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
Monday, January 9th, 2017 at 5:27 pm
In 2014, the US Food and Drug Administration (FDA) issued a warning about the potential risks of using laparoscopic power morcellators in hysterectomies or myomectomies. Since the announcement, there was a decrease in the utilization of minimally invasive hysterectomies, based on a retrospective cohort study conducted by the faculty from the University of Michigan Department of Obstetrics and Gynecology.
In the review, the utilization of power morcellators has significantly decreased, but cases in which a practitioner still opts to use major surgical non-transfusion, complications have increased by 27 percent and occurrences of 30-day hospital re-admissions have increased by 25 percent. Although the cause of the shift in practice patterns has yet to be determined, the study suggests that it has something to do with the FDA announcement discouraging the use of the medical device.
If you or someone you know has developed an undetected cancer following a hysterectomy or myomectomy involving a power morcellator, you may be entitled to a financial compensation. Our lawyers at Williams Kherkher have worked closely with these lawsuits and can properly represent you in court. Get in touch with us at (888) 220-0640 to learn more about your legal options.
Thursday, January 5th, 2017 at 12:49 pm
At least fifteen hospitals across the United States failed to comply with the medical device reporting requirements, according to the FDA.
The FDA issued a Form FDA 483 to some prominent hospitals, including Massachusetts General Hospital and New York Presbyterian Hospital, for not promptly reporting deaths and injuries related to medical devices pursuant to 21 CFR Part 803. Under the federal regulation, user facilities, such as hospitals and health centers, have only ten days to submit reports about deaths of patients and serious injuries linked to medical devices to its manufacturer and the FDA. The rule also states that a user facility should maintain a medical device event filing system, which can be inspected by FDA. Out of 17 hospitals, 15 medical centers reportedly demonstrated failures to comply with the federal rule following FDA nationwide inspections. The inspection was initiated last December 2015.
If you or your loved one has been physically injured due to an accident involving a power morcellator, you may be entitled to a monetary claim. Our lawyers at Williams Kherkher have the experience and skills to properly represent you in court. Get in touch with us at (888) 220-0640.
Wednesday, January 4th, 2017 at 4:36 pm
A power morcellator is an electronic surgical device that has been used by doctors to minimize how invasive several abdominal procedures can be. However, in 2014, the usage of the device was put under criticism following the announcement of the US Food and Drug Administration (FDA) against the device, citing evidence that morcellators could spread cancer cells throughout a patient’s body. Here are some things you need to know about the device:
- Morcellators had been introduced to the public 20 years ago – The US Government Accountability Office (GOA) is investigating the case to determine why FDA cleared morcellators for use despite its potential risks.
- Risks of using morcellators are often overlooked – A recent study in South Korea shows that morcellating tumors is more dangerous than removing them with more invasive measures, as this is more likely to spread cancer.
- Warning led to changes in surgeries – After the morcellator issue had been spilled into the public sphere, US gynecologists changed the way they perform hysterectomies, preferring other options with fewer complications.
If you have developed cancer following a procedure involving a power morcellator, we might be able to help you. Contact our lawyers from Williams Kherkher at (888) 220-0640.