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." when one lumen of a structured implant ruptures, it leaks and empties. the other lumen remain intact and the implant only partially deflates, allowing for ease of explant and replacement. 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. 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 use of a funnel device for implant insertion has also been shown to reduce the rate of capsular contracture. 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 woman 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 (class iii medical device, in the u.s.), it is likely she might require replacing the breast implants. the 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 3.0% at the 7-year-mark, compared with the re-operation rate of 20% at the 3-year-mark, as reported by the u.s. food and drug administration. systemic disease and sickness since the 1990s, reviews of the studies that sought causal links between silicone-gel breast implants and systemic disease reported no link between the implants and subsequent systemic and autoimmune diseases. nonetheless, during the 1990s, thousands of women claimed sicknesses they believed were caused by their breast implants, including neurological and rheumatological health problems. breast implant: the chest x-ray of a woman with bilaterally emplaced breast implants shows that the prostheses are radiographically opaque, and are foreign objects in her body, but not of her body. in the study long-term health status of danish women with silicone breast implants (2004), the national healthcare system of denmark reported that women with implants did not risk a greater incidence and diagnosis of autoimmune disease, when compared to same-age women in the general population; that the incidence of musculoskeletal disease was lower among women with breast implants than among women who had undergone other types of cosmetic surgery; and that they had a lower incidence rate than like women in the general population. follow-up longitudinal studies of these breast implant patients confirmed the previous findings on the matter. european and north american studies reported that women who underwent augmentation mammoplasty, and any plastic surgery procedure, tended to be healthier and wealthier than the general population, before and after implantation; that plastic surgery patients had a lower standardized mortality ratio than did patients for other surgeries; yet faced an increased risk of death by lung cancer than other plastic surgery patients. moreover, because only one study, the swedish long-term cancer risk among swedish women with cosmetic breast implants: an update of a nationwide study (2006), controlled for tobacco smoking information, the data were insufficient to establish verifiable statistical differences between smokers and non-smokers that might contribute to the higher lung cancer mortality rate of women with breast implants. the long-term study of 25,000 women, mortality among canadian women with cosmetic breast implants (2006), reported that the "findings suggest that breast implants do not directly increase mortality in women." the study silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women (2001), reported increased incidences of fibromyalgia among women who had extracapsular silicone-gel leakage than among women whose breast implants neither ruptured nor leaked. the study later was criticized as significantly methodologically flawed, and a number of large subsequent follow-up studies have not shown any evidence of a causal device–disease association. after investigating, the u.s. fda has concluded "the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants." the systemic review study, silicone breast implants and connective tissue disease: no association (2011) reported the investigational conclusion that "any claims that remain regarding an association between cosmetic breast implants and ctds are not supported by the scientific literature". platinum toxicity breast-implant: the metallic element platinum (pt, 78) a catalyst in the manufacture of silicone breast implants, was a suspected cause of toxic contamination (tissue ionization) in the bodies of women with such implants. the manufacture of silicone breast implants requires the metallic element platinum (pt, 78) as a catalyst to accelerate the transformation of silicone oil into silicone gel for making the elastomer silicone shells, and for making other medical-silicone devices. the literature indicates that trace quantities of platinum leak from such types of silicone breast implant; therefore, platinum is present in the surrounding pectoral tissue(s). the rare pathogenic consequence is an accumulation of platinum in the bone marrow, from where blood cells might deliver it to nerve endings, thus causing nervous system disorders such as blindness, deafness, and nervous tics (involuntary muscle contractions). in 2002, the u.s. food and drug administration (u.s. fda) reviewed the studies on the human biological effects of breast-implant platinum, and reported little causal evidence of platinum toxicity to women with breast implants. furthermore, in the journal analytical chemistry, the study "total platinum concentration and platinum oxidation states in body fluids, tissue, and explants from women exposed to silicone and saline breast implants by ic-icpms" (2006) proved controversial for claiming to have identified previously