolapse and may be presented as a symptom of POP.
Management of Pelvic Floor Disorders
- Non-Surgical Methods
Non-surgical treatment methods are suggested for individuals with minor pelvic floor disorders. The common treatment methods are
- Pelvic floor exercises/Kegels
- Pessary
- Oral medications
- Injections
- Nerve stimulation
- Surgical Methods
When the condition is severe and non-surgical options fail, the physician may suggest a surgical procedure. It is done either to repair the affected tissue or organ or to remove the organ itself. Surgical repair of pelvic floor disorders may be done with or without the use of mesh implants.
Vaginal Mesh in Treating Pelvic Floor Disorders
A vaginal mesh is more or less similar to that of a hernia mesh used to treat an abdominal hernia. It is a synthetic net-like substance implanted during surgery for pelvic floor disorders. It reinforces the weakened soft tissue by growing into the pores present in it. Vaginal meshes are intended to be permanent implants.
Traditionally, surgery for pelvic floor disorders was carried out without the usage of surgical mesh products. Soon after the success of surgical meshes in inguinal hernia surgery, gynecologists started using those mesh products for repairing pelvic organ prolapse and Stress Urinary Incontinence.
As the pelvic disorder cases escalated, the need for precisely designed mesh implants raised which triggered manufacturing companies to design surgical mesh implants for pelvic floor disorders. Surgery for pelvic floor disorder with the implementation of vaginal mesh is reported to increase the success rate and longevity of the procedure.
In 1990, vaginal meshes were classified as moderate-risk devices by the FDA’s 510k program. In 1996 and 2002, the FDA cleared the first surgical mesh product specifically designed for implantation in SUI and POP respectively.
Surgical repair of SUI and POP can be done through an abdominal incision using sutures or by placing a vaginal mesh through via vaginal incision. It is called transvaginal mesh when implanted through the vagina. A small incision is made in the vaginal wall, and the surgical mesh is implanted. It is then fixed firmly by sutures or tissue fixation devices. A vaginal mesh is also known as tape, ribbon, sling, or hammock.
The type of placement of the vaginal mesh in POP varies depending upon the organ prolapse. For instance, correction of cystocele involves the placement of the mesh in the anterior vaginal wall. This is called anterior repair. For rectocele correction, posterior repair is carried out. For uterine prolapse or vaginal apical prolapse, the mesh is placed to the top of the vagina.
Complications of Vaginal Mesh Implants
Every medical advancement would have pros and cons and transvaginal mesh implants are not exceptions. The following are the most commonly reported problems of a vaginal mesh.
- Pain
- Infection
- Vaginal bleeding
- Perforations of the bowel, bladder and blood vessels
- Vaginal scarring
- Mesh exposure and erosion
- Organ perforation
- Painful sex
- Autoimmune problems
Many of these complications are reported even years after the surgery. Considering the thousands of women who had the implants, the number of cases of adverse reactions is high. The truth of the matter is that vaginal mesh complications often end up in revision surgeries to remove the implanted mesh.
Vaginal Mesh Complications and Recalls
In 2010, approximately 300,000 women in the U.S. underwent surgical repair for POP. 75,000 of the surgeries used vaginal meshes implanted, and around 67,500 of these procedures used non-absorbable meshes. However, studies on these patients suggested that the mesh offered no clinically significant benefits instead ended up in serious complications. Based on these reports, the Public Citizen called upon the FDA to recall non-absorbable vaginal mesh products in the market.
In July 2011, the FDA issued a safety alert indicating that serious complications of surgical meshes used in POP surgeries are not rare. The skyrocketing reports on vaginal mesh problems have obliged the FDA in 2012 to put forward a proposal to reclassify them from Class II (moderate-risk) to Class III (high-risk) medical devices.
In January 2016, the reclassification was implemented stating that the manufacturers should submit a premarket approval (PMA) application demonstrating the safety and effectiveness of vaginal meshes used in POP surgeries. However, this is only for transvaginal meshes used in the POP repair and not for SUI or abdominal repair of POP.
