April 2, 2004 The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued a Public Health Notification today reminding physicians that a serious adverse event can occur with use of absorbable hemostatic agents, used to promote coagulation and stop internal bleeding during surgical procedures.
The FDA has received more than 110 reports of adverse events related to absorbable hemostatic agents since 1996. These events have continued to occur despite specific advice and warnings in the device labeling.
Eleven of these events resulted in paralysis or other neural deficits. A common factor in these events was the use of an absorbable hemostatic agent on or near a bony or neural space, and left within 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, a hematoma formed from the pooled blood behind the implanted hemostatic agents, which exerted pressure on neural tissue and caused a range of neural deficits.
The CDRH emphasizes that although these events are rare, following FDA recommendations may prevent them.
The FDA recommends that users of absorbable hemostatic agents review the device labeling, especially contraindications, warnings, and precautions.
If these agents are to be used near bony or neural spaces, the minimum amount needed to achieve hemostasis should be used and as much as possible removed thereafter. This will reduce the possibility of damage to neural and other soft tissue from agent swelling and/or migration and swelling of fragments.
Further information is available from Ms. Quynh Hoang via mail at the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, MD 20850; by telephone at 1-301-594-0650; by fax at 1-301-594-2968; or by email at email@example.com.
Clinicians can send reports of possible adverse events to MedWatch, the FDA’s voluntary adverse events reporting program. Reports to MedWatch may be submitted 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 at http://www.fda.gov/medwatch/report.htm.