MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 20 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	20-375
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930)
Date of Event	02/23/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "infection (late onset)", "metastatic breast cancer: mets to bone and lungs"-ndr (not device related) and "capsular contracture, baker grade unknown".This record is for the left side.Device was explanted and replaced.
Additional Manufacturer Narrative
Information contained in this report was previously submitted through asr / psr on july 25th and 26th of 2012.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/will be requested.No additional information is available at this time.The reason(s) for reoperation is/are: "infection (late onset)" and "capsular contracture, baker grade unknown".The following reported event(s) are physiological complication(s), and device analysis typically does not help allergan determine the cause: infection and capsular contracture grade unknown.Clarification to h10: related report is contra-lateral side.Fi 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.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.Two additional complaints were noted for devices sterilized under sterilization run (b)(4).However, it is unlikely that the events related to the reported infection are associated with 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 non-sterile 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.

• Brand Name: STYLE 20 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: 23728847
• Report Number: 9617229-2025-21113
• Device Sequence Number: 18795590
• Product Code: FTR
• UDI-Device Identifier: 10888628001695
• UDI-Public: 10888628001695
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Study,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

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: 06/27/2014
• Device Catalogue Number: 20-375
• Device Lot Number: 1749201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/05/2025
• Date Device Manufactured: 07/28/2009
• 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: 40 YR
• Patient Sex: Female
• Patient Race: White