Print

Print


Could this help us???

                  FDA Approves Implants That Restore Lost Voice

BALTIMORE, MD -- June 9, 1998 -- Johns Hopkins physicians have designed
a series of implants that restore bulk to weakened vocal cords,
returning the power of speech to those who have lost their voices from
paralysis associated with throat cancers, strokes or other conditions.

The patented implants were approved by the U.S. Food and Drug
Administration in early spring.

The implants, shaped like the heads of tiny hammers, are made of
hydroxylapatite, a chalk-like substance that melds into the body's
tissue over time. Available in five sizes, the devices add volume to a
weakened vocal cord, pushing it to the center of the voice box so it can
meet its counterpart and produce sound.

Patients can lose the ability to speak when the nerve supply that
normally pushes the cords together is lost. This condition affects about
5,000 to 10,000 people each year and can follow stroke or traumatic
injury. It also can arise without an identifiable cause, explained
Charles Cummings, M.D., professor and chairman of otolaryngology-head
and neck surgery. There are more serious complications, too.

"People who can't close their vocal folds cannot project their voices or
trap air effectively, which makes it difficult to exercise or even walk
upstairs," he said. "There is also a danger of choking on food, as the
folds that normally protect the voice box can't close."

During a half-hour surgical procedure using local anesthesia, physicians
drill a small hole in the side of the neck, creating about an inch-size
opening in the thyroid cartilage to reach the vocal cord. Using
specially designed instruments, they insert sizers, or dummy devices of
varying sizes and ask the patients to speak. When the patient recognizes
his or her correct voice, the physicians remove the sizer and replace it
with a same-size implant, locking it in place with a small shim of the
same material.

"There's no greater thrill for both the patient and the doctor than to
hear the patient speak again in his or her natural voice," Cummings
said. "Patients can talk immediately following the surgery, but it may
take up to six weeks for them to gain optimal pitch range."

Cummings and his colleague, Paul Flint, M.D., have used similar implants
for about 10 years. Before the FDA's approval of their design, Cummings
and Flint had to hand-carve an implant for each patient using sialastic,
a less sturdy material. Having the pre-cut hydroxylapatite implants has
cut their operating room time in half and helped reduce post-operative
swelling.
--
Judith Richards, London, Ontario, Canada
[log in to unmask]