FDA Warning on Morcellators

The Food and Drug Administration issued a safety communication April 14, 2014 discouraging the use of morcellators in laparoscopy-assisted hysterectomy (LASH). Power morcellators were used for women undergoing hysterectomies to cut the uterus into tiny pieces, which can then be removed through a small incision rather than through more invasive surgery. Power morcellators were also used to cut up and remove uterine fibroids through a procedure called a myomectomy. Unfortunately, the use of this medical device can cause an unreasonable risk of spreading cancerous cells throughout a patient’s abdomen and pelvic region.

Women who had a gynecological procedure involving the use of a morcellator may be able to take legal action against the manufacturer to obtain compensation for injury. Johnson & Johnson’s Ethicon Division is one manufacturer of morcellators; Wolf Corporation also makes morcellators. These and other manufacturers could be held legally responsible for medical costs, lost income, pain and suffering, emotional distress or wrongful death. An experienced defective medical device lawyer at Jeffrey Glassman Injury Lawyers can provide assistance to patients adversely affected by morcellator use.

The Food and Drug Administration has determined that approximately 1 in 350 women undergoing either a hysterectomy or myomectomy has a type of uterine cancer called uterine sarcoma. This type of cancer cannot be diagnosed prior to removal of the tissue. When the morcellator cuts up the tissue, the procedure can spread the cancerous tissue within the abdomen and pelvis. The spread of the cancer cells can significantly worsen a patient’s long-term likelihood of survival.

The deputy director for science and the chief scientist at the FDA’s Center for Devices and Health stated: “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

Unfortunately, many patients did not have the opportunity to discuss these risks because the women were not adequately warned of the dangers of morcellator use prior to the FDA’s communication. Manufacturers failed to provide appropriate warnings to patients about the potential spread of cancer that these products can cause. Ethicon has now temporarily removed its morcellators from the market until it can be determined if there is a safe way to use the devices for fibroid or uterine removal. But some women have already had their cancer spread because of the devices.

The FDA has also announced that a public meeting of the Obstetrics and Gynecological Medical Devices Panel will be held to discuss the risks of laparoscopic power morcellation. Until more information is available, the agency’s recommendation is to avoid the use of morcellation when uterine cancer is suspected and to discuss the risks of treatment with all patients. The use of power morcellation is also discouraged in all procedures and the dangers should be considered since there are other treatment options that do not involve the risk of spreading cancer.

Patients who have already had procedures using a morcellator have begun filing lawsuits to obtain monetary damages. The FDA information and medical evidence linking morcellators with cancer metastases can be used by patients to show that they were harmed as a result of morcellator use.

The Jeffrey Glassman Injury Lawyers can help women and their families if they suspect that their cancer spread as a result of power morcellation. Contact us today to speak with a member of our legal team to learn more about taking legal action to recover compensation.