Senators Encourage FDA to Ban Use of Power Morcellator Devices and Morcellation Procedures Due to Cancer Risk
Although the Food and Drug Administration has already expressed concern about morcellation procedures to remove uterine fibroids and perform hysterectomies, due to the possibility of spreading uterine and ovarian cancer, the regulatory agency said it would not outright ban the devices.
Now, two US Senators – Senator Elizabeth Warren (D-Mass) and Senator Kirsten Gillibrand (D-NY) – have written to FDA Commissioner Margaret Hamburg to ask why the agency has not considered a device recall and ban on morcellation procedures and power morcellator devices because of the risk of cancer spread and death.
“While we appreciate that the agency has taken several steps to further evaluate these devices this year, we remain concerned that women around the country are not receiving clear information about the potential risks associated with morcellating undetected malignancies during laparoscopic procedures,” their memo said.
At least three of Sen. Warren’s female constituents in Massachusetts have died because a morcellation procedure spread undetected cancer through their reproductive system. One of those women – Brenda Leuzzi, 44 – died in October of this year after she and her husband filed a personal injury lawsuit against Johnson & Johnson and their subsidiary Ethicon for spreading her undiagnosed uterine cancer.
“I really want to see this banned more than anything,” George Leuzzi said in an interview on Monday, November 17th.
Morcellation procedures are supposed to be simple, non-invasive procedure in which the laparoscopic device is used to find fibroid tissue in the uterus, and grind fibroids down to be removed through a small incision in the abdomen. Uterine fibroids can cause pain and annoyance with menstruation, so many women choose to undergo the surgery to reduce those complications. However, grinding down fibroids, which are assumed to be non-cancerous, can actually cause the spread of cancer when a tumor is ground down.
According to FDA estimates, as many as 1 in 350 women have undetected uterine cancer that can look like fibroids, and the cancerous tissue can be ruptured with morcellation surgery. The previous rate was estimated at 1 in every 7,000 women.
“In light of the attention the FDA has given this procedure and the morcellator devices, several medical societies published position papers on the topic advising varying degrees of caution about the procedure and device. We are concerned the lack of consensus among stakeholders is preventing women from getting complete information necessary to making an informed decision about their individual health care needs,” the senators’ memo continued.
“I think we’re going to lose this one, at least for now,” Leuzzi said about his morcellation lawsuit.
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