Cancer treatments with radiation from high voltage accelerators, X-ray generators and radio-isotopes (cobalt 60) are common. The probability of having an implant patient involved in such treatments is therefore significant. In the light of present knowledge, only general guidelines exist with respect to the treatment of such patients. There is data for the correction of doses in situations involving solid tumors "shaded" by prosthetic material. Devices cause a net reduction in the radiation exposure of the target.

Some patients facing complications from implants have a history of radiotherapy prior to implantation. Irradiation is a comparatively harsh treatment and often compromises the success of subsequent reconstructive surgery. It can greatly increase the probability of complications immediately following the attempted implantation. Tissue changes affecting elasticity of skin and the wound healing capacity of the site take place after irradiation. Return to the original tissue condition does not take place for many months and for many senior patients, it may not take place at all.

Other patients exposed to therapeutic irradiation have a history of failed implants with gross contamination of the implant site with prosthetic debris and degradation products. Many have undergone removal of the implants at the time of the radiotherapy treatment. The presence of such debris greatly complicates the analysis of the procedure and its impact on tissue and tumors. The area appears nearly devoid of studies.

Individuals with implants in situ subjected to radiation treatment habitually have a poor prognosis from the outset. Thus, they constitute a special sub-population of implant users. For users who undergo reconstruction after irradiation, the prognosis for acceptable cosmetic results is also much diminished. Use of tissue expanders is frequent and further complicates the evaluation of this class of patient.

There is yet another class of irradiated implant users. They are individuals where severe surface scarring took place and where treating physicians deemed it appropriate to prescribe irradiation of the scar and keloid-like tissue in the hope of mitigating further scarring. Whereas the procedure imparts considerable tissue damage it also appears ineffective as a treatment modality for scar and contracture control. Such individuals form a special sub-class of users.

Radiochemical changes take place in biological material exposed to ionizing radiation. Irradiated tumor sites containing synthetic debris behave differently from tissue without prosthetic substances, in particular silicone derivatives and oils. The long term consequences of broad irradiation of oil and elastomer-contaminated tissue are unknown. A priori, the procedure is deemed undesirable strictly on a molecular biology basis. Finely dispersed abiotic substances such as silicone oils, catalyst fragments and other reactive debris would be expected to cross-react with tissue thus producing new and potentially hazardous molecules which may complicate or nullify the therapeutic effect of the treatment.

Since prosthetic debris is associated with fatty tissue, it follows that these areas are primarily hydrophobic and their ability to irrigate the areas subsequent to the treatment is diminished. The formation of reactive irritating molecules is expected from irradiation. Entities such as free radicals and other molecules with high energy form in irradiated sites. Many have the capacity to alkylate tissue thus adding more disruptive components to an already unstable physiologic environment. Inflammation of tissue, necrosis and other degenerative tissue phenomena generally accompany the irradiation of tissue in proximity with synthetic implants.

A direct link between the formation of malignant tissue and inappropriately designed debris-releasing implants is not demonstrated. However, the irradiation of tissue exposed to such environments may be decisive in converting or accelerating pathogenic processes into more difficulty-managed conditions. Implants tend to exist in areas where the vascularization of the tissue is compromised; as such, they are more subject to radiation damage with severe complications that may include the sloughing off of thin tissue flaps overlying large prostheses. Inflammatory diseases, in particular carcinomas, may be exacerbated when they occur adjacent to prosthetic systems which are subsequently irradiated.