MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	MX-410445
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Erythema (1840); Failure of Implant (1924); Unspecified Infection (1930); Breast Discomfort/Pain (4504); Swelling/ Edema (4577)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported swelling, pain, "hot to the touch", redness and implant exchange from textured to smooth due to the patients concerns with the product, intracapsular leak confirmed via ct scan, lump by the left armpit and left side has "significantly dropped" and "collapsed".Patient later reported "infection, palpable lump on left side, shooting and burning pain of both breast, redness of the skin, and significant increase of nipple sensation".The device remains implanted.This relates to the left side.
Additional Manufacturer Narrative
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.The sterilization run 30017603 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.
Additional Manufacturer Narrative
The event of "infection (late onset)" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: infection (late onset).
Event or Problem Description
Patient reported swelling, pain, "hot to the touch", redness and implant exchange from textured to smooth due to the patients concerns with the product, intracapsular leak confirmed via ct scan, lump by the left armpit and left side has "significantly dropped" and "collapsed".Patient later reported "infection, palpable lump on left side, shooting and burning pain of both breast, redness of the skin, and significant increase of nipple sensation".The device remains implanted.This relates to the left side.
Event or Problem Description
Patient reported swelling, pain, "hot to the touch", redness and implant exchange from textured to smooth due to the patients concerns with the product, intracapsular leak confirmed via ct scan, lump by the left armpit and left side has "significantly dropped" and "collapsed".The device remains implanted.This relates to the left side.
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: rupture.
Additional Manufacturer Narrative
The reported events are physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for these events.Reason for reoperation: breast pain, edema, and erythema.
Event or Problem Description
Patient reported swelling, pain, "hot to the touch", redness and implant exchange from textured to smooth due to the patients concerns with the product, intracapsular leak confirmed via ct scan, lump by the left armpit and left side has "significantly dropped" and "collapsed", patient reported "infection, palpable lump on left side, shooting and burning pain of both breast, redness of the skin, and significant increase of nipple sensation".The device remains implanted.This relates to the left side.

• Brand Name: STYLE 410 COHESIVE 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: 22594749
• Report Number: 9617229-2025-12495
• Device Sequence Number: 13056352
• Product Code: FTR
• UDI-Device Identifier: 10888628003750
• UDI-Public: (01)10888628003750(10)2685165(11)141216(17)191116
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2019
• Device Catalogue Number: MX-410445
• Device Lot Number: 2685165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 08/19/2025; 11/11/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/18/2025; 09/12/2025; 11/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2014
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White