MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ ETHICON, INC. TITANIUM LIGATURE CLIPS; CLIP, IMPLANTABLE

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Foreign Body Reaction (1868); Renal Impairment (4499); Ankylosis (4527)

Event Date 06/27/2014

Event Type  Injury  

Event Description

I had an elective procedure that resulted in 30 titanium ligature clips being inserted in my abdomen for a muscle repair - without my knowledge.Within two years i developed autoimmune disease- was so severely fatigued, i was under numerous medical specialists.I was diagnosed with hla b27- an overactive immune system gene and then following that ankylosing spondylitis which when i was getting images done i realized i had metal clips- i had no knowledge up until this point.I was started on serious immune suppression drugs including biologics- multiple different versions as after about 6 months my body would develop antibodies and i would no longer have any effect.After investigating metal hypersensitivity and looking into literature reviews and research articles- i was very concerned that i was having a foreign body reaction to these metal clips.I approached the surgeon who put them in and he was completely dismissive and said it was unheard of.I emailed numerous other surgeons around (b)(6) and two in (b)(6).Eventually a plastic surgeon from (b)(6) responded to me directly.His name is (b)(6).Because i am a registered nurse and have pretty good understanding of the body, when i started putting this all together i was like an investigator trying to give enough evidence.I emailed him with blood tests, rubella antibodies (off the charts), all my crps(c-reactive proteins) from prior to surgery (normal) and after surgery (always high), my kidney function- always normal prior to 2014 and after slightly impaired.My assessments from a medical doctor saying i had chronic fatigue, and all my rheumatology notes saying i kept developing antibodies to my medication- because i was trying to prove that my immune system is very over reactive- and i can not have foreign metals in my body.Some people probably can just fine, but those with a slightly overreactive immune system can't! off topic but again to prove my immune system is not ok with metals, foreign stuff, vaccines even- i actually developed pulmonary embolisms 10 days after my last covid vaccine something drs tried saying were unrelated but i knew it was! so the surgeon (b)(6) removed my clips and i paid (b)(6) dollars! and then i gave all my information to acc and they reimbursed me because guess what happened? all my inflammation and crp went down! i still have ankylosing spondylitis but the longer the time went on without the clips the better i got! and now i'm off biologics and methotrexate.

• Brand Name: TITANIUM LIGATURE CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): JOHNSON AND JOHNSON/ ETHICON, INC.
• MDR Report Key: 18573849
• MDR Text Key: 333722324
• Report Number: MW5150677
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: White