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

Model Number	TCM-275
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Capsular Contracture (1761); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported right side "dropped below the pocket, abnormal lab test after receiving allergan textured breast implants, positive ana, abnormal thyroid even on treatment, arthritis, significant increase in all over joint stiffness and pain, thyroid nodules, skin rashes, difficulty swallowing, difficulty breathing at times, insomnia, fatigue dry eyes, stomach pain" which are all considered not device related.Patient reported "dropped below the pocket".Patient additionally reported "capsular contracture, baker grade unknown." device has been explanted.
Additional Manufacturer Narrative
In response to fda report number: mw5101414.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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 requested.No additional information is available at this time.Reason for reoperation: "dropped below the pocket, abnormal lab test after receiving allergan textured breast implants, positive ana, abnormal thyroid even on treatment, arthritis, significant increase in all over joint stiffness and pain, thyroid nodules, skin rashes, difficulty swallowing, difficulty breathing at times, insomnia, fatigue dry eyes, stomach pain" and capsular contracture.
Additional Manufacturer Narrative
Visual analysis of the photographs identified: red biological tissue in the shell.Device analysis performed through photographs, due to the impossibility to perform microscopic analysis it is not possible to determine the most likely failure mode.
Event or Problem Description
Patient additionally reported "symptoms of lupus and rheumatoid arthritis among a host of other strange problems.".

• Brand Name: INSPIRA TEXTURE 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 13361384
• Report Number: 9617229-2022-00484
• Device Sequence Number: 11178180
• Product Code: FTR
• UDI-Device Identifier: 10888628030855
• UDI-Public: 10888628030855
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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: 11/03/2021
• Device Model Number: TCM-275
• Device Catalogue Number: TCM-275
• Device Lot Number: 2993969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2016
• 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: 55 YR
• Patient Sex: Female