Company representative reported following a mastopexy procedure performed with implantation of seri, pt presented with right side "blisters" at the implant site.Antibiotics were prescribed at the onset of symptoms, however, physician also noted extrusion of the device in a "nickel-quarter sized area" and that these portions of the device were "un-incorporated".Non-adherent pieces of seri were initially removed, and eventually the remainder of the device was explanted.Physician reports there was "no skin breakdown or redness".
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The device has been explanted but the availability for return is unk.Therefore, allergan may not receive it and analysis or testing may not be done.The events of extrusion, irritation/inflammation, 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.Device labeling addresses the reported events of extrusion and irritation/inflammation as follows: "adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion".This event is reported against the right side, and is the same event and the same pt reported under mdr id # 3008374097-2014-00005.(b)(4).
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