The plastic surgical emplacement of<unk>  devices, either for breast reconstruction or for aesthetic purpose, presents the same health risks common to surgery, such as adverse reaction to anesthesia, hematoma (post-operative bleeding), late hematoma (post-operative bleeding after 6 months or more), seroma (fluid accumulation), incision-site breakdown (wound infection). Complications specific to breast augmentation include breast pain, altered sensation, impeded breast-feeding function, visible wrinkling, asymmetry, thinning of the breast tissue, and symmastia, the “bread loafing” of the bust that interrupts the natural plane between the breasts. Specific treatments for the complications of indwelling<unk> s—capsular contracture and capsular rupture—are periodic MRI monitoring and physical examinations. Furthermore, complications and re-operations related to the implantation surgery, and to tissue expanders (implant place-holders during surgery) can cause unfavorable scarring in approximately 6–7 percent of the patients. Statistically, 20 percent of women who underwent cosmetic implantation, and 50 percent of women who underwent breast reconstruction implantation, required their explantation at the 10-year mark. Safety In the early 1990s, the national health ministries of the listed countries reviewed the pertinent studies for causal links among silicone-gel<unk> s and systemic and auto-immune diseases. The collective conclusion is that there is no evidence establishing a causal connection between the implantation of silicone<unk> s and either type of disease. The Danish study Long-term Health Status of Danish Women with Silicone<unk> s (2004) reported that women who had<unk> s for an average of 19 years were no more likely to report an excessive number of rheumatic disease symptoms than would the women of the control group. The follow-up study Mortality Rates Among Augmentation Mammoplasty Patients: An Update (2006) reported a decreased standardized mortality ratio and an increased risk of lung cancer death among<unk>  patients, than among patients for other types of plastic surgery; the mortality rate differences were attributed to tobacco smoking. The study Mortality Among Canadian Women with Cosmetic<unk> s (2006), about some 25,000 women with<unk> s, reported a 43 per cent lower rate of breast cancer among them than among the general populace, and a lower-than-average risk of cancer. Year Country Systemic Review Group Conclusions 1991–93 United Kingdom Independent Expert Advisory Group (IEAG) There was no evidence of an increased risk of connective-tissue disease in patients who had undergone silicone-gel<unk>  emplacement, and no cause for changing either<unk>  practice or policy in the U.K. 1996 United States U.S. Institute of Medicine (IOM) There was "insufficient evidence for an association of silicone gel- or saline-filled<unk> s with defined connective tissue disease." 1996 France Agence Nationale pour le Developpement de l’Evaluation Medicale (ANDEM) National Agency for Medical Development and Evaluation French original: "Nous n'avons pas observé de connectivité ni d'autre pathologie auto-immune susceptible d'être directement ou indirectement induite par la présence d'un implant mammaire en particulier en gel de silicone...." English translation: "We did not observe connective tissue diseases to be directly or indirectly associated by the presence of a<unk> , in particular one of silicone gel...." 1997 Australia Therapeutic Devices Evaluation Committee (TDEC) The "current, high-quality literature suggest that there is no association between<unk> s and connective tissue disease-like syndromes (atypical connective tissue diseases)." 1998 Germany Federal Institute for Medicine and Medical Products Reported that "silicone<unk> s neither cause auto-immune diseases nor rheumatic diseases and have no disadvantageous effects on pregnancy, breast-feeding capability, or the health of children who are breast-fed. There is no scientific evidence for the existence of silicone allergy, silicone poisoning, atypical silicone diseases or a new silicone disease." 2000 United States Federal court-ordered review "No evidence of an association between... silicone-gel-filled<unk> s specifically, and any of the individual CTDs, all definite CTDs combined, or other auto-immune or rheumatic conditions." 2000 European Union European Committee on Quality Assurance & Medical Devices in Plastic Surgery (EQUAM) "Additional medical studies have not demonstrated any association between silicone-gel filled<unk> s and traditional auto-immune or connective tissue diseases, cancer, nor any other malignant disease. . . . EQUAM continues to believe that there is no scientific evidence that silicone allergy, silicone intoxication, atypical disease or a 'new silicone disease' exists." 2001 United Kingdom UK Independent Review Group (UK-IRG) "There is no evidence of an association with an abnormal immune response or typical or atypical connective tissue diseases or syndromes." 2001 United States Court-appointed National Science Panel review The panel evaluated established and undifferentiated connective tissue diseases (CTD), and concluded there was no causal evidence between<unk> s and these CTDs. 2003 Spain Science and Technology Options Assessment (STOA) The STOA report to the European Parliament Petitions Committee reported that the current scientific evidence demonstrates no solid, causal evidence linking SBI silicone<unk> s to severe diseases, e.g. breast cancer, connective tissue diseases. 2009 European Union International Committee for Quality Assurance, Medical Technologies & Devices in Plastic Surgery panel (IQUAM) The consensus statement of the Transatlantic Innovations conference (April 2009) indicated that additional medical studies demonstrated no association between silicone gel-filled<unk> s and carcinoma, or any metabolic, immune, or allergic disorder. Implant rupture Implant rupture visualized by Breast-Computertomography Because a<unk>  is a Class III medical device of limited product-life, the principal rupture-rate factors are its age and design; nonetheless, a<unk>  device can retain its mechanical integrity for decades in a woman's body. When a saline<unk>  ruptures, leaks, and empties, it quickly deflates, and thus can be readily explanted (surgically removed). In some cases, saline implant rupture can result in an infection due to bacteria or mold that had been within the implant, though this is uncommon. The follow-up report, Natrelle Saline-filled<unk> s: 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<unk> s 10-13% significantly reduced the rupture-deflation rate to 1.83% at 8-years post-implantation. A<unk>  failure: the parts of a surgically explanted<unk>  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<unk>  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<unk>  rupture are: * damage during implantation * damage during (other) surgical procedures * chemical degradation of the<unk>  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<unk> s, the European literature about second generation silicone-gel<unk> s (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<unk> s 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<unk>  has ruptured. The study, The Diagnosis of Silicone<unk>  Rupture: Clinical Findings Compared with Findings at Magnetic Resonance Imaging (2005), reported that, in asymptomatic patients, only 30 per cent of the ruptured<unk> s are accurately palpated and detected by an experienced plastic surgeon, whereas MRI examinations accurately detected 86 per cent of<unk>  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<unk>  rupture; and (ii) for the confirmation of mammographic and ultrasonic studies that indicate the presence of a ruptured<unk> . Furthermore, The Effect of Study design Biases on the Diagnostic Accuracy of Magnetic Resonance Imaging for Detecting Silicone<unk>  Ruptures: a Meta-analysis (2011) reported that the breast-screening MRIs of asymptomatic women might overestimate the incidence of<unk>  rupture. In the event, the U.S. Food and Drug Administration emphasised that<unk> s are not lifetime devices. The longer a woman has silicone gel-filled<unk> s, the more likely she is to experience complications.” Capsular contracture
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Polypropylene breast implant
Breast surgery
Breast augmentation
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