For FDA, maggots are a kind of device

GAITHERSBURG, Md. -- What do pacemakers, stents, and artificial hips have in common with leeches and maggots?

According to the Food and Drug Administration, they are all medical devices.

FDA advisers considering how much scrutiny to give to leeches and maggots used for medicinal purposes yesterday decided they should require a prescription.

Leeches have been used by doctors for centuries to control bleeding. Maggot therapy was used hundreds of years ago by indigenous Australians and has been credited with disinfecting the wounds of World War I soldiers who lay untreated for days in battlefields.

With FDA approval, doctors now use maggots to trim dead flesh with more precision than scalpels, and leeches to draw excess blood that can collect when severed fingers are reattached.

For Barbara Enser, the old-fashioned technique succeeded when modern medicine failed.

The 57-year-old diabetic said she is grossed out by creepy, crawly things. But she got over her revulsion within minutes after her doctor said maggots were the last option for saving her right foot.

Enser's left foot was amputated about four years ago because it, too, had ulcers that refused to heal.

The Michigan woman agreed to Dr. Gerald Dowling's plan to apply dozens of disinfected maggots, white as snow and wiggling in a jar, to her foot wound.

''Go ahead and do it. I just don't want to know what you're doing," Enser said she told him last month.

Dowling said he recommends maggots in ''salvage" cases, when nothing else seems to be effective. ''The maggots do work," he said.

The maggots, larvae of green blow flies, devoured Enser's decayed skin during two treatments, each lasting about two days. That allowed Dowling to stitch up the wounds, which are now healing properly.

''They don't eat good flesh. They only eat rotten flesh. That's why it works," Enser said. ''I would do it again."

Federal advisers yesterday contemplated how to classify such uses, which are known as biotherapy because they use living organisms.

To be sure, maggot medicine remains a niche therapy. But its growing supporters are enthusiastic.

They include Dr. Elliot Lach, a Massachusetts doctor who admits to feeling a bit ''heartbroken" when he unseals a troublesome wound and finds that maggots have died before finishing their clean-up duties. He prefers to see them writhing.

''You know they survived and they were eating the entire time. Then, you know they did the job," said Lach, of Boston Surgical Group in Southborough.

Whether the patient has a tree limb impaled in his thigh or is a diabetic facing amputation of toes, maggots can be more surgically precise than a surgeon in attacking dead tissue.

When doctors operate, ''you just make a bigger hole than the hole that you had," Lach said. ''Maggots can do it, first of all, with relatively no pain, no need to go to operating room, and no bleeding, typically."

Dr. Ron Sherman's maggot therapy laboratory at the University of California, Irvine, ships maggots grown under sterile conditions to US and Canadian doctors.

Sherman said that last year, he sent enough medical-grade maggots for about 2,000 treatments.

In addition to ulcers, maggots have been used to treat bedsores and to aid burn victims -- including some injured in the Sept. 11, 2001, Al Qaeda attack on the Pentagon.

Before the FDA endorsed disinfected maggots as medical devices in 2004, doctors tapped local insect specialists for their supplies, said Gilbert Waldbauer, a professor emeritus of entomology at the University of Illinois at Urbana-Champaign.

Maggots flood the wound with their own version of an antibiotic and depress the number of bacteria, which compete for the decaying flesh, said Waldbauer, author of ''Insights From Insects: What Bad Bugs Can Teach Us."

Today, the FDA treats maggots roughly the same way as class II medical devices such as implantable surgical mesh. The FDA has not received reports of serious side effects from their use.

The general and plastic surgery devices panel reviewing the biotherapies declined to bump maggots to a higher classification that would require suppliers to submit costly, time-consuming applications for FDA review.

But if the FDA follows the panel's recommendations, new maggot suppliers won't save on paperwork.

They will need to submit documents for FDA review before marketing their products.

Some panel members yesterday could not resist attempts at humor when the subject turned to what happens to the leeches after treatments.

''Maybe they can be given the job of eating up the maggots," said Brent Blumenstein, a panel member who is a consultant based in Seattle.

When the tittering subsided, the talk turned somber.

Because medicinal leeches become engorged with potentially tainted human blood, they must be disposed of as biohazardous waste.

The leeches, imported from France, elicited sympathy from one panel member who worried they would be tossed into disposal incinerators while still alive.

The panel then suggested the FDA include instructions on how to humanely kill leeches before disposal.

Diedtra Henderson can be reached at dhenderson@globe.com.