Johnson & Johnson has called for doctors worldwide to stop using laparoscopic power morcellators and return the devices due to the risk of spreading undiagnosed uterine sarcomas and other tissue throughout a patient’s body. “It looks like the sarcoma risk is much higher than we originally thought,” Ethicon consultant Steven McCarus told The Wall Street Journal.
“Because of this uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk,” the company wrote in a letter. According to the company, the market withdrawal is not a recall because the morcellators function as designed.
If you or a loved one has been diagnosed with a uterine sarcoma after a surgery involving a power morcellator, or had fibroids or uterine tissue removed from other organs after such a surgery, you should consult an attorney to assess your legal options.
Power Morcellators are surgical devices used during laparoscopic or robotic surgeries to cut or sever large masses of tissue so that they can be more easily removed from the internal surgical site. Serious risks associated with the devices have led the FDA to discourage the use of power morcellators during hysterectomy and myomectomy and discuss the possibility of an outright ban. As a response, Ethicon, a division of Johnson & Johnson and a major power morcellator manufacturer, suspended worldwide sales pending further study. Importantly, this suspension does not constitute a recall.
Minimally invasive (laparoscopic) surgery is growing in popularity across general medicine and many clinical areas of speciality including pulmonology, cardiology, and gynecology. To create both more space to maneuver and clear visuals within the incision site, a surgeon will often use a gas or fluid along with monitoring instruments such as an ultrasound, microscope, or endoscope. While minimally invasive techniques may potentially lead to shorter recovery times and minimize patient trauma over traditional open surgery, many surgical techniques are difficult to accomplish through the small incision sites used in these procedures.
For instance, in some laparoscopic procedures that require tissue removal, the excised tissue may be too large to pull through the opening of a thin tube, or cannula, and must be cut into smaller pieces to do so more easily. Power morcellators are designed to perform this function electromechanically, making it possible to remove large tissue masses through small incisions.
Within gynecology, methods of vaginal morcellation, specifically removing a large uterus through the vaginal opening, have been routinely implemented for more than half a century, but a focused effort was placed on the idea of removing large tissue through small incisions rather than through the vagina after the first laparoscopic hysterectomy in 1989 and a subsequent laparoscopic subtotal hysterectomy in 1991. Minimally invasive gynecologic surgery grew as a result and led to the invention of power morcellators in 1993.
Traditionally, morcellation is performed manually with a laparoscopic scalpel, and there are several different variations and alternatives. Power morcellation, however, is a relatively modern, electromechanical method and is currently under critical examination.
This procedure involves the use of powered surgical devices, or power morcellators, that pull large masses of tissue into a spinning blade, which then cuts the tissue at a high velocity into smaller pieces to be more easily removed through laparoscopic incision sites. The first electromechanical design was invented in the early 1990s and included a sheathed cutting device and a grasper that cored pieces of tissue into cylinders. All power morcellators today are modeled after this and permit more continuous tissue removal.
Generally, the cutting device is attached to the end of a rotating tube system. The surgeon inserts a grasper through this rotating tube to pull the tissue that needs to be lacerated up against the sharp, rotating edge of the tube, severing the grabbed portion from the rest of the large mass. The design allows the surgeon to continuously pull cut portions of tissue up through the tube while repeating the process, thus removing large masses of tissue in small pieces relatively quickly. These small pieces of tissue, or “morcels,” are generated by the power morcellator to fit more easily through minor incisions.
Power morcellators have become common in minimally invasive procedures spanning across various specialties, including uterine, fibroid, liver, kidney, and spleen removal surgeries.
Power morcellators were first used for uterine extraction and have since become heavily implemented during laparoscopic gynecological procedures, particularly in minimally invasive myomectomies and robotic, supracervical hysterectomies. While an exact estimate of power morcellator use has yet to be determined, in the United States, roughly 20,000 laparoscopic hysterectomies are performed every year for various reasons, including the complete elimination of fibroids.
The number of laparoscopic, robotic myomectomies to remove fibroids for various reasons, including the treatment of infertility, is also on the rise, though studies indicate that there is a greater chance of fibroid recurrence following a laparoscopic myomectomy than with other procedures.
