NASHVILLE — After the FDA announced its strongest black box warning label for the dangerously defective medical device, power morcellators, a major hospital chain has banned the use of it any of its facilities.
HCA Bans Power Morcellators
HCA Holdings, Inc (HCA) is a hospital chain based out of Nashville, Tennessee that operates 280 facilities in both the United States and England. It has 165 hospitals and 113 surgery centers spread across twenty states in the U.S. On the same day the Food and Drug Administration (FDA) announced the power morcellator could spread cancer (a widely known fact) and updated its guidelines, the hospital announced it will stop the use of the device in all of its facilities. An HCA spokesman confirmed via email: “We are implementing a prohibition of the use of power morcellation in laparoscopic uterine surgery. The implementation is under way and applies to all of the hospitals and surgery centers.”
Black Box Warning Issued for Power Morcellators
The FDA announced that a “black box” warning for the laparoscopic power morcellator would be issued immediately. This is the strongest warning the agency can issue on a particular drug or device. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health was quoted in the Wall Street Journal saying, “We believe that in the vast majority of women, the procedure should not be performed.”
What is a Power Morcellator?
The power morcellator is a surgical device used in minimally invasive procedures to remove benign growths known as uterine fibroids from women’s bodies, especially the uterus. It was first approved for use in the early 1990s. The device works by shredding the fibroid into small pieces with a fast-spinning blade so the shreds may then be removed through a small incision in the abdomen. Unfortunately, fibroids are hard to distinguish from Uterine Sarcoma (Metastatic Leiomyosarcoma in particular), a deadly and unpredictable form of cancer that is very hard to detect and often remains dormant for years at a time. When the morcellator is used to then remove what is assumed to be a benign fibroid, there is an extremely high risk that it will instead shred cancerous tissue, thus spreading the malignancy throughout the uterus and others parts of the body. This significantly worsens the cancer and can even cause death.
Thousands of women have undergone morcellation for the removal of benign growths , myomectomy, and hysterectomies. It has been found that 1 in 350 women undergoing such a procedure were found to have an unsuspected or previously undetected type of uterine cancer. The risk of this sarcoma being spread by the morcellator makes it even more dangerous.
The issuance of an FDA black box warning label is not a total ban on the use of morcellator. Temple University Hospital in Philadelphia and Massachusetts General Hospitals were two of the first major facilities to ban use of the devices earlier this year. HCA’s ban of the morcellator is a major step forward in protecting women from the dangerous of this minimally invasive surgical device, but the device is still used in many hospitals and healthcare facilities.
If you or a loved one has received fibroid-related treatment, myomectomy, or a hysterectomy from a hospital that has not banned the use of power morcellators, there is a chance you are in danger of more serious health complications or the risk of cancer being spread.
Our Lawyers Can Help
Our dangerous device attorneys can help if you or someone you care about was harmed by morcellator surgery. Lawsuits have been filed against the device maker by both patients and their families seeking compensation for injuries caused by the dangerous device. You may be entitled to a settlement. We do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it all in writing for you. Our morcellator cancer lawyers will help you file your lawsuit.
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