Concerns over the cancer risk created by power morcellation have spurred
a new medical device safety measure in Congress. The House of Representative
recently approved legislation that would require medical device identifiers
to be included in patients’ electronic health records.
The proposal is part of the larger 21st Century Cures bill, which alters
how the U.S. Food and Drug Administration (FDA) approves some drugs and
increases funding for medical research. The medical device proposal was
sponsored by Rep. Mike Fitzpatrick, (R., Pa.), who is a cancer survivor.
detailed by the
Wall Street Journal, Rep. Fitzpatrick acknowledged that he was prompted to introduce the measure
in the wake of the controversy surrounding the use of power morcellators,
and he hopes it sparks a larger debate about how medical devices are regulated
and tracked. “What happened with the power morcellator should never
be allowed to happen again,” Rep. Fitzpatrick stated at a hearing
of the House Rules Committee.
As we have previously discussed on this San Diego Injury Blog, laparoscopic
power morcellators are inserted into the abdomen during hysterectomies
and fibroid removal procedures and used to cut up tissue in order to remove
it through a small incision. While the medical devices allow doctors to
perform a less invasive procedure, they can unknowingly spread cancer
cells throughout the body.
According to statistics compiled by the U.S. Food and Drug Administration
(FDA), approximately 1 in 350 women who undergo a hysterectomy or fibroid
removal surgery are found to have an unsuspected uterine sarcoma. If laparoscopic
power morcellation is performed in these patients, the cancerous tissue
is often spread within the body and can significantly decrease the odds
of long-term cancer survival.
Given the risks, the
FDA recommends that device manufacturers include a boxed warning — the strongest warning possible — in their product safety
statements and advises that the medical devices should not be used in
If the 21st Century Cures bill is also approved by the Senate, healthcare
providers would be required to include the make or model number of any
devices used in treatment. The goal of incorporating the information in
electronic health records is to more accurately detect and track patient harm.
If you or someone you love has been seriously injured by a dangerous or
defective medical device, don’t hesitate to
contacta San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.