MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN SALINE IMPLANTS; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number UNK_SALINE IMPLANTS

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

Patient Problems Autoimmune Reaction (1733); Neurological Deficit/Dysfunction (1982); No Code Available (3191)

Event Date 03/01/2004

Event Type  Injury  

Manufacturer Narrative

At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).

Event Description

It was reported (via fda medwatch) that a patient who underwent an unknown procedure with unspecified mentor saline breast prostheses experienced the following: " i got implants.Within 3 months started having pain.Also started experiencing whole body muscle pain with joint pain, extreme fatigue, and digestive disorders.Also, i had 2 revisions to discover the implants were on nerves.Years later dr diagnosed me with autoimmune illness, fibromyalgia, sjogren's syndrome, interstitial cystitis, memory problems, concentration problems, corrective tissue illness and problems finding words when talking.I have become very clumsy, falling often, due to dizziness when i least expect it.I have fallen and injured my cervical spine two times requiring surgery with hardware for stabilization.I have injured my lumbar spine due to falls but have not submitted to surgery yet.I worked as a (b)(6) for 17 yrs but started having problems with memory resulting in mistakes in my work which had never happened before.I could not concentrate.After approx 7 yrs i started having problems communicating.It made me look like someone with brain damage when i would be talking and all of a sudden either couldn't think of a word i needed to use in a sentence or lose my train of thought completely.I ended up having to leave my job due to these disabilities.Now i read that every symptom could be related to implants.I am currently in the process of trying to have the implants removed but insurance, of course, does not want to pay for explant and all prices were anywhere from (b)(6) to (b)(6).This price does not include mastopexy (breast lift).Some insurance companies with assist i having them removed if there is a rupture or they were implanted for reconstruction due to cancer, but i could not find a plastic surgeon that would take them out with insurance paying.I did research what i could find previous to getting my implants and found no negative reports at that time.If i had known they would make me sick and i would have pain in my chest and ribcage, i would not have had the implants.Ladies need to be made aware this can happen to them so they can make the decision to risk problems.I had no idea.Please help make the mfr put a warning, so ladies will know what they may be dealing with in the future due to breast implant illness." the patient reported that she had 2 revisions, however, the details of these surgical interventions are unknown.No product issue, such as rupture, was reported.The root cause of the patient's symptoms is unclear.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the right breast prosthesis.

• Brand Name: UNKNOWN SALINE IMPLANTS
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-868
• MDR Report Key: 7998002
• MDR Text Key: 124794048
• Report Number: 1645337-2018-06378
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SALINE IMPLANTS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other