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At least 19 recordsLinked to original sources
PubMed1993

Silicone gel breast implants, breast cancer and connective tissue disorders.

Recent worldwide media speculation that silicone gel-filled breast implants may be linked to an increased incidence of breast and other cancers, and connective tissue disease (particularly systemic sclerosis) has caused concern to the medical profession and public alike. Until carefully controlled studies have been performed to prove the safety of these implants, the US Food and Drug Administration has restricted their use to research and breast reconstruction. Research has so far failed to prove a causative relationship between silicone implants and cancer or connective tissue disorders.

Animals↗
PubMed2006

Scanning electron microscope fractography of induced fatigue-damaged saline breast implants.

Breast implant strength and durability is presently an important topic in biomaterials science. Research studies are being conducted to determine the mechanisms and rates of failure in order to assess the in vivo performance of breast implants. Fatigue life is a measure of breast implant durability since fatigue failure is a potential in vivo failure mechanism. This study describes the characterization of the fracture surface morphology of breast implant shell regions that have failed due to cyclic fatigue. Saline breast implants were fatigue tested to failure using a laboratory apparatus in which flat plates cyclically compressed the implants. The implants were unimplanted control devices of both textured and smooth saline implants. The failure surfaces of the fatigued shells were examined using scanning electron microscopy (SEM). The morphological features of the failure surfaces are described for implants with short and long fatigue lifetimes. The details of both the inside and outside surfaces of the shell at the failure location are described. Two different modes of failure were observed in both the textured and smooth shells. These modes depend on the magnitude of the cyclic load and corresponding number of fatigue cycles at failure. The first mode is a tear in the shell of about 18 mm in length, and the second mode is a pinhole approximately 1 mm in diameter. Details of the surface morphology for these two types of failure modes and shell thickness data are presented herein. There was no significant change in the crosslink density of the shell as a result of fatigue.

Breast Implants↗
PubMed1997

Lack of evidence of systemic inflammatory rheumatic disorders in symptomatic women with breast implants.

Breast implants containing silicone have been used for approximately 30 years for breast augmentation or reconstruction. In general, the implants have been well tolerated and reports have indicated a high degree of patient satisfaction. Nonetheless, there have been anecdotal reports of patients with musculoskeletal complaints that have been attributed to silicone breast implants. To investigate this further, we prospectively examined 70 women with silicone breast implants who had complaints that they or their referring physicians thought were related to their implants. On clinical examination, the majority of the patients had fibromyalgia, osteoarthritis, or soft-tissue rheumatism. One patient had rheumatoid arthritis, which predated her implants, and one had Sjõgren's syndrome. Because many of our patients had myalgic symptoms, we further evaluated these patients by measuring circulating levels of soluble factors including interleukin-6, interleukin-8, tumor necrosis factor-alpha, soluble intercellular adhesion molecule-1, and soluble interleukin-2 receptor, which have been previously found to be elevated in patients with inflammatory diseases. We found that the levels of these molecules in women with silicone breast implants were not different from those seen in normal subjects and were significantly less than those seen when examining chronic inflammatory disorders such as rheumatoid arthritis or systemic lupus erythematosus. In summary, our clinical and laboratory evaluation of symptomatic breast implant patients argues against an association of silicone breast implants with a distinctive rheumatic disease or a systemic inflammatory disorder. Given these findings and the clinical picture, it is our impression that most symptomatic women with silicone breast implants have well-delineated noninflammatory musculoskeletal syndromes. Moreover, these data fail to support the concept that their symptoms are due to a systemic inflammatory response related to their implants.

Breast Implants↗
PubMed2001

Self-reported symptoms among women after cosmetic breast implant and breast reduction surgery.

A retrospective cohort study was performed in Sweden to evaluate the possibility that an individual symptom or constellation of illness symptoms related to silicone occurs in women after breast implant surgery. A random sample (n = 2500) of all women in the Swedish national implant registry who underwent breast augmentation surgery with alloplastic breast implants during the years 1965 through 1993 was compared with a sample (n = 3500) of women who underwent breast reduction surgery during the same period, frequency matched to the implant patients for age and calendar year at the time of surgery. In total, 65 percent of the breast implant patients (n = 1546) and 72 percent of the breast reduction patients (n = 2496) completed a self-administered questionnaire covering 28 rheumatologic and other symptoms and lifestyle and demographic factors. Practically all of the 28 symptoms inquired about were reported more often by women in the breast implant cohort, with 16 (57 percent) significantly more common in breast implant recipients. In contrast, few significant differences or consistent patterns were observed in the length of time since the implant and in the type (silicone or saline) or volume of the implant. Although women with breast implants report a multitude of symptoms more often than women who have breast reduction surgery, the lack of specificity and absence of dose-response relationships suggest that the excess of reported symptoms is not causally related to cosmetic implants.

