As we recently posted, the U.S. Food and Drug Administration (FDA) has warned against the use of morcellators in laparoscopic procedures. Johnson & Johnson, Ethicon and other manufacturers, as well as hospitals and medical facilities have halted the use of these devices.
The FDA announced earlier this month that using power morcellators in laparoscopic myomectomy or hysterectomy presents the risk of spreading unseen cancers. Based on available data, the FDA determined that 1 in 350 women undergoing these surgeries to treat uterine fibroids have an unsuspected type of cancer called uterine sarcoma. Used in tens of thousands of procedures each year since the 1990s, the FDA warns that power morcellation can significantly worsen the odds of long-term survival.
According to the FDA, use of these power morcellators to remove fibroids, which could possibly contain cancerous cells, presents a “risk that the procedure will spread the cancerous tissue within the abdomen and pelvis.”
A morcellator is used to divide and remove tissue masses during surgery using hollow cylinders tipped with cutting implements that divides the uterus during laparoscopic surgery. The device cuts the tissue mass into pieces, which the surgeon then pulls out through tiny incisions, reducing size of scarring and recovery time. The concern is when the power morcellators are used, undetected, cancerous tissue within the abdomen or pelvis can raise the risk of malignant cancer cells becoming embedded within other tissues, elevating the undetected cancer to a more advanced stage. Uterine sarcomas cannot be accurately detected prior to removal and can be mistaken for fibroids. The cancer is typically discovered only after the mass has been removed and studied by pathologist.
This is why the scientific journal JAMA expressed concerns in their recent article about this procedure. They stated that since it is difficult to detect the presence of these cancerous tumors before the surgery, the procedure may, in fact, “be too risky under any circumstance.”
It is unclear why warnings were not provided until recently despite the fact that the morcellator’s fatal flaws date back to its early use. In the late 1990s, doctors noticed that sometimes tissue fragments were left behind. As early as 2003, data suggested that if those fragments were malignant, they could seed rapid cancer growth. Some morcellator makers have recommended containing the risky tissue in a surgical bag, which is the standard practice for some specialties, gynecologists rarely used bags, considering the risk too low and their use too cumbersome.
As we posted earlier, although the FDA warned about the cancer risks associated with the use of power morcellators, they did not ban the use outright. According to experts, although the FDA does not regulate how doctors practice medicine, the FDA’s advising against a procedure can significantly change practice by raising the risk of lawsuits for doctors who go against that advice. According to I. Glenn Cohen, a Harvard Law School professor, “The fact that the FDA released this warning makes it more likely that a doctor who went against it will be held to have practiced in a way below the standard of care. Second, this increases the chance that a patient may succeed in suing for a failure to get informed consent.”
Several women have filed lawsuits alleging that they have been diagnosed with uterine sarcoma following morcellation procedures. These individuals and their families want to know why they were not made aware of the risks and whether the manufacturers may have failed to make the devices as safe as they could have been. Why, if there were concerns of a “fatal flaw” as early as the 1990s, are patients learning about it now, more than twenty years later, and what else could have been done?
If you or a loved one underwent power morcellation laparoscopy and have been diagnosed with a new cancer, you may be entitled to compensation for your damages. For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).