MAUDE Adverse Event Report: ALLERGAN STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

Catalog Number UNK STYLE 410

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Seroma (2069); Anaplastic Large Cell Lymphoma (3264)

Event Date 01/01/2010

Event Type  Injury  

Event Description

Anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an (b)(6) report written in aesthetic plastic surgery 2013 reports alcl, seroma, pain.

Manufacturer Narrative

(b)(4). The 410 device labeling addresses anaplastic large cell lymphoma (alcl): anaplastic large cell lymphoma. 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 pts with an implant history that includes allergan's and other mfr's breast implant. You should consider the possibility of alcl when you have a pt with late onset, persistent peri-implant seroma. In some cases, pts 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 pt is diagnosed with peri-implant alcl, develop an individualized treatment plan in coordination with a multi-disciplinary care team. "e. R. Of cases worldwide, there is no defined consensus treatment regimen for peri-implant alcl. " for more complete and up-to-date information on fda's analysis and review of the alcl pts with breast implants, please visit http:www. Fda. Gov/medical devices/productsand medicalprocedures/implantsandprosethetics/breastimplants/ucm239995. Htm. The 410 labeling addresses seroma and pain: additional complications - after breast implant surgery, the following may occur and/or persist, with varying intensity and/or for a varying length of time: pain, hematoma/seroma, changes in nipple and breast sensation, implant extrusion, necrosis, delayed wound healing, and breast tissue atrophy/chest wall deformity. Calcium deposits can form in the tissue capsule surrounding the implant with symptoms that may include pain and firmness. Lymphadenopathy has also been reported in some women with implants.

Manufacturer Narrative

(b)(4).

Event Description

Additional information noted in article anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an italian report written in aesthetic plastic surgery 2013 article notes in regards to the right side, "necrosis and chronic inflammation signs are present" and "skin above the implant became red and painful and the patient had febrile episodes. " treatment noted for the event of seroma as "a broad-spectrum antibiotic. ".

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Manufacturer (Section D): ALLERGAN; arklow, county wicklow ; EI
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615405
• MDR Report Key: 3134124
• Report Number: 2024601-2013-00511
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK STYLE 410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 61 YR
• Patient Treatment(s): NO INFORMATION
• Patient Outcome(s): Required Intervention