On Monday, the FDA announced that it is requiring a boxed warning for laparoscopic power morcellators to address the risk of the spread of cancer. Now HCA Holdings Inc, the largest for-profit U.S. hospital operator, has announced these morcellators will no longer be used at their facilities for uterine fibroid removal or hysterectomies.
Healthcare providers are taking the new FDA guidelines seriously and prohibiting the use of power morcellation in laparoscopic uterine surgery. Unfortunately, this doesn’t come soon enough for some women. The manufacturers need to be held accountable for not taking steps to protect the safety and well-being of women against the spread of unsuspected cancer.
Cancer Risk
Laparoscopic power morcellators grind up fibroids and then extract the tissue through a small tube. During this process, some of the tissue can be sprayed throughout the abdominal and pelvic areas. If a woman has undetected cancer in a uterine fibriod, cancerous tissue can be spread outside the uterus.
Our law firm has been contacted by patients and their families about this issue.
The FDA addressed this risk by requiring a boxed warning and 2 contraindications, which recommend that these morcellators not be used to remove uterine fibroids if the woman is peri- or post-menopausal, or whose fibroids can be removed intact through the vagina or a small incision.
A HCA Holdings email reads “We are implementing a prohibition of the use of power morcellation in laparoscopic uterine surgery,” according to Reuters. The company operates 165 hospitals and 113 surgical centers.
Johnson & Johnson Suspends Sale of Laparoscopic Power Morcellators
In April, Johnson & Johnson’s Ethicon unit, one maker of the morcellators, suspended sales and distribution of the devices and asked doctors to stop using them pending the FDA review of the issue. In July, J&J formally withdrew morcellators from the market, but fell short of issuing a formal recall. However, the company is contacting hospitals and other customers to ask them to return the devices.