Adult↗
PubMed2004

[Silicone gel-filled breast implants and breast cancer--an update and safety].

Silicone gel-filled breast implants have long been an important method of breast reconstruction and breast augmentation. In 1992, the Food and Drug Administration (FDA), implemented a voluntary but strongly urged moratorium on the sale and use of silicone gel-filled breast implants. This was due to previous anecdotal reports regarding possible health hazards associated with these types of implants, including the emergence of breast cancer. The FDA allowed the use of silicone gel-filled breast implants for post-mastectomy reconstruction, and also in a small number of breast augmentation patients who were willing to enroll in a long-term prospective study. In this article, we review the current available literature that failed to produce any evidence associating the use of silicone breast implants with the increased risk of breast cancer.

Breast Implants↗
PubMed1997

[Silicone breast implants and breast cancer].

The authors discuss the immunological and oncological risk of prefilled silicone gel breast implants. A comparative study of 146 patients undergoing breast reconstruction by silicone implant at the Institut Gustave-Roussy and 146 matched controls demonstrated the absence of any difference between the two groups concerning survival, local recurrence rate and metastases.

Bioprosthesis↗
PubMed1997

[Silicone breast implants and breast cancer].

Sarcomas have been shown to develop next to foreign body implants, silicone included, in animal experiments. However, this carcinogenesis is not believed to have any human relevance. A review of the existing epidemiological studies suggests that women with silicone breast implants have a reduced risk for developing breast cancer. However, the presence of breast implants does obscure mammographic visualization as well as palpation of mammary tissue. This has led to the assumption that breast cancer detection could be compromised in women with breast implants. In the few studies that have dealt with this issue, women with breast implants were diagnosed with the same stage of disease as women without implants. However, the percentage of false negative mammographies was increased in one study. In conclusion, there is currently no evidence of an association between breast implants and cancer or postponed breast cancer detection.

Breast Implants↗
PubMed1988

Preoperative planning of breast implants using the breast implant planning device (BIPD).

Interstitial implantation of the tumor excision site is an important component of the treatment program of breast-conserving surgery and irradiation. The currently accepted method of designing and performing the implant in the operating room does not assure adequate coverage of the volume of tissue at risk, i.e., the tissue immediately adjacent to the walls of the original tumor excision cavity. This communication describes a technique of preoperative implant planning that consistently and reliably ensures adequate coverage of the volume of tissue at risk. An integral part of this technique is the use of a new device called the Breast Implant Planning Device. This device is a modification of previously described implant template devices.

Breast Neoplasms↗
PubMedDate not supplied

Local infiltrative anesthesia for transaxillary subpectoral breast implants.

Breast augmentations using a transaxillary subpectoral approach are usually performed under general anesthesia. This article describes a technique that uses local infiltrative anesthesia in breast augmentation, adenomastectomies with immediate breast reconstruction, and when placing breast expansors. Large anesthetic solutions with vasoconstrictor and long-acting effects are prepared. The axila, the subpectoral space, and a surrounding area of 3 cm outside the demarcation limits are infiltrated. Minimal bleeding, long-lasting effects, and a considerable postoperative analgesic effect are some of the advantages of this procedure.

Adult↗
PubMed1991

Detection of toluenediamines in the urine of a patient with polyurethane-covered breast implants.

Breast prostheses are implanted for augmentation or during reconstructive surgery. One of the more commonly used prostheses is the polyurethane-sponge-covered silicone gel implant. Some clinicians are concerned about the safety of this product because the polyurethane foam disintegrates in vivo, and its subsequent fate is not known. Polyurethane is a polymer formed by reacting diisocyanates and polyols. This study indicates that the polymer sponge breaks down into its reactive monomers, 2,4- and 2,6-toluenediisocyanate, which are converted into their corresponding diamines. We present evidence of the excretion of the diamine metabolites in the urine of a patient implanted with polyurethane-covered prostheses.

Adult↗
PubMed2000

[Tolerance, reliability and efficiency of inflatable breast implants after breast reconstruction. Retrospective study of 101 consecutive cases].

A long-term retrospective study of breast reconstruction with inflatable implants is presented. One hundred and one patients were studied, with a median follow-up of 44 months. Prosthetic implants used were round McGhan implants, model 168. Median volume was 215 mL. Twenty-two patients had contralateral symmetrisation, an average of five months after implant. The advantages of this sort of reconstruction are ease, speed and homogenously good results. Drawbacks include the appearance of prosthetic leaks (7%), waves and folds (13%), stage III and IV capsular contractures (26%), asymmetry and incorrect placement of the implant (25%). Breast reconstruction with implants alone gives good results for specific indications: immediate reconstructions, bilateral reconstructions, no history of radiotherapy, and good quality chest wall tissues.