undocumented toxic platinum oxidative states in vivo. later, in a letter to the readers, the editors of analytical chemistry published their concerns about the faulty experimental design of the study, and warned readers to "use caution in evaluating the conclusions drawn in the paper". furthermore, after reviewing the research data of the study "total platinum concentration and platinum oxidation states in body fluids, tissue, and explants from women exposed to silicone and saline breast implants by ic-icpms", and other pertinent literature, the u.s. fda reported that the data do not support the findings presented; that the platinum used in new-model breast implant devices likely is not ionized, and therefore is not a significant risk to the health of the women. non-implant breast augmentation non-implant breast augmentation with injections of autologous fat grafts (adipocyte tissue) is indicated for women requiring breast reconstruction, defect correction, and the æsthetic enhancement of the bust. breast reconstruction: post-mastectomy re-creation of the breast(s); trauma-damaged tissues (blunt, penetrating), disease (breast cancer), and explantation deformity (empty breast-implant socket). congenital defect correction: micromastia, tuberous breast deformity, poland's syndrome, etc. primary augmentation: the aesthetic enhancement (contouring) of the size, form, and feel of the breasts. the operating room time of breast reconstruction, congenital defect correction, and primary breast augmentation procedures is determined by the indications to be treated. the advent of liposuction technology facilitated medical applications of the liposuction-harvested fat tissue as autologous filler for injection to correct bodily defects, and for breast augmentation. melvin bircoll introduced the practice of contouring the breast and for correcting bodily defects with autologous fat grafts harvested by liposuction; and he presented the fat-injection method used for emplacing the fat grafts. in 1987, the venezuelan plastic surgeon eduardo krulig emplaced fat grafts with a syringe and blunt needle (lipo-injection), and later used a disposable fat trap to facilitate the collection and to ensure the sterility of the harvested adipocyte tissue. to emplace the grafts of autologous fat-tissue, doctors j. newman and j. levin designed a lipo-injector gun with a gear-driven plunger, which allowed the even injection of autologous fat-tissue to the desired recipient sites. the control afforded by the lipo-injector gun assisted the plastic surgeon in controlling excessive pressure to the fat in the barrel of the syringe, thus avoiding over-filling the recipient site. the later-design lipo-injector gun featured a ratchet-gear operation that afforded the surgeon greater control in accurately emplacing grafts of autologous fat to the recipient site; a trigger action injected 0.1 cm3 of filler. since 1989, most non-surgical, fat-graft augmentations of the breast employ adipocyte fat from sites other than the breast, up to 300 ml of fat in three equal injections, is placed into the subpectoral space and the intrapectoral space of the pectoralis major muscle, as well as the submammary space, to achieve a breast outcome of natural appearance and contour. autologous fat grafting the technique of autologous fat-graft injection to the breast is applied for the correction of breast asymmetry or deformities, for post-mastectomy breast reconstruction (as a primary and as an adjunct technique), for the improvement of soft-tissue coverage of breast implants, and for the aesthetic enhancement of the bust. the careful harvesting and centrifugal refinement of the mature adipocyte tissue (injected in small aliquots) allows the transplanted fat tissue to remain viable in the breast, where it provides the anatomical structure and the hemispheric contour that cannot be achieved solely with breast implants or with corrective plastic surgery. non-implant breast augmenation: the pre-procedural aspects (left) and the post-procedural aspects (right) of breasts enlarged and contoured with autologous fat grafts in fat-graft breast augmentation procedures, there is the risk that the adipocyte tissue grafted to the breast(s) can undergo necrosis, metastatic calcification, develop cysts, and agglomerate into palpable lumps. although the cause of metastatic calcification is unknown, the post-procedure biological changes occurred to the fat-graft tissue resemble the tissue changes usual to breast surgery procedures such as reduction mammoplasty. the french study radiological evaluation of breasts reconstructed with lipo-modeling (2005) indicates the therapeutic efficacy of fat-graft breast reconstruction in the treatment of radiation therapy damage to the chest, the incidental reduction of capsular contracture, and the improved soft-tissue coverage of breast implants. the study fat grafting to the breast revisited: safety and efficacy (2007) reported successful transfers of body fat to the breast, and proposed the fat-graft injection technique as an alternative (i.e., non-implant) augmentation mammoplasty procedure instead of the surgical procedures usual for effecting breast augmentation, breast defect correction, and breast reconstruction. structural fat-grafting was performed either to one breast or to both breasts of the 17 women; the age range of the women was 25–55 years; the mean age was 38.2 years; the average volume of a tissue-graft was 278.6 cm3 of fat