A prospective outcome analysis was conducted on 100 consecutive women who requested explanation of their silicone gel breast implants from January 6, 1992 (the moratorium), through 1995. Eighteen patients were referred by rheumatologists with a diagnosis of autoimmune or rheumatic disease. Six had autoimmune disease (systemic lupus, 2 patients; rheumatoid arthritis, 2 patients; multiple sclerosis, 1 patient; and Raynaud's disease, 1 patient). Twelve had rheumatic disease (fibromyalgia, 10 patients; inflammatory arthritis, 2 patients). All of these 18 patients had developed symptoms of their disease after they had received implants. All 100 patients were extensively evaluated pre- and postoperatively by interviews, clinical assessment, and by assay of the following laboratory tests: rheumatoid factor, ESR, ANA, and anti-Ro/SSA, -La/SSP, -Sm, -RNP, -double-stranded deoxyribonucleic acid, -Scl-70, -centromere, and -cardiolipin. Patients were also evaluated by a questionnaire that was sent at a mean time of 2.7 years postexplantation (range, 1–5 years), which had a 75% response rate. Reasons for implants were augmentation, 75%; lifting, 11%; reconstruction, 12%; and congenital aplasia, 2%. The mean age at first implant was 28.9 years (range, 13–55 years) and at explantation was 41.5 years (range, 25–65 years). The mean duration of implantation was 12.0 years (range, 1–27 years). Thirty-six percent of the patients had undergone at least one closed capsulotomy and 54% at least one open capsulotomy. The main reasons for explantation were suspected silicone-related health problems, 76%; suspected rupture, 59%; breast firmness, 36%; breast pain, 36%; and musculoskeletal pain, 23%. Before explantation 75% of the questionnaire respondees had lost some sensitivity in their nipples following their breast augmentation. In 36% of those 75 patients, that loss was almost complete. Loss of sensitivity was related to capsular contracture and to pain (p < 0.05). Following explantation there was significant improvement in nipple sensitivity in 38% of breasts in the 75 respondees. A total of 186 implants were removed. Fifty-seven percent had failed by rupturing or leaking. Only 3.2% demonstrated extravasation extracapsularly. Twenty-five percent of the capsules were calcified, demonstrating visible plaques of calcification on their inner surface. Forty-two percent were colonized by bacteria. The prevalence of class III–IV capsular contracture was 61% and it was related to implant location, duration in situ, and capsular calcification (p < 0.05), but not to capsular colonization or implant integrity (p > 0.05). Only 43 of the 100 patients elected to have saline implants inserted. Of the others, 56% felt that the shell of the saline implant could be associated with medical problems. The others felt that breast size was of minor importance to them at this time. There were few complications from the explantation procedure. Two “masses” were discovered—one was an occult carcinoma, the other a galactocele. There was one wound infection, which responded to antibiotics. Three patients developed decreased sensitivity and 3 developed increased breast pain. From the patient questionnaires, in those women who did not have saline implants inserted, 15% felt that their breast appearance was improved after explantation, 36% were “pleased,” 33% were disappointed, and 13% felt “mutilated.” In women who did have saline implants inserted, 18% felt that their breast appearance was now improved, 60% were “pleased,” and 14% were disappointed, mainly because of wrinkling. At a mean time of 2.7 years (range, 1–5 years) after explantation, 45% of the 75 questionnaire respondees felt that their implants had caused permanent health problems and 56% felt that they had not been given adequate informed consent by their original surgeon (particularly regarding implant rupture and a possible relationship to medical disease). Nineteen patients had breast fed after implantation (only 1 patient felt that her implants had adversely affected her child), 28% had attended an implant support group, 24% had undergone professional psychological support, and 43% were involved in litigation against implant manufacturers. Of the 75 respondees, those who had no proved rheumatic or autoimmune disease responded most favorably to explantation. In those patients, more than 80% related “major improvement” in their symptoms and more than 93% related significantly improved psychological well-being. In patients with fibromyalgia or inflammatory arthritis, most experienced an initial, almost euphoric improvement in symptoms during the first few months after explantation. However, their symptoms subsequently recurred over the following 6 to 12 months. Ultimately, 11 of these 12 patients related no change or further deterioration from their preexplantation status. One patient related “slight” improvement. In all 6 patients with autoimmune disease, there was no improvement in clinical or laboratory findings after explantation.
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