Many women who undergo hysterectomy surgery elect to have the surgery performed laparoscopically (through a small abdominal incision), rather than though a larger incision in the abdomen. During a laparoscopic hysterectomy, before the uterus is taken out, it must first be cut into tiny pieces so that it can then be removed through a small tube. The devices that are used to dissect the tissue into small pieces are called power morcellators. These devices are also used when a woman undergoes laparoscopic surgery to remove uterine fibroids (this surgery is called a "myomectomy").
The problem with the use of power morcellators is that very small pieces of tissue can be left behind. As a result, if the patient has an undetected uterine cancer, the use of the power morcellator ends up spreading the cancerous cells throughout the body. Many uterine cancers cannot be detected unless and until a biopsy is performed. Thus, there is no reliable way to determine prior to surgery if a uterine fibroid is cancerous.
FDA Warning about Power Morcellators
According to the FDA, approximately 1 out of every 350 women who undergo hysterectomy or myomectomy has an unsuspected cancer (called a sarcoma). As early as 2011, medical studies began to document that women who had undergone hysterectomy or myomectomy with the use of a power morcellator had higher rates of cancer than woman who had undergone surgery without the use of the power morcellator. In April of 2014, the FDA published a safety communication which outlined some of the dangers associated with the use of power morcellators:
When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the DFA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
Immediately after the FDA issued this statement in April of 2014, Johnson & Johnson, one of the leading companies who manufactures power morcellation devices, suspended its sales of the devices. A few months later, in July of 2014, Johnson and Johnson voluntarily withdrew its devices from the market.
In November of 2014, the FDA released a second statement, which was even stronger than the first. This document states:
The FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of fibroids. Limiting the patients for whom laparoscopic morcellators are indicated, the strong warning on the risk of spreading unsuspected cancer, and the recommendation that doctors share this information directly with their patients, are part of the FDA guidance to manufacturers of morcellators. The guidance strongly urges these manufacturers to include this new information in their product labels.
Hospitals Ban the Use of Morcellation Devices
On November 26, 2014, just days after the FDA issued its statement, HCA Holdings, Inc., a large hospital network that includes 160 hospitals in 20 states, announced that it was prohibiting the use of power morcellation devices in laparoscopic uterine surgery.
Attorneys for Your Power Morcellator Lawsuit
Many lawsuits have already been filed against the manufacturers of power morcellation devices. These lawsuits allege that the manufacturers failed to warn that the use of their products could result in the spread of undiagnosed cancer throughout the body. If you or someone you know has been diagnosed with cancer after having undergone surgery with the use of a power morcellator, please contact The Mahoney Law Firm, P.C. for a free consultation to see if you have a claim. You will talk with an attorney, not a call center. We provide you a personal, confidential consultation.
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