Study Finds Some Transvaginal Mesh Degrades Within 2 Months After It Is Implanted

The findings of a new study suggest that a material once commonly used to make transvaginal mesh products may begin disintegrating within about 60 days after it is implanted in a human body, scattering debris into the surrounding tissue.

Until a few years ago, transvaginal mesh procedures were widely used throughout the United States for the treatment of pelvic organ prolapse or female stress urinary incontinence. It involved the use of synthetic mesh, often made of polypropylene, to reinforce a weakened vaginal wall or support the bladder.

However, more than 10 years ago, the U.S. Food and Drug Administration (FDA) warned about widespread reports of transvaginal mesh problems, such as the mesh eroding into the vagina, contracting, or shrinking, which led to infections, pelvic pain, vaginal scarring and other painful complications.

In 2019, the FDA announced the removal of transvaginal mesh products from the market, indicating that manufacturers had failed to establish that the implants provide more benefits than health risks, which could be significant and life-changing.

Now, new findings published ahead-of-print in the December issue of the Journal of the Mechanical Behavior of Biomedical Materials indicate that part of the problem may be that polypropylene quickly begins to degrade in the human body, shedding particles into the surrounding tissue.

The degradation of the polypropylene mesh was discovered by researchers at the University of Sheffield in the U.K., when sheep were used to study the effects on tissue. Researchers used sheep tissue to evaluate the safety of polypropylene transvaginal mesh, due to its close resemblance to the structure of human tissue.

Researchers found that the polypropylene fibers quickly stiffened and began to degrade within 60 days inside the sheep. They also discovered residual mesh particles in the tissue surrounding implantation sites. Over time, as the material degraded, more polypropylene particles built up in the surrounding tissue.

“One key contributor is the pronounced physico-mechanical mismatch between the polypropylene (PP) fibres and surrounding tissues, resulting in substantial physical damage, inflammation, and persistent pain. However, the primary cause of sustained inflammation due to polypropylene itself remains incompletely understood,” the team said. “Our study shows surface alterations which indicate that PP is evidently less chemically inert than was initially presumed. These findings underscore the need for a re-evaluation of the biocompatibility and long-term consequences of using PP mesh implants.”

The researchers noted that these findings may lead to a better understanding of the problems with polypropylene transvaginal mesh, and how future products could avoid similar results.

Transvaginal Mesh Problems Led to Massive Litigation

More than 100,000 women have pursued transvaginal mesh lawsuits against manufacturers like Johnson & Johnson, Bard, Boston Scientific and others over the past decade, resulting in billions paid in settlements and jury awards in recent years.

The litigation over transvaginal surgical mesh has been one of the largest mass torts in U.S. history, and new claims continue to be filed as women continue to experience complications caused by design defects associated with the polypropylene products.

Although the transvaginal mesh is no longer commercially available, it remains implanted in the bodies of women throughout the United States, and continues to fail, resulting in painful and debilitating injuries.