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Power morcellators are medical devices that are frequently used during laparoscopic, minimally invasive surgeries. The device cuts tissue into smaller pieces, allowing a surgeon to easily remove it through a small incision site. These devices are frequently used in surgeries that remove the gallbladder, kidney, liver, uterus, uterine non-fibroids, and the spleen.
Traditionally, laparoscopic surgery is associated with a shorter post-operative recovery time and reduced risk of infection compared to a surgery done through an abdominal incision. Although a faster recovery time and the reduced risk of infection sounds appealing, it is not necessarily the safest option. This is especially true when a power morcellator is involved in uterine fibroid surgery, a hysterectomy, and laparoscopy myomectomy. The reason why a power morcellator is harmful in these surgeries is because it can liquefy cancer cells, making it easier for them to invade healthy cells.
Uterine sarcoma, a type of cancer in the uterus, is more common in women undergoing surgeries from uterine fibroids than previously suspected. In fact, the United States Food and Drug Administration (FDA) found that approximately 1 in 350 women who had hysterectomies and myomectomies had undetected uterine sarcomas. Doctors may find it challenging to distinguish between a uterine sarcoma and a uterine fibroid prior to surgery with available tests. Post-surgery, there is full analysis of the presumed fibroid. In some cases, it is actually uterine sarcoma, which means the risk of spreading cancerous cells beyond the uterus is damage that cannot be undone.
The FDA’s studies show that using laparoscopic power morcellators during gynecological surgeries in women with hidden uterine sarcomas is associated with lowering their chances of long-term survival. Growths that are thought to be benign leiomyomas may turn out to be the more serious and malignant. Leiomyosarcoma is the malignant growth of smooth muscle connective tissue. The power morcellator causes the cancer cells to liquefy, making the cells easier to spread to healthy cells. This liquifying process applies to all uterine growths when power morcellators are involved.
It is important to note that doctors are obligated to tell the patient the risks associated with any treatment. The FDA continues to recommend limiting the use of laparoscopic power morcellation to selected women undergoing myomectomy or hysterectomy. When morcellation is appropriate, doctors recommend that only contained morcellation should be performed.
In the case where a power morcellator was used to remove uterine tissue, the doctor should have told the patient that there was a risk of occult cancer. The doctor should have also discussed available options with the patient, including the risks and benefits associated with all medical devices and procedures in each option. If a patient suspects that a power morcellator caused their cancer to spread, the following questions should be asked:
The following can increase the risks of uterine cancer:
It is critical that patients are aware that uncontained power morcellation is associated with the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis.
Additionally, the risk of occult cancer and uterine sarcoma increases with age. After 50 years old or post-menopause, the use of laparoscopic power morcellators to remove suspected fibroids is avoided. Furthermore, it is recommended that a candidate who needs a mini-laparotomy incision should not have a power morcellator involved in their procedure.
If the patient had a myomectomy or hysterectomy for fibroids, they should know that the tissue removed during the procedure is usually tested for the presence of cancer. If the patient was informed that these tests were normal, they should continue a follow-up with their health care provider. Any other questions or concerning symptoms that cause the patient to believe their cancer has spread should be consulted with their health care provider.
Hospitals are required to report some adverse events related to medical devices. Hospitals should also report the spread of unsuspected cancer when using laparoscopic power morcellation for hysterectomies or myomectomies in women with symptomatic uterine fibroids. Federal regulations require user facilities to report suspected medical device-related deaths to both the FDA and the manufacturers. User facilities must also report serious injuries to the manufacturers or to the FDA. If the medical provider fails to do so, the victim should contact a lawyer to discuss their legal options.
In April 2014, the FDA issued a safety communication discouraging the use of power morcellators during hysterectomy and myomectomy procedures due to the possible spread of cancers. The FDA also recommended that doctors discuss risks with patients prior to morcellator surgeries, even with the use of specimen bags designed to contain uterine tissues from spreading to other parts of the body.
Various companies have been specifically named in lawsuits for injuries and deaths caused by the spread and development of uterine cancers after power morcellator use.
If a patient continues to suspect or experience a problem after a laparoscopic power morcellation, the FDA encourages them to report the problem. It is challenging to come to terms that a medical procedure that was meant to help actually caused more harm, however, it is imperative to take action. By being proactive, a victim can recover the damages they lost during the surgery while also preventing this damage from happening to other women.
Quickly reporting adverse effects helps the FDA identify and better understand the risks associated with medical devices. If a patient suspects that a power morcellator malfunctioned or contributed to their cancer spreading, they are encouraged to file a report to the FDA.
Once a report is filed, the final step is deciding whether to bring a power morcellation lawsuit against the manufacturer. A victim who chooses to pursue legal action over a defective medical product should contact a lawyer right away. A lawyer will hold the manufacturer accountable and help a victim recover financial and emotional damages resulting from the device.
If you have a power morcellation injury, including the spread of cancer, you deserve full compensation for your injury-related losses. Our Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler are dedicated to helping you get full compensation. For more information and a free consultation, complete our online form or call us at 215-569-4000. Located in Philadelphia, we serve clients throughout Pennsylvania and New Jersey, including Delaware County, Chester County, and Montgomery County.