Stanley Lugowski

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.

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 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.)

Silicon assays in women with and without silicone gel breast implants--a review.

During the past 5 years, as the failure properties of silicone gel breast implants have emerged, there has been considerable interest in measuring the levels of silicone and silicon in blood, serum, breast milk, and body tissues. Assays have been done in control patients without implant exposure, and in patients with silicone gel implants in an attempt to predict implant failure. Nuclear magnetic resonance measurements of silicone compounds have not been helpful because of their low sensitivity of detection. However, all compounds containing the element silicon, which includes silicone, have been measured accurately. Modern techniques, such as electrothermal atomic absorption spectrometry, direct-current plasma emission spectrometry, and inductively coupled plasma emission spectroscopy have allowed precise measurement of silicon in body fluids and tissues. Using these techniques, recent studies have demonstrated consistent levels of silicon in the blood and plasma of control women without exposure to implants. In one study, plasma silicon was shown to be 140 +/- 10 ng per milliliter. In four other studies, serum silicon levels in control patients were the following: mean, 130 +/- 70 ng per milliliter; mean, 170 +/- 100 ng per milliliter; median, 100 ng per milliliter (range, 30-209 ng per milliliter); and 10 to 250 ng per milliliter. Three independent studies have shown that women with silicone gel implants have higher blood and serum silicon levels than control subjects, but their values were still within the range of control subjects. One study has shown that the mean silicon level in breast milk was not significantly different between 15 implant patients and 34 control patients. The measurement of silicon in control breast tissue has shown consistent results in three different studies, with most tests varying from <0.2 to 2.2 microg per gram dry weight. Three studies have shown that capsules from women with silicone gel breast implants had markedly elevated silicon levels compared with control breast tissue. Median silicon levels varied from 9,980 to 14,390 microg per gram dry weight. There was no significant difference in capsule silicon level between intact and ruptured implants or associated with implant duration in situ or year of implantation. Four studies have shown that capsules from saline implants had elevated levels of silicon compared with control tissue, but their silicon levels were much lower than those of gel implants. The median levels of silicon in the capsules of these studies were as follows: 7.7, 71.5, 198, and 1,100 microg per gram dry weight. Based on current knowledge, because of the large variability among patients, the use of silicon measurements in blood, serum, breast milk, or implant capsule tissue has no clinical role for the effective monitoring of implant leakage in women with silicone gel breast implants.

Titanemia from total knee arthroplasty: A case resulting from a failed patellar component

The subject of this case report is a patient with elevated serum levels of titanium (77 parts/billion [ppb]; normal, 3.3 ppb) and vanadium (0.38 ppb; normal, 0.17 ppb) resulting from excessive wear of a metal-backed patellar component in a total knee arthroplasty. The patellar component was worn through both its polyethylene and metal backing as a result of abnormal contact between the patellar and femoral components. Scanning electron microscopic examination of the ingrowth surface of the patellar component indicated that particle debonding occurred as a result of overloading of the sintered neck regions at the particle-substrate interface, suggesting a possible damage during initial insertion of the device, which may have predisposed it to loosening and abnormal contact with the femoral component. Wear particles resulted in staining of the tissues within the knee and an inflammatory and immune response in the synovium consisting of giant cells and T lymphocytes. The serum metal levels were reduced 22 weeks after replacing the patellar component; however, the titanium level was still slightly elevated (8 ppb).

Silicon and Silicone Levels in Patients with Silicone Implants

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 easily allow precise measurements of silicone in tissues. However, all compounds containing silicon (which would include 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. The mean silicon levels in 16 breast tissue control samples from 8 patients undergoing breast reduction varied from 0.046 to 0.742 micrograms/g dry weight, with the median mean being 0.0927. The median silicon level in capsules from 6 patients with saline implants was 7.7 micrograms/g (range 36.6). The median silicon level in capsules from 5 patients with silicone inflatable penile prostheses was 19.5 micrograms/g (range 34.8). 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 9979 micrograms/g). Of the 58 silicone gel breast implants (from 20 patients with bilateral implant removal and 18 patients with unilateral removal) which 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: 9979 (152,000), 10,477 (88,703), 6592 (65,396), and 9922 (152,387) micrograms/g respectively. There were no significant differences in silicon levels associated with implant status, duration in situ, or year of implantation. Capsule contracture was not associated with higher levels of capsule silicon. Capsule silicon levels were about 10(6) times higher than previously assayed blood silicon levels. This may be because silicone released from implants remains localized in capsular tissue, or because blood-borne silicone is quickly excreted. Using 29Si nuclear magnetic resonance spectroscopy, no detectable silicone was found in the blood of 7 control women and 7 women with silicone-gel implants (5 with known implant rupture).

Dissolution behavior of calcium phosphate nanocrystals deposited on titanium alloy surfaces

We have recently shown that a new implant surface design, achieved by the deposition of discrete nanocrystals of calcium phosphate on microtopographically complex titanium-based substrates, accelerates osteoconduction and also renders the implant surface bone bonding. Thus, we wished to examine the elution behavior of these calcium phosphate nanocrystals and their modulation in vivo. We first compared the total amount of calcium phosphate on these implants with that of plasma-sprayed implants, by measuring the eluted calcium using atomic absorption spectrophotometry. We then plotted their dissolution behavior in vitro as a function of pH relevant to physiological conditions. To assess their structural stability in vivo for periods of up to 1 month, we placed samples in diffusion chambers, implanted them in the abdominal cavity of rats, and examined their surfaces by scanning electron microscopy following retrieval. Our results show that these nanocrystals are stable at normal pH but, as expected, dissolve at acidic pH, and that they remain unchanged when exposed to body fluid in vivo for up to 1 month.