MAUDE Adverse Event Report: METAL SURGICAL CLIP; CLIP, IMPLANTABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Neuropathy (1983); Rash (2033); Tachycardia (2095); Tinnitus (2103); Burning Sensation (2146); Numbness (2415); Shaking/Tremors (2515); Abdominal Distention (2601); Weight Changes (2607); Constipation (3274); Dry Mouth (4485); Cramp(s) /Muscle Spasm(s) (4521); Eczema (4547)

Event Date 11/14/2018

Event Type  Injury  

Event Description

Without asking my consent nor whether i had a metal allergy, surgeon placed over 20 surgical clips in my neck for a hemithyroidectomy.I was never told they were placed here.I began having symptoms within days of the surgery symptoms that have worsened and morphed over the past three years: developing ventricular tachycardia (non-sustained), esophageal spasms, gall bladders spasms, eczema, nose bleeds (3-4 x/week), more headaches in 3 years than all the previous years of my life put together.Tinnitus through the roof.Burning mouth.Dry mouth.Dry eyes and resulting eye infections.Unexplained shakiness/weakness.Swelling lip.Change in hair texture/hair loss.Constipation.Weight gain.Bloating.Neuropathy like tingling and numbness in legs and toes.Bloating.Transient earaches.Chest pain.Vaso vagal collapse.Neck pressure resulting in vocal changes.None of those were present prior to the surgery.In (b)(6) of 2021, i discovered via x-ray that clips were in me.I had a known nickel allergy (titanium almost always contains a small amount of nickel), and have since tested positive for titanium dioxide and aluminum hypersensitivity.Nickel is a known metalloestrogen and yet metal is used in breast cancer patients.It's known to be toxic to the kidneys, heart, and liver.It has been implicated in raising cholesterol and in causing thyroiditis (and yet they used it for my hemithyroidectomy.Is it any wonder that i have now been diagnosed with thyroiditis in the remaining portion?).In europe they've recognized how problematic nickel allergy/hypersensitivity is, particularly in women who are sensitive at much higher rates than men, and created laws and directives to protect people.Why are we behind in protecting people? research in europe shows that people who have genetics that make them susceptible to metal hypersensitivity frequently go on to have autoimmune disorders.Does the overall rise in autoimmune disorders parallel the rise in use of metal clips/devices left in people? robust research shows metal causes oxidative stress and chronic inflammation response in susceptible people two things doctors warn us to avoid to reduce illness.And yet my surgeon caused this, by putting metal in me.Now i have to undergo the expense and substantial risk of challenging surgery (due to scar tissue from the initial surgery plus the cramped "real estate" in the neck) to try to get these clips removed.This was totally avoidable.For the past three years of my life my quality of life has been reduced and i've spent thousands of dollars trying to figure out what's wrong.Surgeons these days believe that titanium and stainless steel have no risks.They are uninformed of the research and just get their information from johnson and johnson, the clip maker.Most surgeons dismiss and minimize our concerns because they don't believe metal can make people sick and therefore aren't reporting to you how many of us are sickened by metal in our body.Getting it wrong in this case is not benign.Getting it wrong causes harm.I can't believe your october 2021 update on surgical clips didn't mention the possibility of people being made sick by them.The cdrh arm of the fda itself acknowledges there are "gaps" (their word) in how susceptible people may have an immunological response.That was a lost opportunity.I also had a known history of a weepy bleeding blister rash in response to nickel.(b)(6) couldn't tell me.Suspected neuropathy and/or sjogrens as a result of the metal, but rather than waste more money treating these symptoms, i am choosing to get the clips removed.Other than the symptoms and life changes from the metal, i have no known medical consisting.I was healthy prior to the initial surgery.Fda safety report id # (b)(4).

• Brand Name: METAL SURGICAL CLIP
• Type of Device: CLIP, IMPLANTABLE
• MDR Report Key: 12634077
• MDR Text Key: 276903401
• Report Number: MW5104625
• Device Sequence Number: 6
• Product Code: FZP
• 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: 10/08/2021
• 20 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Weight: 55