OUR STANDARD
We ask people to trust us with information about the device inside their body. That is a serious ask. These are the rules we hold ourselves to — publicly, consistently, and without exception.
We are an independent patient-safety publisher. We monitor FDA recall and enforcement data, the FDA's adverse-event database (MAUDE), and the peer-reviewed medical literature. We translate what we find into plain language.
We are not a medical provider, a law firm, or a source of referral compensation.
Every factual claim traces to a primary source. Government and peer-reviewed records come first: FDA recall and enforcement entries, FDA safety communications, MAUDE records, published studies, court filings, sworn testimony, and regulator actions.
Patient reports and press coverage are leads, never substitutes for primary-source verification. Every number carries the date it was pulled.
MAUDE entries are reports, not findings. A report means someone believed a device may have caused or contributed to an event. It is not a determination that it did.
MAUDE has no denominator and cannot be used to calculate individual risk. When we estimate or extrapolate, we show the source, assumptions, arithmetic, and label the result as an estimate.
We do not blame clinicians — surgeons, hospitals, nurses, or device representatives. The failure we report is structural: the information system that fails the patient can also fail the people treating them.
Manufacturer conduct is reported through documented, dated, on-the-record facts. We do not characterize intent we cannot document.
We never tell an individual what to do with their body or their device. We explain how systems work and what questions are worth asking. Clinical questions belong with the reader's own care team.
We never create urgency about removal, revision, explant, or replacement.
Where documented facts are alarming, we say so. But we hold a hard line between alarm and fear. Our reporting is aimed at the system and the missing route to the patient — not the reader's own body or device.
Our standard: as loud as the truth allows, and not one decibel louder.
Naming a person carries risks. We use public-record material, follow consent standards, and treat people as the protagonists of their stories.
Anyone who has asked us to stop using their story is honored without argument.
We take no money from medical-device manufacturers through sponsorship, advertising, consulting, speaking fees, or paid content.
No one can buy a story, a placement, favorable framing, or their way out of coverage. Funding sources and commercial relationships are disclosed and kept current.
We will get things wrong. What matters is what happens next. Corrections are made publicly on the asset itself rather than quietly deleting an error.
We distinguish clarifications, corrections, significant corrections, and retractions. Living recall and signal data also carries an update log as the record changes.
Our platforms are for patients. We keep patient stories, questions, frustration with the system, and disagreement with us.
We remove threats, harassment, doxxing, violence, medical speculation about named individuals, scams, fundraising links, and impersonation.
We use AI tools for research assistance, drafting, and organizing source material.
No AI output is published as fact. Every claim in a finished piece is traced to a primary source, cleared by a human being, and approved externally by the founder before publication.
John P. Owens, Founder, is the final approver on everything external and is accountable for every published claim.
Questions about these standards, or challenges to something we published, can be directed to The Implant Experience.
Precision is the point.
As loud as the truth allows, and not one decibel louder.