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
Tuesday, April 12th, 2016 at 10:31 pm
A power morcellator is an electric device used for surgery, such as laparoscopic hysterectomy or a myomectomy, and its function is to break down large pieces of tissue into smaller fragments. The cut-up tissue is then removed from the body through a small incision. The device resembles a tube with blades used to shred targeted tissue.
Unfortunately, there are some extremely serious side effects that an individual may experience after a procedure done with a morcellator:
- Obstruction of bowel
- Significant bruising in the area
- Reoccurrence of fibroids (or the spread of fibroids to different body parts)
- Damage to the organs
- Excruciating pain on the site of the incision
- Pain on the abdomen and the pelvis
- Soreness of the muscle
A warning by the FDA shocked medical communities after they stated that power morcellators have a tendency to break apart and spread undetected cancer in women. 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, January 15th, 2016 at 11:46 am
Uterine fibroids are non-cancerous, smooth muscle tumors that form on the wall of the uterus, and they usually develop after puberty, typically after age 30. While they are usually benign, there are risks of metastasis when a power morcellator is used in surgery to remove these fibroids.
The Center for Innovative Gyn Care listed the following facts regarding uterine fibroids:
- The development of uterine fibroids in women is common, and approximately 80% of the female population has fibroids.
- Uterine fibroids, also called leiomyomas, are not relative to the risk of uterine cancer.
- The growth of uterine fibroids is generally unpredictable. It may be fast or slow or stay the same. They may grow significantly or shrink.
- About 1 in 1000 women has the risk of leiomyosarcoma, a rare form of cancer.
While uterine fibroids are not dangerous, power morcellation (the breaking down of large tissue into small fragments) may spread these cells throughout the body and put the patient at risk of leiomyosarcoma.
Tuesday, January 12th, 2016 at 11:10 am
Non-cancerous, smooth muscle tumors that develop on the walls of the uterus are called uterine fibroids. Generally, uterine fibroids are harmless and are not associated with the risk of uterine cancer; however, there are cases where the use of a power morcellator in surgery spreads the fibroids throughout the body and creates the risk that these cells will metastasize into a rare cancer called leiomyosarcoma.
Here are the symptoms of uterine fibroids, according to Mayo Clinic:
- Long menstrual periods (seven days or more)
- Heavy menstruation
- Pain and pressure on the pelvis
- Frequent urination
- Difficulty with urination or emptying the bladder
- Painful sensation in the back and legs
If you are experiencing these symptoms, you may want to speak to your doctor about whether or not you have uterine fibroids. The sooner you take action, the better your chance of treating the condition before additional complications occur.
If you have been diagnosed with leiomyosarcoma and you think it was caused by the controversial medical device known as a power morcellator, speak with our lawyers at Williams Kherkher today by calling our office at 800-220-9341.