According to the U.S. Department of Health and Human Services, the majority of American women will develop leiomyomata, or fibroids, at some point in their lifetime, many of which may cause infertility, or negatively affect a woman’s chances of becoming pregnant. Specifically, submucosal fibroids, located near the uterine cavity, hinder implantation, decrease pregnancy rates, and increase instances of spontaneous abortion. Generally, it’s suggested that removal of these fibroids mitigates these issues. Laparoscopic myomectomy is now being used to treat fertility-threatening fibroids, but a review of the medical literature shows that fibroids return more often when laparoscopic myomectomy is used instead of a laparotomy. Thus, its role as an appropriate fertility treatment is a controversial issue.
When a power morcellator is introduced into a laparoscopic myomectomy, studies suggest there is an increased risk of developing new leiomyomas, including parasitic fibroids, from tissue that was displaced by morcellation, further endangering a woman’s fertility and reproductive health.
Power morcellation can allow surgeons to perform minimally invasive surgery of large tissue that otherwise could not be pulled through small incisions. However, power morcellation is currently under critical review by the FDA as they consider banning the device due to the potentially life-threatening risks associated with their use, especially during laparoscopic gynecological procedures.
One of the most alarming risks associated with power morcellators is the potential for the device to spread and upstage undetected malignant uterine tissue during a laparoscopic hysterectomy or myomectomy, significantly worsening a patient’s prognosis. While this risk is difficult to calculate, the FDA has concluded that there is no reliable method for preoperatively predicting whether a woman with fibroids may have a uterine sarcoma. Based on a Quantitative Assessment of power morcellation released in April, the FDA states that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids has an undetected uterine cancer, such as leiomyosarcoma (LMS), a particularly aggressive uterine sarcoma with an already poor prognosis.
Risk factors for uterine cancer:
Even if benign, the tissue that is disseminated by power morcellation may cause ectopic tissue implantation on abdominal organs, potentially leading to inflammation, obstructions, and abnormal growths that require further surgical procedures. Morcellation can also spread fragments of spleen and kidney when used on these organs, leading to morbidity. Using manual morcellation as an alternative has not been proven to mitigate the risk of spreading tissue, although the spinning blades of a power morcellator may exacerbate this risk.
Subsequently, cases of infection, abscess and persistent pelvic pain have been reported in the medical literature. The device itself has also been reported to cause immediate injuries to the surrounding organs within the abdominal cavity, implying the need for highly-skilled, experienced surgeons and adequate visualization techniques.
In early 2014, the FDA issued a statement discouraging the use of power morcellators in gynecological surgery. Soon after, Ethicon, a Johnson & Johnson company, suspended worldwide sales and production of the devices. The company did not issue a recall, however, and thousands of the devices remain in use in hospitals throughout the United States. Hospitals that have elected to stop using the devices include Boston’s Brigham and Women’s, Massachusetts General, and the Cleveland Clinic.
On July 10th and 11th, 2014, the FDA held a Medical Devices Advisory Committee Meeting with the Obstetrics and Gynecology Devices Panel to address the risks and proposed risk mitigation strategies associated with laparoscopic power morcellation, and to discuss appropriate courses of federal action. The FDA is considering options such as classifying power morcellators as Class III devices, the device category that requires the strictest premarket testing. While no formal consensus was reached, they discussed implementing patient consent forms and changing the label to include a black-box warning, as most labels do not currently include information on the risk of the spread of benign and malignant tissue.
Panelists agreed that a label change alone would be insufficient in protecting patients since patients rarely, if ever, see the packaging of medical devices. As a result, the panel recommended requiring patients to sign a consent form that would detail the risk of power morcellation to spread undetected malignancies. A ban on power morcellators is not out of the question, as was emphasized by the FDA moderator.
Women who have been harmed by power morcellators are beginning to sue Ethicon and other manufacturers over their products. These lawsuits are in their early stages. If you have been diagnosed with a uterine sarcoma after a surgery involving a power morcellator, or had fibroids or uterine tissue removed from other organs after such a surgery, you should consult an attorney to assess your legal options. Fill out the form on this page for a free case review.
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