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

Model Number	FF-410740
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
Event or Problem Description
Healthcare professional reported right side exchange due to patient's concern with the product.Patient representative reported "as part of a reconstructive procedure, plaintiff had a right breast implant performed in 2017 with an allergan biocell product, the natrelle 410 highly cohesive anatomically shaped silicone filled breast implant, in breast.Since that time, plaintiff has experienced pain and a collection of fluid in reconstructed breast, which required medical treatment.Around the time of allergan usa, inc.'s 2019 recall of its textured breast implants, the plaintiff was experiencing pain, swelling and fluid collection around implant, therefore patient contacted a physician about condition wherein the decision was made to have biocell natrelle 410 device explanted.After consulting with treating physicians, plaintiff had natrelle 410 device explanted and replaced at own expense.Even with the breast implant being removed, plaintiff will remain at risk for developing bia-alcl and will require regular, invasive, and costly monitoring for the condition.Plaintiff has been be forced to expend substantial sums for the removal of the recalled implants, for surgical and diagnostic fees, including a new implant device, and for associated medications, diagnostic procedures and ongoing medical monitoring as a result of her exposure to the risk of contracting bia-alcl.Plaintiff has experienced physical pain and suffering and psychological effects from the stress, fear, and uncertainty of this perceived and actual cancer risk.".
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.Device evaluation: visual analysis of the returned device identified: weight to the spec, crease fold, deformation, yellow particles.Cloudy and bubbles were observed after autoclave disinfection process.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.The event of seroma - late 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: "collection of fluid in reconstructed breast".

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14596798
• Report Number: 9617229-2021-57580
• Device Sequence Number: 2058644
• Product Code: FTR
• UDI-Device Identifier: 10888628002739
• UDI-Public: 10888628002739
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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: 01/25/2020
• Device Model Number: FF-410740
• Device Catalogue Number: FF-410740
• Device Lot Number: 2710660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2015
• 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 Sex: Female
• Patient Weight: 78 KG