11
seconds
One adverse-event report every 11 seconds. ~2.89 million reports filed in 2025.
Source: openFDA].
RETHINK THE NARRATIVE
If your device
were recalled tomorrow
would anyone
tell you?
For most recalls, nobody is required to, and it’s something no one talks about. So we are.
An estimated 32 million Americans — roughly 1 in 10 — live with an implanted medical device. The data that could protect them exists, in FDA recalls, enforcement actions and adverse-event reports. It was just never built to reach the patient the device sits inside.
You own what’s inside your body. So track it. And stay informed.
THE NUMBERS
The system wasn’t designed to
protect you.
The numbers prove it.
9
in 10
Recalls were never designed to reach you. 91% of device recalls are Class II or III — tiers with no structural path to the patient.
Source: openFDA enforcement records, .
30
months
Median time from a device shipping to its recall being initiated. FDA Class I recalls, 2018–22.
Source: FDA Class I recalls, 2018–22.
5.9
years
Average gap between the first documented knowledge of a problem and the public being told, across 34 documented cases.
Source: The Implant Experience, Delay Evidence Brief.
0
Nobody is legally required to tell you. There is no standing requirement for patient notification.
Source: GAO-26-107619.
THE PATH SAFETY INFORMATION TAKES
where it stops ↓MANUFACTURER
FDA
DISTRIBUTOR
HOSPITAL
SURGEON
YOU
MANUFACTURER
FDA
DISTRIBUTOR
HOSPITAL
SURGEON
YOU
For most recalls, the line never reaches the last node. This isn’t a failure in the system — it's how the system was built. We close the gap.
32M+ IMPACTED
24/7 SAFETY & COMPLICATION MONITORING
AIM THE ALARM
Be alarmed. And aim it correctly.
Not at your own implant. Most implants serve people well, and nothing on this site measures anyone’s personal risk. We will never tell you your device is dangerous, and we will never tell you to have anything removed.
Aim it at a system that holds the information and isn’t required to hand it to you.
Every question about your own body goes to your own care team. That has not changed and it never will.
THE RELATIONSHIP
You have a relationship with the healthcare industry.
Not with a doctor, but with the industry itself. It's one of the most consequential relationships in your life, and it has your body in it.
A relationship has two parties, and information is supposed to flow between them. In this one, it's broken both ways. Safety information about your implant, like recalls, adverse events and material risks, is published and public, but it was never built to reach you, so it rarely does. And we, the patients, haven't been sending information back. When something goes wrong, most of it never makes it into the record. We've been the silent partner.
If something has already happened to you, you didn't miss anything you should have caught. The information simply wasn't reaching you, or your surgeon, or us. That's not a failure of any one person. It's a gap, and gaps can be closed. That starts here.
We each have a role in it.
When an implant causes problems, the first signs show up in patients' lives, long before they show up anywhere else. Those experiences are early warning signals. But a signal only counts once it's on the record, and our research shows adverse events are grossly underreported. When signals go unrecorded, it can take years for a pattern to become visible, and years more before a recall is initiated, if one is initiated at all.
We can shorten that timeline. It takes three things:
Report it.
The FDA's adverse-event database is only as complete as what goes into it. When something goes wrong with your implant, report it. Every report is a signal, and every signal makes the pattern easier to see.
Watch it.
Stay informed about the device inside you. By monitoring reported activity, we can see early warning signals sooner and know earlier when action may need to be taken.
Speak up.
Your voice matters. When patients see the same signals and raise concerns together, those concerns carry weight.
OUR MISSION
The Ethical
Obligation.
"Patients have an absolute, uncompromisable right to know what is in their bodies and the current safety status of those devices."
Born from the urgent need exposed by countless device failures,
we provide the transparency that the system denies patients by
exposing the real-world side effects and adverse events the
industry hides.
OUR PROMISE
We promise to be your unwavering advocate in the complex world of medical devices. To deliver information without bias, to fight for transparency without compromise, and to ensure that no patient ever has to say 'I wish I had known about these dangerous side effects sooner'
What We Do
Manufacturers notify distributors. Distributors notify hospitals. Hospitals notify doctors.
But who notifies you? Often, structural failings mean vital information regarding device safety and complications stops before reaching the patient.
Track it
Every device you carry, in one record: name, model, manufacturer, UDI, date and surgeon. Yours to keep, ready when you need it.
Stay informed
We watch FDA recall and enforcement data, the adverse-event database, and the medical literature every day. When something touches a device in your record, you hear it from us — not from a news cycle you happened to catch.
Speak up
Know what the record says in plain language and what to ask your doctor. And if something goes wrong, we'll show you how to report it to the FDA, help you gather what you need, and make submitting it easier.
The path to patient safety runs through all of us.
You own what's inside your body. So track it. And stay informed
Take Control of Your Data
Join the patients securing their right to know. Membership is strictly confidential, and our independence is guaranteed.
✓
Direct FDA Recall Alerts
✓
Unbiased Adverse Event & Side Effect Reporting Assistance
✓
Secure Platform-to-Patient Advocacy
✓
Implant Intel™ - Your Personal Implant Companion
Informed patients change outcomes — The Weekly Show
Every week, we take one piece of the implant story and look at it closely, using public records and real documented cases. Then we round up the week's top recalls and safety signals, straight from the FDA's own data.
Watch, share, and follow along. The more of us who stay informed, the sooner the signals get seen.
Explore More
Choose how the information
reaches you.
Stay informed about the landscape for free, or have it matched to your exact device and pushed to you the moment it matters.
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Stay informed about the landscape.
- Follow your device categories and get every FDA recall in the categories you follow, as it posts.
- General adverse-event updates and emerging safety signals.
- Plain-language library: recalls, the 510(k) pathway, and what to watch for.
- Ask The Implant Guide your questions, any time.
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- Real-time alerts matched to your exact device — down to the lot numbers.
- Monitoring beyond the FDA — adverse-event trends, research, global regulators.
- The Implant Guide — understand what each alert means and what to do next.
- Secure vault for your implant cards and records — for you and your family.
- Everything in Free, included.
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