MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number 110-390

Device Problem Folded (2630)

Patient Problems Seroma (2069); Lymphoma (3263)

Event Date 01/21/2014

Event Type  Injury  

Event Description

Healthcare professional reported a left side implant had "folds" with "liquid" around the implant and "remote possibility of alcl".

Manufacturer Narrative

Unique identifier (udi) #: (b)(4).Device labeling addresses lymphoma: there were no reported events of lymphoma/alcl, for pts in the core study, in the labeling for silicone implants.Device labeling addresses seroma: "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".Device labeling addresses crease/folding of implant: "the following things may cause implants to rupture: damage by surgical instruments; stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell".

Manufacturer Narrative

Analysis of device is as follows: the implant weighed 394.26 grams.Gray particles were observed on the implant shell.One linear opening was observed on the radius of the implant shell.Creases were observed on the implant shell.One striated opening, 1.1 mm in length, was located on the posterior portion of the implant.

Event Description

Healthcare professional reported a left side implant had "folds" with "liquid" around the implant and "remote possibility of alcl.".

Manufacturer Narrative

The reason for reoperation was seroma and suspected lymphoma alcl.

Event Description

Healthcare professional reported a left side implant had "folds" with "liquid" around the implant and "remote possibility of alcl.".

• Brand Name: STYLE 110 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; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 4407133
• MDR Text Key: 5301992
• Report Number: 2024601-2014-00718
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2014
• Device Catalogue Number: 110-390
• Device Lot Number: 1708168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2009
• 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: 46 YR