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
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.
Sunday, December 4th, 2016 at 12:24 pm
The US Food and Drug Administration pushes hospitals to streamline their process of reporting problems related to medical devices.
After receiving reports about the potential risk of using hysterectomy surgery devices, the FDA is said to be enhancing the agency’s current reporting system by determining how a medical device causes deaths or injuries. They are also looking at the possibility of forcing all hospitals to submit death and injury reports related to the issue.
The FDA is currently targeting laparoscopic morcellators following the death of a 51-year-old woman who died from uterine cancer. According to reports, the Brigham and Women’s Hospital did not report a case in which a power morcellator reportedly triggered the proliferation of cancer cells in the patient’s body. Meanwhile, the U.S. Government Accountability Office is currently conducting an investigation and will be releasing a report in January.
If you or someone you know has developed cancer after undergoing a surgery involving a power morcellator, get in touch with a lawyer from Williams Kherkher at (888) 220-0640.
Tuesday, November 15th, 2016 at 4:54 pm
Though the list of side effects in regards to the use of power morcellators tends to grow more and more frightening the longer you look at it, many people claim that the chances of such effects are incredibly low and the question about whether people should use morcellation during surgery lingers.
In the case of Amy Reed, a doctor and opponent to the use of the instrument, had personally undergone uterine fibroid removal three years ago. After her surgery, a rare cancer appeared in her uterine wall and she has since undergone four separate surgeries to remove the subsequent tumors.
Furthermore, the FDA has released a public warning against the use of power morcellators, claiming that they spread the same rare cancer that Reed has faced. The use of the tool has decreased from 13.5% of surgeries calling for them to 2.8%. The number of complications in hysterectomy surgeries has since remained about the same, but the spread of cancer has decreased.
Johnson & Johnson, the largest distributor of the tool, did issue a recall fo their devices, but since it was voluntary, the residual effects have not totally bumped the tool from use. There are several active lawsuits that directly address the morcellator misuse, proving that most people understand that the danger is real.
If you developed previously undetected cancer in the uterine wall following morcellator use, or some other side effect in direct conjunction with the tool, contact one of our attorneys of Williams Kherkher today. Call us at (888) 220-0640 to learn more information.