Implantation Time Has No Effect on the Morphology and Extent of Previously Reported "Degradation" of Prolene Pelvic Mesh

Female Pelvic Med Reconstr Surg. 2020 Feb;26(2):128-136. doi: 10.1097/SPV.0000000000000837.

Abstract

Objectives: Prolene polypropylene ("Prolene") meshes demonstrate no in vivo degradation, yet some claim degradation continues until no more Prolene polypropylene can be oxidized. We studied whether implantation time affects the morphology/extent of previously reported as cracking/degradation of completely cleaned Prolene explants.

Methods: Urogynecological explants (248 patients) were collected. After excluding non-Prolene/unknown meshes and those without known implantation times, completely cleaned explants (n = 205; 0.2-14.4 years implantation) were analyzed with light microscopy, scanning electron microscopy, and Fourier transform infrared spectroscopy. Based on implant times and storage (fixative or dry), representative specimens were randomly selected for comparison. Controls were unused ("exemplar") TVT specimens with and without intentional oxidation via ultraviolet light exposure.

Results: Prolene explants included 31 dry (18 TVT; 7 Prolift; 4 Gynemesh; 2 others) and 174 wet (87 TVT; 47 Prolift; 10 Gynemesh; 30 others) specimens. Specimens had similar morphologies before cleaning. Progressive cleaning removed tissue and cracked tissue-related material exposing smooth, unoxidized, and nondegraded fibers, with no visible gradient-type/ductile damage. Fourier transform infrared spectroscopy of the explants confirmed progressive loss of proteins. Cleaning intentionally oxidized exemplars did not remove oxidized carbonyl frequencies and showed deep cracks and gross fiber rupture/embrittlement, unlike the explants and nonoxidized exemplars.

Conclusions: If in vivo Prolene degradation exists, there should be wide-ranging crack morphology and nonuniform crack penetration, as well as more cracking, degradation, and physical breakage for implants of longer implantation times, but this was not the case. There is no morphologic or spectral/chemical evidence of Prolene mesh degradation after up to 14.4 years in vivo.

MeSH terms

  • Device Removal*
  • Equipment Failure Analysis / methods
  • Equipment Failure Analysis / statistics & numerical data
  • Equipment Safety / methods
  • Female
  • Gynecologic Surgical Procedures / instrumentation*
  • Gynecologic Surgical Procedures / methods
  • Humans
  • Long Term Adverse Effects / diagnosis
  • Long Term Adverse Effects / prevention & control
  • Materials Testing / methods
  • Pelvis / surgery*
  • Plastic Surgery Procedures / instrumentation*
  • Plastic Surgery Procedures / methods
  • Polypropylenes* / adverse effects
  • Polypropylenes* / therapeutic use
  • Surgical Mesh / standards

Substances

  • Polypropylenes