MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	115-253
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Malposition of Device (2616)
Health Effect - Clinical Codes	Capsular Contracture (1761); Fatigue (1849); Unspecified Infection (1930); Pain (1994); Seroma (2069); Vomiting (2144); Fluid Discharge (2686); Cancer (3262)
Date of Event	06/30/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under legacy complaint (b)(4).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 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: cancer, malposition, visibility/palpability, vomiting, pain, drainage, capsular contracture, seroma, lump/nodule, infection (late onset).
Event or Problem Description
Patient reported left side "breast has flipped over, developed a seroma, had an infection, painful, tender to touch, the appearance and feel of it is different, there's lumps all around, a lot of inflammatory and discomfort.I also believe that i could be suffering from breast implant illness.Systemically i feel fatigue, joint pain muscle pain, brain fog and cognitive issues with hair loss.Maybe i have some scar tissue formation or possibly a capsular contracture "baker unknown".I have increased, extreme fibroglandular tissue and previous to that, i have giant cells.It has been painful, a hardship and stressful, caused alot of suffering".The device remains implanted.
Event or Problem Description
Patient reported left side "breast has flipped over, developed a seroma, had an infection, painful, tender to touch, the appearance and feel of it is different, there's lumps all around, a lot of inflammatory and discomfort.I also believe that i could be suffering from breast implant illness.Systemically i feel fatigue, joint pain muscle pain, brain fog and cognitive issues with hair loss.Maybe i have some scar tissue formation or possibly a capsular contracture "baker unknown".I have increased, extreme fibroglandular tissue and previous to that, i have giant cells.It has been painful, a hardship and stressful, caused alot of suffering".The device remains implanted.
Additional Manufacturer Narrative
Further investigation summary: 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.Primary packaging inspection 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.3 additional complaints were noted for devices sterilized under sterilization run 30017365.However, it is unlikely that the events related to the reported infection are associated to the sterilization methods utilized.The terminal sterilization cycle used by abbvie was developed and validated to achieve a high level of sterility assurance.The sterilization cycle has been validated to ensure that the chance of a nonsterile device is less than one in a million.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.Additional, changed, and/or corrected data: h11.

• Brand Name: STYLE 115 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: 22682869
• Report Number: 9617229-2025-12956
• Device Sequence Number: 9663798
• Product Code: FTR
• UDI-Device Identifier: 10888628002357
• UDI-Public: (01)10888628002357(10)2675573(11)141122(17)191022
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

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: 10/22/2019
• Device Catalogue Number: 115-253
• Device Lot Number: 2675573
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 11/22/2014
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White