MAUDE Adverse Event Report: UNKNOWN BREAST BIOPSY MARKER (TITANIUM); MARKER, RADIOGRAPHIC, IMPLANTABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anemia (1706); Asthma (1726); Hypersensitivity/Allergic reaction (1907); Neurological Deficit/Dysfunction (1982); Tinnitus (2103); Burning Sensation (2146); Arthralgia (2355); Reaction (2414); Numbness (2415); Palpitations (2467); Weight Changes (2607)

Event Date 06/04/2015

Event Type  Injury  

Event Description

In (b)(6) 2015 i had breast biopsies because i found lumps.The good news about these biopsies is that they showed no signs of cancer.The bad news about these biopsies was that the radiologist inserted tiny titanium markers at the biopsy sites, as a marker in case a surgeon needed to come back in and do a lumpectomy.I did not know they would insert these markers until they told me while i was on the table, and i told the radiologist dr.(b)(6) at the (b)(6) hospital in (b)(6) that i was sensitive to earrings and was concerned about these implants.She told me they cause "no side effects".I felt unsure going forward but the fear of cancer compelled me to accept the implants.I healed from the biopsies, though i had a burning sensation at the site of the markers, but i didn't think anything was wrong.However, things started to get strange about 6 weeks later.In (b)(6) 2015 the burning sensation stayed with me and i started to develop other symptoms: severe asthma, reactions to all smells and odors (things i never reacted to before), numbness in my fingers and toes.I went to the doctor and got a nebulizer and lots of inhalers and was told i had the lungs of a 54-year-old.I started to have anaphylactoid reactions as my new allergist calls them, reactions to everyday exposures.This had never happened before in my life.There were lots of trips to the er over the next few months.And each time i was prescribed a steroid and told to 'work on managing stress'.But in the meantime, the pain and burning in my chest were getting worse.The numbness was slowly progressing up my extremities, i was developing more and more symptoms and no doctor found an explanation which addressed all the things that were happening.To be honest, i had no idea.I had genuinely forgotten about the biopsies and the metal markers until a lightbulb went off for me.This was (b)(6) 2015.The good news is that the markers were the explanation.The bad news is that it took four or more months, three more er visits, a lot of condescension from doctors and nurses and severely worsening symptoms before i finally got the metal out.While i was on the table after the second metal implant was removed from my breast, three of my symptoms improved (rapid heartbeat, joint pain and the burning in my breast).Getting the metal out was the first step to regaining my health, but still had a few things to figure out.It turns out i had developed two autoimmune disorders during this time.For me it is pretty clear- cut that the metal triggered a strong immune reaction, thus, these new disorders, but figuring out the disorders took a while too, since they are both rare.I will bore you with how i figured out these illness another day.It turns out have pernicious anemia (pa), a b12 deficiency.My pa had progressed quite severely.I had lost 20 pounds and had a number of neurological symptoms (memory issues, balance problems, numbness that had progressed to face and lips, tinnitus, poor proprioception, loss of grip and strength to open doors and a reduced ability to think clearly).I require a shot of b12 subcutaneously every day to keep my symptoms at bay.So pa was the first medical issue, but the strange allergic reactions that sometimes led to anaphylaxis seemed to be a different thing.I have a great allergist now who has run the traps to figure out what is happening.I don't have a clear diagnosis for this one, but i am taking lots of allergy drugs and histamine degranulating drugs prescribed for people with mastocytosis and other histamine disorders.They seem to work well for me and as long as i am super careful about my exposures, especially to food and smells, then i am ok.Fda safety report id # (b)(4).

• Brand Name: BREAST BIOPSY MARKER (TITANIUM)
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8659396
• MDR Text Key: 147063994
• Report Number: MW5087069
• Device Sequence Number: 1
• Product Code: NEU
• 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: 05/28/2019
• 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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 39 YR
• Patient Weight: 68