MAUDE Adverse Event Report: MENTOR COHESIVE GEL BREAST IMPLANTS

Model Number 350-5455BC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anemia (1706); Autoimmune Disorder (1732); Pain (1994); Myalgia (2238)

Event Type  No Answer Provided  

Event Description

I have mentor cohesive gel breast implants and experienced symptoms almost immediately.They continue to get worse.I have been diagnosed with sjogrens, myalgia, low c4 and anemia.Rheumatologist said i am at high risk for lymphoma.I have chronic widespread pain and digestive trouble.Severe food, drink and chemical sensitivity.I was healthy and active prior to breast implants.

• Brand Name: COHESIVE GEL BREAST IMPLANTS
• Type of Device: COHESIVE GEL BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6537228
• MDR Text Key: 74303719
• Report Number: MW5069470
• Device Sequence Number: 2
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-5455BC
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CBD OIL; IRON.; OTC MEDS: PROBIOTICS; RX MEDS: CBD OIL 250 MLG PER DAY.
• Patient Age: 40 YR
• Patient Weight: 52