Radiation-induced capsule tissue reactions around textured breast implants in a rat model.

Capsule fibrosis and other complications around various filled breast implants were evaluated in a rat radiation model after 12 months of implantation. Model implants, one per rat, were implanted subcutaneously. One month after subcutaneous implantation, high voltage radiation followed one half each group. A higher rate of capsule fibrosis occurred in radiated animals. Malignant tumors at the implantation site developed in 40% of radiated and 24% of non-radiated animals, with a much higher rate of mitosis in the radiated group (Mann-Whitney, P=0.008). The presence of an implant is a cofactor for tumor development in rats (chi2-test, chi2=6.927; P=0.008) as well as radiation, since none of the control animals developed tumors. Applied to humans, capsule contracture (fibrosis) is a common complication of radiation, while development of radiation-induced sarcoma is a rare complication after postoperative radiotherapy by all account. Still further long-term follow-up human studies are necessary.