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

Model Number	TRM-520
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Granuloma (1876); Necrosis (1971); Seroma (2069)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformance's noted.Device evaluation: visual analysis of the returned device identified: weight to the spec, yellow particles on the surface of the shell.Cloudy was observed after autoclave disinfection process.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.The events of seroma - late, necrosis, and granuloma 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/will be requested.No additional information is available at this time.Reason for reoperation: rupture; ¿breasts appear swollen¿, ¿fluid formation up to 1 cm wide around the left breast implant, accentuated in the lower breast section¿; ¿numerous foreign-body giant cells¿, ¿granulation tissue [and] scar tissue with foreign-body type granulation tissue¿; ¿some necrotic material¿, ¿fatty tissue necrosis.".
Event or Problem Description
Patient reported swelling in the breast and pain.Patient is worried if this is the implant which could cause cancer.The patient underwent an ultrasound which confirmed the left side device was ruptured and fluid was present.Diagnostic reports state: ruptured device, strong capsular contracture, baker grade unknown, and scar tissue with granulation tissue of the foreign body.Healthcare professional further reported ¿double capsulation¿, ¿intense pain¿, ¿intermittent swelling and reddening¿, ¿breasts appear swollen¿, ¿fluid formation up to 1 cm wide around the left breast implant, accentuated in the lower breast section¿, ¿numerous foreign-body giant cells¿, ¿granulation tissue [and] scar tissue with foreign-body type granulation tissue¿, and ¿some necrotic material¿, ¿fatty tissue necrosis¿.Additionally reported was that the ¿patient also feels languorous and exhausted¿ which has been deemed not related to the device.Affected side is left.The device has been explanted.
Event or Problem Description
Patient reported swelling in the breast and pain.Patient is worried if this is the implant which could cause cancer.The patient underwent an ultrasound which confirmed the left side device was ruptured and fluid was present.Diagnostic reports state: ruptured device, strong capsular contracture, baker grade unknown, and scar tissue with granulation tissue of the foreign body.Healthcare professional further reported ¿double capsulation¿, ¿intense pain¿, ¿intermittent swelling and reddening¿, ¿breasts appear swollen¿, ¿fluid formation up to 1 cm wide around the left breast implant, accentuated in the lower breast section¿, ¿numerous foreign-body giant cells¿, ¿granulation tissue [and] scar tissue with foreign-body type granulation tissue¿, and ¿some necrotic material¿, ¿fatty tissue necrosis¿.Additionally reported was that the ¿patient also feels languorous and exhausted¿ which has been deemed not related to the device.Affected side is left.The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.

• Brand Name: INSPIRA TEXTURED 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: 15199147
• Report Number: 9617229-2021-48601
• Device Sequence Number: 2239601
• Product Code: FTR
• UDI-Device Identifier: 10888628008168
• UDI-Public: 10888628008168
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: 02/08/2021
• Device Model Number: TRM-520
• Device Catalogue Number: TRM-520
• Device Lot Number: 2880727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2016
• 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 Sex: Female