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 (800) 220-9341 and learn more about what our team is prepared to do for you.
Recent Morcellator Blog Posts
Monday, August 1st, 2016 at 2:37 pm
The PneumoLiner, a tissue container bag to be used in morcellator procedures, has been approved by the U.S. Food and Drug Administration (FDA). The device is comprised of a containment bag and tube-like plunger that delivers the device to the abdominal cavity. Removed tissue will be placed in the bag and sealed to prevent the spread of cancerous cells.
About 1 in 350 estimated women that undergo a hysterectomy or myomectomy due to fibroids may have undetected uterine cancer. The FDA still warns against the dangers of morcellators, but is allowing the use of the PneumoLiner when the uterine tissue is not suspected to be cancerous, only for women without uterine fibroids being treated with a hysterectomy, and for some pre-menopausal women with fibroids who are still hoping to have children.
William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health (CDRH), said in a statement, “We want to be clear that, although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery.”
If you have faced complications from a morcellator treatment and are looking for legal options, contact the attorneys of Williams Kherkher at (800) 220-9341.
Friday, July 15th, 2016 at 5:07 pm
As of March 15, 2016, there are about 31 pending morcellator lawsuits filed by women who had hysterectomies or uterine fibroid removal against J&J’s Ethicon unit before Judge Kathryn H. Vratil in Kansas, according to the Judicial Panel on Multidistrict Litigation.
In 2014, the U.S. Food and Drug Administration released a warning that about 1 in 350 women had an undiagnosed uterine cancer that could be spread by the surgical device. Lawsuits against Johnson & Johnson (J&J) and Ethicon claim the devices are defective and that the company knew about the possibility of spreading cancer but failed to warn the public. J&J claimed that their morcellators have always included cautions in their instruction for use about the potential spread of malignant tissue. J&J is already in talks to settle more of its cases. Individual settlements differ based on the specific injuries and circumstances of the case, but so far, the range of each settlement runs from $100,000 to about $1 million, according to Wall Street Journal.
If you have suffered from the aggressive growth of cancer after undergoing a medical procedure that made use of a power morcellator, please speak with our lawyers at Williams Kherkher. Call us today at (800) 220-9341 to learn more about your rights.
Friday, June 24th, 2016 at 3:43 pm
A morcellator is a device used to trap cancerous tissue during hysterectomies and surgeries to remove fibroids. The devices resemble a drill with sharp blades at the end. Doctors insert the long, tube-like portion into small incisions in the abdomen, perform morcellation of the uterus or fibroid by chopping up the tissue, and vacuum it out of the body.
The use of morcellators has been linked to cancer growth in women. The U.S. Food and Drug Administration allowed an Irish company to market its new power morcellator tissue collection system. The bag promises to trap potentially cancerous tissue and prevent it from spreading in the body, but the new tool is not guaranteed to stop the spread of cancer.
If you have suffered from the aggressive growth of cancer after undergoing a medical procedure involving a power morcellator, please speak with the lawyers at Williams Kherkher. Call us today at (800) 220-9341 to learn more about your rights and to hold negligent parties responsible.