Table 1.
Preclinical and clinical studies allowed a comparison and evaluation of the test materials regarding their fibrotic tendencies.
| Year[Reference] Author | Category [species, application] | Type of material | Outcome |
|---|---|---|---|
| 201532 Kindsfater | clinical study [human, knee bearing] | Polyethylene | PE showed no revisions, osteolysis or implant dissociation. |
| 201033 Deshpande | clinical study [human, facial skeletal augmentation] | Polyethylene | PE had a good long-term survivorship and a low complication incidence. |
| 199334 Wellisz | clinical study [human, facial or head reconstruction] | porous Polyethylene | Porous PE exhibited tissue ingrowth. |
| 200835 Suska | animal study [rat, subcutaneous implant] | Titanium, cupper | Titanium surrounded a thinner fibrous capsule with lower inflammatory cells and vascularity than cupper. |
| 199436 Ungersböck | animal study [rabbit, tibia implant] | Titanium, stainless steel | Fibrous tissue surrounding titanium was thinner and inflammatory cellular numbers were lower compared to stainless steel. |
| 199737 Shannon | animal study [rats, subcutaneous implant] | Titanium, stainless steel | In between titanium and stainless steel no differences in capsule thickness and cell response were found. Qualitative capsule characterization revealed less dense and circumferentially-packed tissue around titanium compared to stainless steel. |
| 198638 Thomsen | animal study [rat, abdominal wall implant] | Titanium, PTFE | Titanium implants were in direct contact with the connective tissue without inflammatory cells. In contrast, a fibrous capsule surrounded the PTFE implants. |
| 197839 von Recum | animal study [dog, aortic patch] | PTFE, Polyurethan | Polyurethan was encapsulated in a fluid cyst, whereas PTFE was moderately surrounded by tightly adherent fibrous tissue. |
| 200240 Batniji | animal study [rabbit, subperiosteal pocket implant] | PTFE, Silicone | The silicone implants elicited compared to PTFE a significantly thicker capsule and less neovascularization. |
| 200541 Ustundag | animal study [rabbit, paraglottic space implant] | PTFE, Silicone | Around silicone a fibrous capsule formed, whereas PTFE limited the formation of a fibrous capsule. |
| 199642 Trumpy | clinical study [human, subcutaneous implant] | PTFE, hard and soft Silicone | All materials developed a fibrous capsule decreasing in order to soft silicone, PTFE and hard silicone. |
| 200343 Siggelkow | clinical study [human, breast implant] | Silicone | A main reason for explantation of intact implants was capsular contracture, which was related to capsule thickness. |
These studies emphasized an increasing fibrotic response from PE, titanium, PTFE to silicone. This literature-based biomaterial ranking finally substantiated the validation of our test conditions on their predictive power.