Frequently utilized to remove fibroids or other noncancerous growths during a hysterectomy or a myomectomy, morcellators are no longer uniformly recognized as safe and effective medical devices to perform these procedures. Recently, the pharmaceutical company Johnson & Johnson recalled three of its power morcellators—the Morcellex Sigma, the Gynecare Morcellex, and the Gynecare X-Tract—following study results that demonstrated a significant correlation between the use of the devices and cancer growth. As such, the morcellator lawsuit attorneys at Williams Kherkher are now investigating claims regarding the use of morcellators and cancer growth. If you suffered from cancer growth after a surgical procedure involving a morcellator, we believe that the responsible medical device manufacturer needs to be held accountable for their dangerous products. Our team has experience going up against some of the largest medical device manufacturers in the country, and we know what it takes to see that justice is served and that our clients’ interests and well-being are protected.
Correlation Between Morcellator Use and Cancer Growth
Morcellators are particularly well-suited to remove certain noncancerous growths during a laparoscopic surgical procedure, as these devices can help break down non-cancerous tumors and tissues into smaller pieces. However, if a patient does have cancerous tumors or growths, it can spread this cancerous tissue. As such, the unintended consequences associated with the use of morcellators can be devastating and may include:
- Cancer growth, particularly
- Metastatic leiomyosarcoma
- Uterine cancer
- Uterine sarcoma
- Endometrial stromal sarcoma
- The abnormal growth of tissue
- Direct harm to healthy tissue
In July of 2014, an article published in the Journal of the American Medical Association (JAMA) stated that the rate of undetected uterine cancer among women who underwent a hysterectomy involving a power morcellator could be as high as 27 out of every 10,000 procedures, or 1 in 370. These statistics soberly illustrate the very real dangers that women who have undergone procedures involving power morcellators were regularly and unknowingly exposed to.
Morcellators and the FDA
In April of 2014, the United States Food and Drug Administration (FDA) warned doctors not to use the power morcellators that have since been recalled by Johnson & Johnson. This warning came in advance of a June 2014 meeting in which an advisory panel to the FDA met and discussed safety issued related to the use of power morcellators, as well as possible changes to the regulatory status applied to these devices. Shortly after this meeting, another advisory panel met to discuss possible ways that the dangers posed by power morcellators could be avoided.
Then, on November 24, 2014, the FDA issued a Safety Communication, in which they attached a “Black Box” warning to power morcellators because of the extreme risks they pose to users. This warning stated that the risks posed by morcellators outweigh any potential benefits that, in almost all circumstances, the use of these devices should not be used. The warning referenced that as many as 1 in every 350 women who undergo a procedure involving a power morcellator could have undetected uterine cancer, and that the use of these devices puts too many women at needless risk.
While the FDA has not yet officially banned power morcellators, it is possible that a ban may be issued in the near future over concerns regarding their dangerous side effects. Sadly, this ban may come too late for some who have already suffered devastating side effects due to morcellator use in surgical procedures.
Consult With a Morcellator Lawsuit Attorney
At Williams Kherkher, our morcellator lawsuit attorneys want to help patients who experienced cancer growth following a surgical procedure involving the use of a morcellator. If your cancer has spread, and you believe that this is due to morcellator use, we want to put our years of experience handling cases just like these to work for you. You should not be forced to deal with the financial burdens of a health situation caused by a dangerous medical device, so call us today at (888) 220-0640 and learn more about what our team is prepared to do for you.
Recent Morcellator Blog Posts
Saturday, October 15th, 2016 at 4:03 pm
Power morcellators have been the subject of many discussions, both medical and scientific, for several years. However, many people are unsure what exactly morcellators are, how they work, and why they could be dangerous.
Q: What is the basic use of a power morcellator?
A: Power morcellators are small enough to be held and are comprised of a long, hollow cylinder and sharp edges. These sharp jaws are used to remove uterine fibroids and the cylinder suctions out the tissue.
Q: What exactly are Uterine Fibroids?
A: Uterine fibroids are an often noncancerous growth on the muscle tissue of a uterus, sometimes known to host undetected cancerous cells.
Q: What are the two types of fibroid removal?
A: Someone receiving a myomectomy will have the fibroids removed one at a time, while someone receiving a hysterectomy is having all or part of their uterus removed.
Q: What is the potential danger associated with Morcellators nowadays?
A: If the person having fibroid removal via morcellator has undetected cancer, the morcellator will spread the cancer cells around the abdomen, promoting the growth of further cancerous cells.
In surgeries to remove fibroids before the invention of morcellators, doctors would’ve had to make an incision that ranged from three to seven inches and required longer recovery time. In these cases, the fibroids or uterus were removed intact and the spread of cancer was significantly lowered because the fibroids weren’t opened.
Despite the fact that morcellators have been in recall for the past two years, many people still use them. If you’ve experienced new or aggravated forms of uterine cancer following a myomectomy or hysterectomy with a morcellator, you may have a legal option in receiving compensation. Contact an attorney with Williams Kherkher at (888) 220-0640 for more information.
Wednesday, September 28th, 2016 at 2:52 pm
Although proponents for morcellators argue that they are overall beneficial to the medical community, several reports of women developing uterine cancers cannot be ignored.
The Food and Drug Administration (FDA) has issued no involuntary recalls on the item but they have released reports and warnings in relation to the suspected harmful effects of morcellator use. Though Johnson & Johnson subsidiary Ethicon issued a recall of the item, it was voluntary and some of their morcellators have a high possibility of still being in use.
Multiple lawsuits have been brought up against the pharmaceutical giant in regards to their morcellators:
- In Pennsylvania on March 2014, a man filed his suit in memory of his 53-year-old wife, who had died a mere year after her hysterectomy done with a power morcellator. She had developed uterine cancer.
- In New York, a woman diagnosed with occult uterine leiomyosarcoma, which dramatically shortened her projected lifespan, filed a suit claiming she had developed cancer following a hysterectomy in which a power morcellator was used.
- In Florida, another hysterectomy patient experienced the spread of endometrial stromal sarcoma, which she had previously been unaware of.
The claims all include accusations that the companies failed to create safe devices and knew of these shortcomings and released them to the public with little warning anyway.
If your cancer has spread due to morcellator use, learn more about how you can alleviate financial burdens through legal means. Speak with morcellator attorneys of Williams Kherkher, by calling (888) 220-0640.
Thursday, September 1st, 2016 at 11:13 am
There is a significant decrease in the use of power morcellators after the U.S. Food and Drug Administration (FDA) issued warning that the tissue chopped by morcellators could contain cancerous cells and may spread throughout the abdominal cavity.
Since the FDA released its new guidelines, the rate of new minimally invasive hysterectomies using power morcellators has been declining. In 2013, 14 percent of minimally invasive hysterectomies were performed using morcellators. The number dropped to just three percent in 2015.
Despite the advisory, some doctors still support the use of morcellators. Women need to be aware of the risks that morcellation carries.
If you have undergone a medical procedure involving a power morcellator and have developed cancer in the process, speak with the Morcellator lawsuit lawyers at Williams Kherkher by calling (800) 220-9341 and learn how to assert your rights and to hold negligent parties responsible.