MAUDE Adverse Event Report: MENTOR SMOOTH ROUND HIGH GEL BREAST IMPLANT

Catalog Number 350-4504C

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Pain (1994); Cramp(s) (2193); Dizziness (2194); Anxiety (2328)

Event Date 03/01/2011

Event Type  Injury  

Event Description

Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete.Worsened over a period of 5-7 years post implant.Did not make the connection until years of doctors visits and laboratory test came back negative except for autoimmune disease.Epidurals and physical therapy for years.Only improvement with prednisone.No improvement with nsaids (multiple tried).Developed anxiety and uncontrolled vaso-vagal responses.

• Brand Name: SMOOTH ROUND HIGH GEL BREAST IMPLANT
• Type of Device: SMOOTH ROUND HIGH GEL BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6452817
• MDR Text Key: 71649415
• Report Number: MW5068832
• 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: 03/30/2017
• 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
• Device Operator: No Information
• Device Catalogue Number: 350-4504C
• Device Lot Number: 5778410
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: VITAMIN D; PROBIOTIC; RX MEDS: NONE.
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 73