Walter Peters

Pulmonary Complications in Inhalation Injuries with Associated Cutaneous Burn

This retrospective study of 100 consecutive patients with inhalation injury documents that adult respiratory distress syndrome (ARDS) and pneumonia are common complications. Pulmonary complications cause or directly contribute to death in 77% of patients with combined inhalation and cutaneous burn injury. Additionally, the high fluid requirements of these patients worsens their pulmonary injury and is associated with adverse outcome. Independent factors predictive of death include ARDS and expected fluid requirements as well as age and percentage of total body surface area burned. An abnormal chest roentgenogram in the first 48 hours after injury is also associated with death. The development of ARDS is predicted by the actual volume of fluid resuscitation, despite normal pulmonary wedge pressure or normal central venous pressure reflecting increased microvascular permeability. These findings indicate a need for reevaluation of fluid resuscitation of patients with inhalation injury.

An outcome analysis of 100 women after explantation of silicone gel breast implants.

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 Raynauds 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.

Capsular calcification associated with silicone breast implants : Incidence, determinants, and characterization

Capsular calcification was present clinically in 64 of 404 silicone gel breast implant capsules (15.8%) analyzed from 1981 to 1996. It presented as white-gray plaques on the inner surface of capsules in 62 of 64 capsules, and as massive heterotopic ossification in 2 capsules. Chi-squared analysis confirmed that calcification was related to the generation of the implant (i.e., year of manufacture;p<0.001). All 28 first-generation implants (1963-1972, with Dacron patches) were clinically intact and all demonstrated extensive calcification. Their mean duration in situ was 17.6 years (range, 14-28 years). Thirty-four of the 348 second-generation implants (9.8%; 1973-1987) were associated with capsular calcification. Their mean duration in situ was 16.0 years (range, 13-22 years). Because all first-generation implants demonstrated calcification, they were compared with the second-generation implants that had been in place for the same duration (>14 years). Only 42% of these 81 secondgeneration implants demonstrated calcification, compared with 100% of the first-generation implants (p<0.001). Thus, thicker first-generation implants with Dacron patches are more likely to calcify and the effect is not entirely due to their longevity. None of the 28 third-generation implants (1987-1991) demonstrated calcification. Their mean duration in situ was 4.2 years (range, 2-7 years). For second-generation implants, calcification was related to duration in situ (p<0.001). None of the 294 implants in place for less than 11 years were associated with significant clinical calcification. The percentages of capsules with calcification were 13 to 14 years, 33%; 15 to 16 years, 45%; and 17 to 22 years, 57%. Calcification with second-generation implants was not associated with patches on the envelopes. Of the 34 second-generation implants with calcification, only two had patches (composed of silicone, not Dacron). Among secondgeneration implants, calcification was related to implant integrity. Of implants in place for more than 12 years, 52.5% of those implants that were ruptured showed calcification, but only 10.0% of intact implants demonstrated calcification (p<0.001). Seventeen of the 64 calcified capsules were examined histologically. In all of these specimens, calcification existed in two forms: globular aggregates on the surface of the capsule (adjacent to the implant) and actual bone formation within the fibrous tissue of the capsule. All calcified capsules demonstrated both globular aggregates and true bone formation regardless of the implant generation, duration in situ, or integrity. Ultrastructural analysis was performed on four capsules from 2 women who had received first-generation Dow Coming gel implants 24 and 28 years previously, and on 2 capsules from one woman who had received Heyer-Schulte gel implants 21 years previously. These capsules were analyzed according to distribution, density, mineral nature, crystal phases, and elements within crystals by electron microscopy, energy-dispersive X-ray spectrometry, and electron diffraction. These analyses confirmed two types of calcification, each with hydroxyapatite crystals. In areas of heterotopic bone, crystals 40 × 10 nm were deposited in an orderly fashion on collagen fibers. In contrast, in areas of globular aggregates, spherulitic aggregates of much larger crystals were present, without any relationship to the collagen. Titanium was demonstrated in capsules of first-generation implants at areas of attachment of the Dacron patches. The calcification associated with saline implants revealed only one form of crystal: agglomerates, which were adherent to the elastomeric shell of the implants. A hypothesis is presented to explain the differences in calcification deposition properties between silicone gel-filled and saline-filled breast implants.

Factors affecting the rupture of silicone-gel breast implants.

