Article citation: walker, j, pinkner, c, myckatyn, t et al.The detection of bacteria and matrix proteins on clinically benign and pathologic implants.Prs global open.2019;1-7.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.This is a known potential adverse event addressed in the product labeling.[(b)(4)].
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Through journal article "the detection of bacteria and matrix proteins on clinically benign and pathologic implants", healthcare professional reported patients with tissue expanders experienced "infection, double capsule, seroma and capsular contracture".Device status is unknown.Affected sides are unknown.
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