A report today from the Food and Drug Administration contains some disturbing news – that surgeons leave parts of medical devices inside patients nearly 1,000 times a year.
“Patients may not be aware that this has occurred,” said Dr. Daniel Schultz, director of the FDA Center for Devices and Radiological Health. “CDRH receives nearly 1,000 adverse event reports each year … these included more than 200 different medical devices and numerous medical specialties.”
Effects from the devices inadvertently left behind include: local tissue reaction, infection, perforation, obstructions of blood vessels and death.
In addition, if a patient undergoes an MRI procedure, magnetic fields might cause metallic fragments to move, and radiofrequency fields might cause them to heat, causing internal tissue damage or burns.
The FDA requires hospitals and other facilities to report deaths and serious injuries associated with the use of medical devices.
The FDA encourages reporting adverse events of unretrieved device fragments that do not meet the requirements for mandatory reporting.
Reports can be made to the FDA’s MedWatch Adverse Event Reporting program or by calling 800-FDA-1088.