MAUDE Adverse Event Report: MENTOR WORLDWIDE, LLC. MENTOR SMOOTH ROUND MODERATE PROFILE SALINE IMPLANTS 300CC; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Lot Number REF 350-1645

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Chest Pain (1776); Hypersensitivity/Allergic reaction (1907); Muscle Weakness (1967); Rash (2033); Red Eye(s) (2038); Anxiety (2328); Ambulation Difficulties (2544); Swollen Lymph Nodes/Glands (4432); Unspecified Immune System Problem (4435); Unspecified Eye / Vision Problem (4471); Breast Discomfort/Pain (4504); Swelling/ Edema (4577)

Event Date 04/26/2022

Event Type  Injury  

Event Description

Breast implant illness.I had surgery on (b)(6) 2022 to remove breast implants.I got the implants in 2014 and my first symptoms began in 2018 and got progressively worse through the date that i had surgery.Over that period of time i had rashes, bloodshot eyes and vision issues especially on electronic devices, severe allergic reactions, swollen glands in my neck and underarms, difficulty taking a deep breath, symptoms of lupus and other autoimmune diseases that tests came back negative for, steven johnson's syndrome with mucosal only involvement twice, leg weakness and went from running 5 miles a day to barely being able to walk the length of my house.I had pain in my left breast, stabbing pains in the center of my chest, i felt like i was literally going to drop dead the last couple of weeks before having them removed and had severe anxiety because of that.I went to (b)(6) clinic for evaluation in 2022 by allergy and was also sent neurology given the issues walking.I learned about bii and identified that i had 39 of the symptoms.I had mentor saline 300cc implants removed.Since removal 3 weeks ago 36 of the 39 symptoms have resolved.I had a large amount of inflammation in the left breast, the implant had turned sideways, i had a great deal of inflamed tissue removed and 2 masses removed that came back benign.My implants were removed via enbloc procedure.I'm happy to discuss the full timing of all events over these years.Fda safety report id # (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PROFILE SALINE IMPLANTS 300CC
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR WORLDWIDE, LLC.
• MDR Report Key: 14471015
• MDR Text Key: 292497316
• Report Number: MW5109828
• 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: 05/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: REF 350-1645
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: VITAMIN C 1000MG DAILY
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 6 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White