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Synthetic implants and their role in the treatment of female pelvic disease

31 August 2020
Article by Rita Rynkevic, INEGI’s researcher in the field of Biomechanics and Health

Pelvic organ prolapse is a condition that affects the quality of life of millions of women around the world. The estimated prevalence of prolapse is between 2.9% and 8% of the female population, and recent estimates suggest that women have a 12.6% risk, over their lifetime, of being operated on for prolapse1.

Treatment is difficult, due to the complex nature of the dysfunction. Commonly, it starts with recommendations related to a lifestyle improvement or a vaginal pessary, which helps in the mechanical support of the affected organs. However, surgical treatment of prolapse remains the basis of therapy in the most severe cases.

To improve the anatomical results obtained using only native tissues, the use of synthetic implants (nets) has become widespread in recent decades. However, the transvaginal insertion of nets has been associated with a high rate of complications, due to multiple causes, namely, insufficient biocompatibility and inadequate mechanical properties of the nets, in addition to factors related to the patient or the surgeon2.

Several research projects focused on the mechanical properties of the available implants have demonstrated that there is still no perfect product. The development of an implant that has properties and functionality close to those of natural biological tissue is an enormous challenge, which requires new approaches in the manufacture of implants and new material formulations.

The use of biodegradable materials has been identified as one possible strategy to avoid or reduce complications related to the use of implants, particularly when combined with their manufacture using electrospinning technology, which allows the mimicking of the structure of the natural biological tissue. Creating personalized implants, with less chance of rejection, is thus made possible thanks to the modification of the process parameters, choice of different polymers, modification of the implant surface and functionalization (also known as bioactivation).

At European level, this path has been explored, namely through the BIP-UPy project (Bioactive Implantable Polymers based on UreidoPyrimidinone), co-financed by the European Commission, and in which the author participated. Recent experimental studies have shown that the use of new mesh prototypes can cause high rates of herniation or insufficient mechanical support3, 4, and thus, within the scope of this project, new formulations of polymer materials with a slower degradation rate were developed, which allowed positive results5.

However, although this technology has great potential, while it allows the customization of several parameters associated with the development of the implant, there are still significant knowledge gaps about the compatibility between the tissue and the implants, with regard to the mechanical behavior of the implants.

At INEGI, we have been strengthening scientific research, technological development and innovation in the scope of this theme, over the past few years.

In this way, we hope to be able to advance the state of scientific knowledge, and, consequently, contribute to the therapeutic success and the improvement of the quality of life of women suffering from pelvic organ prolapse, while helping, in parallel, to reduce the financial impact of the disease in National Health Systems.

[1] Geynisman-Tan J, Kenton K. Surgical Updates in the Treatment of Pelvic Organ Prolapse. Rambam Maimonides Med J. , vol. 8, no. 2, 2017.
[2] Food and Drug Administration, "Serious Complications Associated With Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence”. Food and Drug Administration FDA, Public Health Notification, 2008. 
[3] da Cunha, M. G. M. C. M., Hympanova, L., Rynkevic, R., Mes, T., Bosman, A. W., & Deprest, J., "Biomechanical behaviour and biocompatibility of ureidopyrimidinone-polycarbonate electrospun and polypropylene meshes in a hernia repair in rabbits". Materials, vol. 12, no. 7, 2019.  
[4] Hympanova, L., Mori da Cunha, M. G. M. C., Rynkevic, R., Wach, R. A., Olejnik, A. K., Dankers, P. Y. W., … Deprest, J., "Experimental reconstruction of an abdominal wall defect with electrospun polycaprolactone-ureidopyrimidinone mesh conserves compliance yet may have insufficient strength". Journal of the Mechanical Behavior of Biomedical Materials, vol. 88, p. 431–441, 2018.  
[5] Hympánová, L., Rynkevic, R., Román, S., Mori da Cunha, M. G. M. C., Mazza, E., Zündel, M., … Deprest, J., " Assessment of Electrospun and Ultra-lightweight Polypropylene Meshes in the Sheep Model for Vaginal Surgery". European Urology Focus, 2018.