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

Catalog Number 27-MX120-325

Device Problems Folded (2630); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 10/15/2014

Event Type  Injury  

Event Description

Healthcare professional reported right side "radial folds without signs of rupture" per mri results.Upon explant the device was found to be "intact but tense with increase in volume.".

Manufacturer Narrative

Unique identifier (udi)#: na.Medwatch submitted on 05/14/2015.Reviewed device labeling: "implants are not considered lifetime devices, and pts likely will undergo implant removal(s), with or without replacement, over the course of their lives"."when mri signs of rupture are found (such as subcapsular lines, characteristic folded wavy lines, teardrop sign, keyhole sign, noose sign), or if there are signs or symptoms of rupture, you should remove the implant and any gel you determine your pt has, with or without replacement of the implant.It also may be necessary to remove the tissue capsule.".

Manufacturer Narrative

Medwatch sent to fda on 08/04/2015.Analysis of the device noted.Brown particles were seen on the outside of the device.The device was noted to be deformed.The device weighted 326.6 grams and is considered to be within specifications.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Manufacturer (Section D): ALLERGAN; arklow, county wicklow ; EI
• Manufacturer (Section G): ARKLOW; kilbride industrial estate ; arklow, county wicklow ; EI
• Manufacturer Contact: krista alvarado ; 301 w howard ln; ste 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4777113
• MDR Text Key: 16185740
• Report Number: 9617229-2015-00047
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P040046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Catalogue Number: 27-MX120-325
• Device Lot Number: 1522745
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2007
• 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: 68 YR