MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 468 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	468-230
Medical Device Problem Codes	Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	03/12/2018
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.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.Deflation ¿ breast implants are not lifetime devices.Saline breast implants deflate when the shell develops a tear or hole.Deflation can occur at any time after implantation, but they are more likely to occur the longer the implant is implanted.The following things may cause implants to deflate: damage by surgical instruments; folding or wrinkling of the implant shell; excessive force to the chest (e.G., during closed capsulotomy, which is contraindicated); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.Laboratory studies have identified some of the causes of deflation for allergan¿s product; however, it is not conclusively known whether these tests have identified all causes of deflation.
Event or Problem Description
Healthcare professional reported a left side deflation.The device remains implanted.
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: a non penetrating nick, crease fold and opening.A leak test was performed and found an opening on the posterior side.A microscopic analysis was performed which identified a sharp edge opening assessed as unidentified tear opening.A dimension measurement in the shell was performed which identified the thickness to be within specifications.A fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is: a sharp opening on posterior side due to an unidentified (tear) opening.
Event or Problem Description
Additionally healthcare professional reported left side pain and capsular contracture, baker grade unknown.The device has been explanted.

• Brand Name: STYLE 468 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: 7397203
• Report Number: 9617229-2018-02100
• Device Sequence Number: 1094266
• Product Code: FWM
• UDI-Device Identifier: 10888628001091
• UDI-Public: 10888628001091
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 11/17/2019
• Device Catalogue Number: 468-230
• Device Lot Number: 2846660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/20/2018
• 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: 52 YR