MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	68-150
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
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.Device labeling: potential adverse events that may occur with saline-filled breast implant surgery include: reoperation, pain, wrinkling, asymmetry, implant palpability/visibility, implant removal, capsular contracture, changes in nipple and breast sensation, implant displacement/migration, implant deflation, scarring, infection, hematoma/seroma, breastfeeding complications, implant extrusion, necrosis, delayed wound healing, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy.Capsular contracture ¿ patients should be advised that capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.Capsular contracture occurs more commonly in revision patients than in primary augmentation or reconstruction patients.Capsular contracture is also a risk factor for implant deflation, and it is one of the most common reasons for reoperation.Patients should also be advised that additional surgery may be needed in cases where pain and/ or firmness are severe.This surgery ranges from removal of the implant capsule tissue to removal and possible replacement of the implant itself.This surgery may result in loss of breast tissue.Capsular contracture may happen again after these additional surgeries.Capsular contracture may increase the risk of deflation.
Event or Problem Description
Healthcare professional reported right side capsular contracture, baker grade iii "plus".Device remains implanted.

• Brand Name: STYLE 68 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7806451
• Report Number: 9617229-2018-06255
• Device Sequence Number: 11130029
• Product Code: FWM
• UDI-Device Identifier: 10888628000162
• UDI-Public: 10888628000162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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: 12/07/2020
• Device Catalogue Number: 68-150
• Device Lot Number: 3005752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/22/2018
• 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
• Patient Age: 32 YR