MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	110-270
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare provider reported "patient has textured mammary implants and has recently noticed a change in the implants and breast asymmetry.Possible rupture or leakage suspected.Patient wishes to have the implants removed." this is for the right side.The device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation: rupture.
Additional Manufacturer Narrative
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.
Event or Problem Description
Healthcare professional additionally reported "the patient complained of pain involving both breasts and tightness involving both breast.The patient also complained of severe drooping".During surgery it was noted "severe contracture of the implant was found to be present." healthcare provider reported capsular contracture baker grade iii/iv.This is for the right side.The device has been explanted and replaced.
Event or Problem Description
Healthcare provider reported "patient has textured mammary implants and has recently noticed a change in the implants and breast asymmetry.Possible rupture or leakage suspected.Patient wishes to have the implants removed." healthcare professional additionally reported "the patient complained of pain involving both breasts and tightness involving both breast.The patient also also complained of severe drooping".During surgery it was noted "severe contracture of the implant was found to be present." healthcare provider reported capsular contracture baker grade iii/iv.Healthcare provider reported observation made during surgery of "any creases".This is for the right side.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: anxiety¿product/procedure-breast: unable to observe since it is not related to the device.Rupture-breast: not observed.Capsular contracture-breast: unable to observe since it is not related to the device.Visibility/ palpability-breast: unable to observe since it is not related to the device.Crease/ folding of implant-breast: observed, flat creases.Additional observations: deformation is observed.No further actions are required since no issue in the manufacturing of the device is observed.
Event or Problem Description
Healthcare provider reported "patient has textured mammary implants and has recently noticed a change in the implants and breast asymmetry.Possible rupture or leakage suspected.Patient wishes to have the implants removed".This is for the right side.The device remains implanted.
Additional Manufacturer Narrative
Corrected data: g3: of supplemental medwatch 2 should have been listed as 10apr2024.

• Brand Name: STYLE 110 SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18457748
• Report Number: 9617229-2024-00352
• Device Sequence Number: 15251952
• Product Code: FTR
• UDI-Device Identifier: 10888628002210
• UDI-Public: 10888628002210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2014
• Device Catalogue Number: 110-270
• Device Lot Number: 1707489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 02/20/2024; 03/25/2024; 05/14/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/15/2024; 05/07/2024; 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White