MAUDE Adverse Event Report: MENTOR MEMORY SHAPE GEL TEXTURED; BREAST IMPLANTS

Model Number 334-1305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Capsular Contracture (1761)

Event Date 10/14/2015

Event Type  Injury  

Event Description

Started having a capsule around this date.I still have the textured implant in my body.I fit several symptoms of the rare cancer symptoms.I have contacted mentor and they have informed me a few cases doesn't make them have to stand behind removing them although i am one clearly having many symptoms.They said fda had done no recalls there for it was my problem and i could take out a loan and pay to have them removed if i was that concerned or worried.They also decided assisting with any cost to my ps office as well.Have been on a medication to help the capsule or blood vessels and it no longer works.My left breast is distorted and double the size of right one from capsule and hardened tissues.I also have pictures of all this.

• Brand Name: MEMORY SHAPE GEL TEXTURED
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6584865
• MDR Text Key: 75857910
• Report Number: MW5069938
• Device Sequence Number: 1
• Product Code: FTR
• 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: 05/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/08/2015
• Device Model Number: 334-1305
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 59