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

Model Number	334-1305
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	10/14/2015
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6584865
• Report Number: MW5069938
• Device Sequence Number: 10602370
• Product Code: FTR
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 01/08/2015
• Device Model Number: 334-1305
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Weight: 59