Surgical meshes have become common implants used to provide additional support and structure for weakened or damaged tissue. 

Two areas where meshes are frequently used are pelvic organ prolapse (POP) and urinary incontinence (UI) in women, and hernia repairs in both men and women. However, while hernia mesh products have continued to be widely used with relatively few issues, vaginal mesh implants have come under intense scrutiny and sparked thousands of lawsuits due to serious complications. 

What accounts for these very different outcomes? While both meshes provide valuable benefits, understanding their types and potential risks is crucial before making any medical decisions. In this blog, we will take a closer look at vaginal and hernia meshes.

What Are Vaginal Meshes?

Vaginal mesh implants are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These conditions often affect women after childbirth or with a weakening of pelvic floor muscles. 

The mesh acts as a hammock-like support for organs like the bladder or uterus that may bulge or descend due to muscle weakness. The mesh is usually made up of polypropylene and is woven into a supportive structure that mimics the natural tissue it reinforces. 

While vaginal meshes were initially considered groundbreaking, they’ve faced scrutiny due to reported complications. According to TruLaw, there are reports of patients suffering from mesh erosion and breakdown, organ damage, urinary and nerve damage, and severe reactions to mesh material.

What Are Hernia Meshes?

Hernia mesh implants are used to repair openings or weaknesses in the abdominal wall. 

They can be used in all types of hernias, such as inguinal, femoral, hiatal, congenital diaphragmatic, incisional, umbilical, ventral, and perineal hernias. These meshes reinforce the weakened abdominal walls and allow the tissues to heal. 

Hernia meshes come in various types, including synthetic and biological options. The choice often depends on the patient’s health, the type of hernia, and the surgeon’s preference. These meshes have been integral to reducing recurrence rates for hernias.

Key Differences Between the Meshes

While both types of surgical mesh are made from polypropylene, a type of plastic, vaginal mesh is lighter, and thinner, with a more flexible structure suitable for insertion through delicate vaginal tissue. 

Hernia mesh tends to be heavier and sturdier as it is implanted through abdominal incisions. Both meshes now come in biocompatible form. Vaginal meshes derived from animal tissues and hernia meshes derived from animal and human tissues are much better alternatives than their synthetic counterparts. 

The method of implantation also differs, with hernia mesh simply laid and sutured over the hernia defect, while vaginal mesh arms are anchored to pelvic bone and tissue. As a result, the risk profile is much higher with transvaginal implantation.

Complications and Safety Concerns with Vaginal Meshes

Since the early 2000s, the FDA has received thousands of adverse event reports associated with vaginal mesh complications. These include erosion through vaginal walls, intense pain, infection, organ perforation, and urinary problems.

Following an influx of these reports in 2019, the FDA banned the sale of such transvaginal meshes in the US. It also concluded that the risks outweigh the benefits in this case. The FDA reports the average erosion rate of a vaginal mesh to be 4% within 23 months of its insertion. 

Vaginal mesh lawsuits claim mesh manufacturers like Johnson & Johnson and C.R. Bard rushed defective products to market without sufficient testing or clinical trials. As of February 2024, over 94% of the lawsuits have been resolved. The total amount of settlement in the transvaginal mesh lawsuits is estimated to be around $8 billion to $11 billion. 

When it comes to hernia meshes, the picture isn’t much better. There have been reports of tens of thousands of patients suffering from ill effects due to hernia implant insertion. 

Following such reports, the FDA recalled over 210,000 hernia mesh products, from 2005 to early 2019, having classified them as ‘Class 1’ and ‘Class 2’ recalls. Class 2 means that the recalled product might cause temporary or permanent health consequences. Class 1 recall means there’s a higher risk of severe health effects or death.

As of February 2024, about 25,030 hernia mesh lawsuits are pending in the four MDLs across the country. The accused in these lawsuits include Atrium (2,770 lawsuits), Covidien (893 lawsuits), C.R. Bard (21,169 lawsuits), and Ethicon (194 lawsuits). While there has been some success in the bellwether trials, no settlements have been reached.

The Ethicon MDL resulted in a settlement, but the details remain confidential. However, experts estimate the settlement amounts to vary from $60,000 to $1 million based on individual case specifics.

In conclusion, the differences between vaginal and hernia meshes are significant. While both vaginal and hernia meshes offer potential benefits, understanding their differences and inherent risks is crucial for informed decision-making. 

Ultimately, the complications and risks seem to arise not from an inherent flaw in mesh technology, but from insufficient testing and vetting before widespread patient use. Thorough clinical trials, and collecting data on long-term safety and efficacy, are vital to upholding the bioethical principle of “do not harm.” 

Patients deserve implants proven to be both effective and safe through rigorous science. In the future, we must apply the lessons learned from mesh controversies to ensure all medical devices are held to the highest standards before allowing access to precious human lives.