MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 40 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	40-280
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.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.
Event or Problem Description
Healthcare professional reported capsular contracture, baker grade iii.This record is for the right side.The device was explanted.
Event or Problem Description
Healthcare professional reported "capsular contracture", baker grade unknown.Healthcare professional later reported "grade iii capsular contracture", "recurrent wound and drainage" from the patient's reconstructed right breast, which "has been treated multiple times with antibiotics".Healthcare professional also reported "extensive calcification in the area where the recurrent drainage occurs" observed via ct scan, "noted asymmetry" between the patient's breasts, the patient previously had a "reduction" performed for symmetry, "no evidence of acute infection", "radiation-induced skin necrosis", and "the implant is likely ruptured".Healthcare professional later reported "implant was found to be intact" during explant surgery.Capsulectomy was performed.This record is for the right side.The device was explanted and replaced and has been returned.
Additional Manufacturer Narrative
Clarification to b3 date of event: partial date april 2025 - patient began experiencing symptoms "about 3 months ago" relative to date of consult on 23/july/2025.The events of "capsular contracture" and "infection" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Reason for reoperation: capsular contracture baker grade iii; "recurrent wound and drainage" further investigation: with the information collected during the investigation, there is enough evidence to support that units involved in this work order were manufactured under controlled conditions in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents related to the reported event.Seal strength was successfully completed and results were acceptable.Environmental monitoring results were found to be acceptable, and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.The sterilization run 30002212 is not related to any additional complaint infection record reported as of today.Considering that there is no adverse trend for this type of event, no additional actions are deemed required at this time.The issue with infection will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.Given the fact that the cause of the infection cannot be specifically associated with the manufacturing process, and there is not an adverse trend for this type of event, and no er/ ncr(s) were identified during the investigation associated with this lot and the complaint, no corrective action is deemed necessary at this time.Device evaluation: based on the product analysis performed, the assessments of the complaints are: ¿ capsular contracture: unable to observe as it is not related to the manufacturing process.¿ rupture: not observed.¿ infection (late onset): unable to observe as it is not related to the manufacturing process.¿ calcification: not observed.As per the investigation procedures, creases, wear abrasion, non-penetrating nicks and deformation were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.

• Brand Name: STYLE 40 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 ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 23196420
• Report Number: 9617229-2025-16727
• Device Sequence Number: 15737951
• Product Code: FTR
• UDI-Device Identifier: 10888628001916
• UDI-Public: 10888628001916
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: 10/17/2015
• Device Catalogue Number: 40-280
• Device Lot Number: 2044062
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2010
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White