Research
Urogynecology
Fate of collagen-based implants used in pelvic floor surgery: A 2-year follow-up study in a rabbit model

Preliminary data for this study were presented at the joint meeting of the International Continence Society and the International Urogynecological Association, Paris, France, Aug. 23-27, 2004. Follow-up data were presented at the 31st Annual Meeting of the International Urogynecological Association, Athens, Greece, Sept. 6-9, 2006.
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Objective

The purpose of this study was to compare the long-term host response to 2 different collagen matrices versus macroporous polypropylene mesh.

Study Design

Four full-thickness abdominal wall defects in 35 rabbits were reconstructed with either polypropylene (Prolene), porcine dermal (Pelvicol), or small intestine submucosal collagen matrix (SIS). Animals were sacrificed on day 30, 60, 90, 180, 365, 540, and 720 days to evaluate morphologic and biomechanical properties of explants.

Results

Prolene provoked a fibrotic reaction within 30 days. SIS was entirely replaced by a thin fibrotic layer within 60 days. Pelvicol was encapsulated, remaining structurally unchanged up to 180 days. Thereafter, half underwent degradation by a foreign body reaction.

Conclusion

Prolene was integrated by an increasingly organised fibrotic scar while SIS was entirely remodelled within 60 days. Pelvicol implants underwent late onset (≥ 180 days) degradation. After 2 years of implantation there were no differences in tensiometric strength between the 3 different materials.

Section snippets

Studied implants and experimental animals

We used 3 types of implants. Prolene PM-S (Ethicon, Dilbeek, Belgium) is a nonabsorbable monofilament polypropylene implant with large pore size (1500 μm) and a density of 85 g/cm2. Surgisis (SIS; Cook) is a porcine small intestinal submucosa derived acellular noncrosslinked xenograft. We used the 4-layer graft, which was at that time the marketed product for pelvic floor reconstruction. Pelvicol (Bard) is another porcine acellular yet dermal collagen and elastin matrix crosslinked with

Macroscopy

All animals had an uneventful postoperative recovery, except 4 rabbits (180 days: n = 1; 540 days: n = 3) who died before sacrifice. Postmortem examination did not reveal any abnormalities at the implant site nor the cause of death. Observations from these animals were excluded from further analysis; however, in retrospect, inclusion would not have affected results. In 1 rabbit (Pelvicol 60 day group) there was a seropurulent subcutaneous collection on the Pelvicol implant. On histology, the

Comment

In a 2-year follow-up study we compared different xenogenic collagen constructs to polypropylene when used to cover abdominal wall defects in rabbits. Prolene induces a persisting chronic inflammatory response, with moderate numbers of FBGCs in a permanent fibrotic scar, coinciding with increasing tensiometric strength. SIS is degraded in a proportionally strong chronic inflammatory reaction, which tapers off by 3 months. The material is replaced within 60 days by a markedly thin and weak layer

References (30)

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    Then, the former surgical area was resected ‘en bloc’ including (1) the initial implant; (2) the interface and (3) 1 cm of the neighbouring native tissue. The presence of adhesions was scored using a scale of 0–3 (0 representing no adhesion, 1 minimal adhesion easily separated, 2 for adhesion more difficult to separate and 3 for adhesion which can only be surgically separated) together with their extent (area in percent) according to earlier experience [19,22–24]. At sacrifice the following measurements were made: (1) implant thickness (mm) which was the average of three random measurements over the central part of the implant in areas devoid of pores using a micrometer (Mitutoyo, Kawasaki, Japan; accuracy 0.01 mm), and (2) implant surface (cm2).

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Cite this article as: Claerhout F, Verbist G, Verbeken E, et al. Fate of collagen-based implants used in pelvic floor surgery: A 2-year follow-up study in a rabbit model. Am J Obstet Gynecol 2008;198:94.e1-94.e6.

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