MAUDE Adverse Event Report: ALLERGAN, INC. NATRELLE SALINE - FILLED BREAST IMPLANT

Model Number STYLE # 468

Device Problem Insufficient Information (3190)

Patient Problem Anaplastic Large Cell Lymphoma (3264)

Event Date 04/01/2010

Event Type  Injury  

Event Description

On (b)(6) 2010, diagnosed with anaplastic large cell lymphoma (alcl) alk-negative. Possibly related or caused by breast implants received in (b)(6) 2002 for augmentation. Experienced complications with left implant diagnosed as capsular contraction. Implant replaced on (b)(6) 2008. Still experiencing capsular contraction after replacement. (b)(6) 2010 - (b)(6) 2011: received 12 doses of chemotherapy, received 20 doses of radiation therapy. Preparing for stem cell transplant scheduled for (b)(6) 2011. (b)(6) 2010: needle biopsy - diagnosis lymphoma. (b)(6) 2010: surgical biopsy - diagnosis alcl. (b)(6) 2010: surgical biopsy - diagnosis alcl.

• Brand Name: NATRELLE
• Type of Device: SALINE - FILLED BREAST IMPLANT
• Manufacturer (Section D): ALLERGAN, INC.; irvine CA
• MDR Report Key: 2030915
• MDR Text Key: 1919205
• Report Number: MW5019936
• Device Sequence Number: 1
• Product Code: FWM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/16/2011
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2011
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: STYLE # 468
• Device Lot Number: RIGHT: 579142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 03/17/2011 Patient Sequence Number: 1