Recent MAUDE Adverse Event Reports Regarding Filshie Clip Migration Harm

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE (Manufacturer and User Facility Device Experience Database) contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.

Recent MAUDE Adverse Event Reports Involving Filshie Clips

A MAUDE Adverse Event Report received by the FDA on November 12, 2021 stated, “Had to have 4 filshie clamps removed that has migrated throughout my pelvic/abdominal cavity. Had no medical conditions at time of filshie clamps as they were placed in 2009s.” Source Another MAUDE Adverse Event Report received by the FDA on December 10, 2021 stated, “My doctor recommended filshie clips for tubal ligation. I asked to have my tubes tied but she pushed the clips. Almost immediately after getting them, i started having pain. I went back to the dr. And she said it wasn’t the clips. I went to 5 doctors in a year. They all said “it was ibs” or “just my period”. I knew it was from the filshie clips but no one would listen. They prescribed me medications i didn’t need and ibuprofen that didn’t help. Finally a dr. Listened and found that both the clips had migrated into my uterus. I asked to have the clips and the dr. Refused to give them to me. I can’t file a lawsuit until you remove them from the market. I’m not alone. Thousands of women have gone through the same thing or worse. I still experience excruciating pain a year after removal from scarring. Do the right thing for us who are still suffering. Never tested for ibs. Avalon medical corporation.” Source A MAUDE Adverse Event Report received on August 6, 2021 stated, “Fertility issues; filshie clips were place (b)(6) 2017 and was notified after unrelated ct that the left clip has dislodged and migrated into the right pelvis. Previous ct done on (b)(6) 2019 showed now issues with clips.” Source

On January 6, 2022, the FDA made a final decision regarding Femcare Ltd.’s FILSHIE CLIP (MARK VI) SYSTEM Premarket Approval Supplement providing “Approval for revisions to the Instructions for Use to clarify symptomatic versus asymptomatic clip migration rates for the Filshie Clip (Mark VI) System.” Source

A pamphlet prepared by Femcare Ltd. intended for women considering Filshie clips for contraception states, “After tubes eventually separate, some clips may migrate within the abdominal cavity. This is normally without symptoms, and is less risk to long-term well-being than removing a migrated clip,” citing to a study published in 2010. Source

Most of the women who contact us regarding Filshie clips advise us that they were unaware that Filshie clips could migrate, which raise possible informed consent and other issues, and that they would not have agreed to Filshie clips had they been fully informed. Most of these women tell us that they suffer substantial pain and other harms due to Filshie clip migration.

WE ARE CURRENTLY INVESTIGATING FILSHIE CLIP MIGRATION CLAIMS THROUGHOUT THE UNITED STATES.

If you or a loved one suffered injury or other harm from Filshie clip migration in the United States, you should promptly find a lawyer who may investigate your Filshie clip migration claim for you and represent you or your loved one in a Filshie clip migration case, if appropriate.

Visit our website or call us toll-free in the United States at 800-295-3959 to find Filshie clip attorneys who may assist you with your Filshie clip migration claim.

Turn to us when you don’t know where to turn.

This entry was posted on Friday, February 18th, 2022 at 5:30 am. Both comments and pings are currently closed.

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