Article citation: suga, hirotaka, md, tomohiro shiraishi, md, naoko tsuji, md, and akihiko takushima, md."risk factors for complications in expander-based breast reconstruction: multivariate analysis in asian patients," plastic and reconstructive surgery, volume 5, issue 11, 2017, p.1-4.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of skin necrosis, hematoma, infection, and exposure are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling: the following is a list of potential adverse events that may occur with breast implant surgery.The risks include: implant deflation/leakage, additional surgery, capsular contracture, infection, toxic shock syndrome, necrosis, hematoma, seroma, extrusion, breast pain, changes in nipple sensation, changes in breast sensation, dissatisfaction with cosmetic results (wrinkling, folding, displacement, asymmetry, palpability, visibility, ptosis, sloshing), calcific deposits, irritation/inflammation, delayed wound healing, hypertrophic scarring, breast tissue atrophy/chest wall deformity, difficulty/inability in breast feeding, and inability to adequately visualize breast lesions with mammography.In addition to these potential adverse events, there have been concerns with certain systemic diseases.Postoperative hematoma and seroma may contribute to infection.Postoperative hematoma and seroma may be minimized by meticulous attention to hemostasis during surgery, and possibly by postoperative use of closed drains.Persistent, excessive bleeding must be controlled before the device is implanted.Active infection anywhere in the body may increase risk of periprosthetic infection.Do not expose the tissue expander or injection needles to contaminants, which increase the risk of infection.Patients who present wound dehiscence, tissue erosion, ischemia or necrosis run an increased risk of periprosthetic infection.Measures to protect such areas from infection should be taken.Signs of acute infection reported in association with tissue expanders include, tenderness, fluid accumulation, pain and fever.Infection may compromise the expansion process.Postoperative infections should be treated aggressively according to standard medical practices to avoid more serious complications.Infection that is unresponsive to treatment or necrotizing infection may require premature tissue expander removal.
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Reported events of unknown side skin necrosis (18 patients), hematoma (7 patients), infection (4 patients), and expander exposure (2 patients) for patients implanted with ¿textured tissue expanders¿ manufactured by allergan were found in ¿risk factors for complications in expander-based breast reconstruction: multivariate analysis in (b)(4) patients,¿ published in plastic and reconstructive surgery, volume 5, issue 11, 2017, p.1-4.The devices were removed and replaced.
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