Biodegradation of the polyurethane foam covering of breast implants.

Although it is generally accepted that polyurethane-covered breast implants have decreased the incidence of clinical capsular contracture, there remain many unanswered questions regarding the physical and chemical degradation of the polyurethane foam covering itself. We have systematically studied the fibrous capsule and polyurethane foam recovered from human breast "explants" in an effort to characterize more precisely the biodegradation of polyurethane foam in the human body. Seventy-five freshly retrieved polyurethane-covered implants and surrounding capsule from 47 patients have been analyzed. Capsular tissue from several sampling sites around the surface of the implants was digested in a collagenase solution until foam was recovered or all tissue was digested. Additional samples were fixed in 10% formalin. Scanning electron microscopy was used to look for structural changes in the recovered intact foam and to determine the foam strut widths. Fourier transform IR spectroscopy and x-ray photoelectron spectroscopy were used to analyze the chemical composition of the polyurethane. The formalin-preserved capsule samples were examined histologically for further evidence of foam degradation. Of the 75 prostheses analyzed, 36 (48 percent) were removed because of capsular contracture and 10 (13 percent) because of infection or exposure of the prosthesis. The remaining 29 (39 percent) implants were removed for various other reasons. Visibly intact foam was recovered from 36 (48 percent) prostheses after enzymatic digestion of capsule tissue. There was a progressive decline in the ability to recover intact foam as the total implantation time increased. Scanning electron microscopy revealed fractures and fissures in the foam structure and thinning of the polyurethane struts. The mean strut width of control, unimplanted foam was 49 +/- 1.5 microns (+/- SEM). Retrieved foam from implants which developed capsular contracture and the infected implants had strut widths of 30 +/- 3.1 and 32 +/- 3.1 microns, respectively. In implants removed for other reasons, the polyurethane foam strut width was 41.2 +/- 2.3 microns. Despite an inability to recover visibly intact foam from 39 specimens, standard light microscopy of 37 of these same specimens showed residual polyurethane still present in the capsule. Various degrees of scalloping and fracturing of the foam were seen in the histologic sections. There is convincing evidence by scanning electron microscopy and histology that polyurethane is degrading. It was not possible to quantitate accurately the rate of degradation, but factors such as capsular contracture, infection, and time appear to have a role in the biodegradation of polyurethane in the human body. These relationships require further study.