FDA Warns Doctors to Retrieve Device Fragments

The FDA has recently become apprised of something that plaintiff’s lawyers have known for years: Surgeons sometimes leave medical devices or parts of those devices in their patients. 

Noting that the Center for Devices and Radiological Health receives almost 1000 reports of adverse effects each year, the FDA issued a Public Health Notification.  These adverse effects have included more than 200 different medical devices that cause reaction in local tissue, infection, perforation and obstruction of blood vessels, and death.
The FDA has made the following recommendations to surgeons, none of which sound particularly earth-shattering:

1.       Use medical devices in accordance with their labeled indications and the manufacturer’s instructions for use, especially during insertion and removal.

2.       Inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure.

3.       Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.

4.       If the device is damaged, retain it to assist with the manufacturer’s analysis of the event.

5.       Carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs. leaving the fragment in the patient.

6.       Advise the patient of the nature and safety of unretrieved device fragments including the following information:

a.       The material composition of the fragment (if known);

b.       The size of the fragment (if known);

c.        The location of the fragment;

d.       The potential mechanisms for injury, e.g., migration, infection;

e.       Procedures or treatments that should be avoided such as MRI exams in the case of metallic fragments. This may help to reduce the possibility of a serious injury from the fragment.