April 2, 2004
This is to remind you of a rare but devastating adverse event that can occur with the use of an absorbable hemostatic agent, a device used to promote coagulation and stop internal bleeding during surgical procedures. Unfortunately, these events continue to occur despite specific advice and warnings in the device labeling. We ask that you take action to minimize the risk in your patients and help spread the message in this announcement.
Nature of Problem
Since 1996, FDA has received reports of over 110 adverse events related to absorbable hemostatic agents. Eleven of the events resulted in paralysis or other neural deficits. The last reported paralysis occurred in October, 2003. The common thread in all 11 events was an absorbable hemostatic agent that was used on or near a bony or neural space and left inside the patient. When wetted, the material swelled and exerted pressure on the spinal cord or other neural structures, resulting in pain, numbness or paralysis. In some cases, blood pooled behind the implanted absorbable hemostatic agents, forming a hematoma that exerted pressure on neural tissues and caused a range of neural deficits.
Although these events are rare, they can have serious consequences. These consequences are preventable.
FDA recommends that users of absorbable hemostatic agents review the device labeling, especially the contraindications, warnings and precautions.
If you use an absorbable hemostatic agent on or near bony or neural spaces:
- use the minimum amount necessary to achieve hemostasis; and,
- remove as much of the agent as possible after hemostasis is achieved.
This will reduce the likelihood of neural and other soft tissue damage from swelling of the absorbable hemostatic agent, and/or migration and swelling of fragments of the agent.
Reporting Adverse Events to FDA
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of an absorbable hemostatic agent, you should follow the reporting procedure established by your facility.
We also encourage you to report adverse events related to absorbable hemostatic agents that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online.
Getting More Information
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
David W. Feigal, Jr., MD, MPH
Center for Devices and Radiological Health
Food and Drug Administration