MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 168 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	168-450
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information regarding the event, product, or patient details has been requested of the reporter by allergan; no additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.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 or 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.Unsatisfactory results ¿ patients should be informed that dissatisfaction with cosmetic results related to such things as scar deformity, hypertrophic scarring, capsular contracture, asymmetry, wrinkling, implant displacement/migration, incorrect size, and implant palpability/visibility may occur.Careful surgical planning and technique can minimize, but not preclude, the risk of such results.Pre-existing asymmetry may not be entirely correctable.Revision surgery may be indicated to maintain patient satisfaction but carries additional considerations and risks.
Event or Problem Description
Physician reported right side deflation and that the side is "grossly deformed." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: black particles on 20% of shell, mold like appearance, fluids inside device and one opening curved in posterior side.A leak test was performed which identify one opening on the device.Microscopic analysis was performed which identified: one opening curved in posterior side displayed striated edge consistent with the use of a surgical tool.A fill inspection was performed and identified no blockage in valve.Based on the device analysis the final assessment is: one opening due to surgical damage.
Event or Problem Description
Physician reported right side deflation and that the side is "grossly deformed." device has been explanted.

• Brand Name: STYLE 168 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: 6795831
• Report Number: 9617229-2017-00864
• Device Sequence Number: 13485375
• Product Code: FWM
• UDI-Device Identifier: 10888628000865
• UDI-Public: (01)10888628000865(10)2700435(11)150130(17)181230
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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: 12/30/2018
• Device Model Number: 168-450
• Device Catalogue Number: 168-450
• Device Lot Number: 2700435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 09/18/2017
• 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