ALLERGAN (COSTA RICA) UNK GEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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Catalog Number UNK GEL BREAST IMPLANT |
Device Problems
Device Appears to Trigger Rejection (1524); Material Rupture (1546); Patient-Device Incompatibility (2682)
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Patient Problems
Capsular Contracture (1761); Foreign Body Reaction (1868)
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Event Type
Injury
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Manufacturer Narrative
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The reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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, rupture, product discolored, exposure.
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Event Description
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Healthcare professional reported right side capsular contracture baker grade iii, rupture, product discolored, and exposure of device.Device has been explanted.
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Event Description
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Healthcare professional reported right side capsular contracture baker grade iii, rupture, product discolored, and exposure of device.Device has been explanted.
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Search Alerts/Recalls
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