In 2019, the FDA halted the marketing of transvaginal mesh products manufactured by companies like Davol, Johnson & Johnson aka Ethicon, Boston Scientific Uphold Lite, Boston Scientific Xenform, and Coloplast Direct Fix Anterior for POP. These manufacturers could not prove the benefits of their products overshadowed the risks.
This month, the final results of the Boston Scientific Transvaginal Mesh for Pelvic Organ Prolapse (POP) 522 studies are revealed. The FDA had reviewed this Post Market Surveillance Studies and found that the mesh had similar effectiveness and risks of a native tissue repair. However, mesh exposure and erosion were found to be serious complications that demanded a recall of the product from the market.
How to Pursue a Vaginal mesh Lawsuit?
Debilitating pain, relapse of the condition, and other vaginal mesh complications oblige the victim to come up with a product liability claim against the product manufacturer. The following damages sustained by the claimant are considered in vaginal mesh lawsuits.
- Diagnosed organ damage
- Ongoing severe symptoms
To be successful, a vaginal mesh lawsuit should prove any of the following
- Design defects
- Manufacture defect
- Failure to warn patients of the potential complications of the surgical mesh
Failure to accommodate methods to remove a defective mesh, improper testing of the product, intentional misleading of the FDA, and insufficient risk analysis are other key points that could be used against the manufacturer.
Can a vaginal mesh complication be the result of medical negligence?
In most cases, the vaginal mesh manufacturer is sued for mesh complications and transvaginal mesh settlement. The surgeon or the healthcare provider involved in the implantation procedure could be sued only if medical malpractice is evident in the procedure. The surgeon could also be held if he had intentionally implanted a dangerous/recalled mesh product.
Blaming the surgeon for the complication of the mesh implant is one of the common defenses used by mesh manufacturing companies. They argue that the complication stemmed from negligence or medical error and not because of the surgical mesh. However, a well-prepared medical records review report can easily defeat the argument.
To proceed with a vaginal mesh lawsuit, the claimant should hire a product liability lawyer. After case evaluation, the lawsuit would be filed. The discovery phase would be completed during which the necessary evidence and documents to substantiate the claim would be collected by both parties.
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Depending upon the worth of the case, there is a chance for settlement between the claimant and the defendant. The compensation demanded by the claimant depends upon the severity of the damages sustained.
The vaginal mesh manufacturer may opt for settlement rather than proceeding with the trial. When the claim reaches the court, it may turn out hefty for the manufacturer. If a fair settlement is not reached during the negotiation between the two parties both sides will proceed to a jury or bench trial.
Filing a lawsuit and getting a deserving pay-out is a herculean task as the claim involves investigating the role of the manufacturer, supplier, physician, etc. An easy way to claim is to join a Multidistrict Litigation (MDL) that is already in motion. MDL for vaginal mesh involves a group of claimants who sustained damages from the same mesh product. The defendant would be the same in the litigation.
It may take years to complete a vaginal mesh MDL. The claimant would be deposed regarding the mesh implantation procedure and the complications. A medical professional appointed by the defendant would conduct an independent medical examination of the claimant. This is to evaluate the health condition of the claimant after the mesh implant.
Compensation covered in vaginal mesh lawsuits would include current and future medical expenses, medication expenses, rehabilitation expenses, pain and suffering, emotional distress, and disability if caused by the mesh implant.
In 2019, Johnson & Johnson and its Ethicon business unit had to pay out a compensation of $117 million in a vaginal mesh settlement. Becton Dickinson had reached a $60 million vaginal mesh settlement in 2020. Boston Scientific would pay $189 million to settle a multi-state lawsuit this year.
Conclusion
POP and SUI terribly restrict a woman’s social activities and sexual lives. It distresses their sense of being in the pink of health. Pain in hush is not required if you are battling with a vaginal mesh implant.
If you endure any complications, immediately report the adverse event to the FDA. Utilize reporting systems like MedWatch, the FDA Safety Information and Adverse Event Reporting program. There are currently no FDA-approved vaginal mesh products marketed in the United States for the repair of pelvic organ prolapse.
Reach out to a seasoned product liability attorney and get an evaluation of your matter. A well-built squad of a product liability lawyer and a medical records review company would make your claim competent. Each of your medical bills and reports may turn out imperative in the legal pursuit.
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