Between January 1990 and April 1993, over 500 patients with silicone-gel breast implants were clinically assessed regarding their implant status. Of these, 57 patients requested implant removal. Reasons for removal were capsular contracture (39 patients), possible implant rupture, suggested by ultrasound testing or mammography (7 patients), “silicone phobia” (7 patients), and asymmetry (4 patients). Of the 102 implants that were removed, 60% were intact, 33% were ruptured, and 7% were leaking. There was a positive correlation between duration of implantation time and the number of ruptured and leaking implants. Of the 45 implants that had been in place for 5 years or less, 93% were intact. Of the 29 implants that had been in place for 6 to 10 years, only 31% were intact (59% were ruptured and 10% were leaking). Similar results were obtained in 20 implants after 11 to 15 years (30% were intact, 55% were ruptured, and 15% were leaking). Of 8 implants that were in place for 16 to 26 years, 50% were intact and 50% were ruptured. In this study, the integrity of breast implants was not related to the degree of capsular contracture.

Is there a relationship between autoantibodies and silicone-gel implants?

The present study was conducted to determine if 200 patients with silicone-gel implants demonstrated elevated levels of autoantibodies, compared with a similar group of 100 age-matched control subjects without breast implants. These results were then compared with 29 patients who had demonstrated implant rupture. Differences in the frequency of autoantibody levels were determined by the chi-squared test. Differences in autoantibody titers were determined by Wilcoxons signed rank test. Differences were considered significant with p > 0.05. The prevalence of a positive antinuclear antibody (ANA) test (dilution 1:100) in the 200 patients with breast implants was 26.5% compared with 28% in the 100 control subjects. In 29 patients with implant rupture, only 17.2% tested ANA positive. These values were not significantly different. In addition, there were no significant differences between the ANA titers of positive patients in each group. In each of the three groups, all patients who tested ANA positive were analyzed to assess the frequency and titer of other autoantibodies, including anti-DNA, anti‐cardiolipin, anti-SSA, anti-SSB, anti-SM, anti-RNP, and anti-Scl-70. There were no significant differences between the frequency or titer of any of these autoantibody levels in each of the three groups of patients. These studies strengthen the concept that there is no conclusive evidence that silicone-gel implants are related to the development of connective tissue disease.

Complications from injectable materials used for breast augmentation

Fewer surgical procedures have a history as fascinating and as terrifying as breast augmentation. Initial efforts at augmentation involved injection of substances such as paraffin or oil into the breast tissue, or the implantation of substances including ivory or glass balls, or rubber. More recent efforts have included the injection of liquid silicone or polyacrylamide hydrogel. The current paper reviews four distinct eras of breast augmentation, and provides the current status of these injection materials. A case report is presented on a woman whose breasts were injected with polyacrylamide hydrogel in Iran. The current status of this group of materials is also presented. During the past 110 years, history has repeated itself during each of the four eras of injection.

Analysis of silicon levels in capsules of gel and saline breast implants and of penile prostheses.

Although a potential link between silicone-gel breast implants and autoimmune connective tissue disease has been suggested, none has been proven. The potential role of silicone as an immune adjuvant remains very controversial. Currently available techniques do not allow precise measurements of silicone in tissues. However, all compounds containing silicon (including silicone) can be measured accurately. The present study was designed to measure silicon levels in the fibrous capsules of patients with silicone-gel breast implants, saline breast implants, and silicone inflatable penile prostheses. Baseline control silicon levels were obtained from the breast tissue of patients undergoing breast reduction, who had no exposure to breast implants. All silicon measurements were carried out using atomic absorption spectrometry with a graphite furnace. Silicon was measured in a normal heptane extract of silicone from dried tissue. The mean silicon levels in 16 breast tissue control samples from 8 patients undergoing breast reduction varied from 0.025 to 0.742 μg/gm with the median mean being 0.0927. The median silicon level in capsules from six patients with saline implants was 7.7 μg/gm (range, 1.9–36.6 μg/gm). The median silicon level in capsules from five patients with silicone inflatable penile prostheses was 19.5 μg/gm (range, 1.9–34.8 μg/gm). Although the levels of silicon in capsules of patients with saline breast prostheses and penile implants were higher than in control samples, they were much lower than those from the capsules of the 58 gel implants (median, 9,979 μg/gm; range, 371–152,000 μg/gm). Of the 58 silicone-gel breast implants (from 20 patients with bilateral implant removal and 18 patients with unilateral removal) that had been inserted from 1974 to 1990, 28 were intact, 8 had pinhole leaks, and 22 were ruptured. Median capsule silicon levels and ranges for all 58 implants, for intact only, for leaking, and for ruptured were, respectively, as follows: 9,979 (371–152,000); 10,477 (371–88,703); 6,592 (3,235–65,396); and 9,922 (1,762–152,387) μg/gm. There were no significant differences in silicon levels associated with implant status, duration in situ, or year of implantation.

