SILVER SPRING, Md. — The FDA issued its strongest warning for the power morcellator surgical device and acknowledged that the dangerous medical device spreads cancer in women. “We believe that in the vast majority of women, the procedure should not be performed,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
Warning Issued by the FDA
On November 24, the FDA issued a warning against the use of morcellators in most women. According to the agency’s official release, because of the availability of safer alternative options, it is warning against the use of power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of fibroids. The release goes on to detail there is a strong warning on the risk of spreading unsuspecting cancer. The FDA has also requested that manufacturers of the device add a new black box warning to the surgical tool’s label. The black box warning is the FDA’s strongest safety alert. The alert is to include information on the risk of previously undetected cancer within the uterine tissue.
Furthermore, the new black box warning also cautioned against the use of the power morcellator in women who are entering or have been through menopause, and who are candidates for uterus removal either through the vagina or via minilaparotomy. This, combined with the above warnings, would apply to most of the women who would require a hysterectomy or fibroid removal – the two most common circumstances in which power morcellators are used in surgery.
What are Power Morcellators?
A morcellator is a minimally invasive surgical tool used to treat benign growths in the uterus, known as fibroids. It shreds the tissues within the uterus so they may be removed through a small incision in the abdomen. However, there are frequently dormant or hidden cancer cells, uterine sarcoma, that are near the uterine fibroids or are frequently mistaken for fibroids. Typically this type of sarcoma cannot be detected prior to surgery. When the tissue is shredded by the morcellator, there is a significant risk of the sarcomas being spread. The cancerous cells then worsen the condition, and even cause death. Fibroid removal surgery is a common practice for many women; in fact, 1 in 350 women who have undergone fibroid surgery have been found to have an undetected sarcoma.
While the FDA did not outright ban the use of the tool – it wanted to leave open its use in a very small window of women (typically younger) who may need only a fibroid removal, and not the whole uterus – the agency’s warning and new label requirements acts as a very strong message to the health care and device industry and will significantly limit the use of the morcellator.
By having the new black box label include two “contraindications” (situations in which the power morcellator cannot be used), the agency is very clear in what situations the device can absolutely not be used. Black box labels are rarely issued by the agency and are typically reserved for drugs for serious psychiatric or physical effects, e.g.: Chantix for its psychiatric side effects and Yaz for causing blood clots.
The power morcellator’s largest manufacturer, Johnson & Johnson, has already recalled its power morcellators, but other brands still exist on the market and are still used by hospitals and medical professionals.
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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