an infection due to bacteria or mold that had been within the implant, though this is uncommon. the follow-up report, natrelle saline-filled breast implants: a prospective 10-year study (2009) indicated rupture-deflation rates of 3–5 per cent at 3-years post-implantation, and 7–10 per cent rupture-deflation rates at 10-years post-implantation. in a study of his 4761 augmentation mammaplasty patients, eisenberg reported that overfilling saline breast implants 10-13% significantly reduced the rupture-deflation rate to 1.83% at 8-years post-implantation. a breast implant failure: the parts of a surgically explanted breast implant are the red, fibrous capsule (left), the ruptured silicone implant (center), and the transparent filler-gel that leaked with the capsule (right). when a silicone breast implant ruptures it usually does not deflate, yet the filler gel does leak from it, which can migrate to the implant pocket; therefore, an intracapsular rupture (in-capsule leak) can become an extracapsular rupture (out-of-capsule leak), and each occurrence is resolved by explantation. although the leaked silicone filler-gel can migrate from the chest tissues to elsewhere in the woman's body, most clinical complications are limited to the breast and armpit areas, usually manifested as granulomas (inflammatory nodules) and axillary lymphadenopathy (enlarged lymph glands in the armpit area). the suspected mechanisms of breast implant rupture are: damage during implantation damage during (other) surgical procedures chemical degradation of the breast implant shell trauma (blunt trauma, penetrating trauma, blast trauma) mechanical pressure of traditional mammographic breast examination silicone implant rupture can be evaluated using magnetic resonance imaging; from the long-term mri data for single-lumen breast implants, the european literature about second generation silicone-gel breast implants (1970s design), reported silent device-rupture rates of 8–15 per cent at 10-years post-implantation (15–30% of the patients). the study safety and effectiveness of mentor's memorygel implants at 6 years (2009), which was a branch study of the u.s. fda's core clinical trials for primary breast augmentation surgery patients, reported low device-rupture rates of 1.1 per cent at 6-years post-implantation. the first series of mri evaluations of the silicone breast implants with thick filler-gel reported a device-rupture rate of 1 percent, or less, at the median 6-year device-age. statistically, the manual examination (palpation) of the woman is inadequate for accurately evaluating if a breast implant has ruptured. the study, the diagnosis of silicone breast implant rupture: clinical findings compared with findings at magnetic resonance imaging (2005), reported that, in asymptomatic patients, only 30 per cent of the ruptured breast implants are accurately palpated and detected by an experienced plastic surgeon, whereas mri examinations accurately detected 86 per cent of breast implant ruptures. therefore, the u.s. fda recommended scheduled mri examinations, as silent-rupture screenings, beginning at the 3-year-mark post-implantation, and then every two years, thereafter. nonetheless, beyond the u.s., the medical establishments of other nations have not endorsed routine mri screening, and, in its stead, proposed that such a radiologic examination be reserved for two purposes: (i) for the woman with a suspected breast implant rupture; and (ii) for the confirmation of mammographic and ultrasonic studies that indicate the presence of a ruptured breast implant. furthermore, the effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis (2011) reported that the breast-screening mris of asymptomatic women might overestimate the incidence of breast implant rupture. in the event, the u.s. food and drug administration emphasised that "breast implants are not lifetime devices. the longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications." capsular contracture main article: capsular contracture the human body's immune response to a surgically installed foreign object—breast implant, cardiac pacemaker, orthopedic prosthesis—is to encapsulate it with scar tissue capsules of tightly woven collagen fibers, in order to maintain the integrity of the body by isolating the foreign object, and so tolerate its presence. capsular contracture—which should be distinguished from normal capsular tissue—occurs when the collagen-fiber capsule thickens and compresses the breast implant; it is a painful complication that might distort either the breast implant, or the breast, or both. capsular contracture is diagnosed through a visual and physical examiniation according to level of increasing severity based on the baker grade scale: baker grade i, baker grade ii, baker grade iii, and baker grade iv. a breast implant failure: capsular contracture is a medical complication, in this case, a baker scale grade iv contraction, of a subglandular silicone implant in the right breast. the cause of capsular contracture is unknown, but the common incidence factors include bacterial contamination, device-shell rupture, filler leakage, and hematoma. the surgical implantation procedures that have reduced the incidence of capsular contracture include submuscular emplacement, the use of breast implants with a textured surface (polyurethane-coated); limited pre-operative handling of the implants, limited contact with the chest skin of the implant pocket before the emplacement of the breast implant, and irrigation of the recipient site with triple-antibiotic solutions. the correction of capsular contracture might require an open capsulotomy (surgical release) of the collagen-fiber capsule, or the removal, and possible replacement, of the breast implant. furthermore, in treating capsular contracture, the closed capsulotomy (disruption via external manipulation) once was a common maneuver for treating hard capsules, but now is a discouraged technique, because it can rupture the breast implant. non-surgical treatments for collagen-fiber capsules include massage, external ultrasonic therapy, leukotriene pathway inhibitors such as zafirlukast (accolate) or montelukast (singulair), and pulsed electromagnetic field therapy (pemft). repair and revision surgeries when the patient is unsatisfied with the outcome of the augmentation mammoplasty; or when technical or medical complications occur; or because of the breast implants' limited product life, it is likely she might require replacing the breast implants. common revision surgery indications include major and minor medical complications, capsular contracture, shell rupture, and device deflation. revision incidence rates were greater for breast reconstruction patients, because of the post-mastectomy changes to the soft-tissues and to the skin envelope of the breast, and to the anatomical borders of the