Vaginal mesh implants made of polypropylene have caused severe medical complications in millions of women across the world, and medical manufacturers from Johnson & Johnson to Bard, acquired by BD last year, have been mired in lawsuits as a result. Now, scientists at the University of Sheffield in the United Kingdom have developed an alternative polyurethane material to treat pelvic organ prolapse and incontinence that is better suited for use in the pelvic floor. Moreover, they have embedded the material with estrogen, which is released into the surrounding pelvic tissue to form new blood vessels and accelerate the healing process. The research is published in the Journal of Neurourology and Urodynamics.
Polypropylene mesh can be beneficial and carries little risk to the patient when it is used as a thin strip to support the urethra and reduce the symptoms of stress incontinence, said Professor Sheila MacNeil, Professor of Tissue Engineering at the university’s Department of Materials Science and Engineering. “However, when much bigger areas of the same material are inserted through the vagina to relieve pelvic organ prolapse, the complication rate is frankly unacceptable. Surgeons who are experts in this area have concluded that there is a need for a new synthetic material that is better suited for use in the pelvic floor. We started our research because it was clear that the polypropylene mesh was not fit for use in the pelvic floor,” said MacNeil in an article on the university website.
Polypropylene (left) is currently used to fabricate vaginal mesh implants. Scientists at the University of Sheffield have developed a polyurethane that would reduce complications caused by these devices.
Image courtesy University of Sheffield.
The scientists spent seven years researching different materials for this application and ultimately settled on polyurethane because of its elasticity, which made the material a better fit than polypropylene for sustaining the pressure that pelvic organs exert on the pelvic floor.
Electrospinning is used to create a fine mesh, which is fabricated in layers to mimic the structure of human tissue, explained MacNeil. “We have shown through our research that it does not provoke inflammation and retains its strength and elasticity. The addition of estrogen is a major breakthrough as we have proved its beneficial effects in regenerating pelvic tissue,” she added.
Pelvic organ prolapse and stress urinary incontinence affect 50% of post-menopausal women worldwide, according to the University of Sheffield website. In addition to the physical symptoms and the inability to have a normal sex life, these disorders can lead to depression, anxiety and a reduction in the quality of social life.
The onerous lawsuits have caused some medical device manufacturers to stop marketing mesh for pelvic organ prolapse. However, they continue to market the same mesh for the treatment of stress urinary incontinence, where a strip of the material is used as a tape under the urethra. That treatment remains very beneficial for the majority of patients with a very low complication rate in experienced hands, according to the University of Sheffield.
The scientists expect the breakthrough research to have a hugely positive impact on millions of women across the globe, but first the polyurethane mesh will need to through clinical trials and the regulatory approval process, which will take a considerable amount of time.