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

Model Number	MF-410525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of seroma 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: "had seromas requiring aspiration and experienced systematic illnesses resulting in bilateral capsulotomies,¿ ¿debilitating physical pain,¿ ¿suffered, and will suffer, painful removal procedures as well as any treatment, therapy, recovery, and expense associated with the removal of the biocell textured breast implants, the potential for the development of bia-alcl, and any condition or symptoms associated with bia-alcl or the prevention of that issue,¿ ¿mental suffering, was/will be required to undergo additional surgeries and other procedures, suffered emotional distress, anxiety, and loss of quality of life,¿ ¿endure emotional distress including suffering, anguish, fright, horror, nervousness, grief, anxiety, worry, shock, humiliation, and shame due to the risk of bia-alcl.¿.
Event or Problem Description
Patient representative reported patient ¿had seromas requiring aspiration and experienced systematic illnesses resulting in bilateral capsulotomies,¿ ¿debilitating physical pain,¿ ¿suffered, and will suffer, painful removal procedures as well as any treatment, therapy, recovery, and expense associated with the removal of the biocell textured breast implants, the potential for the development of bia-alcl, and any condition or symptoms associated with bia-alcl or the prevention of that issue,¿ ¿mental suffering, was/will be required to undergo additional surgeries and other procedures.Suffered emotional distress, anxiety, and loss of quality of life,¿ ¿endure emotional distress including suffering, anguish, fright, horror, nervousness, grief, anxiety, worry, shock, humiliation, and shame due to the risk of bia-alcl.¿ patient representative also reported patient ¿suffered personal injuries and related damages,¿ depression,¿ ¿disfigurement¿ and ¿disability;¿ these events are not related to the device.Device was explanted and replaced.This record is for the left side.A capsulectomy was performed during both the implanting and explanting procedures.

• 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
• MDR Report Key: 11574592
• Report Number: 9617229-2021-05833
• Device Sequence Number: 3521407
• Product Code: FTR
• UDI-Device Identifier: 10888628003507
• UDI-Public: 10888628003507
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 08/30/2019
• Device Model Number: MF-410525
• Device Catalogue Number: MF-410525
• Device Lot Number: 2656328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention