ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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Catalog Number N-SSX310 |
Device Problems
Device Appears to Trigger Rejection (1524); No Apparent Adverse Event (3189)
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Patient Problems
Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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.Reason for reoperation: capsular contracture baker grade iii.
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Event Description
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Healthcare professional reported right side capsular contracture baker grade iii.Device remains implanted.
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Event Description
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Healthcare professional later reported that the event of capsular contracture was confirmed to not have occurred.This record is no longer reportable to the fda and will be un-reported.
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Search Alerts/Recalls
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