This study was initiated to understand why talc was found in the entrance wounds and pericapsular scars of patients with silicone breast implants. Twenty-five surgical gloves made between 1977 and 1992 by a major glove manufacturer were evaluated with infrared spectroscopy. Seven gloves manufactured before early 1983 contained talc. Later manufactured gloves contained calcium carbonate instead of talc. Talc-containing gloves were submitted to independent laboratories for scanning electron microscopic examination and x-ray microanalysis to obtain finer detail. Remnants of the mold-release agent talc were found in the matrix of the patient-contact side of the glove. Wetting studies showed that silicone oil (gel bleed) immediately wet the surface of rubber glove. After donning, silicone oil was massaged between the thumb and index finger of each washed, talc-containing glove for 1 minute and then daubed from the glove to a microscopic slide. The slide was viewed with polarized light microscopy for the presence of talc crystals. Transfer of talc occurred using silicone oil, but not saline, in each talc-containing glove. Three factors were likely involved in the greater talc deposition that occurred with patients undergoing silicone gel-filled breast implantation than in patients undergoing other surgical procedures. (1) The wetting of the gloves with silicone gel bleed from implants loosened the talc in the glove matrix. (2) Hand-intensive surgical use freed the talc from the gloves. (3) Loose talc adhered to the silicone elastomer of the breast implants and was deposited with implant placement.
Talc was found to contaminate peri-implant scars in patients with silicone gel-filled breast prostheses resulting from the physical interaction between implant and surgical glove. This study reports the frequency and distribution of the problem and its relationship to changes in glove manufacture. Peri-implant scar tissue, obtained from a population with breast implants, was evaluated for talc. Patients were considered positive if more than two talc particles were seen intracellularly in more than two microscopic fields. The largest Texas glove manufacturer stopped using talc in 1983. Patients were grouped to demonstrate the difference in talc exposure in Texas after this manufacturing change. Of those receiving implants before 1984, 136 of 140 were positive for talc. Of those receiving implants after 1983, 24 of 54 were positive (p < 0.000; RR = 42.5; CI: 13.7-131.6). Widespread prevalence of contamination was evidenced by findings of talc in patients from various facilities, different surgeons, and multiple sites within Texas.
Capsular contracture, constrictive tightening of scar tissue around implants, was historically the primary reason for reoperating breast-implanted women. Yet, capsular contracture remains of unknown etiology. Contamination with foreign material is one of several suspected causes. Talc, a known fibrogenic agent, was recently found in peri-implant scars. A comparison of 192 explanted women was designed to investigate the role of talc in the induction of capsular contracture. This study included women implanted with silicone gel-filled implants for whom tissue samples were available. Patients were evaluated for the occurrence of capsular contracture and the presence of intracellular talc particles in peri-implant tissues. There was a significant association between talc and capsular contracture (odds ratio = 18.0, 95% confidence interval = 5.9-55, P < 1 x 10(-9)). This study indicates that talc was a major risk factor for capsular contracture in women augmented before 1992.
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