MAUDE Adverse Event Report: MENTOR SALINE IMPLANTS; SALINE BREAST IMPLANTS

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

Patient Problems Arthritis (1723); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Memory Loss/Impairment (1958); Muscle Weakness (1967); Pain (1994); Myalgia (2238); Anxiety (2328); Complaint, Ill-Defined (2331); Impaired Healing (2378); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Lethargy (2560); Weight Changes (2607); No Code Available (3191)

Event Date 01/02/2017

Event Type  Injury  

Event Description

I couldn't pick a date as i have been sick from my mentor saline implants since 2014.And continue to get sick today.I got my implants in 2010.Started showing symptoms in 2012.Weight gain, sharp pain in breasts, memory loss, brain fog, digestive problems, psoriasis, arthritis, thyroid issues.Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities.Inflammation, hoarse voice and throat clearing, hair loss, alcohol intolerance, anxiety, fatigue, muscle pain, insomnia.Difficulty concentrating, muscle weakness, dry skin and hair, headaches daily, migraines, monthly, irritable bowel.

• Brand Name: SALINE IMPLANTS
• Type of Device: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7181726
• MDR Text Key: 97091121
• Report Number: MW5074531
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• 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: 01/09/2018
• 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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 42 YR
• Patient Weight: 82