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

Catalog Number	20-550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pallor (2468)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported via regulatory agency "raynauds' phenomenon (numbness, pain, or color changes in the fingers and toes often brought on by the cold or emotional distress)" and "lymphadenopathy".Later healthcare professional report "no complaint against the device.".This record is for the right side.Device remains implanted and it will be returned.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.The event of pallor 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: raynaud's phenomenon.
Additional Manufacturer Narrative
Information contained in this report was previously submitted through psr on 26/apr/2011.Correction to b7 other relevant history in the initial medwatch: patient was in the breast implant follow-up study (bifs) but is not in an active clinical study.Reason for reoperation: contralateral side rupture; "raynauds' phenomenon" previously reported but not indicated as the reason for removal.Additional, changed, and/or corrected data: a2, a6, b3, b5, b6, d6a, d6b, e1, e2, e3, g2, h6, h11.
Event or Problem Description
Patient reported via bifs (breast implant follow-up study) "raynauds' phenomenon (numbness, pain, or color changes in the fingers and toes often brought on by the cold or emotional distress)".Patient also reported "enlarged lymph nodes in [their] groin", which is not device-related.Later healthcare professional reported "no complaint against the device".This record is for the right side.Device was explanted and replaced.
Event or Problem Description
Patient reported via bifs (breast implant follow-up study) "raynauds' phenomenon (numbness, pain, or color changes in the fingers and toes often brought on by the cold or emotional distress)".Patient also reported "enlarged lymph nodes in [their] groin", which is not device-related.Later healthcare professional reported "no complaint against the device".This record is for the right side.Device was explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported events lymphadenopathy and raynauds phenomenon was received on april 06, 2026, with lot number 1401904.Per the investigation procedure, the device is analyzed through visual inspection microscopic inspection if openings are observed and a weight verification.Per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: ¿ lymphadenopathy: unable to observe through visual inspection as it is a physiological phenomenon.¿ raynauds phenomenon: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis deformation, wear abrasion and creases are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.

• 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: 23844542
• Report Number: 9617229-2025-22173
• Device Sequence Number: 21290873
• Product Code: FTR
• UDI-Device Identifier: 10888628001756
• UDI-Public: 10888628001756
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Study,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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: 02/05/2012
• Device Catalogue Number: 20-550
• Device Lot Number: 1401904
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 04/13/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/23/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2007
• 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 Weight: 64 KG
• Patient Race: White