Adult↗
PubMed1995

Breast implants and breast cancer--reanalysis of a linkage study.

BACKGROUND: In 1992, Berkel and colleagues reported in the Journal the results of their study of the potential association of breast augmentation and breast cancer. The study reported that women who had breast augmentation had a significantly lower subsequent risk of breast cancer (P < 0.01) than the general population, with a standardized incidence ratio of 0.48 overall. Assuming a 10-year induction period (that is, assuming that cancers found within 10 years of the augmentation might have been the result of a process begun before surgery and therefore should not be considered), the reported standardized incidence ratio was 0.16. Problems were later identified involving some of the study methods. This paper reports a second analysis of these data. METHODS: We used a data set from Alberta Health Care to identify eligible women with bilateral breast augmentation. Using a combination of deterministic and probabilistic methods, we linked this data set to the Alberta Cancer Registry to identify subsequent breast cancers that developed during the study period. Multiple estimates of standardized incidence ratios were calculated on the basis of differing study-eligibility dates, induction periods, and types of breast-cancer (invasive only or invasive plus in situ). RESULTS: The reanalysis found substantial differences in the numbers of person-years at risk, resulting in higher standardized incidence ratios than in the original analysis. The final ratios for all breast cancers, with October 1, 1973, used as the starting date of the study, were 0.76 (95 percent confidence interval, 0.55 to 1.02), 0.85 (95 percent confidence interval, 0.58 to 1.19), and 0.68 (95 percent confidence interval, 0.32 to 1.25) for induction periods of 0, 5, and 10 years, respectively. None of these standardized incidence ratios were significantly different from 1. CONCLUSIONS: On the basis of this reanalysis, the incidence of breast cancer among the women who had breast augmentation could not be said to be either significantly higher or lower than that among the general population over the period during which this cohort was followed.

Adult↗
PubMed2006

A comparison of 500 prefilled textured saline breast implants versus 500 standard textured saline breast implants: is there a difference in deflation rates?

BACKGROUND: This study provides the first large-volume (1000 implant) comparison of the deflation rates of Poly Implant Prosthesis prefilled textured saline breast implants versus a control group of Mentor Siltex textured saline implants. METHODS: A consecutive series of 500 Poly Implant Prosthesis prefilled textured saline breast implants was compared with a consecutive series of 500 Mentor Siltex breast implants. Each breast implant was evaluated for a 4-year period, and the annual deflation rate (number of deflations during a given year divided by the total number of implants) and cumulative deflation rate (cumulative total of deflations through a given year divided by the total number of implants) were recorded. Statistical significance was calculated using the Fisher's exact test at year 1 and the chi-square analysis at years 2 through 4. RESULTS: The cumulative deflation rates of the Poly Implant Prosthesis implants was as follows: year 1, 1.2 percent; year 2, 5.6 percent; year 3, 11.4 percent; and year 4, 15.4 percent. The cumulative deflation rates of the Mentor implants was: year 1, 0.2 percent; year 2, 0.6 percent; year 3, 1.6 percent; and year 4, 4.4 percent. At year 1, the difference between deflation rates was not statistically significant (Fisher's exact test, p > 0.05). However, at year 2 (chi-square, 13.29; p < 0.001), year 3 (chi-square, 37.91; p < 0.001), and year 4 (chi-square, 32.69; p < 0.001), the difference was statistically significant. CONCLUSIONS: There was a statistically significant difference between the overall deflation rates of Poly Implant Prosthesis prefilled textured saline breast implants and Mentor Siltex breast implants at year 2, year 3, and year 4. After 4 years, the 15.56 percent cumulative deflation rate of Poly Implant Prosthesis implants was over 3.5 times higher than the 4.31 percent deflation rate of the Mentor Siltex implants. There may be several factors contributing to the higher deflation rate seen in Poly Implant Prosthesis implants, including possible in vitro deflation before implantation and silicone shell curing technique. Nevertheless, this statistically significant deflation difference must be taken into account when balancing the risks and benefits of Poly Implant Prosthesis breast implants.

Breast Implantation↗
PubMedDate not supplied

Breast implants and breast cancer screening.

Concern about breast prostheses impairing breast cancer detection has become a priority issue. This article provides a review of the literature on the influence of implants on early detection methods of breast cancer, specifically breast self-examination (BSE), clinical breast examination (CBE), and mammography. Background information on implants is presented, including indications for surgery, types of prostheses, location of placement, and associated complications. Conclusions from the literature suggest that the presence of implants may facilitate BSE and CBE, yet challenge interpretation of mammography. However, there is no evidence that these women will have a later stage diagnosis or a poorer prognosis if diagnosed with breast cancer.

Adult↗