MAUDE Adverse Event Report: ALLERGAN UNK SALINE IMPLANT

Catalog Number UNK SALINE IMPLANT

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Lymphoma (3263)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Device labeling reviewed: there were no reported events of lymphoma/alcl for pts in the a95/r95 study included in the labeling for saline breast implants. The following is a list of potential adverse events that may occur with breast implant surgery. The risks include: implant deflation/leakage, additional surgery, capsular contracture,. "infection, toxic shock syndrome, necrosis, hematoma, seroma, extrusion, breast pain, changes in nipple sensation, changes in breast sensation, dissatisfaction with cosmetic results (wrinkling, folding, displacement, asymmetry, palpability, visibility, ptosis, sloshing), calcific deposits, irritation/inflammation, delayed wound healing, hypertrophic scarring, breast tissue atrophy/chest wall deformity, difficulty/inability in breast feeding, and inability to adequately visualize breast lesions with mammography. In addition to these potential adverse events, there have been concerns with certain systemic diseases.

Event Description

Healthcare professional reports a case of lymphoma and other b-symptoms via mw (b)(4) the mw notes that: "the reporter called on behalf of a pt who was diagnosed with alcl. The pt presented with anaplastic large cell lymphoma, diagnosed in 2013. History of hodgkin's lymphoma diagnosed in 2011. These two events came about after the pt underwent breast augmentation in 1994. In 2010, pt presented with an abnormal mammogram performed in 2010. Breast pain, skin color change, skin texture change, and inflowing diffusion form the right breast up to right neck and shoulder. The pt was running a fever throughout the entire process. After an mri and subsequent test, the pt was diagnosed with hodgkin's lymphoma and underwent mantle radiation. In 2012, the pt underwent surgery essentially for a breast mass, but the pt also desired a mastectomy for removal of right and left implants and capsules. The pathology of the operation soon reported that the pt also has alcl; the mass had come from the lymphoma. ".

Event Description

This medwatch is for the left side see mfr report # 2024601-2013-00935 for the right side.

• Brand Name: UNK SALINE IMPLANT
• Manufacturer (Section D): ALLERGAN; boleta CA
• Manufacturer Contact: karen herrera ; 71 s. los carneros rd; boleta, CA 93117 ; 8059615405
• MDR Report Key: 3487103
• MDR Text Key: 16377709
• Report Number: 2024601-2013-00941
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• PMA/PMN Number: P990074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK SALINE IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2013
• 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 Treatment Data

Date Received: 11/07/2013 Patient Sequence Number: 1