The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling addresses: "patients should be advised that capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.Capsular contracture occurs more commonly in revision patients than in primary augmentation or reconstruction patients.Capsular contracture is also a risk factor for implant deflation, and it is one of the most common reasons for reoperation.Patients should also be advised that additional surgery may be needed in cases where pain and/or firmness are severe.This surgery ranges from removal of the implant capsule tissue to removal and possible replacement of the implant itself.This surgery may result in loss of breast tissue.Capsular contracture may happen again after these additional surgeries.Capsular contracture may increase the risk of deflation." 'bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma¿ 137, 6, (1659-1669) by honghua hu, ph.D.; khalid johani; ahmad almatroudi; karen vickery, ph.D., b.V.Sc.; bruce van natta, m.D.; marshall e.Kadin, m.D.; garry brody, m.D.; mark clemens, m.D.; chan yoon cheah, m.D.; stephen lade, m.D.; preeti avinash joshi, m.D.,ph.D.; h.Miles prince, m.D.,ph.D.; anand k.Deva, b.Sc.(med.), m.B.B.S., m.S.Published june 2016.
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Literature article ¿bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma¿ reports ¿twenty-six breast implant¿associated alcl samples were gathered from four centers for this international collaborative study from a total of 22 patients (table 1).¿ article goes on to state: ¿both the breast implant¿associated alcl and nontumor capsule samples yielded high mean numbers of bacteria (breast implant¿associated alcl, 4.7 × 106 cells/mg of tissue; capsule, 4.9 × 106 cells/mg of tissue).Analysis of the microbiome in breast implant¿associated alcl specimens showed significant differences with species identified in nontumor capsule specimens.There was a significantly greater proportion of ralstonia spp.Present in alcl specimens compared with nontumor capsule specimens (p < 0.05).In contrast, significantly more staphylococcus spp.Were found associated with nontumor capsule specimens compared with breast implant¿associated alcl specimens (p < 0.001).Bacterial biofilm was visualized both on scanning electron microscopy and fluorescent in situ hybridization.¿ cytological markers alk- and cd30+ have been reported.Article further states: ¿nontumor capsule specimens from 62 patients undergoing revision surgery for high-grade capsular contracture.¿ there is currently no way to determine which cases had which device type.This report will capture 62 cases of nontumor non alcl capsular contracture.
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