Do patients with silicone-gel breast implants have elevated levels of blood silicon compared with control patients?

Whole blood silicon levels in 30 patients with silicone-gel implants (inserted between 1973 and 1991) were compared with those of 24 healthy, age-matched, female patients without breast implants using atomic absorption spectrometry with a graphite furnace. The blood silicon levels in the implant patients were significantly higher than those of controls (medians 33.45 vs 17.05 ng/ml; p=0.005). Of the 30 patients with implants, 15 had received their implants between 1973 and 1985, and 15 had received implants between 1986 and 1991. Implants made between 1973 and 1985 have been shown to be weaker and to have higher silicone “bleed” levels than those made from 1986 onward. However, there were no significant differences in the blood silicon levels between these two groups of patients.

Calcification of breast implant capsules: incidence, diagnosis, and contributing factors.

From January 1990 to August 1994, more than 600 patients with silicone-gel breast implants were clinically assessed regarding their implant status. Of these, 82 patients requested removal of their implants (150 implants). Of the 150 implants that were removed, 24 (16%) demonstrated calcified capsules. All 12 patients with calcification demonstrated this finding bilaterally. All calcified capsules demonstrated discrete calcified plaques on their inner surface. All 12 patients presented with Baker class IV contractures, with pain as their chief complaint. One patient demonstrated calcification on a routine chest radiograph. One patient demonstrated a stippled appearance on xeromammogram. Capsular calcification was related to the duration of implantation. All 6 implants that had been in place for 23 to 26 years were associated with calcification. These implants were all of the thick-walled Dacron-backed type. All thick-walled Dacron-backed implants that were removed in this study were associated with calcification. Of the 69 implants that had been inserted for 11 to 20 years, 18 (26.1%) were associated with calcification. Fifteen of these 16 implants were ruptured. None of the implants that had been in place for 10 years or less demonstrated calcification.

Calcification properties of saline-filled breast implants.

Three patients requested explantation of their salinefilled breast implants. Bilateral calcification had occurred in all six implants. Four of the implants were manufactured by McGhan Corporation (Santa Barbara, Calif.), and two, by the Simaplast Company (Toulon, France). All implants had been inserted in the subglandular plane and had been in place for 7 to 23 years. At the time of explantation, patients were 32, 34, and 44 years old. Calcification on the surface of the implants and capsules was analyzed. Implant surface calcification was clinically evident on all six implants, appearing as ivory‐colored, tenaciously adherent deposits, only on the anterior surface of the implant. Capsular calcification, which was observed only microscopically, was characterized by poorly organized, irregularly shaped, calcified agglomerates; this calcification also occurred only on the anterior surface of the capsule, adjacent to the area of calcification on the implant. Ultrastructural analysis of scrapings from the implant surface showed large, electron‐dense aggregates of crystals, with individual crystals measuring approximately 40 × 10 × 10 nm. In contrast, capsular calcification was characterized by two patterns of deposition, spherulitic aggregates of needle‐shaped crystals and areas of metaplastic bone. The individual crystals were approximately 40 × 10 × 10 nm. Energy‐dispersive x‐ray spectroscopy of specimens from the areas of calcification on the implant and capsule surfaces demonstrated calcium and phosphorus. Electron diffraction of crystals from the implant and capsule surfaces demonstrated the D‐spacings characteristic of calcium apatite. There were many differences between the calcification properties of these six saline implants and those of silicone gel implants. For example, mineralization has not been observed on the surface of gel implants, but in these saline implants it occurred primarily on the implant surface. Also, capsular calcification has been observed clinically in gel implants across the surface of the capsule (except at the site of attachment of a Dacron patch), but in this study it was observed only microscopically and was located on the anterior surface of the capsule, adjacent to the area of calcification on the implant. In addition, crystals 100 times larger than those observed on the six saline implant capsules have been observed on the surface of gel implant capsules. A model is presented to explain the mechanism of calcification associated with breast implants and to explain the observed differences between saline‐filled and gel‐filled implants. (Plast. Reconstr. Surg. 107: 356, 2001.)