MAUDE Adverse Event Report: Allergan (Costa Rica) Style 20 Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	20-375
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "capsular contracture" baker grade iii, " breast tissue hangs off inferiorly", " implants sit high on the chest" and "past medical history of depression/anxiety".This record is for the left side.Device remains implanted.Healthcare professional also reported "ptosis" and "past medical history of cold sores" which are not device related.Patient is taking the following medications: glp1, ambien, estrogen 0.5 mg, ezetimibe 5 mg, progesterone micronized 200 mg capsule, prozac, rosuvastatin, testosterone, tizanidine 4 mg capsule.Patient was prescribed hibiciens soap and scopolamine patch.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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 iii.

• Brand Name: Style 20 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; la aurora de heredia ; CS
• Manufacturer (Section G): Allergan (Costa Rica); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 50943665
• Report Number: 9617229-2026-18512
• Device Sequence Number: 18753480
• Product Code: FTR
• UDI-Device Identifier: 10888628001695
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 12/04/2010
• Device Catalogue Number: 20-375
• Device Lot Number: 1182325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 01/09/2006
• 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: 164 LB
• Patient Race: White