Polydioxanone implants: A systematic review on safety and performance in patients

Abstract

Background Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and safety has been published. Objective This systematic review intends to review and assess commercially available polydioxanone implants and their safety and performance in patients. Methods We searched for approved polydioxanone implants in several Food and Drug Administration databases. Then, we performed a literature search for publications and clinical trials where polydioxanone devices were implanted in patients. This search was performed on MEDLINE, Embase, Scopus and other databases. Safety and performance of polydioxanone implants in patients were assessed and compared with the implantation of non-polydioxanone devices, when possible, based on scoring systems developed by the authors that analyse surgical site infection rates, inflammatory reaction rates, foreign body response, postoperative pain and fever. Results Food and Drug Administration databases search revealed that 48 implants have been approved since 1981, with 1294 adverse reactions or product malfunction in the last decade and 16 recalls. A total of 49 clinical trials and 104 scientific publications were found. Polydioxanone sutures and meshes/plates had low rates of surgical site infection, inflammatory reaction, foreign body response and postoperative fever. Polydioxanone clips/staples reported high rates of surgical site infection, postoperative fever and pain, with sub-optimal clinical performance and poor safety rates. The remaining implants identified showed high levels of safety and performance. Safety scores of polydioxanone implants and non-polydioxanone alternatives are similar. Polydioxanone monofilament sutures perform better than non-polydioxanone alternatives but performance did not differ with remaining polydioxanone implant types. Conclusions Although polydioxanone clips/staples should be implanted with caution and monitored carefully, in general, safety and performance scores of other polydioxanone implants did not differ from non-polydioxanone alternatives. This review will be a useful reference for researchers and industries developing new polydioxanone medical devices.

Accelerated Degradation of polymeric surgical suture materials

“…This reduces the molecular weight but not the mass. Short crystalline polymer chains are hydrolized and in a last step the remaining polymer chains are removed by the surrounding medium which leads to loss of polymer mass, molecular weight and physical properties [6,7]. Regarding the molecular weight loss (Figure 2), PDO shows the major changes in the first week resulting in a value of 38% (see table 1) caused by the hydrolysis of amorphous PDO regions, enhanced by temperature and elevated pH.…”

Development of a polycaprolactone/poly(p-dioxanone) bioresorbable stent with mechanically self-reinforced structure for congenital heart disease treatment

“…It has been reported that PPDO implants are able to maintain mechanical integrity in three months and absorbed entirely in 6 months in aqueous environment [ 50 ]. In addition, PPDO implant has been certified by FDA [ 51 ], which shows good biocompatibility in vivo in many studies [ 37 , 52 , 53 ]. Thus, the BRS fabricated by PPDO material can maintain lumen open during vascular healing process with acceptable biocompatibility and suitable degradation time, which is beneficial for patients with congenital heart disease.…”

In Vivo Versus In Vitro Degradation of a 3D Printed Resorbable Device for Ligation of Vascular Tissue in Horses

“…An easily applied resorbable device designed as a self‐locking loop for larger vessels or vascular tissue could be a valuable surgical aid, especially when performing standing castrations in horses. Simultaneously with the reorganization of the vascular tissue, the device would ideally be hydrolyzed into low molecular weight products or metabolized, [ 4 ] which will finally lead to complete absorption of the device with a minor immunological response. A commonly used monofilament suture material is polydioxanone (PDO), a flexible, biodegradable, and biocompatible polymer.…”