A new bill which would require doctors to report any potentially serious
problem with medical devices to the FDA is expected to be introduced before
Congress. The Medical Device Guardian’s Act is intended to raise
awareness of the risks associated with some medical devices which could
potentially cause serious harm to patients. The impetus for the bill came
from a device known as a
The power morcellator is a surgical tool used to remove uterine fibroids
and perform hysterectomies. The morcellator has small, sharp, rotating
blades which break large masses of tissue into smaller pieces, allowing
them to be vacuumed out of the woman’s body. Unfortunately, in some
instances the tissues contain cancerous cells, which can spread to other
parts of the body when the morcellator drops them.
Doctor and Her Husband Lead the Crusade Against Power Morcellators
In 2014, a black box warning was issued by the FDA for power morcellators,
curtailing the use of the devices which can potentially spread hard-to-detect
uterine cancer during the procedure. Despite the fact that medical literature
highlighted the risk of power morcellators as far back as the 1990s, the
FDA was, apparently, unaware of the risks until 2013, when a physician
and her husband began talking to anyone who would listen about a surgical
procedure the physician underwent to remove fibroid tumors.
The procedure was done with a power morcellator, which minced up the leiomyosarcoma—a
rare cancer—implanted in her uterine wall. She was forced to undergo
four more operations generated by the morcellator, and now faces a very
uncertain future. If her sarcoma had been taken out whole, she would have
had a five-year survival rate of 50 percent, but once the cancerous cells
were morcellated, her five-year survival rate dropped to between zero
and 20 percent—very bad odds for a young woman with six children to raise.
Bill Would Force Doctors to Report Hazards Associated with Medical Devices
Following this report of morcellation-caused cancer, hundreds of other
adverse event reports began pouring in to the FDA. The bill introduced
before Congress would amend the Federal Food, Drug, and Cosmetic Act,
requiring physicians and physician’s offices to submit reports to
the FDA any time they believe there is a potential hazard associated with
a medical device. While the bill was a response to the power morcellator
issue, it has implications for the entire medical device industry.
Under the bill, adverse events are classified as those in which a medical
device has caused or contributed to a death or a serious injury or illness
which is either life-threatening, permanently impairs a bodily function,
or necessitates medical intervention to preclude permanent impairment.
The new bill would change nothing as far as the current reporting requirements
for medical device companies.
The existing law requires manufacturers of medical devices to report:
- Information received which suggests a device could have contributed to
or caused an injury or death, or
- Information received which suggests a device has malfunctioned in a manner
which could lead to a death or serious injury, should the malfunction occur.
Overall, if the bill passes, it could increase the level of scrutiny the
FDA subjects medical device manufacturers to, as well as highlighting
the importance of seeking and responding to information regarding device
performance problems. Some experts estimate that currently only about
10 percent of medical device problems and complications experienced by
doctors and hospitals are reported, which makes it considerably more difficult
for both regulators and the medical community to identify the risks of
Getting Help if You Have Suffered Injury from a Faulty Medical Device
If you have suffered injury from a
faulty medical device or defective product, it could be extremely beneficial to speak to an
experienced medical device attorney who can help you recover damages for
your medical expenses, lost wages and pain and suffering. Call the product
liability lawyers at Golomb & Honik, P.C. today for a consultation
and to learn about your legal options. Our goal is to get you the greatest
maximum recovery for your physical and emotional suffering.
To learn more about your legal options or to schedule a free consultation,
call the Philadelphia product liability lawyers at Golomb & Honik,
P.C. today at
(215) 278-4449. You can also fill out our confidential