Company representative reported the receipt of an explanted seri device.Upon follow up, healthcare professional reported post-mastopexy and implantation of seri on (b)(6) 2013, patient presented on (b)(6) 2014 with right side drainage of "purulent material." exploratory surgery was performed on (b)(6) 2014, and seri device was found to be "100% non-adherent" and subsequently explanted.Events have resolved since explant surgery, and device is pending analysis.
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Allergan has received the product, however, the analysis has not been completed at this time.The events of drainage and non adherence are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.
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