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

Catalog Number	SRL-350
Medical Device Problem Codes	Material Invagination (1336); Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Ptosis (2620); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side "rupture, capsular contracture baker grade iv, its folded in half, terrible pain and bruised, cutting off circulation to her nipple and its turning blue if moved in a certain way, a lot of pressure and baring down on her nipple area".Healthcare professional later reported "capsular contracture baker grade iii and mammary ptosis".Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: capsular contracture baker grade iii, rupture, ptosis.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, b6, d6b, h6.
Event or Problem Description
Later patient reported "no rupture".The device has been explanted.
Event or Problem Description
Patient reported left side "rupture".Later, patient reported "no rupture".The previously reported event of "rupture" is no longer reportable.Patient additionally reported "capsular contracture baker grade iv, [implant] folded in half, terrible pain and bruised, cutting off circulation to her nipple and its turning blue if moved in a certain way, a lot of pressure and baring down on her nipple area".Healthcare professional later reported "capsular contracture baker grade iii and mammary ptosis".The device has been explanted.
Additional Manufacturer Narrative
Clarification to partial date of occurrence b3: 2025 was provided.Laboratory analysis summary: the device related to the reported events crease/folding of implant and capsular contracture was received on jun 24, 2025, with lot number 2805553.Based on the product analysis performed, the assessments of the complaint codes are: ¿ crease / folding of implant: observed creases on device.¿ capsular contracture: unable to observe as it is not related to the manufacturing process.As per the investigation procedure, deformation were observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.

• Brand Name: INSPIRA SMOOTH 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: 22066198
• Report Number: 9617229-2025-08441
• Device Sequence Number: 20919629
• Product Code: FTR
• UDI-Device Identifier: 10888628006737
• UDI-Public: (01)10888628006737(10)2805553(11)150927(17)200827
• 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: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2025

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: 08/27/2020
• Device Catalogue Number: SRL-350
• Device Lot Number: 2805553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 07/14/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/25/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2015
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White