• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALLERGAN STYLE 115 SILICONE GEL FILLED BREAST IMPLANT Back to Search Results
Catalog Number 115-378
Device Problem No Apparent Adverse Event
Event Date 07/23/2013
Event Type  Injury  
Event Description

Company rep reported right side anaplastic large-cell lymphoma and "subcutaneous nodules and lymph nodes. " the pt had a bilateral reconstruction seven years ago with style 410 breast implant placed on the left side and a style 115 placed on the right side. The pt had done well until she presented last week with a pathology report from her oncologist stating that she had alcl. The pt stated that she had nodules on the right axilla. A pet scan was carried out that showed metastasis in the lung and bone marrow involvement. No seroma was noted. The oncologist has decided on her treatment plan to exclude radiation. Explant surgery will take place (b)(6) 2013.

 
Manufacturer Narrative

Medwatch submitted: 05/20/2013. Allergan labeling addresses the event of breast lumps as follows: breast self-examinations: following breast augmentation, you should continue to perform breast self-examination monthly. This may be more difficult with a breast implant in place. To continue to perform a monthly breast self examination efficiently, you should ask your surgeon to help you identify the difference between the implant and your breast tissue. Being able to identify the implant from breast tissue will decrease the necessity of excessive squeezing of the implant during examination. Any new lumps should be evaluated with a biopsy, as appropriate. If a biopsy is performed, be sure to inform the medical professional performing the biopsy that you have breast implants so that care will be taken to avoid injuring the implant. The 410 device labeling addresses anaplastic large cell lymphoma (alcl): based on info 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 manufacturers' breast implants. 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. Because of the small number of cases worldwide, there is no defined consensus treatment regimen for peri-implant alcl. For more complete and up-to-date info on fda's analysis and review of the alcl in pts with breast implants please visit: http://www. Fda. Gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm239995. Htm.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTYLE 115 SILICONE GEL FILLED BREAST IMPLANT
Manufacturer (Section D)
ALLERGAN
la aurora de heredia
CS 
Manufacturer Contact
karen herrera
71 south los carneros road
goleta , CA 93117
8059615405
MDR Report Key3199749
Report Number2024601-2013-00387
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/24/2011
Device Catalogue Number115-378
Device LOT Number1267625
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/23/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/20/2013 Patient Sequence Number: 1
Treatment
NO INFO.
-
-