MAUDE Adverse Event Report: FEMCARE-NIKOMED LTD FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Fatigue (1849); Headache (1880); Itching Sensation (1943); Memory Loss/Impairment (1958); Pain (1994); Hot Flashes/Flushes (2153); Tingling (2171); Cramp(s) (2193); Anxiety (2328); Depression (2361); Reaction (2414); Irritability (2421); Sweating (2444); Sleep Dysfunction (2517); Abdominal Cramps (2543); Cognitive Changes (2551); Weight Changes (2607); Heavier Menses (2666); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 07/24/2020

Event Type  Injury  

Event Description

I'll describe below; i had a tubal in (b)(6) of 2013.I asked for cut and tie.I started having symptoms shortly after.Doctors brushed off my symptoms as "postpartum", "age", or "in my head".I went to several doctors.In (b)(6) of 2017, i had to get my obgyn to get the hospital's surgery report, because the surgeon's office wouldn't return my calls.That's how i found out that the clips had been used.I've since been trying to find any doctor to hear me.I finally found an allergist willing to perform a metal allergy test, scheduled for next week.Then in (b)(6) 2020, i thought i had a kidney infection or stone, and went to an urgent care facility.They thought i had a kidney infection, and gave me antibiotics while they sent off cultures to a lab.After 5 days on antibiotics, i was still in the same amount of pain, so i went back in on (b)(6), to my regular practitioner.After seeing my pain, and hearing me, he set up an xray of my midsection.It shows that one of the clips had migrated, and was on the side where i was having so much pain.Pain that shoots up to my flank area and down my leg.It's not getting better.I need help.Here is a list of my related symptoms over the past 7 years: menstrual problems (more than heavy periods-flooding, like can't leave the house for 4-5 days a month because no feminine products will stop the flooding), hot flashes, flushes, night sweats, anxiety-never had it before this sense of impending doom, unprovoked chronic fatigue, brain fog/trouble focusing/memory loss-never had any problems with this before, severe skin itching/crawling- like bugs are on me but they aren't- severe nerve issues, getting stabby tingles, reminds me of shingles, stabbing pains in pelvic area, excessive cramping-like pms but all the time headaches/migraines, depression, ibs, severe mood swings with no pattern- sudden tears, outbursts, unprovoked irritability, insomnia, painful intercourse, gum deterioration- no history or family history of gum problems before this and it keeps getting worse; all prior minor allergies now have major reactions- such as seasonal or insect bites or stings- severe over-reactions; plus adding new severe allergic reactions, such as deodorant, weight gain in the abdominal area that can not be lost by diet and exercise, inner ear problems, such as being off balance, fullness, or feeling like popping like on a plane i did not consent to metal devices being put into my body.My insurance says removing the clips is "elective" surgery and not covered.I've spoken to lawyers who all said there's a 2 year statute of limitations for this kind of case.What am i supposed to do? i have been victimized by a system that protects the doctors and manufacturers and leaves women like me to live in excruciating pain for life.It is criminal.Help.So far i've paid (b)(6) in office visit fees just in the past month, but this has been going on for seven years.And i'm not the only one.Thousands of women have problems from this procedure and can't get anyone to listen.Why are these devices still on the market? why are doctors allowed to implant devices into women without their prior knowledge or consent? there are many more victims who don't even know their symptoms are related because they don't know the devices are in them, and their doctors are covering each others asses.This should be a crime.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE-NIKOMED LTD
• MDR Report Key: 10396187
• MDR Text Key: 202753433
• Report Number: MW5096023
• Device Sequence Number: 1
• Product Code: KNH
• 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: 08/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 39 YR
• Patient Weight: 109