MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 15 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number 15-397

Device Problems Folded (2630); Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Seroma (2069); Lymphoma (3263)

Event Date 08/01/2013

Event Type  Injury  

Manufacturer Narrative

Information contained in this report was previously submitted through psr on 21/jan/2016 and 18/apr/2016.(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device analysis results: visual analysis of the returned device identified creases, wear abrasion, crystalline deformation, dark ring on the device, and found the weight to be within specification.Voids, bubbles, and cloudiness observed after autoclave disinfection process.Based on the device analysis the final assessment is: creases fold condition was observed.This event is not related to the manufacturing process.No issues found related with the manufacturing process.Further information from the reporter regarding event details and pathological markers has been requested.No additional information is available at this time.Device labeling: potential adverse events that may occur with silicone gel-filled breast implant surgery include: implant rupture, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy.Based on information reported to fda and found in medical literature, a possible association has been identified between breast implants and the rare development of anaplastic large cell lymphoma (alcl), a type of non-hodgkin¿s lymphoma.Women with breast implants may have a very small but increased risk of developing alcl in the fluid or scar capsule adjacent to the implant.Alcl has been reported globally in patients with an implant history that includes allergan¿s and other manufacturers¿ breast implants.You should consider the possibility of alcl when you have a patient with late onset, persistent peri-implant seroma.In some cases, patients presented with capsular contracture or masses adjacent to the breast implant.When testing for alcl, collect fresh seroma fluid and representative portions of the capsule, and send for pathology tests to rule out alcl.If your patient is diagnosed with peri-implant alcl, develop an individualized treatment plan in coordination with a multi-disciplinary care team.Because of the small number of cases worldwide, there is no defined consensus treatment regimen for peri-implant alcl.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 rupture, and it is one of the most common reasons for reoperation.

Event Description

Health professional initially reported left side capsular contracture, baker grade iv, folding of the implant, thickening of the fibrous capsule superior and laterally, and left side "feels squishy".Imaging report notes, "lump" and "several small cysts are noted." a biopsy was performed which discovered patient has anaplastic large cell lymphoma- alcl.As pathological markers confirming alcl have not been received, the event will be captured as lymphoma.The device has been explanted.This medwatch is for the left side.See mfr # 9617229-2017-01568 for the right side.

Event Description

Health professional initially reported left side capsular contracture, baker grade iv, folding of the implant, thickening of the fibrous capsule superior and laterally, and left side "feels squishy".Imaging report notes, "lump" and "several small cysts are noted." a biopsy was performed which discovered patient has anaplastic large cell lymphoma- alcl.The device has been explanted.Pathological markers confirming alcl have been received.This medwatch is for the left side.See mfr # 9617229-2017-01568 for the right side.

• Brand Name: STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 6840047
• MDR Text Key: 84614376
• Report Number: 9617229-2017-01558
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2015
• Device Catalogue Number: 15-397
• Device Lot Number: 1822121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR