First Device to Prevent Hemorrhoids During Vaginal Birth Given FDA Approval

Natural child birth is famous for the vaginal pain women experience, but it ain't no

joke that the anus is also subject to a good deal of force in the process. That is why

around a quarter of vaginal births result in hemorrhoids, something you really don't

want to be dealing with when you just had a baby. Nurses will often use their hand to

counteract the pressure on the anus, but this can be extremely tiring as labor can take

hours. David Blurton, a medical device industry veteran, became acutely aware of the

problem when his wife gave birth. Confounded by the fact that there was no available

solution to the issue, he developed the Hem-Avert device that effectively reproduces

the actions of the nurse's hand in preventing hemorrhoids.

Plexus Biomedical out of Oakland, TN, the company started by Blurton, has received FDA

clearance for the Hem-Avert. This followed a clinical study that showed that the new

device prevented hemorrhoids in all of the women that wore it during labor compared

with a 25% hemorrhoid rate in the control group.

Because of the novel nature of the device, incomparable with anything else that has

come before the FDA, it went through a rather rare de novo 510(k) clearance process.

More about the Hem-Avert from the product insert:

    The Hem-Avert Perianal Stabilizer is a non-invasive instrument used to help provide

continuous pressure to the anus and perianal region as a means to provide support

during the labor process. Hem-Avert Perianal Stabilizer is a single-use disposable

instrument used only during vaginal deliveries. The instrument consists of three

components. The rigid polymer base is manufactured from medical grade polycarbonate.

The centrally located cushioning pad is made of a laminate of medical grade polyester

non-woven tape and medical grade polyethylene foam tape.

    The instrument is kept in place by two lateral hook and loop fasteners (loop strips

that attach to the mating hook) that are attached to adhesive tape. The adhesive tape

is made from medical grade resin acetate woven fabric. The cushioning pad and adhesive

strips are manufactured from materials commonly used in medical procedures.