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

Model Number	FX-410775
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
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 capsular contracture 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: capsular contracture, baker grade unknown.
Event or Problem Description
Patient's relative reported a right side exchange of textured breast implants due to the patient¿s concern with the product.Patient representative reported "plaintiff has suffered from pain, capsular contracture, implant malposition, deformity, and asymmetry.Plaintiff did not receive any update or warning from allergan any time before or after surgeries about the clearly established link between allergan's biocell textured breast implants and bia-alcl.Following the worldwide recall and revelations about the dangers of allergan's products, the plaintiff consulted with doctor who recommended removal of breast implants and capselectomy as well as the removal and replacement of all dermacell, to remove the risk of alcl.Plaintiff underwent a removal of the potentially cancer-causing breast implants, exchange to smooth implants, and total bilateral capsulectomies to rule out anaplastic large cell lymphoma to implant capsules.Plaintiff had to pay out of pocket for the removal of breast implants because allergan has refused to do so.Plaintiff has worried about the risk they face, have also been subject to out of pocket expenses in relation to seeking medical advice, evaluating the flawed product implanted into body, removal of the cancer-causing breast implants, ad seeking recommendations for future care and treatment.Plaintiff has suffered and continues to suffer from mental stress, anxiety, worry, humiliation, fear, concern and other personal and financial hardship due to the continuous fear of developing bia-alcl.Plaintiff has had to take time away from work in order to seek medical treatment, advice, and consultation, and due to the stress and anxiety related to plaintiff 's flawed allergan implants.Plaintiff would not have had biocell textured breast implants implanted had the defendants honestly, fully, and completely disclosed the risks." device has been explanted and replaced.

• 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15131808
• Report Number: 9617229-2022-01514
• Device Sequence Number: 5619133
• Product Code: FTR
• UDI-Device Identifier: 10888628003040
• UDI-Public: 10888628003040
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: 08/11/2023
• Device Model Number: FX-410775
• Device Catalogue Number: FX-410775
• Device Lot Number: 3249037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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