breast, especially in women who received adjuvant external radiation therapy. moreover, besides breast reconstruction, breast cancer patients usually undergo revision surgery of the nipple-areola complex (nac), and symmetry procedures upon the opposite breast, to create a bust of natural appearance, size, form, and feel. carefully matching the type and size of the breast implants to the patient's pectoral soft-tissue characteristics reduces the incidence of revision surgery. appropriate tissue matching, implant selection, and proper implantation technique, the re-operation rate was 3 percent at the 7-year-mark, compared with the re-operation rate of 20 per cent at the 3-year-mark, as reported by the u.s. food and drug administration. systemic disease chest x-ray showing breast implants in the 1990s, the national health ministries of the listed countries reviewed the pertinent studies for causal links among silicone-gel breast implants and systemic and diagnosed autoimmune diseases and breast cancer. a study by researchers at the u.s. national institute of health reported an increase in four types of cancer among women with breast implants compared to other plastic surgery patients of the same age and similar demographic traits and health habits. this increase in cancer was attenuated but did not disappear when the researchers followed the women for 5 more years, with a 43% increase in brain cancer and a 63% increase in respiratory cancer compared to other plastic surgery patients. a study by watad et al. evaluated the medical records of more than 24,000 women with breast implants compared to more than 98,000 women with the same demographic traits who did not have breast implants. the researchers found a statistically significant 22 percent increase in several diagnosed diseases, increasing to more than 60% for sjogren's syndrome, multiple sclerosis, and sarcoidosis after investigating this issue, in 2021 the u.s. fda revised its "black box warnings" on breast implants to acknowledge the association between breast implants and systemic autoimmune, rheumatologic, and neurological symptoms to state: "patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. individual patient risk for developing these symptoms has not been well established. some patients report complete resolution of symptoms when the implants are removed without replacement". a 2021 study by cleveland clinic physicians investigated the outcome of breast implant removal on women with breast implants who had reported difficulty breathing or tightness in their chest; this is one of the symptoms associated with breast implant illness. the study examined breast implant patients who reported problems breathing, comparing their scores on 6 pulmonary function tests before and after their implants and scar capsules were removed. the researchers reported that 74% of the patients reported significant improvements on at least 3 of the pulmonary function tests. in self-reports, all study participants reported that their breathing improved after their implant surgery. platinum toxicity platinum is a catalyst used in the making of silicone implant polymer shells and other silicone devices used in medicine. the literature indicates that small amounts of platinum leaches (leaks) from these implants and is present in the surrounding tissue. the fda reviewed the available studies from the medical literature on platinum and breast implants in 2002 and concluded there was little evidence suggesting toxicity from platinum in implant patients. the fda revisited this study and additional literature several years later, reaffirming prior conclusions that platinum catalysts used in implants is likely not ionized and therefore would not represent a risk to women. anaplastic large-cell lymphoma main article: anaplastic large-cell lymphoma § breast implant-associated anaplastic large-cell lymphoma the fda has identified that breast implants may be associated with a rare form of cancer called anaplastic large-cell lymphoma (alcl), which some experts believe is believed to be associated with chronic bacterial inflammation. similar alcl phenomena have been seen with other types of medical implants including vascular access ports, orthopedic hip implants, and jaw (tmj) implants. the causal association between breast implants and alcl was conclusively established in december 2013, when researchers at md anderson cancer center published a study of 60 women with breast implants who were diagnosed with alcl in the breast. in 2015, plastic surgeons published an article reviewing 37 articles in the literature on 79 patients and collected another 94 unreported cases, resulting in 173 women with breast implants who had developed alcl of the breast. they concluded that "breast implant-associated alcl is a novel manifestation of site- and material-specific lymphoma originating in a specific scar location, presenting a wide array of diverse characteristics and suggesting a multifactorial cause." they stated that "there was no preference for saline or silicone fill or for cosmetic or reconstructive indications." where implant history was known, the patient had received at least one textured-surface device. in 2016, the world health organization (who) officially recognized bia-alcl. as of april 2022, the fda has received 1,130 global medical device reports (mdrs) of bia-alcl, including 59 deaths. since alcl was thought to be diagnosed in only 1 woman in half a million, 60 women was a much higher number than would be expected. the researchers pointed out that bia-alcl could be fatal. if women with implants present with delayed swelling or fluid collection, cytologic studies and a test for the marker cd30 are suggested. the american society of plastic surgery (asps) states, "cd30 is the main diagnostic test that must be performed on the seroma fluid as routine pathology or h&e staining can frequently miss the diagnosis." diagnosis and treatment of breast implant-associated alcl now follows standardized guidelines established by the national comprehensive cancer network. the current lifetime risk of bia-alcl in the u.s. is unknown, but estimates have ranged between one in 70,000 and one in 500,000 women with breast implants, according to the md anderson cancer center. countries with breast implant registries have the best data on the risks of bia-alcl. for example, as of october 2020, the therapeutic goods administration of australia and new zealand reported a "1:3,345 risk with allergan biocell and a 1:86,029 risk with mentor siltex." ain the u.s, estimates of the risk of bia-alcl in textured implants ranges from 1.79 per 1,000 (1 woman with bia-alcl per 559 implants) to 2.82 per 1,000 (1 woman per 355 implants). as of april 2022, the fda reported 1,130 medical device reports (mdrs) of bia-alcl. of those mdrs, 59 of the women died . fda states that 798 of the 1,130