MAUDE Adverse Event Report: JOHNSON AND JOHNSON, / ETHICON, INC. TITANIUM SURGICAL CLIPS USED IN PARTIAL THYROIDECTOMY; CLIP, IMPLANTABLE

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Dysphagia/ Odynophagia (1815); Irritation (1941); Pain (1994); Suicidal Ideation (4429)

Event Date 12/01/2020

Event Type  Injury  

Event Description

Use of surgical clips in my partial thyroidectomy (b)(6) 2020 has left me in chronic pain.Poking, sharp sensation with each swallow.Soreness, irritation.Surgeons need to stop using them.People are suffering from these clips put in them without their knowledge.They are known to migrate and can cause pain being that they are foreign bodies.Just because a titanium clip is "inert" doesn't mean it's not pressing on or irritating a nerve or placed wrong.And surgeons should be held accountable for not disclosing this important fact (lack of informed consent) to a patient before inserting clips.Suicidal from clip pain; used in partial thyroidectomy.I will get the model and maker soon.Fda safety report id# (b)(4).

Event Description

Additional information received from reporter on 2/17/2021 for report mw5098486.Chronic pain / md depression; access# mw 5098486; why are titanium surgical clips allowed to be used in thyroid surgery? many people, including me, are suffering from a foreign body sensation in their neck/throat from these clips.I have four inserted in me which i was not told about before surgery (lack of informed consent) and i can feel them poking at me all day when swallowing and moving my head around.How dare surgeons be allowed to insert these without informing patients beforehand.Clips being called a 'standard of care' needs to be updated.Maybe they were 'standard of care' back in the old days, but not these days.Sutures and/or cauterization is used as well these days which should be the norm.Many people have many more clips in their neck than i do.Some feel them, some don't.The word 'inert' means nothing when these horrible pieces of metal are rubbing/scraping/poking inside you and/or touching on nerves in the neck.I'm tired of doctors saying it's rare to feel these things.How do they know? do they have clips in their neck? some surgeons say it is possible though to feel them.It's rare because no one speaks up about them.Clips ought to be banned from use in thyroid surgery.Sutures or cauterization can be used instead.Steadyhealth.Com/topics/surgical clips in my neck after total thyroidectomy has posts of many people suffering from these clips.One lady in (b)(6) had 25 in her neck after thyroid surgery and had to wait 18 months of suffering to find a willing surgeon to remove them.Unfathomable.The worst part is that many head and neck surgeons/ents are not even willing to remove them because of possible complications of removing them.They can remove your thyroid, with possible complications, but not some clips? huh? or they just don't want to remove them, don't have the confidence/skill needed to or don't care if the patient is suffering from them.Luckily i have found a good surgeon who is willing to remove these four horrible clips from my neck.I have to fly from (b)(6) for this surgeon and undergo another surgery to get these things out of me.It's been the worst time of my (b)(6) years of life and i pray i make it through.I am married and have 2 teen boys i'd love to watch grow up and who need me.How about the fda look into this subject? when i get these out of me, i will have the surgeon save them for me for evidence.This reminds me of breast implants.It's taken some 30 years for the fda, doctors, etc.To admit they are causing problems in women with bii.Well, duh.They are a foreign body just like titanium surgical clips.Fda safety report id# (b)(4).

• Brand Name: TITANIUM SURGICAL CLIPS USED IN PARTIAL THYROIDECTOMY
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): JOHNSON AND JOHNSON, / ETHICON, INC.
• MDR Report Key: 11064435
• MDR Text Key: 223374742
• Report Number: MW5098486
• Device Sequence Number: 2
• 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,Followup
• Report Date: 02/17/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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
• Treatment: LORAZEPAM; NORCO
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 61