Pelvic Mesh: Your Device is Tracked Unless You Opt-Out

The FDA requires Medical Device distributors to track your device up until and including your death—including your name, address, phone number and social security number. Title 21 of the FDA regulations require the device distributor, final distributor, or multiple distributors (devices that move from patient to patient), promptly upon purchase, provide the manufacturer the name and addresses of all distributors along its journey to you, including the lot number, the date the device was received, and the person from whom it was received.

Tracking Devices vs. Device Tracking

The last distributor before your implant must also provide the manufacturer with their own name and address, the unique device identifier (e.g. lot or serial number), your name, address, phone number and social security number—unless you refuse to release that information under 821.55(a).* They must also record the date of your implant, name, address, and phone of both implanting surgeon and regular physician, and the date the device was explanted.

If a patient dies, the end point distributor must provide the date of death, name, address, and phone of treating physician, date of any explant with contact information for explanting physician, and, where applicable, and the date the device was returned to the manufacturer, retired from use or disposed of in any other way.

* Any patient receiving a device subject to tracking may refuse permission to release their name, address, phone and social security number or any other identifying information but, the hundreds of pelvic mesh implantees who were not told they had an implant or that a tracking system exists, would have no way to refuse permission. Title 21 can override a patient’s right to privacy if the “health or safety of the patient requires that such persons have access to the information.”

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Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.

If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at [email protected]..

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6 responses to “Pelvic Mesh: Your Device is Tracked Unless You Opt-Out

  1. Barbara Butterton

    Hello, I would like to know if I am the only victim who was implanted with polypropelene mesh (Ethicon Prolift) who had pre-existing pelvic fused ecotopic kidneys. I have been told by physicians since implant that I should never have been implanted with this material. It was done at UCLA by a physician named Ha-Jong Kim in March 2010. I had gone to UCLA not with concerns about prolapse or incontinence but ONLY to learn about how to care for my malformed kidneys which I had just learned I had (They appeared on imaging when I was diagnosed with Ishemic Colitis following ingestion of “bad” seafood. The identification was made by a physician at a local hospital who was treating me. Also, I was told by Doctors Veronikis and Margolis whom I consulted about removal that because of my kidneys and the degree of adhesions following implant the probability of death in surgery was too high to attempt removal. Please tell me if I am the only one, someone! Thank you.

    • I remember you, Barbara. I’m so sorry you are stuck with the implant. Have you found any things that make life even a little easier? Peggy

  2. Hi
    Thankyou for all the information you have provided on your website, i am slowly reading through it all.
    I live in England and would like to know how i can find out who manufactured my device and its numbers etc.
    Many thanks
    Sandra xxx

    • I must aplogize for letting so many weeks go by without answering. The hospital where you had your implant is the place where the implant log is recorded. Go to their medical records department and ask for a copy of any labels in your operative report. Be persistant, sometimes they don’t realize what you need at first. Best, Peggy

  3. Sandra Pitrelli

    I have sent seven requests to Sibley Memorial Hospital.
    No success

    • Are you trying to get your serial number for your device. I’d suggest you walk in the medical records department and ask for the manager. Take her my article describing how to find the number. Let me know if this is the information you need.

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