FDA Approves Leeches as Medical Devices

The government has lent its seal of approval to a marketing an age-old medical device — leeches (search).

The Food and Drug Administration (search) said Monday that Ricarimpex SAS (search), a French firm, is the first company to request and receive FDA clearance to market the bloodsucking aquatic animals as medical devices.

Leeches are already widely used in American hospitals, and companies that raised and sold them here before 1976 were allowed to continue doing so. However, the medical device law passed that year required newcomers to the field to seek approval.

For many people, leaches conjure up the image of Humphrey Bogart removing the bloodsuckers from his legs in "African Queen," but FDA reports that leeches can help heal skin grafts by removing blood pooled under the graft and restore blood circulation in blocked veins by removing pooled blood.

Indeed the use of leeches to draw blood goes back thousands of years. They were widely used as an alternative treatment to bloodletting and amputation for several thousand years. Leeches reached their height of medicinal use in the mid-1800s.

FDA noted that today they are used in medicine throughout the world as tools in skin grafts and reattachment surgery.

Medicinal leeches — Hirudo medicinalis — normally make their home in fresh water.

In considering the Ricarimpex application, FDA said it analyzed the use of leeches in medicine, evaluated safety data provided by the firm and studied how the leeches are fed, their environment and the personnel who handle them.